Page last updated: 2024-11-04

amlodipine

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Description

Amlodipine: A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

amlodipine : A fully substituted dialkyl 1,4-dihydropyridine-3,5-dicarboxylate derivative, which is used for the treatment of hypertension, chronic stable angina and confirmed or suspected vasospastic angina. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID2162
CHEMBL ID1491
CHEMBL ID3304444
CHEMBL ID3211346
CHEBI ID2668
SCHEMBL ID26478
MeSH IDM0026284

Synonyms (148)

Synonym
BIDD:GT0810
HMS3394N03
STL356053
AB01274726-02
BRD-A22032524-074-03-2
BRD-A22032524-074-02-4
CHEMBL1491
hgp0904
ckd-330 component amlodipine
hgp-0904
AKOS015843475
istin
uk-4834011
3-ethyl 5-methyl 2-{[(2-aminoethyl)oxy]methyl}-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
norvasc
hsdb 7079
caduet
amlocard
amlodipino [spanish]
amlodis
lipinox
3,5-pyridinedicarboxylic acid, 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester
amlodipinum [latin]
coroval
amlodipine [inn:ban]
amlodipine (usp/inn)
D07450
SPECTRUM5_001550
BSPBIO_002727
amlodipine base
smr000469198
MLS001401409
C06825
amlodipine
88150-42-9
NCGC00165957-01
amlodipine free base
(rs)-3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
DB00381
3-ethyl 5-methylester, (+/-)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
norvasc (tn)
KBIOGR_001643
KBIO3_001947
SPECTRUM4_001132
SPECTRUM3_001004
SPBIO_000351
SPECTRUM2_000486
NCGC00165957-03
NCGC00165957-02
HMS2052N03
HMS2089H07
AC-4535
morphine sulfate pentahydrate usp
FT-0662111
FT-0657130
FT-0662112
amlodipino
3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
3-ethyl-5-methyl (+-)-2-(2-aminoethoxymethyl)-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
amlodipinum
CHEBI:2668 ,
3-o-ethyl 5-o-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
3-ethyl 5-methyl ester 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylic acid
A842481
NCGC00165957-05
NCGC00165957-04
3-ethyl-5-methyl (+-)-2-((2-aminoethoxy)methyl)-4-(2-chlorphenyl)-1,4-dihydro-6-methyl-3,5-pyridindicarboxylat
3-ethyl 5-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
ec 425-820-1
unii-1j444qc288
1j444qc288 ,
3-ethyl-5-methyl (+-)-2-((2-aminoethoxymethyl)-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
BCP9000295
HMS2231K08
CCG-101157
BCPP000403
FT-0602653
S1905
copalia (amlodipine + valsartan)
gtpl6981
o3-ethyl o5-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
HMS3370G17
katerzia® (amlodipine oral suspension, 1 mg/ml)
CHEMBL3304444
amlodipine [inn]
3-ethyl 5-methyl (+/-)-2-((2-aminoethoxy)methyl)-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
amlodipine [ema epar]
amlodipine [vandf]
3,5-pyridinedicarboxylic acid, 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester, (+/-)-
amlodipine [mart.]
amlodipine [who-dd]
amlodipine [mi]
amlodipine [orange book]
CCG-220414
CPD000469198
HY-B0317
AB01209618-01
2-(2-aminoethoxy)methyl-4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl-1,4-dihydropyridine
2-[2-aminoethoxymethyl]-4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl-1,4-dihydropyridine
2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl-1,4-dihydropyridine
2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylic acid 3-ethyl 5-methylester
2-[2-aminoethoxymethyl]-3-ethoxycarbonyl-4-(2-chlorophenyl)-5-methoxycarbonyl-6-methyl-1,4-dihydropyridine
NC00407
SCHEMBL26478
AB01274726-01
NCGC00165957-07
racemic amlodipine
3-ethyl-5-methyl (.+/-.)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
3-ethyl 5-methyl 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
bdbm50088383
CHEMBL3211346
AB01274726_03
AB01274726_05
AB01274726_04
DTXSID7022596 ,
mfcd00864687
3,5-pyridinedicarboxylic acid, 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester
uk-48340
SR-05000001461-5
sr-05000001461
HMS3651I04
SR-05000001461-4
SR-05000001461-3
HMS3713C10
SW220228-1
Q411347
amlodipine (norvasc)
AS-13747
BCP02420
BRD-A22032524-074-04-0
3-o-ethyl 5-o-methyl 4-(2-chlorophenyl)-1-deuterio-2-[2-(dideuterioamino)ethoxymethyl]-6-methyl-4h-pyridine-3,5-dicarboxylate
SY104813
88150-42-9 (free base)
amlodipine 100 microg/ml in acetonitrile
BA164164
3-ethyl5-methyl2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
PD003146
EN300-708796
c08ca01
(rs)-3-ethyl 5-methyl 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
dtxcid302596
3-ethyl 5-methylester, (+-)-2-((2-aminoethoxy)methyl)-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
katerzia (amlodipine oral suspension, 1 mg/ml)
3-ethyl-5-methyl (+-)-2-((2-aminoethoxy)methyl)-4-(2-chlorphenyl)-1,4-dihydro-6-methyl-3,5-pyridindicarboxylate
amlodipinum (latin)
amlodipina
amlodipine (mart.)
PD033068

Research Excerpts

Overview

Amlodipine besylate is an antihypertensive agent recommended for the management of hypertension in children and adolescents. It is a dihydropyridine calcium channel blocker widely used in the treatment of high blood pressure and coronary heart disease. Amlodipsine is metabolized by CYP3A4 so predisposed to a risk of DDIs.

ExcerptReferenceRelevance
"Amlodipine is a long-acting dihydropyridine and inappropriate dosage poses a great threat for profound vasodilation, hypotension, and refractory vasopressor-resistant shock."( Refractory Shock from Amlodipine Overdose Overcomed with Hyperinsulinemia.
Kakava, K; Koliastasis, L; Lampadakis, I; Milkas, A; Papaioannou, S; Sourides, V; Strempelas, P; Tsioufis, P, 2022
)
1.76
"Amlodipine is a comparatively newer calcium channel blocker that with a longer duration of action and lesser side effects as compared to nifedipine."( Amlodipine Induced Gum Hypertrophy: A Rare Case Report.
Bohra, GK; Chhabra, V; Kumar, D; Midha, N; Reddy, SC, 2022
)
2.89
"Amlodipine besylate is an antihypertensive agent recommended for the management of hypertension in children and adolescents. "( Physicochemical Stability of Compounded Amlodipine Besylate Suspensions in PCCA Base, SuspendIt.
Bostanian, LA; Graves, RA; Mandal, TK; Morris, TC; Nguyen, AT; Pramar, YV; Swopes, D,
)
1.84
"Amlodipine is a dihydropyridine calcium channel blocker widely used in the treatment of high blood pressure and coronary heart disease. "( Postmortem fatal and non-fatal concentrations of amlodipine.
Alvarez, JC; Cappy, J; Knapp-Gisclon, A; Lorin de la Grandamison, G; Mayer-Duverneuil, C, 2020
)
2.26
"Amlodipine is a commonly prescribed antihypertensive drug metabolized by CYP3A4, thus predisposed to a risk of DDIs."( Population pharmacokinetic modelling to quantify the magnitude of drug-drug interactions between amlodipine and antiretroviral drugs.
Alves Saldanha, S; Buclin, T; Cavassini, M; Courlet, P; Csajka, C; Decosterd, LA; Guidi, M; Marzolini, C; Stoeckle, M, 2021
)
1.56
"Amlodipine is a calcium channel blocker shown to be effective in lowering blood pressure with minimal adverse effects in mammals. "( Use of Amlodipine in Psittacine Birds: 5 Cases (2010-2018).
Fink, DM; Mans, C, 2021
)
2.52
"Amlodipine is a general antihypertensive drug used in combination with various other antihypertensive agents."( Effect of Co-Administration of Curcumin with Amlodipine in Hypertension.
Choi, HY; Jo, C; Lee, K; Lee, S, 2021
)
1.6
"Amlodipine is a mixture of two enantiomers, one of which (S- enantiomer) has L-type channel blocking activity, while the other (R+ enantiomer) shows ~1000-fold weaker channel blocking activity than S- enantiomer and has other unknown effects."( Amlodipine Inhibits Vascular Cell Senescence and Protects Against Atherogenesis Through the Mechanism Independent of Calcium Channel Blockade.
Hayashi, Y; Ikegami, R; Katsuumi, G; Kayamori, H; Minamino, T; Shimizu, I; Suda, M; Wakasugi, T; Yoshida, Y, 2018
)
2.64
"Amlodipine is a classical drug with varied properties extending from control of blood pressure to as an antianginal and anti atherosclerotic agent. "( Amlodipine in the Era of New Generation Calcium Channel Blockers.
Kashyap, R; Langote, A; Tiwaskar, M; Toppo, A, 2018
)
3.37
"Amlodipine (AMLO) is a calcium channel blocker with vasodilating properties, in which the specific effects on the coronary circulation are not fully known. "( Effects of amlodipine and adenosine on coronary haemodynamics: in vivo study and numerical simulation.
De Lazzari, C; L'Abbate, A; Micalizzi, M; Neglia, D; Trivella, MG, 2014
)
2.23
"Amlodipine is a dihydropyridine calcium channel blocker that is used in the management of both hypertension and angina. "( Amlodipine-induced gingival hyperplasia in chronic renal failure: a case report.
Aldemir, NM; Begenik, H; Emre, H; Erdur, FM; Soyoral, Y, 2012
)
3.26
"Amlodipine is a racemic mixture of CCB; S-amlodipine has higher activity than R-form."( Pharmacokinetics, tolerability, and safety of the single oral administration of AGSAV301 vs Exforge: a randomized crossover study of healthy male volunteers.
Bae, KS; Choi, HY; Kim, MJ; Kim, YH; Lee, SH; Lim, HS; Noh, YH, 2014
)
1.12
"Amlodipine is a commonly prescribed calcium channel blocker for the treatment of hypertension and ischemic heart disease. "( Amlodipine metabolism in human liver microsomes and roles of CYP3A4/5 in the dihydropyridine dehydrogenation.
Chen, W; Du, A; Li, Q; Tang, W; Wang, F; Zhu, M; Zhu, Y, 2014
)
3.29
"Amlodipine is a commonly used agent in allogeneic stem cell transplant patients. "( Possible amlodipine-induced hepatotoxicity after stem cell transplant.
Hammerstrom, AE, 2015
)
2.28
"Amlodipine is a representative calcium channel blocker that is frequently prescribed for the treatment of hypertension. "( Effects of orally administered antibiotics on the bioavailability of amlodipine: gut microbiota-mediated drug interaction.
Kim, DH; Kim, IS; Yoo, DH; Yoo, HH, 2016
)
2.11
"Amlodipine is an antihypertensive agent recommended for the management of hypertension in children and adolescents. "( Design and stability study of an oral solution of amlodipine besylate for pediatric patients.
Hanff, LM; Koch, BC; Postma, DJ; Smeets, OS; van der Velde, I; van der Vossen, AC; Vermes, A; Vulto, AG, 2016
)
2.13
"Amlodipine is a non-antibiotic compound with anti-inflammatory activity."( The potential role of amlodipine on experimentally induced bacterial rhinosinusitis.
Halici, Z; Korkmaz, M; Parlak, SN; Polat, E; Tatar, A; Uslu, H; Yayla, M,
)
1.17
"Amlodipine is a racemic mixture, composed of the S(-)-enantiomer, which is the pharmacologically active isomer, and the R(+)-enantiomer, which is 1000-fold less active."( Efficacy and safety profiles of a new S(-)-amlodipine nicotinate formulation versus racemic amlodipine besylate in adult Korean patients with mild to moderate hypertension: an 8-week, multicenter, randomized, double-blind, double-dummy, parallel-group, ph
Ahn, TH; Chung, N; Kim, SA; Lim, DS; Oh, BH; Park, S; Tahk, SJ; Yang, JY, 2008
)
1.33
"Amlodipine is a racemic mixture composed of S- and R-form and metabolized stereoselectively. "( Effect of cytochrome P450 3A5*3 genotype on the stereoselective pharmacokinetics of amlodipine in healthy subjects.
Kim, KA; Park, JY; Park, PW, 2009
)
2.02
"Amlodipine is a calcium-channel antagonist with neuropharmacological properties believed to be protective against cerebral hypoperfusion, microinfarcts, and excitoxic cell death. "( Measures of cognitive functioning as predictors of treatment outcome for cocaine dependence.
Herron, J; Horner, MD; LaRowe, S; Malcolm, R; Turner, TH, 2009
)
1.8
"Amlodipine is a third-generation dihydropyridine calcium antagonist for the treatment of angina and hypertension. "( Pharmacokinetics and bioequivalence evaluation of two formulations of 10-mg amlodipine besylate: an open-label, single-dose, randomized, two-way crossover study in healthy Chinese male volunteers.
Jia, J; Li, S; Liu, G; Liu, Y; Lu, C; Yu, C, 2009
)
2.03
"Amlodipine is a long-acting calcium channel blocker capable of producing hypotension and dysrhythmia in overdose. "( Amlodipine toxicity in children less than 6 years of age: a dose-response analysis using national poison data system data.
Bakhireva, LN; Benson, BE; Spyker, DA; Troutman, WG; Watson, WA, 2010
)
3.25
"Amlodipine is a potent vasodilator with a long half-life and delayed onset of action that is particularly concerning after an overdose. "( Methylene blue in the treatment of refractory shock from an amlodipine overdose.
Hoffman, RS; Jang, DH; Nelson, LS, 2011
)
2.05
"Amlodipine is a dihydropyridine calcium channel blocker used in the treatment of hypertension and angina pectoris. "( Amlodipine fatality in an infant with postmortem blood levels.
Bosse, GM; Milliner, BA; Spiller, HA, 2012
)
3.26
"Amlodipine is a dihydropyridine calcium antagonist drug with distinctive pharmacokinetic characteristics that seem to be attributable to a high degree of ionization. "( Amlodipine-induced delirium in a patient with ischemic stroke.
Dikici, S; Kocaman, G; Kocer, A; Ozdem, S, 2012
)
3.26
"Amlodipine poisoning is an uncommon presentation with potentially life threatening complications. "( Amlodipine poisioning complicated with acute non-cardiogenic pulmonary oedema.
Hasson, R; Mulcahy, V; Tahir, H, 2011
)
3.25
"Amlodipine is a racemic mixture and the calcium channel blocking (CCB) effect is confined to S-amlodipine, whereas R-amlodipine has a 1000-fold lower activity and no racemization occurs in vivo in human plasma."( Pharmacokinetic interaction of telmisartan with s-amlodipine: an open-label, two-period crossover study in healthy Korean male volunteers.
Bae, KS; Choi, HY; Jin, SJ; Kim, MJ; Kim, YH; Lim, HS; Lim, J; Noh, YH; Sung, HR, 2012
)
1.35
"Amlodipine is a well-known inhibitor of CYP 3A4, an isoenzyme of CYP3A that activates clopidogrel."( Amlodipine, clopidogrel and CYP3A5 genetic variability: effects on platelet reactivity and clinical outcomes after percutaneous coronary intervention.
Kang, HJ; Kang, J; Kim, HS; Koo, BK; Lee, HY; Oh, BH; Park, JJ; Park, KW; Park, YB; Yang, HM, 2012
)
2.54
"Amlodipine is a dihydropyridine calcium channel antagonist extensively used for the treatment of arterial hypertension, with predominant effect on the peripheral vascular territory. "( Cardiac rhythm disturbances associated with amlodipine acute intoxication.
de Carvalho Borges, M; Fiorante, F; Galli, AM; Guimarães, EG; Miranda, CH; Misiara, GP; Pazin-Filho, A; Xavier, L, 2012
)
2.08
"Amlodipine is a racemic mixture of (R)- and (S)-enantiomers. "( Quantification of pedal edema during treatment with S(-)-amlodipine nicotinate versus amlodipine besylate in female Korean patients with mild to moderate hypertension: a 12-week, multicenter, randomized, double-blind, active-controlled, phase IV clinical
Choi, DJ; Kang, HJ; Lee, HY; Oh, BH; Oh, GC; Zo, JH, 2012
)
2.07
"Amlodipine is a dihydropyridine calcium channel antagonist that is useful in the treatment of hypertension and angina pectoris. "( The physicochemical equivalence of eight brands of amlodipine tablets in Lagos, Nigeria.
Akinleye, MO; Awodele, EO; Idris, O; Oladimeji-Salami, J; Olayemi, SO,
)
1.83
"Amlodipine (AML) is an inhibitor of CYP3A2 in rats."( Effect of amlodipine on the pharmacokinetics of tacrolimus in rats.
Cheng, ZN; Li, J; Li, PJ; Liu, Z; Tan, HY; Wang, CJ; Yang, GP; Yang, M; Yuan, H; Zhang, BK; Zhou, LY; Zhou, YN; Zuo, XC, 2013
)
1.51
"Amlodipine is an effective antianginal agent, whereas ARBs are not."( Amlodipine versus Angiotensin-receptor blockers for nonhypertension indications.
Kalus, JS; White, CM, 2002
)
2.48
"Amlodipine is a dihydropyridine calcium antagonist and is widely used for the treatment of cardiovascular diseases. "( Stereoselective pharmacokinetics of amlodipine in elderly hypertensive patients.
Arakawa, M; Fujimura, A; Harada, K; Hifumi, S; Miyamori, I; Ohmori, M; Takasaki, H,
)
1.85
"Amlodipine is a calcium antagonist of the dihydropyridine class. "( Pharmacokinetics of amlodipine in hypertensive patients undergoing haemodialysis.
Kungys, G; Naujoks, H; Wanner, C, 2003
)
2.09
"Amlodipine besylate is a potent dihydropyridine calcium channel blocker also with dose-related antihypertensive efficacy, but with possible dose-limiting AEs, particularly peripheral edema."( A randomized, double-blind, active-controlled, parallel-group comparison of valsartan and amlodipine in the treatment of isolated systolic hypertension in elderly patients: the Val-Syst study.
Borgnino, C; Capuano, V; Malacco, E; Palatini, P; Spagnuolo, V; Varì, N, 2003
)
1.26
"Amlodipine is a potent peripheral and coronary vasodilator with high selectivity for vascular smooth muscle, and is widely used in mild to moderate hypertension, chronic stable angina and vasospastic angina. "( Amlodipine associated hyperpigmentation.
Erbagci, Z, 2004
)
3.21
"Amlodipine is an effective treatment for hypertension. "( Hemodynamic effects of amlodipine, bisoprolol, and lisinopril in hypertensive patients after liver transplantation.
Alexander, GJ; Brown, MJ; Byrne, CD; Neal, DA; Wilkinson, IB, 2004
)
2.08
"Amlodipine is a long-acting dihydropyridine derivative that is suitable for use as a once-daily calcium antagonist."( The calcium antagonists in vasospastic angina.
Chahine, RA, 1991
)
1
"Amlodipine is a dihydropyridine calcium channel blocker that is widely used for the treatment of hypertensive patients and has an antioxidant effect on vessels in vitro. "( Amlodipine-induced reduction of oxidative stress in the brain is associated with sympatho-inhibitory effects in stroke-prone spontaneously hypertensive rats.
Hirooka, Y; Ito, K; Kimura, Y; Nozoe, M; Sagara, Y; Sunagawa, K, 2006
)
3.22
"Amlodipine is a calcium channel blocker (CCB) known to stimulate nitric oxide production from endothelial cells. "( The calcium channel blocker amlodipine promotes the unclamping of eNOS from caveolin in endothelial cells.
Balligand, JL; Batova, S; Dessy, C; DeWever, J; Feron, O; Godfraind, T, 2006
)
2.07
"Amlodipine was shown to be a well tolerated and effective drug in one in three patients, and achieved the therapeutic goal in a higher proportion of patients at specialised-care centres compared with those in primary care, and in those receiving combined therapy compared with monotherapy."( Efficacy and safety of amlodipine: a comparative study of hypertensive patients treated at primary- and specialised-care centres.
Arístegui, R; Gil, A; Hernández, V; Jiménez, R; Valcárcel, Y, 2006
)
2.09
"Amlodipine is a highly effective and safe antihypertensive dihydropyridine calcium channel blocker. "( Combination therapy with renin-angiotensin system blockers: will amlodipine replace hydrochlorothiazide?
Fornoni, A; Lenz, O; Materson, BJ; Tejada, T, 2007
)
2.02
"Amlodipine camsylate is a newer formulation developed for generic use."( Results of a phase III, 8-week, multicenter, prospective, randomized, double-blind, parallel-group clinical trial to assess the effects of amlodipine camsylate versus amlodipine besylate in Korean adults with mild to moderate hypertension.
Ahn, YK; Chung, WS; Kim, HS; Kim, IJ; Kim, JJ; Kim, SH; Kim, YD; Lee, JW; Lim, DS; On, YK; Park, JB; Seo, HS; Shin, EK; Yang, JY; Yoon, MH, 2007
)
1.26
"Amlodipine is a dihydropyridine that blocks L-type channels, thereby preventing entry of Ca2+ into the muscle."( Effect of chronic blood pressure reduction on soleus muscle contractile properties in spontaneously hypertensive rats.
Atherley, R; Carlsen, RC; Gray, SD, 1994
)
1.01
"Amlodipine is a potent peripheral and coronary vasodilator with high selectivity for vascular smooth muscle and minimal effect on myocardial contractility or cardiac conduction."( Amlodipine: a new calcium antagonist.
Clavijo, GA; de Clavijo, IV; Weart, CW, 1994
)
2.45
"Amlodipine is a calcium channel blocker used in the management of angina and hypertension. "( Amlodipine-induced gingival overgrowth.
Ellis, JS; Idle, JR; Monkman, S; Seymour, RA; Thomason, JM, 1994
)
3.17
"Amlodipine is a recently introduced, dihydropyridine with a long half life."( Amlodipine in patients with angina uncontrolled by atenolol. A double blind placebo controlled cross over trial.
Channer, KS; Morice, AH; Stewart, AG; Woodmansey, PA, 1993
)
2.45
"Amlodipine is an intrinsically long-acting, vasoselective calcium antagonist structurally related to nifedipine, but with unique binding and pharmacologic properties that distinguish it from other agents of this class. "( Unique pharmacologic properties of amlodipine.
Burges, R; Moisey, D, 1994
)
2.01
"Amlodipine is a long-acting calcium antagonist and effectively lowers BP in patients with essential hypertension."( Double-blind comparison between nifedipine and amlodipine for the treatment of essential hypertension.
Cappuccio, FP; Carney, C; Crane, M; MacGregor, GA; Markandu, ND; Singer, DR, 1993
)
1.26
"Amlodipine is a novel, relatively well tolerated, calcium antagonist."( Acute pulmonary vasodilatory properties of amlodipine in humans with pulmonary hypertension.
Channer, KS; Morice, AH; O'Toole, L; Woodmansey, PA, 1996
)
1.28
"Amlodipine is a dihydropyridine calcium antagonist with prolonged duration of action. "( Hemodynamic and 24-h blood pressure profile of amlodipine monotherapy.
el-Boghdadly, B; Ibrahim, MM; Zaghloul, SS, 1996
)
1.99
"Amlodipine appears to be a safe and effective oral treatment for systemic hypertension in cats when used chronically once daily as a single agent."( Treatment of systemic hypertension in cats with amlodipine besylate.
Henik, RA; Snyder, PS; Volk, LM,
)
1.11
"Amlodipine is a dihydropiridine with a pharmacologic profile different from other C.A.T.S."( [Clinical pharmacokinetics of calcium antagonists].
Sesin, J; Tamargo, J, 1997
)
1.02
"Amlodipine is a relatively new agent that has the longest half-life of all calcium channel blockers. "( Amlodipine overdose causes prolonged calcium channel blocker toxicity.
Adams, BD; Browne, WT, 1998
)
3.19
"Amlodipine proved to be an effective, more safe and better-tolerated therapeutical alternative for hypertension management than nifedipine retard."( Antihypertensive effect of amlodipine compared with nifedipine retard in patients with mild and moderate essential hypertension.
Gross-Furek, V; Herman, ZS; Kalina, Z; Madej, A; Maślankiewicz, A; Okopień, B; Szwed, Z; Tokarz, D,
)
1.87
"Amlodipine is a calcium antagonist with a long elimination half-life (35 to 50 h) allowing a once daily dosing in the treatment of hypertension. "( Prolonged antihypertensive effect of amlodipine: a prospective double-blind randomized study.
Biston, P; Clement, D; Degaute, JP; Mélot, C; Quoidbach, A, 1999
)
2.02
"amlodipine, is a milestone in the effort to test whether newer compounds offer a better reduction of the cardiovascular consequences of hypertension, as well as good BP control."( Long-term potential of angiotensin receptor blockade for cardiovascular protection in hypertension: the VALUE trial. Valsartan Antihypertensive Long-term Use Evaluation.
Julius, S, 1999
)
1.02
"Amlodipine is a calcium channel antagonist of the dihydropyridine group. "( Enzyme linked immunosorbent assay for determination of amlodipine in plasma.
Arafat, T; Badwan, A; El-Thaher, T; Jehanli, A; Matalka, K; Saleem, M, 2001
)
2
"Amlodipine is a mixture of two enantiomers, one having L-type channel blocking activity (S-) and the other about 1,000-fold weaker activity and of little known other activity (R+). "( Paradoxical release of nitric oxide by an L-type calcium channel antagonist, the R+ enantiomer of amlodipine.
Chahwala, S; Hintze, TH; Loke, KE; Mital, S; Zhang, XP, 2002
)
1.97
"Amlodipine is a dihydropyridine calcium antagonist with a long elimination half life making it suitable for once-daily dosing. "( Intra-arterial monitoring of the antihypertensive effects of once-daily amlodipine.
al-Khawaja, I; Brigden, G; Broadhurst, P; Heber, ME; Raftery, EB, 1992
)
1.96
"Amlodipine is a new calcium antagonist of the 1.4-dihydropyridine group for treatment of hypertension and angina pectoris. "( [Amlodipine: pharmacokinetic and pharmacodynamic profile of a calcium antagonist with prolonged effect].
Heynen, G, 1992
)
2.64
"Amlodipine is a dihydropyridine calcium antagonist drug with distinctive pharmacokinetic characteristics which appear to be attributable to a high degree of ionisation. "( Clinical pharmacokinetics of amlodipine.
Elliott, HL; Meredith, PA, 1992
)
2.02
"Amlodipine is a low-clearance, dihydropyridine calcium antagonist. "( Pharmacokinetics and pharmacodynamics of amlodipine.
Abernethy, DR, 1992
)
1.99
"Amlodipine is a newly developed long-acting dihydropyridine-based calcium antagonist. "( (-)[3H]amlodipine binding to rat cardiac membranes.
Gu, XH; Nayler, WG, 1991
)
2.18
"Amlodipine is a 1,4-dihydropyridine calcium antagonist which, although structurally related to nifedipine, has a number of important distinguishing properties. "( Amlodipine: a once daily calcium antagonist.
Burges, RA, 1991
)
3.17
"Amlodipine is a dihydropyridine calcium antagonist which can be used once daily in hypertension. "( Amlodipine: an effective once-daily antihypertensive agent.
Tyler, HM, 1991
)
3.17
"Amlodipine is a 'second generation', long-acting calcium antagonist. "( The unique binding properties of amlodipine: a long-acting calcium antagonist.
Gu, XH; Nayler, WG, 1991
)
2.01
"Amlodipine is a dihydropyridine calcium antagonist that has unique pharmacokinetic properties. "( The efficacy of amlodipine in the management of ischaemic heart disease.
McGibney, D, 1991
)
2.07
"Amlodipine is a novel dihydropyridine calcium antagonist with distinctive pharmacokinetic and pharmacodynamic properties, including slow onset and long duration of action, with minimal effects on cardiac electrophysiology and myocardial contractility. "( The pharmacological profile of amlodipine in relation to ischaemic heart disease.
Burges, RA, 1991
)
2.01
"Amlodipine is a long-acting dihydropyridine calcium antagonist with vascular selectivity. "( Vascular and myocardial effects of amlodipine: an overview.
Gu, XH; Nayler, WG, 1991
)
2
"Amlodipine is a dihydropyridine calcium antagonist with a unique pharmacokinetic profile providing advantages over other therapies of its kind. "( A review of amlodipine in myocardial ischaemia.
Taylor, SH, 1991
)
2.1
"Amlodipine is a powerful arterial vasodilator with no negative inotropic effects."( Haemodynamic and electrophysiological effects of amlodipine, a new long-acting calcium antagonist.
Dailey, S; Epstein, A; Kay, G; Plumb, V; Vetrovec, GW, 1991
)
1.26
"Amlodipine is a long acting dihydropyridine calcium antagonist recently introduced for the treatment of angina and hypertension. "( Liquid chromatography assay for amlodipine: chemical stability and pharmacokinetics in rabbits.
Mosher, SJ; Pollak, PT; Yeung, PK, 1991
)
2.01
"Amlodipine is a very weak inhibitory of 5-HT-induced aggregation."( How can we inhibit 5-HT-induced platelet aggregation and why should we bother?
Bevan, J; Heptinstall, S, 1988
)
1
"Amlodipine is a long-acting dihydropyridine-based calcium antagonist developed for use on a once-a-day basis. "( The effect of amlodipine on hypertension-induced cardiac hypertrophy and reperfusion-induced calcium overload.
Nayler, WG, 1988
)
2.08
"Amlodipine is a new long-acting calcium antagonist that has a long half-life and appears to be suitable for once-daily administration. "( A double-blind evaluation of the effect of amlodipine on ambulatory blood pressure in hypertensive patients.
Allenby, KS; Burris, JF; Mroczek, WJ, 1988
)
1.98
"Amlodipine is a useful new calcium antagonist for the treatment of hypertension producing smooth, dose-dependent blood pressure reductions with convenient once daily dosing."( A dose-response study of amlodipine in mild to moderate hypertension.
Frick, MH; McGibney, D; Tyler, HM, 1989
)
1.3
"1. Amlodipine is a novel calcium antagonist which, although pharmacologically similar to other dihydropyridine calcium antagonists, has a long plasma half-life, permitting steady state blood levels to be achieved with a once-daily dose regimen. "( 24 h blood pressure control with the once daily calcium antagonist, amlodipine.
Al-Khawaja, I; Brigden, G; Heber, ME; Raftery, EB, 1989
)
1.13
"Amlodipine is a dihydropyridine derivative belonging to the group of pharmacologic calcium entry blocking agents and is characterized as having a slow onset and relatively long duration of action with minimal effects on cardiac electrophysiology and myocardial contractility. "( Cardioprotective effects of amlodipine in the ischemic-reperfused heart.
Hoff, PT; Lucchesi, BR; Tamura, Y, 1989
)
2.01
"Amlodipine is a light-insensitive and water soluble 1,4-dihydropyridine with prolonged vasodilatory action and plasma half-life. "( Relaxation of potassium chloride-induced contractions by amlodipine and its interaction with the 1,4-dihydropyridine-binding site in pig coronary artery.
Matlib, MA, 1989
)
1.96
"Amlodipine is a long-acting dihydropyridine-based Ca2+ channel blocker, developed for use on a once-daily basis. "( Amlodipine pretreatment and the ischemic heart.
Nayler, WG, 1989
)
3.16
"Amlodipine is a potent calcium antagonist, inhibiting Ca2+-induced contractions of depolarized rat aorta with an IC50 of 1.9 nM. "( Pharmacologic profile of amlodipine.
Burges, RA; Dodd, MG; Gardiner, DG, 1989
)
2.02
"Amlodipine is an antihypertensive and antiischemic agent that has the combined advantages of a good safety profile with once-daily dosage and a smooth onset and long duration of action."( The safety of amlodipine.
Osterloh, I, 1989
)
1.36

Effects

Amlodipine has a beneficial effect on LVH and also is an effective and safe drug to treat mild to moderate hypertension. In the GITS formulation the sophisticated delivery system allows for once-daily dosing.

Amlodipine has been reported to improve endothelial function in patients with arterial hypertension and to significantly limit the progression of carotid atherosclerosis. S-amlodipne has been broadly used to treat hypertension, but its protective effects and underlying mechanism remain controversial. Amlodipin has effects on hemorheology (HR), and its hemodilutory property may partly contribute to its antihypertensive action.

ExcerptReferenceRelevance
"Amlodipine has an inherently long pharmacokinetic half-life, whereas, in contrast, nifedipine has an inherently short half-life but in the GITS formulation the sophisticated delivery system allows for once-daily dosing."( Long-acting dihydropyridine calcium-channel blockers and sympathetic nervous system activity in hypertension: a literature review comparing amlodipine and nifedipine GITS.
Elliott, HL; Meredith, PA; Toal, CB, 2012
)
1.3
"Amlodipine has a beneficial effect on LVH and also is an effective and safe drug to treat mild to moderate hypertension."( [Effect of the treatment with amlodipine on left ventricular hypertrophy in hypertensive patients].
Hoyos, M; Justo, E; Moreno, R; Oliván, J; Pérez Cano, R; Pizarro, JL; Ramos, E; Rodríguez, A, 1996
)
2.03
"Amlodipine also has a long elimination half-life, which makes it suitable for use on a once-daily basis."( The efficacy of amlodipine in the management of ischaemic heart disease.
McGibney, D, 1991
)
1.35
"Amlodipine has low renal clearance (7 mL/min/mg) and long half-life (35-50 h) and duration of action, which allows it to sustain its anti-hypertensive effect for more than 24 h following a single dose."( Amlodipine in the current management of hypertension.
Palmer, BF; Sever, P; Vogel Anderson, K; Wang, JG, 2023
)
3.07
"Amlodipine has longer biological half life and lower potential to stimulate SNS."( An Open Label Prospective Study on Evaluation of Safety and Efficacy of Cilnidipine Over Amlodipine in Stage 1 Hypertensive Patients.
Das, K; Harlalka, S; Majumdar, G; Mandal, P; Roy, UK,
)
1.07
"S-amlodipine has been broadly used to treat hypertension, but its protective effects and underlying mechanism remain controversial. "( S-amlodipine improves endothelial dysfunction via the RANK/RANKL/OPG system by regulating microRNA-155 in hypertension.
He, C; Si, D; Yang, J; Yang, P; Zhao, Y, 2019
)
1.96
"Amlodipine has effects on hemorheology (HR), and its hemodilutory property may partly contribute to its antihypertensive action."( Amlodipine alters hemorheological parameters: Increased efficacy at the cost of edema?
Arunkumar, S; Lokhandwala, Y; Padgaonkar, K; Panicker, G; Puniyani, RR; Ravindra, RP; Sharma, R; Vadivelu, R,
)
2.3
"Amlodipine has been shown to improve vascular endothelial function in hypertensive patients, but whether S(-)-amlodipine has a similar effect remains controversial. "( The effects of amlodipine and S(-)-amlodipine on vascular endothelial function in patients with hypertension.
Ding, M; He, Y; Li, B; Ni, L; Si, D; Yang, C; Yang, P, 2014
)
2.2
"Amlodipine has greater potential for vascular endothelial protection than S(-)-amlodipine."( The effects of amlodipine and S(-)-amlodipine on vascular endothelial function in patients with hypertension.
Ding, M; He, Y; Li, B; Ni, L; Si, D; Yang, C; Yang, P, 2014
)
1.48
"Amlodipine (Aml) has R- and S-isomers with different pharmacological effects. "( Effects of (S)-amlodipine and (R)-amlodipine on L-type calcium channel current of rat ventricular myocytes and cytosolic calcium of aortic smooth muscle cells.
Jiang, WP; Lai, LH; Li, XR; Wang, RX, 2008
)
2.14
"Amlodipine, however, has been shown to be effective in reducing BP throughout the day and night, independent of dosing time."( Chronotherapy with valsartan/amlodipine fixed combination: improved blood pressure control of essential hypertension with bedtime dosing.
Ayala, DE; Fernández, JR; Fontao, MJ; Hermida, RC; Mojón, A, 2010
)
1.37
"Amlodipine has an inherently long pharmacokinetic half-life, whereas, in contrast, nifedipine has an inherently short half-life but in the GITS formulation the sophisticated delivery system allows for once-daily dosing."( Long-acting dihydropyridine calcium-channel blockers and sympathetic nervous system activity in hypertension: a literature review comparing amlodipine and nifedipine GITS.
Elliott, HL; Meredith, PA; Toal, CB, 2012
)
1.3
"Amlodipine has two stereoisomers [R(+), S(-)], and only the S(-) isomer exerts vasodilating action."( Stereoselective pharmacokinetics of amlodipine in elderly hypertensive patients.
Arakawa, M; Fujimura, A; Harada, K; Hifumi, S; Miyamori, I; Ohmori, M; Takasaki, H,
)
1.13
"Amlodipine has antihypertensive and antioxidant activity in vivo, which effectively inhibits many of the oxidative stress-dependent mechanisms involved in Ang II-mediated cardiovascular injury."( Inhibition of oxidative stress and improvement of endothelial function by amlodipine in angiotensin II-infused rats.
Jaimes, EA; Raij, L; Zhou, MS, 2004
)
2
"Amlodipine has been reported to improve endothelial function in patients with arterial hypertension and to significantly limit the progression of carotid atherosclerosis. "( An in vitro study of the peroxyl and hydroxyl radical scavenging capacity of the calcium antagonist amlodipine.
Carpi, A; Femia, FR; Franzoni, F; Galetta, F; Plantinga, Y; Regoli, F; Santoro, G, 2004
)
1.98
"Amlodipine, therefore, has the potential to become the preferred calcium antagonist for this condition."( The calcium antagonists in vasospastic angina.
Chahine, RA, 1991
)
1
"Amlodipine has been shown to prevent decrease in vascular responsiveness induced by injection of Salmonella typhosa lipopolysaccharide (LPS); however, there is no study reporting if this protection by amlodipine extends to ventricular contractility. "( Protective action of amlodipine on cardiac negative inotropism induced by lipopolysaccharide in rats.
Bravo, G; Hong, E; Huang, F; Kurtansky, A; López-Muñoz, FJ; Rojas, G; Villalón, CM, 2007
)
2.1
"Amlodipine also has beneficial effects in patients with the metabolic syndrome but has no effect on MPV."( Effects of doxazosin and amlodipine on mean platelet volume and serum serotonin level in patients with metabolic syndrome: a randomised, controlled study.
Basar, M; Demirtunc, R; Duman, D, 2007
)
1.36
"Amlodipine besylate has been used in Korea for the treatment of hypertension for >17 years, with well-established efficacy and tolerability. "( Results of a phase III, 8-week, multicenter, prospective, randomized, double-blind, parallel-group clinical trial to assess the effects of amlodipine camsylate versus amlodipine besylate in Korean adults with mild to moderate hypertension.
Ahn, YK; Chung, WS; Kim, HS; Kim, IJ; Kim, JJ; Kim, SH; Kim, YD; Lee, JW; Lim, DS; On, YK; Park, JB; Seo, HS; Shin, EK; Yang, JY; Yoon, MH, 2007
)
1.98
"Amlodipine has FDA-approved labeling for use in the treatment of hypertension, chronic stable angina, and vasospastic angina."( Amlodipine: a new calcium antagonist.
Clavijo, GA; de Clavijo, IV; Weart, CW, 1994
)
2.45
"Amlodipine has slow receptor binding kinetics that result in a gradual onset of action and may allow for less dependence on instantaneous plasma levels."( Unique pharmacologic properties of amlodipine.
Burges, R; Moisey, D, 1994
)
1.29
"Amlodipine has also been found to provide improved antianginal effects when combined to treatment with beta blockers and/or long-acting nitrates."( Amlodipine once a day in stable angina: double-blind crossover comparison with placebo.
Cheitlin, MD; Das, SK; Deedwania, PC; Pasternak, RC; Pool, PE; Singh, JB, 1993
)
2.45
"Amlodipine has a beneficial effect on LVH and also is an effective and safe drug to treat mild to moderate hypertension."( [Effect of the treatment with amlodipine on left ventricular hypertrophy in hypertensive patients].
Hoyos, M; Justo, E; Moreno, R; Oliván, J; Pérez Cano, R; Pizarro, JL; Ramos, E; Rodríguez, A, 1996
)
2.03
"Amlodipine has demonstrated atheroprotection in both rabbit and subhuman primate models of this disease."( Cholesterol, calcium and atherosclerosis: is there a role for calcium channel blockers in atheroprotection?
Laury-Kleintop, L; Mason, RP; Tulenko, TN; Walter, MF, 1997
)
1.02
"Amlodipine has sustained vasodilatory effects and relieves coronary spasm, which may reduce luminal loss and clinical complications after PTCA."( Restenosis and clinical outcome in patients treated with amlodipine after angioplasty: results from the Coronary AngioPlasty Amlodipine REStenosis Study (CAPARES).
Buller, C; Endresen, K; Erikssen, J; Forfang, K; Goulet, G; Hansen, J; Jørgensen, B; Simonsen, S; Thaulow, E; Vatne, K; Webb, J, 2000
)
1.99
"Amlodipine has no demonstrable effect on angiographic progression of coronary atherosclerosis or the risk of major cardiovascular events but is associated with fewer hospitalizations for unstable angina and revascularization."( Effect of amlodipine on the progression of atherosclerosis and the occurrence of clinical events. PREVENT Investigators.
Byington, RP; Furberg, CD; Hunninghake, DB; Mancini, GB; Miller, ME; Pitt, B; Riley, W, 2000
)
2.15
"Amlodipine has potential advantages in children since it can be dissolved into a liquid preparation and has a long elimination half-life, allowing for once-daily administration. "( A randomized prospective crossover trial of amlodipine in pediatric hypertension.
Arbus, GS; Blowey, D; Khattak, S; Koren, G; Lyszkiewicz, DA; Rogan, JW, 2000
)
2.01
"Amlodipine, which has membrane-remodeling properties, is emerging as an important atheroprotective drug."( The smooth muscle cell membrane during atherogenesis: a potential target for amlodipine in atheroprotection.
Chen, M; Ferdinand, FD; Huang, Y; Laury-Kleintop, L; Sumner, AE; Tulenko, TN, 2001
)
1.26
"Amlodipine has significant anti-anginal efficacy."( A double-blind dose-response study of amlodipine in patients with stable angina pectoris.
Alfiero, R; Cocco, G, 1991
)
1.27
"Amlodipine has also been shown to attenuate the cardiac hypertrophy associated with the development of hypertension in spontaneously hypertensive rats."( Amlodipine: a once daily calcium antagonist.
Burges, RA, 1991
)
2.45
"Amlodipine also has a long elimination half-life, which makes it suitable for use on a once-daily basis."( The efficacy of amlodipine in the management of ischaemic heart disease.
McGibney, D, 1991
)
1.35
"Amlodipine has also been found to be effective in reducing the anginal attack rate in patients with vasospastic angina."( The efficacy of amlodipine in myocardial ischemia.
Taylor, SH, 1989
)
1.34

Actions

Amlodipine did not increase cardiovascular morbidity or mortality in patients with severe heart failure. It can inhibit the HKC apoptosis and protect the renal tubule cell from injury induced by meglumine diatrizoate.

ExcerptReferenceRelevance
"Amlodipine blunted the increase in diastolic BP that occurred during the second and third sets of exercise at 40% of 1RM (+75 ± 6 vs."( Amlodipine reduces blood pressure during dynamic resistance exercise in hypertensive patients.
Barros, S; Costa, LA; Forjaz, CL; Gomides, RS; Mion, D; Ortega, KC; Queiroz, AC; Souza, DR; Tinucci, T, 2015
)
2.58
"Amlodipine could suppress Ang-II-induced endothelial dysfunction and apoptosis through diminishing ROCK1 expression."( Amlodipine suppresses Ang-II-induced endothelium dysfunction by diminishing ROCK1 expression.
Cai, A; Feng, Y; Li, L; Mai, W; Qiu, R; Xu, R; Zheng, D; Zhou, Y, 2016
)
3.32
"Amlodipine promotes neovascularization by improving EPC mobilization from bone marrow in diabetic rats after AMI, and activation of VEGF/Akt/eNOS signaling may in part contribute to this."( Amlodipine Ameliorates Ischemia-Induced Neovascularization in Diabetic Rats through Endothelial Progenitor Cell Mobilization.
Dong, L; Ferro, A; Kang, L; Sun, J; Xie, J; Xu, B, 2016
)
2.6
"Amlodipine and the ARBs lower blood pressure to a similar extent. "( Amlodipine versus Angiotensin-receptor blockers for nonhypertension indications.
Kalus, JS; White, CM, 2002
)
3.2
"Amlodipine reduced the increase in oxidative stress by inhibiting excessive MDA production. "( Amlodipine and glutathione cycle in hypercholesterolaemia.
Bayindir, O; Habif, S; Mutaf, I; Ozmen, D; Parildar, Z; Turgan, N; Uysal, A, 2004
)
3.21
"Amlodipine can inhibit the HKC apoptosis and protect the renal tubule cell from injury induced by meglumine diatrizoate."( [Protective effect of amlodipine on the cytotoxicity induced by contrast media in human kidney cells].
Duan, SB; Li, GY; Liu, FY; Liu, RH; Peng, YM; Ye, Y; Zhou, XR, 2007
)
2.1
"Amlodipine can increase CsA levels"( Amlodipine increases cyclosporine levels in hypertensive renal transplant patients: results of a prospective study.
Curtis, JJ; Jones, PA; Julian, BA; Pesavento, TE, 1996
)
2.46
"Amlodipine did not increase cardiovascular morbidity or mortality in patients with severe heart failure. "( Effect of amlodipine on morbidity and mortality in severe chronic heart failure. Prospective Randomized Amlodipine Survival Evaluation Study Group.
Belkin, RN; Carson, PE; Cropp, AB; DeMets, DL; Frid, D; Ghali, JK; Miller, AB; Neuberg, GW; O'Connor, CM; Packer, M; Pressler, ML; Wertheimer, JH, 1996
)
2.14
"Amlodipine was found to inhibit growth and bFGF-induced DNA synthesis in a concentration-dependent manner."( Amlodipine and vascular hypertrophy.
Herembert, T; Iouzalen, L; Marche, P; Stepien, O; Zhu, DL, 1997
)
2.46
"Amlodipine prevented an increase of the weight of right ventricle (0.62 +/- 0.03 g/kg, P < 0.01) and LVDd (7.9 +/- 0.2 mm, P < 0.01 to MI)."( Long acting calcium antagonist amlodipine prevents left ventricular remodeling after myocardial infarction in rats.
Iwao, H; Kim, S; Omura, T; Shimada, T; Takemoto, Y; Takeuchi, K; Yoshikawa, J; Yoshiyama, M, 1998
)
1.31
"3) Amlodipine (10 nM) could inhibit both short-term and long-term p42/p44 MAPKs activation by bFGF."( The inhibitory mechanisms of amlodipine in human vascular smooth muscle cell proliferation.
Gao, PJ; Marche, P; Stepien, O; Wang, XY; Zhang, YZ; Zhang, ZL; Zhu, DL, 2000
)
1.11
"Amlodipine did not cause significant change in oxygen uptake at the anaerobic threshold or at maximum exercise and there was also no change in heart rate or catecholamine responses."( Effect of amlodipine on cardiopulmonary performance in volunteers.
Bjorksten, AR; Blake, DW; Lay, L; Stainsby, GV,
)
1.26
"Amlodipine was found to inhibit hyperplasia and hypertrophy in mesangial cells."( Effect of amlodipine on mesangial cell proliferation and protein synthesis.
Raij, L; Shultz, PJ, 1992
)
1.41
"Amlodipine was found to increase exercise capacity significantly and reduce electrocardiographic evidence of myocardial ischaemia after treadmill exercise testing 24 h after administration compared with placebo in patients suffering from angina pectoris."( A review of amlodipine in myocardial ischaemia.
Taylor, SH, 1991
)
1.38

Treatment

Amlodipine treatment caused a rapid concentration-dependent decrease of intracellular calcium concentration in the HT-39 cell line. Treatment was associated with a slightly higher incidence of side effects compared with placebo. Most of this difference was the result of edema, which was usually well tolerated.

ExcerptReferenceRelevance
"Amlodipine treatment led to a significant reduction in SBP (-24.9 mmHg; 95% CI: -28.3 to -21.6; P<0.0001) and DBP (-14.8; 95% CI: -16.4 to -13.3; P<0.0001), without affecting the heart rate."( Effect of amlodipine on ventricular hypertrophy in hypertension patients: a systematic review and meta-analysis.
Gao, Y; Yang, P; Zhou, D, 2021
)
1.75
"Amlodipine treatment in patients with hypertension significantly reduced the LV mass index and LV posterior wall thickness, without notably affecting the LV end-diastolic diameter. "( Effect of amlodipine on ventricular hypertrophy in hypertension patients: a systematic review and meta-analysis.
Gao, Y; Yang, P; Zhou, D, 2021
)
2.47
"Amlodipine treatment reduced LPK rat blood pressure (untreated vs. "( Amlodipine Improves Vessel Function and Remodeling in the Lewis Polycystic Kidney Rat Mesenteric Artery.
Ameer, OZ; Phillips, JK; Quek, KJ, 2020
)
3.44
"Amlodipine treatment also resulted in decreased parthenogenetic activation and arrested early embryonic development."( The role of L-type calcium channels in mouse oocyte maturation, activation and early embryonic development.
Ge, ZJ; He, GF; Luo, SM; Ma, JY; Shen, W; Sun, QY; Yang, LL; Yin, S, 2017
)
1.18
"Amlodipine treatment at 25 nM prevented apoptosis and restored cellular calcium levels and oxidative damage in cardiomyocytes. "( Amlodipine protects rat ventricular cardiomyoblast H9c2 From hypoxia-induced apoptosis and restores oxidative balance by Akt-1-dependent manner.
Bhardwaj, V; Nehra, S; Saraswat, D, 2014
)
3.29
"Amlodipine treatment did not significantly affect any test score, but VAL treatment significantly increased the word-list memory and word-list recall test scores."( Comparison of effects of valsartan and amlodipine on cognitive functions and auditory p300 event-related potentials in elderly hypertensive patients.
Katada, E; Matsukawa, N; Takuma, Y; Uematsu, N,
)
1.12
"Amlodipine treatment also increased cardiac SDF-1/CXCR4 expression and gave rise to activation of VEGF/Akt/eNOS signaling in bone marrow."( Amlodipine Ameliorates Ischemia-Induced Neovascularization in Diabetic Rats through Endothelial Progenitor Cell Mobilization.
Dong, L; Ferro, A; Kang, L; Sun, J; Xie, J; Xu, B, 2016
)
2.6
"Amlodipine treatment did not cause any serious adverse events."( A randomized trial of amlodipine in addition to standard chelation therapy in patients with thalassemia major.
Baldanzi, GR; Coelho, OR; Costa, FF; Fernandes, JL; Fertrin, KY; Fioravante, LA; Higa, T; Loggetto, SR; Mashima, DA; Piga, A; Saad, ST; Tan, DM; Veríssimo, MP, 2016
)
1.47
"Amlodipine treated group showed significantly increased superoxide dismutase and glutathione levels and decreased malondialdehyde levels compared to all treatment groups."( The potential role of amlodipine on experimentally induced bacterial rhinosinusitis.
Halici, Z; Korkmaz, M; Parlak, SN; Polat, E; Tatar, A; Uslu, H; Yayla, M,
)
1.17
"Amlodipine-based treatment was associated with a smaller arteriolar length:diameter ratio than atenolol-based treatment (13.32 [10.75 to 16.04] versus 14.12 [11.27 to 17.81], median [interquartile range]; P<0.01)."( Differential effects of antihypertensive treatment on the retinal microcirculation: an anglo-scandinavian cardiac outcomes trial substudy.
Allemann, S; Chaturvedi, N; Hughes, A; Mayet, J; O'Brien, E; Poulter, N; Sever, P; Stanton, A; Stettler, C; Tapp, R; Thom, S; Witt, N, 2009
)
1.07
"Amlodipine-treated patients had a higher incidence of peripheral edema (22.4% vs 2.2%) and associated discontinuations (7.3% vs <1%)."( Randomized study to compare valsartan +/- HCTZ versus amlodipine +/- HCTZ strategies to maximize blood pressure control.
Ferber, P; Papst, CC; Zappe, D, 2009
)
1.32
"Amlodipine treatment reduced the contractions and improved relaxation to ACh."( Amlodipine ameliorates endothelial dysfunction in mesenteric arteries from spontaneously hypertensive rats.
Cheng, G; He, X; Jiang, HK; Li, DL; Sun, L; Yang, JL; Yu, XJ; Zang, WJ; Zhang, HL; Zhao, M; Zhao, Q, 2011
)
2.53
"Amlodipine treatment did not modify HDL3c AOX in the whole study population; changes in AOX were, however, positively correlated with SBP (r = 0.37, p = 0.05 for maximal diene concentration; r = 0.34, p = 0.08 for LDL oxidation rate)."( Blood pressure-lowering response to amlodipine as a determinant of the antioxidative activity of small, dense HDL3.
Bittar, R; Bonnefont-Rousselot, D; Bruckert, E; Chantepie, S; Chapman, MJ; Girerd, X; Hansel, B; Kontush, A; Orsoni, A, 2011
)
1.37
"Amlodipine-treated patients experienced a mean decrease in SBP of 26.7 mm Hg, compared with 18.8 mm Hg in patients receiving an ARB and 15.8 mm Hg for patients receiving an ACE inhibitor (P = 0.008, amlodipine vs ACE inhibitor)."( A retrospective electronic chart review of blood pressure changes in elderly patients treated with amlodipine or an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker.
Arocho, R; Brown, C; Dollar, A; McLaughlin, T; Okamoto, L; Putnam, D, 2002
)
1.25
"In amlodipine treated patients these figures were 103.4, 113.1 and 147.1%, respectively."( [Postoperative spasm of mammary-coronary grafts and possibilities of its correction by dihydropyridine calcium antagonists nifedipine and amlodipine].
Dzhavadova, GK; Mamchur, SE; Nemik, BM; Tepliakov, AT; Vecherskiĭ, IuIu, 2002
)
1.03
"Amlodipine treatment significantly reduced calcification in the lesions, whereas atorvastatin alone had no effect."( Differential effects of amlodipine and atorvastatin treatment and their combination on atherosclerosis in ApoE*3-Leiden transgenic mice.
Delsing, DJ; Emeis, JJ; Havekes, LM; Jukema, JW; Princen, HM; van de Wiel, MA; van der Laarse, A, 2003
)
1.35
"Amlodipine treatment reduced left ventricle, aortic and mesenteric artery weight."( Comparative study of the antihypertensive activity of Marrubium vulgare and of the dihydropyridine calcium antagonist amlodipine in spontaneously hypertensive rat.
El Bardai, S; Lyoussi, B; Morel, N; Wibo, M, 2004
)
1.25
"Amlodipine treatment produced a slight decrease of systolic blood pressure and an increased in heart rate, which were more pronounced in women."( Assessment of sex differences in pharmacokinetics and pharmacodynamics of amlodipine in a bioequivalence study.
Abad-Santos, F; Almeida, S; Gallego-Sandín, S; Gálvez-Múgica, MA; García, AG; Novalbos, J; Vallée, F, 2005
)
1.28
"Amlodipine treatment significantly reduced ambulatory blood pressure without altering the normal circadian variation throughout the monitoring period."( Effect of amlodipine on 24-hour ambulatory blood pressure in hypertensive patients.
Allenby, KS; Burris, JF; Mroczek, WJ, 1991
)
1.41
"Amlodipine treatment had no significant effect on heart rate."( Open evaluation of amlodipine in the monotherapeutic treatment of systolic hypertension in the elderly.
Lambert, M; Vandewoude, MF; Vryens, R, 1991
)
1.33
"Amlodipine treatment produced significant falls in blood pressure (-23.7/-17.3 mm Hg; p < 0.05) with no effect on heart rate."( The efficacy and safety of amlodipine in the treatment of mild and moderate essential hypertension in general practice.
Varrone, J, 1991
)
1.3
"No amlodipine-treated patients withdrew due to side effects."( An 8-week double-blind study of amlodipine and diltiazem in patients with stable exertional angina pectoris.
Barth, J; Bernink, PJ; de Weerd, P; Enthoven, R; Haagen, FD; Holwerda, NJ; Klomps, HC; Remme, WJ; ten, CF, 1991
)
1.08
"Amlodipine treatment significantly decreased the serum creatinine, more than 12 per cent lower than the FC group (from 70.4 +/- 6.2 to 61.4 +/- 5.2 micromol/L, p<0.05)."( Amlodipine preserves the glomerular number in spontaneously hypertensive rats.
Bezerra, DG; Mandarim-de-Lacerda, CA; Pires, KM,
)
2.3
"Amlodipine treatment in parallel with HCD feeding reduced the ischemic lesion size in ApoE KO mice."( Amlodipine treatment reduces stroke size in apolipoprotein E-deficient mice.
Chen, R; Horiuchi, M; Ide, A; Iwai, M; Iwanami, J; Mogi, M; Tsukuda, K; Yoshii, T, 2006
)
2.5
"Amlodipine treatment at doses of 1 and 3 mg/kg significantly increased the calcium (P<0.01) and phosphor concentrations (P<0.01) in the femurs of ovariectomized rats, compared to those of control (ovariectomized) group."( Protective effects of amlodipine and lacidipine on ovariectomy-induced bone loss in rats.
Borekci, B; Cadirci, E; Halici, Z; Ozdemir, Y; Suleyman, H, 2008
)
1.38
"Amlodipine treatment was associated with significantly fewer reports of headache and flushing than nifedipine retard (p < 0.05)."( Side effects of dihydropyridine therapy: comparison of amlodipine and nifedipine retard.
Bremner, AD; Fell, PJ; Hosie, J; James, GV; Saul, PA; Taylor, SH, 1993
)
1.25
"Amlodipine treatment (10 mg/kg/day orally) significantly reduced the increase in blood pressure (BP) in SHR, but did not change BP in WKY."( Selective interaction of the calcium antagonist amlodipine with calcium channels in arteries of spontaneously hypertensive rats.
Godfraind, T; Morel, N, 1994
)
1.27
"Amlodipine treatment induced corresponding increases in oxygen delivery (1302 vs."( Amlodipine improves hepatic hemodynamic and metabolic function in the isolated perfused rat liver after sequential cold and warm ischemia.
Dunne, JB; Piratvisuth, T; Tredger, JM; Williams, R, 1995
)
2.46
"Amlodipine treatment did not appear to produce clinically significant changes in blood lipids; HCTZ, however, produced an increase in total plasma cholesterol (delta 22.9 +/- 8.6 mg/dl)."( Double-blind comparison of amlodipine and hydrochlorothiazide in patients with mild to moderate hypertension.
Ames, RP; Applegate, WB; Burris, JF; Davidov, ME; Mroczek, WJ; Ram, CV, 1994
)
1.31
"Amlodipine-treated mice made significantly more avoidances on the test session than control animals."( Effect of the calcium channel blocker amlodipine on memory in mice.
Ermita, B; Hawxhurst, A; Puente, J; Quartermain, D, 1993
)
1.28
"Amlodipine treatment 1) lowered fasting serum insulin (from 273 +/- 19 to 200 +/- 17 pmol/L; P < 0.0005) and glucose (from 5.4 +/- 0.1 to 5.1 +/- 0.1 mmol/L; P < 0.02), 2) reduced the area under the curve for glucose (from 1342 +/- 25 to 1198 +/- 23 mmol/L.min; P = 0.0001) and the area under the curve for insulin (from 155.5 +/- 7.8 to 103.9 +/- 4.3 nmol/L.min; P = 0.0001) during the oral glucose tolerance test, 3) increased fasting serum DHEA-S (from 5.19 +/- 0.37 to 7.95 +/- 0.58 mumol/L; P = 0.0001) and androstenedione (from 5.65 +/- 0.65 to 6.83 +/- 0.53 nmol/L; P < 0.01), and 4) decreased fasting serum cortisol (from 538 +/- 35 to 494 +/- 26 nmol/L; P < 0.05)."( The calcium channel blocker amlodipine raises serum dehydroepiandrosterone sulfate and androstenedione, but lowers serum cortisol, in insulin-resistant obese and hypertensive men.
Beer, NA; Beer, RM; Jakubowicz, DJ; Nestler, JE, 1993
)
1.3
"Amlodipine treatment did not cause any significant change in the total and HDL cholesterol levels in both the obese and non-obese patients."( Relationship between body mass index (BMI) and changes in plasma total and HDL-cholesterol levels during treatment of hypertension in African patients.
Agbedana, OE; Ahaneku, JE; Taylor, OG, 1995
)
1.01
"Amlodipine treatment resulted in significant increase in total exercise time, increase the exercise time to angina onset, increase time to ST segment depression, decrease in ST segment depression, decrease in total duration of ST segment depression and decrease in duration of pain."( [Comparative study to assess the efficacy and adverse effects of amlodipine and nifedipine retard in patients with stable exertional angina and hypertension].
Hlawaty, M; Kubler, G; Negrusz-Kawecka, M; Olszowska, M; Salamon, P; Tracz, W; Witkowska, M, 1997
)
1.26
"Amlodipine-lovastatin cotreatment increased sialic acid and decreased the susceptibility of LDL to oxidation more effectively than amlodipine alone."( Antiatherosclerotic and antiatherogenic effects of a calcium antagonist plus statin combination: amlodipine and lovastatin.
Akhmedzhanov, NM; Orekhov, AN; Pivovarova, EM; Sobenin, IA; Tertov, VV, 1997
)
1.24
"In amlodipine-pretreated rats (15 mg kg(-1) day(-1), orally, for one week), the effect of LPS was lower than in untreated ones and it was completely reversed by L-NNA."( A therapeutic dosage of amlodipine prevents vascular hyporeactivity induced in rats by lipopolysaccharide.
Godfraind, T; Morel, N; Salomone, S, 1998
)
1.12
"Amlodipine treatment effectively reversed the infarct size augmentation in cholesterol-fed rabbits (46.3 +/- 6.3%, n = 9, P < 0.05), but did not affect infarct size in normal-fed rabbits (51.0 +/- 4.7%, n = 8)."( Reduction in infarct size by chronic amlodipine treatment in cholesterol-fed rabbits.
Hori, M; Hoshida, S; Kuzuya, T; Yamashita, N, 1998
)
1.29
"In amlodipine treated patients the increase in AUC of capillary blood cell velocity did not reach the level of statistical significance (1.59 +/- 1.36 to 2.14 +/- 1.05 mm)."( Effects of losartan titrated to losartan/hydrochlorothiazide and amlodipine on blood pressure and peripheral capillary microcirculation in patients with mild-to-moderate hypertension.
Drewe, J; Gasser, P; Martina, B; Weinbacher, M, 1998
)
1.05
"Amlodipine treatment resulted in a greater relative reduction in sudden deaths (21%) than in pump failure deaths (6.6%) overall."( Effect of amlodipine on mode of death among patients with advanced heart failure in the PRAISE trial. Prospective Randomized Amlodipine Survival Evaluation.
Anderson, S; Belkin, RN; Carson, PE; Cropp, AB; DeMets, DL; Frid, DJ; Miller, AB; Neuberg, GW; O'Connor, CM; Pressler, ML; Wertheimer, JH, 1998
)
1.42
"Amlodipine treatment caused a significant decrease in IMT compared with control (-0.052 +/- 0.017 vs."( Effect of calcium channel blocker amlodipine on the intimal-medial thickness of carotid arterial wall in type 2 diabetes.
Koshiyama, H; Minamikawa, J; Tanaka, S, 1999
)
1.3
"Amlodipine treatment slightly but significantly inhibited the enhanced responses in aorta but did not alter the responses in mesenteric arteries."( Effect of prolonged treatment with amlodipine on enhanced vascular contractility in cardiomyopathic hamsters.
Fukao, M; Hattori, Y; Kanno, M; Kitabatake, A; Okamoto, H; Sakuma, I; Sato, A; Tomioka, H; Watanabe, M, 1999
)
1.3
"Amlodipine treatment had no effect on alpha-tocopherol levels in plasma or cardiac tissue in SHR rats."( Effects of lisinopril and amlodipine on antioxidant status in experimental hypertension.
Ahmed, S; MacNee, W; Mantle, D; Patel, VB; Preedy, VR; Rahman, I; Richardson, PJ; Wassif, WS; Why, HJ, 2000
)
1.33
"Amlodipine treatment (0.04 mg amlodipine besylate/rat/day for 30 days) decreased plasma follicle-stimulating hormone and testosterone but not luteinizing hormone or prolactin concentrations (measured by double-antibody radioimmuno-assay)."( Antireproductive effect of the calcium channel blocker amlodipine in male rats.
Almeida, SA; Anselmo Franci, JA; Brentegani, LG; Lamano-Carvalho, TL; Teófilo, JM, 2000
)
1.28
"Amlodipine besilate treatment 1) lowered the fasting serum insulin level and total serum insulin level during 75 g-OGTT and 2) increased serum DHEA and DHEA-S levels."( Effects of amlodipine on serum levels of adrenal androgens and insulin in hypertensive men with obesity.
Miyachi, Y; Tsuboi, K; Ueshiba, H, 2001
)
1.42
"Amlodipine treatment reduced the level of adrenocortical angiotensin II type 2 receptor (AT2R) mRNA in SHR from 8 weeks of age."( Chronic treatment with amlodipine modulates adrenocortical angiotensin II receptors in spontaneously hypertensive rats.
Kataoka, H; Kishida, M; Makino, H; Mimura, Y; Nakamura, Y; Ogura, T; Otsuka, F; Takahashi, M; Yamauchi, T; Yokota, K, 2001
)
1.34
"Amlodipine treatment of hyperlipemic hamster was assessed."( The hyperlipemic hamster - a model for testing the anti-atherogenic effect of amlodipine.
Constantinescu, E; Ologeanu, L; Sima, A; Simionescu, M; Stancu, C,
)
1.08
"Amlodipine pretreatment attenuated this increase in a time- and dose-dependent manner."( Effect of amlodipine pretreatment on ischaemia-reperfusion-induced increase in cardiac endothelin-1 binding site density.
Casley, DJ; Gu, XH; Nayler, WG; Ou, RC, 1992
)
1.41
"Amlodipine treatment caused a rapid concentration-dependent decrease of intracellular calcium concentration in the HT-39 cell line."( Inhibition of cancer cell growth by calcium channel antagonists in the athymic mouse.
Simpson, RU; Taylor, JM, 1992
)
1
"Amlodipine-treated patients reported fewer adverse events (26%) than did the nitrendipine-treated group (47%), with two patients from the nitrendipine group discontinuing treatment due to treatment-related adverse events."( Amlodipine compared to nitrendipine for the treatment of mild-to-moderate hypertension.
Beressem, P; Englert, R; Kramar, M; Stafunsky, M; von Manteuffel, E, 1991
)
2.45
"Amlodipine treated patients had lower arterial pressures in both the supine and upright positions (P less than .001), higher HDL levels (P less than .05) and lower CHOL:HDL and LDL:HDL ratios (P less than .01), than placebo-treated patients."( Antihypertensive effectiveness of amlodipine in combination with hydrochlorothiazide.
Chrysant, C; Chrysant, SG; Hitchcock, A; Trus, J, 1989
)
1.28
"Amlodipine treatment was associated with a slightly higher incidence of side effects compared with placebo, but most of this difference was the result of edema, which was usually well tolerated."( The safety of amlodipine.
Osterloh, I, 1989
)
1.36
"Treatment with amlodipine appears to be effective in lowering SABP in cats with DM and SH."( Concurrent disorders of cats with diabetes mellitus and arterial systolic hypertension.
Hess, RS; Williams, JG, 2023
)
1.25
"Treatment with amlodipine appeared to improve ophthalmic lesions over time."( Ocular fundus abnormalities in cats affected by systemic hypertension: Prevalence, characterization, and outcome of treatment.
Andreani, V; Barsotti, G; Cirla, A; Drigo, M, 2021
)
0.96
"Treatment with amlodipine can be used to control portal hypertension in leukemic children having HCV-induced portal hypertension."( Treatment for hepatitis C virus-induced portal hypertension in leukemic children.
Al-Tonbary, Y; Darwish, A; El-Ashry, R; El-Gendy, AA; Ghayaty, EA; Malek, HA, 2013
)
0.73
"Treatment with amlodipine or atorvastatin alone significantly decreased left ventricular mass index, cardiomyocyte cross-sectional area and interstitial fibrosis in SHR (each P < 0.05)."( Amlodipine and atorvastatin improved hypertensive cardiac hypertrophy through regulation of receptor activator of nuclear factor kappa B ligand/receptor activator of nuclear factor kappa B/osteoprotegerin system in spontaneous hypertension rats.
Cui, W; Du, H; Hao, J; Liu, D; Liu, F; Lu, J; Yang, X, 2016
)
2.22
"Treatment with amlodipine, candesartan, or indapamide did not significantly affect plasma visfatin levels."( Effects of antihypertensive treatment on plasma apelin, resistin, and visfatin concentrations.
Piecha, G; Skoczylas, A; Więcek, A, 2016
)
0.77
"Rats treated with amlodipine showed improved postischemia neovascularization and cardiac function, together with reduced cardiac remodeling, decreased interstitial fibrosis, and cardiomyocyte apoptosis."( Amlodipine Ameliorates Ischemia-Induced Neovascularization in Diabetic Rats through Endothelial Progenitor Cell Mobilization.
Dong, L; Ferro, A; Kang, L; Sun, J; Xie, J; Xu, B, 2016
)
2.2
"Treatment with Amlodipine alone or combination with atorvastatin significantly decreased blood pressure, left ventricle mass index in SHR rats (P < 0.05 for both). "( Amlodipine and Atorvastatin Improved Hypertensive Cardiac Remodeling through Regulation of MMPs/TIMPs in SHR Rats.
Cui, W; Du, H; Hao, J; Li, Y; Lu, J; Xiao, B; Yang, X, 2016
)
2.23
"Treatment with amlodipine, however, was not associated with a significant difference in conduction outcome events (HR, 0.94; 95% CI, 0.81-1.09; P = .42)."( Effect of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) on Conduction System Disease.
Albert, CM; Alonso, A; Davis, BR; Dewland, TA; Haywood, LJ; Magnani, JW; Marcus, GM; Piller, LB; Soliman, EZ; Yamal, JM, 2016
)
0.77
"Pretreatment with amlodipine effectively counteracted the alteration in mitochondrial enzymes induced by ischemia-reperfusion liver damage."( Protective role of the calcium channel blocker amlodipine against mitochondrial injury in ischemia and reperfusion injury of rat liver.
Dagagi, AV; Kumar, WA; Pallab, C; Pronobesh, C, 2008
)
0.93
"Treatment with amlodipine + valsartan + HCTZ for up to 8 weeks was generally well tolerated in the large, phase III trial, with most adverse events being transient and of mild to moderate severity."( Amlodipine/valsartan/hydrochlorothiazide: fixed-dose combination in hypertension.
Deeks, ED, 2009
)
2.14
"Treatment with amlodipine/valsartan/hydrochlorothiazide maintained full 24-h effectiveness, including during the morning hours; all hourly mean ambulatory SBP and mean ambulatory DBP measurements were ≤130/85 mm Hg at end point."( 24-Hour ambulatory blood pressure control with triple-therapy amlodipine, valsartan and hydrochlorothiazide in patients with moderate to severe hypertension.
Calhoun, DA; Crikelair, N; Glazer, RD; Lacourcière, Y; Yen, J, 2011
)
0.95
"Pretreatment with amlodipine resulted in a dose-dependent suppression of Ang II-induced HUVEC apoptosis. "( Amlodipine treatment prevents angiotensin II-induced human umbilical vein endothelial cell apoptosis.
Bian, YF; Gao, F; Xiao, CS; Yang, HY; Yang, ZM; Zhang, NN, 2011
)
2.15
"Treatment with amlodipine is associated with increased clopidogrel OPR and increased risk of thrombotic events after PCI, which is dependent on the CYP3A5 genetic status."( Amlodipine, clopidogrel and CYP3A5 genetic variability: effects on platelet reactivity and clinical outcomes after percutaneous coronary intervention.
Kang, HJ; Kang, J; Kim, HS; Koo, BK; Lee, HY; Oh, BH; Park, JJ; Park, KW; Park, YB; Yang, HM, 2012
)
2.17
"Oral treatment with amlodipine (n=7), initiated at day 0, reduced systolic blood pressure, reversed cerebral edema and restored blood-brain barrier integrity."( Reduction of cerebral injury in stroke-prone spontaneously hypertensive rats by amlodipine.
Blezer, E; Goldschmeding, R; Joles, J; Koomans, H; Nicolay, K, 2002
)
0.86
"Treatment with amlodipine had no significant effect on atherosclerotic lesion area, whereas atorvastatin markedly reduced atherosclerosis by 77% compared with the control group."( Differential effects of amlodipine and atorvastatin treatment and their combination on atherosclerosis in ApoE*3-Leiden transgenic mice.
Delsing, DJ; Emeis, JJ; Havekes, LM; Jukema, JW; Princen, HM; van de Wiel, MA; van der Laarse, A, 2003
)
0.97
"Treatment with amlodipine may be an additional way of therapy in CHF."( [Influence of amlodipine on serum level of some cytokines in patients with congestive heart failure].
Halawa, B; Karolko, B; Salomon, P, 2003
)
1.02
"Treatment with amlodipine markedly inhibited the L-NAME-induced increase in vascular inflammation, oxidative stress, and local ACE and Rho activity and prevented arteriosclerosis."( Novel anti-inflammatory actions of amlodipine in a rat model of arteriosclerosis induced by long-term inhibition of nitric oxide synthesis.
Egashira, K; Hiasa, K; Inoue, S; Ishibashi, M; Kataoka, C; Kitamoto, S; Ni, W; Takeshita, A; Usui, M, 2004
)
0.94
"Pretreatment with amlodipine created no difference in both variables (p > 0.05)."( Radiocontrast-induced nephrotoxicity and urinary alpha-glutathione S-transferase levels: effect of amlodipine administration.
Altun, B; Arici, M; Cağlar, S; Erdem, Y; Kes, S; Turgan, C; Usalan, C; Yasavul, U, 2003
)
0.86
"Treatment with amlodipine and diltiazem resulted in an improvement in total exercise time, time to angina and total work, mean ST-segment deviation at maximum common load, median number of angina attacks/week, and NTG tablet consumption/week."( An 8-week double-blind study of amlodipine and diltiazem in patients with stable exertional angina pectoris.
Barth, J; Bernink, PJ; de Weerd, P; Enthoven, R; Haagen, FD; Holwerda, NJ; Klomps, HC; Remme, WJ; ten, CF, 1991
)
0.9
"Treatment with amlodipine did not significantly lower blood pressure, but resulted in a 43% reduction (P < 0.03) of lesion area as compared with the untreated group."( Anti-atherosclerotic effect of amlodipine, alone and in combination with atorvastatin, in APOE*3-Leiden/hCRP transgenic mice.
de Maat, M; Emeis, J; Havekes, L; Jukema, W; Maas, A; Offerman, E; Princen, H; Szalai, A; Trion, A; van der Laarse, A, 2006
)
0.96
"The treatment with amlodipine (AMLO group) or Tempol (TEMP group) significantly inhibited the development of LV hypertrophy and cardiac dysfunction."( Amelioration of hypertensive heart failure by amlodipine may occur via antioxidative effects.
Aburatani, H; Hasegawa, H; Kohro, T; Komuro, I; Niitsuma, Y; Takano, H; Ueda, K, 2006
)
0.91
"Treatment with amlodipine/benazepril 10/40 mg/day and 10/20 mg/day resulted in a decrease of mean sitting systolic and mean sitting diastolic BP by 13.3/12.7 mmHg and 12.1/11.6 mmHg, respectively, compared with monotherapy (6.6/8.5 mmHg) (p < 0.0001). "( The effects of high-dose amlodipine/benazepril combination therapies on blood pressure reduction in patients not adequately controlled with amlodipine monotherapy.
Arora, V; Chrysant, SG; Khan, M; Lefkowitz, M; Salko, T; Shi, V; Sugimoto, DH, 2007
)
1
"The treatment with amlodipine reduced SBP but failed to ameliorate the ADMA-induced histological changes."( Role of asymmetric dimethylarginine in vascular injury in transgenic mice overexpressing dimethylarginie dimethylaminohydrolase 2.
Hasegawa, K; Hayashi, K; Homma, K; Itoh, H; Kimoto, M; Sugano, N; Tatematsu, S; Wakino, S; Yoshioka, K, 2007
)
0.66
"Treatment with amlodipine either as monotherapy or combined with other antianginal therapy for up to 26 weeks shows that efficacy is maintained, with no evidence of tolerance.(ABSTRACT TRUNCATED AT 250 WORDS)"( Amlodipine once a day in stable angina: double-blind crossover comparison with placebo.
Cheitlin, MD; Das, SK; Deedwania, PC; Pasternak, RC; Pool, PE; Singh, JB, 1993
)
2.07
"Treatment with amlodipine was well tolerated and the incidence of side effects was low.(ABSTRACT TRUNCATED AT 250 WORDS)"( Double-blind evaluation of the dose-response relationship of amlodipine in essential hypertension.
Garland, WT; Gradman, AH; Lopez, LM; Mehta, JL; Nash, DT; O'Connell, MT; Pickering, BI; Vlachakis, ND, 1993
)
0.87
"Treatment with amlodipine in a concentration of 15 mg kg-1 also increased renin immunoreactive areas in the kidney cortex by retrograde recruitment of renin expressing cells in the afferent arterioles."( Effect of amlodipine on renin secretion and renin gene expression in rats.
Hamann, M; Kaissling, B; Krämer, BK; Kurtz, A; Macher, A; Schricker, K, 1996
)
1.04
"Pretreatment with amlodipine did not further modulate the cardiovascular reactivity."( A calcium-channel blocker, amlodipine, attenuates insulin antinatriuresis but does not modulate insulin-mediated attenuation of cardiovascular reactivity in healthy man.
Alvestrand, A; de Potocki, K; Ottosson-Seeberger, A; Stenvinkel, P, 1997
)
0.92
"Treatment with amlodipine alone and the amlodipine-lovastatin combination ameliorated the atherogenic effect of LDL."( Antiatherosclerotic and antiatherogenic effects of a calcium antagonist plus statin combination: amlodipine and lovastatin.
Akhmedzhanov, NM; Orekhov, AN; Pivovarova, EM; Sobenin, IA; Tertov, VV, 1997
)
0.85
"Treatment with amlodipine reduced the elevated fasting- and fed-glucose levels significantly."( Effect of chronic treatment with amlodipine in non-insulin-dependent diabetic rats.
Gokhale, MS; Goyal, RK; Hakim, Z; Santani, DD; Shah, DH, 1998
)
0.92
"The treatment with amlodipine normalized [Ca2+]i of PMNLs as well as the calcium transient in response to 3G8 monoclonal antibody and reversed the defect in their phagocytosis."( Effect of amlodipine therapy on the monoclonal antibody 3G8-induced calcium signal in polymorphonuclear leukocytes of hemodialysis patients.
Ahmed, A; Krol, E; Massry, SG; Smogorzewski, M, 1999
)
1.02
"Treatment with amlodipine versus placebo significantly delayed the mean (+/- SD) time to first hospitalization (447 +/- 26 d vs 315 +/- 18 d, respectively; P = 0.0139)."( Hospital use and costs among patients with nonischemic cardiomyopathy in the first prospective randomized amlodipine survival evaluation study.
Martin, BC; O'Connor, CM; Radensky, PW; Unger, AN, 1999
)
0.86
"Treatment with amlodipine resulted in an average cost per success of $609 per patient compared with $772 per enalapril-treated patient."( A retrospective analysis comparing the costs and cost effectiveness of amlodipine and enalapril in the treatment of hypertension.
Arikian, S; Arocho, R; Casciano, J; Casciano, R; Doyle, J; Gonzalez, MA; Omvik, P, 2001
)
0.88
"Treatment with amlodipine was found to reduce myocardial oxygen demand, improve recovery of peak developed tension, have a favourable effect on Ca2+ fluxes, improve retention of tissue adenosine triphosphate and creatine phosphate, and reduce acidosis in the ischaemic/reperfused myocardium."( The pharmacological profile of amlodipine in relation to ischaemic heart disease.
Burges, RA, 1991
)
0.91

Toxicity

The observation study confirmsthat Amlodipine besylate is an effective and safe antihypertensive drug both in mono and combination therapy. Adverse event incidence was low and comparable between losartan and placebo/amlodipines groups.

ExcerptReferenceRelevance
"The frequency and severity of adverse effects during the first 14 days of treatment with amlodipine (5 mg once daily), nifedipine retard (20 mg twice daily) or placebo were compared in a multicentre, three-way, cross-over study involving 97 patients with mild-to-moderate hypertension."( Comparison of early side effects with amlodipine and nifedipine retard in hypertension.
Bremner, AD; Fell, PJ; Hosie, J; James, IG; Saul, PA; Taylor, SH, 1992
)
0.78
" Most adverse events were mild or moderate and the investigators' overall evaluation of tolerability was excellent or good for 91% of patients."( A study of the efficacy and safety of amlodipine for the treatment of hypertension in general practice.
Varrone, J, 1991
)
0.55
" Thus amlodipine administered once daily is an effective and safe agent for second-step therapy in mild to moderate essential hypertension."( Safety and efficacy of amlodipine added to hydrochlorothiazide therapy in essential hypertension.
Chrysant, SG; Glasser, SP; Graves, J; Koehn, DK; Rofman, B, 1989
)
1.07
" No patient withdrawals resulted from adverse events directly related to amlodipine."( Clinical safety and efficacy of once-a-day amlodipine for chronic stable angina pectoris.
Glasser, SP; West, TW, 1988
)
0.77
" Apart from class-typical effects, such as edema for calcium antagonists, and cough for angiotensin-converting enzyme inhibitors, both drugs were equally well tolerated, with few adverse effects of clinical significance."( A double-blind, long-term, comparative study on quality of life, safety, and efficacy during treatment with amlodipine or enalapril in mild or moderate hypertensive patients: a multicenter study.
Eide, I; Herland, OB; Midha, R; Omvik, P; Thaulow, E; Turner, RR, 1993
)
0.5
" Adverse events were reported in 28% of patients treated with lacidipine and in 48% of patients receiving amlodipine."( Efficacy and safety evaluation of lacidipine compared with amlodipine in mild-to-moderate hypertensive patients.
Lombardo, D; Raimondi, F, 1994
)
0.75
"3% of amlodipine patients recording adverse events, compared with 13."( Amlodipine and the total ischemic burden: circadian anti-ischemia program in Europe (CAPE) trial-methodology, safety and toleration. The Steering Committee members and all of the investigators.
Detry, JM, 1994
)
2.21
" A side effect of mild headache was reported by one patient (2."( Efficacy and safety of amlodipine in hypertensive patients with renal dysfunction.
Abe, K; Iimura, I; Ishii, M; Saruta, T, 1994
)
0.6
" Adverse experiences possibly related to amlodipine were reported by 19."( A multicentre study of the safety and efficacy of amlodipine in mild to moderate hypertension.
Cross, BW; Kirby, MG; Miller, S; Shah, S; Sheldon, DM; Sweeney, MT,
)
0.65
" Therefore, the new once-daily calcium antagonist amlodipine is safe and efficacious in non-hypertensive patients with coronary artery disease."( Safety and efficacy of amlodipine. A new once-daily calcium antagonist in non-hypertensive patients with coronary artery disease.
Ogawa, T; Sugishita, Y; Tomizawa, T; Yasui, K, 1993
)
0.85
" The overall incidence of adverse effects were temporary and extremely limited (2%)."( Middle term evaluation of amlodipine vs nitrendipine: efficacy, safety and metabolic effects in elderly hypertensive patients.
Feraco, E; Grandinetti, O, 1993
)
0.59
" Nineteen patients in the amlodipine group experienced at least one adverse event compared with 12 in the nifedipine coat-core group."( Comparison of the efficacy and safety of nifedipine coat-core versus amlodipine in the treatment of patients with mild-to-moderate essential hypertension. Hypertension Study Group.
Breuer, HW; Knaup, G; Spiecker, C; Steindl, L; Zidek, W,
)
0.67
" Nor have previous studies compared commonly used quality of life instruments for consistency, or investigated whether improvement or worsening of quality of life correlates with adverse events or blood pressure reduction."( Antihypertensive therapy and quality of life. Influence of blood pressure reduction, adverse events, and prior antihypertensive therapy.
Adegbile, IA; Alemayehu, D; Lefkowitz, MP; Papademetriou, V; Prisant, LM; Weber, MA; Weir, MR, 1996
)
0.29
" With the 50-mg dose of mibefradil, the incidence of each adverse event was similar to, or lower than, that observed in the placebo-treated patients."( Safety of mibefradil, a new once-a-day, selective T-type calcium channel antagonist.
Charlon, V; Kobrin, I; Lindberg, E; Pordy, R, 1997
)
0.3
" No serious adverse events occurred in any patients during therapy with amlodipine as well as with nifedipine."( [Comparative study to assess the efficacy and adverse effects of amlodipine and nifedipine retard in patients with stable exertional angina and hypertension].
Hlawaty, M; Kubler, G; Negrusz-Kawecka, M; Olszowska, M; Salamon, P; Tracz, W; Witkowska, M, 1997
)
0.77
" Outcome measures included cardiovascular and noncardiovascular deaths, and adverse cardiovascular events including new/worsened angina, myocardial infarction (MI), serious arrhythmia, stroke, congestive heart failure, and bleeding."( Safety of long-acting dihydropyridine calcium channel blockers in hypertensive patients.
Kloner, RA; Levenstein, M; Materson, BJ; Vetrovec, GW, 1998
)
0.3
"The primary aim of this double-blind, parallel group trial was to compare incidence of newly occurring vasodilatory adverse events in elderly patients treated with recommended once-daily doses of felodipine extended release (ER) or amlodipine."( Improved tolerability of felodipine compared with amlodipine in elderly hypertensives: a randomised, double-blind study in 535 patients, focusing on vasodilatory adverse events. The International Study Group.
Aldons, PM; Burgess, ED; Girerd, X; Morgan, TO; Rehn, L; Schaefer, RM; Singh, GP; Tilvis, R, 1998
)
0.74
" Angiotensin II receptor antagonists provide adequate 24-hour blood pressure control, as measured by ambulatory blood pressure monitoring, and have a side-effect profile similar to placebo."( Safety and efficacy of angiotensin II receptor antagonists.
Neutel, JM, 1999
)
0.3
" Telmisartan, a new angiotensin receptor blocker, is a safe and effective drug to use in combination for the treatment of patients with severe hypertension and proved at least as effective as the enalapril combination."( The efficacy and safety of telmisartan compared to enalapril in patients with severe hypertension.
Neutel, JM; Reilly, PA; Smith, DH,
)
0.13
" Overall adverse events for bisoprolol and amlodipine were 39% and 40%, respectively."( Efficacy, safety, and effects on quality of life of bisoprolol/hydrochlorothiazide versus amlodipine in elderly patients with systolic hypertension.
Benetos, A; Consoli, S; Dubanchet, A; Safar, M; Safavian, A, 2000
)
0.79
"The HOCM, diatrizoate, was more toxic to rat kidneys than the LOCM iohexol; PLA2, LPO and calcium load played a role in producing renal function impairment induced by diatrizoate meglumine; amlodipine protected the renal tissue from nephrotoxicity induced by diatrizoate."( Nephrotoxicity of high- and low-osmolar contrast media. The protective role of amlodipine in a rat model.
Duan, SB; Liu, FY; Liu, RH; Luo, JA; Peng, YM; Wu, HW; Yang, XL, 2000
)
0.72
" The incidence of adverse events was lower in the amlodipine relative to the nifedipine group (11."( [Amlodipine versus nifedipine retard. A randomized double-blind comparative study on long-term efficacy and safety of amlodipine and nifedipine retard in the monotherapy of chronic stable angina pectoris].
Kupper, W; Sauerbrey-Wullkopf, N, 2001
)
1.47
" Given the lower incidence of adverse events with amlodipine and its convenient once daily dosing regimen, however, amlodipine may help to enhance patient compliance."( [Amlodipine versus nifedipine retard. A randomized double-blind comparative study on long-term efficacy and safety of amlodipine and nifedipine retard in the monotherapy of chronic stable angina pectoris].
Kupper, W; Sauerbrey-Wullkopf, N, 2001
)
1.47
" Details of any adverse event reported or noted during the treatment with the combination were recorded in the appropriate section of the case record form, whether considered treatment related or not, as reported by the patients."( Efficacy and safety of losartan-amplodipine combination--an Indian postmarketing surveillance experience.
Gokhale, N; Pawar, D; Shahani, S, 2002
)
0.31
" Adverse events were mild and infrequent (headache, edema, and dizziness at rates of 4% to 15%), and similar for both agents."( Comparative efficacy and safety of nisoldipine extended-release (ER) and amlodipine (CESNA-III study) in African American patients with hypertension.
Ferdinand, K; Noveck, RJ; Saunders, E; White, WB, 2003
)
0.55
"Nisoldipine ER was as effective as amlodipine in reducing 24-h BP in African-American patients with hypertension, with a similar adverse effect profile."( Comparative efficacy and safety of nisoldipine extended-release (ER) and amlodipine (CESNA-III study) in African American patients with hypertension.
Ferdinand, K; Noveck, RJ; Saunders, E; White, WB, 2003
)
0.83
"The observation study confirmsthat Amlodipine besylate is an effective and safe antihypertensive drug both in mono and combination therapy."( [Safety and antihypertensive efficacy of the dihydropyridine calcium antagonist Amlodipine besylate--results from an observational study in 9,672 patients].
Clemens, A; Keck, M; Regourd, E; Sauerbrey-Wullkopf, N, 2004
)
0.83
" No patient required discontinuation of amlodipine because of adverse effects."( Efficacy and safety of prolonged amlodipine treatment in hypertensive children.
Flynn, JT, 2005
)
0.88
" The adverse events related with the treatment were significantly less frequent with E/N than with a (19."( [Double blind study of the efficacy and safety of the fixed dose combination of enalapril 10 mg/nitrendipine 20 mg versus the increase of amlopidine dose in essential hypertensive patients not controlled with amlodipine 5 mg].
de la Figuera-von Wichman, M; de la Sierra-Iserte, A; Delgadillo-Duarte, J; Luque-Otero, M; Marín-Iranzo, R; Oliván-Martínez, J; Pontes-García, C; Redón-Mas, J; Roca-Cusachs, A, 2005
)
0.52
" Evaluation of safety of the trial was based on the evaluation of a physician, standard laboratory evaluation, adverse effects."( Clinical study on safety and efficacy of the administration of amlodipine in a combination with lisinopril in hypertensive patients.
Arslanagic, A; Bajraktarevic, A; Zulic, I, 2005
)
0.57
" Minor adverse effects have been reported, which were not a reason for interruption of the treatment, with the exception of 3 cases (lower leg oedema, dry cough)."( Clinical study on safety and efficacy of the administration of amlodipine in a combination with lisinopril in hypertensive patients.
Arslanagic, A; Bajraktarevic, A; Zulic, I, 2005
)
0.57
" Amlodipine was well tolerated, with most adverse events being mild or moderate."( The efficacy and safety of amlodipine in the treatment of mild and moderate essential hypertension in general practice.
Varrone, J, 1991
)
1.49
" Twenty-seven patients experienced adverse events reported as drug related."( An open multicenter efficacy and safety evaluation of amlodipine in the treatment of symptomatic myocardial ischemia.
Beckerman, B, 1991
)
0.53
" Amlodipine was not associated with adverse effects on hematologic or biochemical safety parameters nor on serum cholesterol or triglyceride levels."( An update on the safety of amlodipine.
Osterloh, IH, 1991
)
1.49
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32
" Following coadministered treatment, the adverse events reported were similar to either agent alone."( Efficacy and safety of coadministered amlodipine and atorvastatin in patients with hypertension and dyslipidemia: results of the AVALON trial.
Bakris, GL; Ferrera, D; Flack, JM; Houston, MC; Lee, E; Messerli, FH; Neutel, JM; Petrella, RJ; Sun, W, 2006
)
0.6
" Effects on systolic blood pressure, heart rate, biochemical variables, adverse events and quality of life were studied as secondary efficacy parameters."( Efficacy and safety of 24 weeks of therapy with bendroflumethiazide 1.25 mg/day or 2.5 mg/day and potassium chloride compared with enalapril 10 mg/day and amlodipine 5 mg/day in patients with mild to moderate primary hypertension : a multicentre, randomis
Borrild, N; Rasmussen, S; Vang Andersen, J, 2006
)
0.53
" The incidences of adverse events were similar in the low-dose bendroflumethiazide groups, with significantly higher incidences in the enalapril and amlodipine groups."( Efficacy and safety of 24 weeks of therapy with bendroflumethiazide 1.25 mg/day or 2.5 mg/day and potassium chloride compared with enalapril 10 mg/day and amlodipine 5 mg/day in patients with mild to moderate primary hypertension : a multicentre, randomis
Borrild, N; Rasmussen, S; Vang Andersen, J, 2006
)
0.73
"2%) experienced adverse events related to the study drug, mostly mild to moderate in nature."( Efficacy and safety of amlodipine: a comparative study of hypertensive patients treated at primary- and specialised-care centres.
Arístegui, R; Gil, A; Hernández, V; Jiménez, R; Valcárcel, Y, 2006
)
0.64
" The most frequent adverse events were visual symptoms and sinus bradycardia with ivabradine (0."( Antianginal efficacy and safety of ivabradine compared with amlodipine in patients with stable effort angina pectoris: a 3-month randomised, double-blind, multicentre, noninferiority trial.
Ford, I; Fox, KM; Ruzyllo, W; Tendera, M, 2007
)
0.58
" Safety and tolerability evaluations were based on adverse events, ECG and laboratory tests, and clinically relevant reports of abnormalities."( Antihypertensive efficacy and safety of manidipine versus amlodipine in elderly subjects with isolated systolic hypertension: MAISH study.
Alberici, M; Lembo, G; Payeras, AC; Sladek, K, 2007
)
0.58
" Overall, coadministered atorvastatin and amlodipine was well tolerated and without adverse pharmacodynamic interaction; combination treatment did not affect the low-density lipoprotein cholesterol-lowering efficacy and safety of atorvastatin, or the systolic blood pressure-lowering efficacy and safety of amlodipine."( A randomized, placebo-controlled trial to evaluate the efficacy, safety, and pharmacodynamic interaction of coadministered amlodipine and atorvastatin in 1660 patients with concomitant hypertension and dyslipidemia: the respond trial.
Dykstra, G; Gillen, D; Harvey, P; Herfert, O; Jukema, JW; Preston, RA; Sun, F, 2007
)
0.81
" However, valsartan/amlodipine offered some advantages in terms of less pronounced BP orthostatic changes and absence of metabolic adverse effects."( Efficacy and safety of two treatment combinations of hypertension in very elderly patients.
Corradi, L; Derosa, G; Fogari, R; Lazzari, P; Mugellini, A; Preti, P; Zoppi, A,
)
0.45
"The addition of an angiotensin II receptor blocker to calcium channel blocker-based antihypertensive therapy may be associated with enhanced efficacy and reduced risk of adverse events."( Effective and safe reduction of blood pressure with the combination of amlodipine 5 mg and valsartan 160 mg in hypertensive patients not controlled by calcium channel blocker monotherapy.
Ansari, A; Brachmann, J; Handrock, R; Klebs, S; Mahla, G, 2008
)
0.58
" Adverse event rates were low in both treatment phases, and most were mild or moderate in severity."( Effective and safe reduction of blood pressure with the combination of amlodipine 5 mg and valsartan 160 mg in hypertensive patients not controlled by calcium channel blocker monotherapy.
Ansari, A; Brachmann, J; Handrock, R; Klebs, S; Mahla, G, 2008
)
0.58
" Also, the incidence and severity of adverse events (AEs) and adverse drug reactions (ADRs) were reported."( Efficacy and safety profiles of a new S(-)-amlodipine nicotinate formulation versus racemic amlodipine besylate in adult Korean patients with mild to moderate hypertension: an 8-week, multicenter, randomized, double-blind, double-dummy, parallel-group, ph
Ahn, TH; Chung, N; Kim, SA; Lim, DS; Oh, BH; Park, S; Tahk, SJ; Yang, JY, 2008
)
0.61
" The combination of A 10 + Val 160 was well tolerated, and the observed adverse events (15."( Efficacy and safety of the single pill combination of amlodipine 10 mg plus valsartan 160 mg in hypertensive patients not controlled by amlodipine 10 mg plus olmesartan 20 mg in free combination.
Ansari, A; Braun, N; Handrock, R; Klebs, S; Ulmer, HJ, 2009
)
0.6
" The most frequently reported adverse events (AEs) were peripheral edema, upper respiratory tract infection, headache and bronchitis."( Long-term safety, tolerability and efficacy of combination therapy with aliskiren and amlodipine in patients with hypertension.
Hollanders, G; Liao, W; Littlejohn, TW; Trenkwalder, P; Zhao, Y, 2009
)
0.58
" Between-group comparisons of adverse events and changes in laboratory parameters did not reach statistical significance, except for uric acid which showed a significant increase in the valsartan/hydrochlorothiazide group compared with the amlodipine group, but was still below the laboratory's upper limit of normal."( Efficacy and safety of valsartan/hydrochlorothiazide fixed-dose combination compared with amlodipine monotherapy as first-line therapy for mild to moderate hypertension.
Chao, CL; Chen, JC; Chiang, FT; Hwang, JJ; Lin, LC; Lin, LY; Lin, YH; Tsai, CT; Wang, YC,
)
0.53
" The most common adverse events were peripheral oedema (11."( International open-label studies to assess the efficacy and safety of single-pill amlodipine/atorvastatin in attaining blood pressure and lipid targets recommended by country-specific guidelines: the JEWEL programme.
Bauer, B; da Silva, PM; Feldman, RD; Genest, J; Gensini, G; Harvey, P; Jenssen, TG; John Mancini, GB; Manolis, AJ; Richard Hobbs, FD, 2009
)
0.58
" Tolerability was assessed by treatment-emergent adverse events."( Evaluation of safety and efficacy of telmisartan-amlodipine combination in treating hypertension.
Faruqui, AA, 2008
)
0.6
" After 8 weeks of treatment, the combination of amlodipine + OM is safe and efficacious, irrespective of baseline hypertension stage or prior antihypertensive medication use."( Subgroup analyses of an efficacy and safety study of concomitant administration of amlodipine besylate and olmesartan medoxomil: evaluation by baseline hypertension stage and prior antihypertensive medication use.
Karki, S; Lee, J; Melino, M; Oparil, S, 2009
)
0.83
" Study medication was safe and well tolerated."( Efficacy and safety of long-term treatment with the combination of amlodipine besylate and olmesartan medoxomil in patients with hypertension.
Chrysant, SG; Heyrman, R; Karki, S; Lee, J; Melino, M; Oparil, S, 2009
)
0.59
" Adverse effects (headache, excessive heartbeat, peripheral edema) were less in patients who have received S(-)AMLODIPINE besylate that contributed to more expressed positive clinical dynamic of the state of patients of this group."( [Comparative estimation of efficiency and safety of racemic amlodipine and its S-enantiomer in hypertensive patients].
Alshantti, IS; Kuz'minova, NV; Sierkova, VK,
)
0.59
" Incidence of adverse events was comparable in monotherapy and combination therapy groups."( [Efficacy and safety of the single pill combination of valsartan 80 mg plus amlodipine 5 mg in mild to moderate essential hypertensive patients without adequate blood pressure control by monotherapy].
Huang, J; Ke, YN; Zhu, JR, 2009
)
0.58
" Safety assessments included monitoring and recording of adverse events (AEs)."( Efficacy and safety of a single-pill combination of amlodipine/valsartan in Asian hypertensive patients inadequately controlled with amlodipine monotherapy.
Cardenas, P; Hong, H; Ke, Y; Wang, R; Zhang, Y; Zhu, D; Zhu, J, 2010
)
0.61
" These results suggest that olmesartan/amlodipine is effective and safe in a wide range of patients, regardless of age or hypertension severity."( Efficacy and safety of olmesartan medoxomil plus amlodipine in age, gender and hypertension severity defined subgroups of hypertensive patients.
Böhm, M; Schmieder, RE, 2011
)
0.89
" Head-to-head randomized controlled trials (RCTs) of 12 months minimum duration reporting comparative efficacy (changes in systolic and diastolic blood pressure) and safety (total adverse events and ankle oedema), were included."( Efficacy and safety profiles of manidipine compared with amlodipine: a meta-analysis of head-to-head trials.
Laurent, S; Richy, FF, 2011
)
0.61
"Two thousand seven hundred and eighty-five patients with arterial hypertension were enrolled, 52 discontinued (eight due to adverse events), and four patients' data were missing."( Real-life safety and effectiveness of amlodipine/valsartan combination in the treatment of hypertension.
Chazova, IE; Dongre, N; Vigdorchik, AV, 2011
)
0.64
" Adverse event incidence was low and comparable between losartan and placebo/amlodipine groups."( Efficacy and safety of losartan in children with Alport syndrome--results from a subgroup analysis of a prospective, randomized, placebo- or amlodipine-controlled trial.
Gleim, GW; Lam, C; Le Bailly De Tilleghem, C; Shahinfar, S; Strehlau, J; Webb, NJ; Wells, TG, 2011
)
0.8
" Adverse events were experienced by 34."( Efficacy and safety of aliskiren-based dual and triple combination therapies in US minority patients with stage 2 hypertension.
Ferdinand, KC; Israel, M; Jaimes, EA; Lee, J; Purkayastha, D; Weitzman, R,
)
0.13
" Both treatment groups had similar adverse event rates (35."( Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension.
Black, HR; Hilkert, R; Israel, M; Izzo, J; Lee, J; Purkayastha, D; Sridharan, K; Weinberger, MH, 2011
)
0.61
" Most treatment-emergent adverse events were mild to moderate in severity."( Efficacy and safety of triple-combination therapy with olmesartan, amlodipine, and hydrochlorothiazide in study participants with hypertension and diabetes: a subpopulation analysis of the TRINITY study.
Chrysant, SG; Fernandez, V; Heyrman, R; Izzo, JL; Kereiakes, DJ; Lee, J; Littlejohn, T; Melino, M; Oparil, S,
)
0.37
" The observational period was 12 weeks, during which time surveys on outpatient blood pressure, adverse events, palatability, etc."( Efficacy, safety, and palatability of RACTAB(®) formulation amlodipine orally disintegrating tablets.
Fukui-Soubou, M; Kawashima, K; Terada, T; Terashima, H; Utsunomiya, O, 2011
)
0.61
" Adverse events observed were not significantly different from those observed during drug use trials of amlodipine formulations reported in 2003."( Efficacy, safety, and palatability of RACTAB(®) formulation amlodipine orally disintegrating tablets.
Fukui-Soubou, M; Kawashima, K; Terada, T; Terashima, H; Utsunomiya, O, 2011
)
0.83
" There were 38 adverse events in 20 patients (21."( Comparative efficacy and safety profile of amlodipine 5 mg/losartan 50 mg fixed-dose combination and amlodipine 10 mg monotherapy in hypertensive patients who respond poorly to amlodipine 5 mg monotherapy: an 8-week, multicenter, randomized, double-blind
Chae, SC; Cho, SY; Hong, TJ; Jeong, JW; Jung, JW; Kang, SM; Kim, CH; Kim, JJ; Kim, MH; Kwon, J; Park, CG; Park, SH; Shin, DG; Yang, JY; Yoon, JH; Youn, JC, 2011
)
0.63
"Antihypertensive therapy is effective in reducing the risk of major adverse cardiovascular events."( Combination of amlodipine plus angiotensin receptor blocker or diuretics in high-risk hypertensive patients: a 96-week efficacy and safety study.
Deng, Q; Liu, L; Liu, M; Ma, L; Sun, H; Wang, J; Wang, W; Zhang, Y; Zhao, Y, 2012
)
0.73
" Safety evaluations included monitoring of any adverse events (AEs)."( Combination of amlodipine plus angiotensin receptor blocker or diuretics in high-risk hypertensive patients: a 96-week efficacy and safety study.
Deng, Q; Liu, L; Liu, M; Ma, L; Sun, H; Wang, J; Wang, W; Zhang, Y; Zhao, Y, 2012
)
0.73
" Adverse events occurred at 11."( Efficacy and safety of aranidipine enteric-coated tablets compared with amlodipine in Chinese patients with mild to moderate essential hypertension: a multicenter, randomized, double-blind, parallel-controlled clinical trial.
Chen, GL; Fan, CM; Li, HM; Li, YS; Lin, YZ; Pang, HM; Wang, L; Wu, SY; Yan, LR; Yu, J; Zhao, RP, 2012
)
0.61
" There were no significant differences in adverse effects between groups, with the exception of more respiratory disorders in the amlodipine/benazepril group than in the valsartan/hydrochlorothiazide group (17 vs 5; P = 0 ."( Comparison of the efficacy and safety profiles of two fixed-dose combinations of antihypertensive agents, amlodipine/benazepril versus valsartan/hydrochlorothiazide, in patients with type 2 diabetes mellitus and hypertension: a 16-week, multicenter, rando
Chen, JF; Hung, YJ; Lee, IT; Lee, WJ; Sheu, WH; Wang, CY, 2012
)
0.8
" However, respiratory adverse events (particularly coughing) were more frequently reported in the amlodipine/benazepril group."( Comparison of the efficacy and safety profiles of two fixed-dose combinations of antihypertensive agents, amlodipine/benazepril versus valsartan/hydrochlorothiazide, in patients with type 2 diabetes mellitus and hypertension: a 16-week, multicenter, rando
Chen, JF; Hung, YJ; Lee, IT; Lee, WJ; Sheu, WH; Wang, CY, 2012
)
0.81
" Safety profile was assessed by recording adverse events reported by patients or observed by the investigator."( I-ADD study: assessment of efficacy and safety profile of irbesartan/amlodipine fixed-dose combination therapy compared with irbesartan monotherapy in hypertensive patients uncontrolled with irbesartan 150 mg monotherapy: a multicenter, phase III, prospec
Bobrie, G, 2012
)
0.61
" Treatment-emergent adverse events were experienced by 10."( I-ADD study: assessment of efficacy and safety profile of irbesartan/amlodipine fixed-dose combination therapy compared with irbesartan monotherapy in hypertensive patients uncontrolled with irbesartan 150 mg monotherapy: a multicenter, phase III, prospec
Bobrie, G, 2012
)
0.61
" Safety profile was assessed by recording adverse events reported by patients or observed by the investigator."( I-COMBINE study: assessment of efficacy and safety profile of irbesartan/amlodipine fixed-dose combination therapy compared with amlodipine monotherapy in hypertensive patients uncontrolled with amlodipine 5 mg monotherapy: a multicenter, phase III, prosp
Bobrie, G, 2012
)
0.61
" Treatment-emergent adverse events were experienced by 13."( I-COMBINE study: assessment of efficacy and safety profile of irbesartan/amlodipine fixed-dose combination therapy compared with amlodipine monotherapy in hypertensive patients uncontrolled with amlodipine 5 mg monotherapy: a multicenter, phase III, prosp
Bobrie, G, 2012
)
0.61
" Safety was assessed by recording all adverse events."( Safety and efficacy of aliskiren/amlodipine/hydrochlorothiazide triple combination in patients with moderate to severe hypertension: a 54-week, open-label study.
Garcia-Puig, J; Koenig, W; Murray, AV; Patel, S; Uddin, A; Zhang, J, 2012
)
0.66
"Olme/Amlo single pill combination can be a safe and effective option to reduce blood pressure, improve insulin sensitivity and decrease inflammatory markers."( Evaluation of safety and efficacy of a fixed olmesartan/amlodipine combination therapy compared to single monotherapies.
Carbone, A; Cicero, AF; D'Angelo, A; Derosa, G; Fogari, E; Maffioli, P; Querci, F, 2013
)
0.64
"7%) patients experienced a total of 174 adverse events (AEs)."( Efficacy and safety of valsartan and amlodipine single-pill combination in hypertensive patients (PEAK study).
Berktaş, M; Boyacı, B; Kızılırmak, P; Yalçın, MR, 2013
)
0.66
" All adverse events (AEs) were resolved without sequelae; no serious AEs were reported."( Pharmacokinetics, tolerability, and safety of the single oral administration of AGSAV301 vs Exforge: a randomized crossover study of healthy male volunteers.
Bae, KS; Choi, HY; Kim, MJ; Kim, YH; Lee, SH; Lim, HS; Noh, YH, 2014
)
0.4
" Incidence of adverse events (AEs) and serious AEs (SAEs) was recorded as safety variables."( Real-life effectiveness, safety, and tolerability of amlodipine/valsartan or amlodipine/valsartan/hydrochlorothiazide single-pill combination in patients with hypertension from Pakistan.
Abid, R; Afzal, J; Iktidar, S; Khan, W; Kumar, K; Maheshwary, N; Moin, N; Qadir, M; Sakrani, J; Siddiqi, A, 2014
)
0.65
" The incidence of adverse events was similar across the treatment groups."( Open-label study assessing the long-term efficacy and safety of triple olmesartan/amlodipine/hydrochlorothiazide combination therapy for hypertension.
Ammentorp, B; de la Sierra, A; Laeis, P; Volpe, M, 2014
)
0.63
" Safety assessments consisted of recording all adverse events."( Efficacy and safety of valsartan/amlodipine single-pill combination in patients with essential hypertension (PEAK LOW).
Ar, I; Ilerigelen, B; Kızılırmak, P, 2014
)
0.68
"2%) experienced a total of 12 adverse events; there were no serious adverse events."( Efficacy and safety of valsartan/amlodipine single-pill combination in patients with essential hypertension (PEAK LOW).
Ar, I; Ilerigelen, B; Kızılırmak, P, 2014
)
0.68
" The incidence of drug-related adverse effects did not differ significantly between the groups."( Efficacy and safety of olmesartan medoxomil/amlodipine fixed-dose combination for hypertensive patients uncontrolled with monotherapy.
Gao, PJ; Zhang, SY; Zhu, JR, 2014
)
0.66
" Tolerability was assessed by recording treatment-emergent adverse events (TEAEs)."( Efficacy and safety of the dual L- and T-type calcium channel blocker, ACT-280778: a proof-of-concept study in patients with mild-to-moderate essential hypertension.
Dingemanse, J; Klainman, E; Kracker, H; Mueller, MS; Otasevic, P; Putnikovic, B; Shakeri-Nejad, K; Zimlichman, R, 2015
)
0.42
" Adverse events were assessed."( Efficacy and safety of fixed-dose losartan/hydrochlorothiazide/amlodipine combination versus losartan/hydrochlorothiazide combination in Japanese patients with essential hypertension.
Azuma, K; Fujita, KP; Nishida, C; Numaguchi, H; Rakugi, H; Shimada, K; Shirakawa, M; Tsuchihashi, T; Yamaguchi, H, 2015
)
0.66
" Deaths and adverse reactions were absent barring clinically insignificant side effects in 28 of the 160 patients (17."( [Effectiveness and safety of losartan and its combination with amlodipine in therapy of arterial hypertension].
Bazaeva, EV; Boitsov, SA; Drapkina, OM; Luk'ianov, MM; Panov, AV; Shchukina, GN; Terent'ev, BP; Tiurin, VP, 2013
)
0.63
"Losartan and amlodipine are effective and safe agents for AH therapy."( [Effectiveness and safety of losartan and its combination with amlodipine in therapy of arterial hypertension].
Bazaeva, EV; Boitsov, SA; Drapkina, OM; Luk'ianov, MM; Panov, AV; Shchukina, GN; Terent'ev, BP; Tiurin, VP, 2013
)
1
" Efficacy was assessed in accordance with the Austrian hypertension guidelines while tolerability was evaluated on the basis of adverse events."( Efficacy, safety, and tolerability of antihypertensive therapy with aliskiren/amlodipine in clinical practice in Austria. The RALLY (Rasilamlo long lasting efficacy) study.
Ratzinger, M; Rosenkranz, AR, 2015
)
0.65
" Overall, 44 adverse events were documented in 41 patients, and physicians reported that 94 % of patients were compliant in a final survey on evaluation of therapy."( Efficacy, safety, and tolerability of antihypertensive therapy with aliskiren/amlodipine in clinical practice in Austria. The RALLY (Rasilamlo long lasting efficacy) study.
Ratzinger, M; Rosenkranz, AR, 2015
)
0.65
"0001), and a lower incidence of pedal edema and adverse events compared with amlodipine."( Efficacy and safety of perindopril arginine + amlodipine in hypertension.
Bakris, GL; Elliott, WJ; Feldstein, JD; Whitmore, J, 2015
)
0.9
" Overall, the olmesartan/amlodipine FDC was well tolerated, and there were no serious adverse events associated with medication."( A multicenter, non-comparative study to evaluate the efficacy and safety of fixed-dose olmesartan/amlodipine in Korean patients with hypertension who are naïve or non-responders to anti-hypertensive monotherapy (ACE-HY study).
Ahn, Y; Bae, JH; Jung, HW; Kang, DH; Kim, CH; Kim, KI; Park, CG, 2015
)
0.94
" Treatment-emergent adverse events (AEs) were also assessed."( A Randomized, Multicenter, Double-blind, Placebo-controlled, 3 × 3 Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of the Combination of Fimasartan/Amlodipine in Patients With Essential Hypertension.
Ahn, T; Ahn, Y; Bae Park, J; Cho, EJ; Choi, DJ; Chull Chae, S; Chun, KJ; Han, KR; Hyon, MS; Jeon, ES; Jeong, JO; Joo, SJ; Kim, DI; Kim, DS; Kim, JJ; Kim, KS; Kim, YJ; Kwan, J; Lee, HY; Oh, SK; Park, JS; Rhee, MY; Seog Seo, H; Shin, JH; Sung, KC; Yoo, BS; Youn, HJ, 2015
)
0.61
" Adverse events (4."( Safety and effectiveness of combined antihypertensive and cholesterol-lowering therapy in high-/very high-risk patients.
Gaszner, B; Hild, G; Kónyi, A; Sárszegi, Z, 2016
)
0.43
" Treatment-emergent adverse events were also assessed."( A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Fimasartan/Amlodipine Combined Therapy Versus Fimasartan Monotherapy in Patients With Essential Hypertension Unresponsive to Fimasartan Monotherapy.
Cha, KS; Chae, SC; Chun, KJ; Ihm, SH; Il Kim, D; Jeong, JO; Joo, SJ; Kim, CH; Kim, DS; Kim, JJ; Kim, KH; Kim, KI; Kim, MH; Kim, YJ; Nam, CW; Park, S; Park, SM; Rhee, MY; Seo, HS; Shin, ES; Shin, J; Shin, MS; Sung, KC; Yoo, BS; Youn, HJ, 2016
)
0.65
" Adverse drug reactions were observed in 9 patients (6."( A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Fimasartan/Amlodipine Combined Therapy Versus Fimasartan Monotherapy in Patients With Essential Hypertension Unresponsive to Fimasartan Monotherapy.
Cha, KS; Chae, SC; Chun, KJ; Ihm, SH; Il Kim, D; Jeong, JO; Joo, SJ; Kim, CH; Kim, DS; Kim, JJ; Kim, KH; Kim, KI; Kim, MH; Kim, YJ; Nam, CW; Park, S; Park, SM; Rhee, MY; Seo, HS; Shin, ES; Shin, J; Shin, MS; Sung, KC; Yoo, BS; Youn, HJ, 2016
)
0.65
"Fimasartan/amlodipine combination therapy exhibited superior efficacy in reducing blood pressure, with no increase in adverse drug reactions, compared with fimasartan monotherapy."( A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Fimasartan/Amlodipine Combined Therapy Versus Fimasartan Monotherapy in Patients With Essential Hypertension Unresponsive to Fimasartan Monotherapy.
Cha, KS; Chae, SC; Chun, KJ; Ihm, SH; Il Kim, D; Jeong, JO; Joo, SJ; Kim, CH; Kim, DS; Kim, JJ; Kim, KH; Kim, KI; Kim, MH; Kim, YJ; Nam, CW; Park, S; Park, SM; Rhee, MY; Seo, HS; Shin, ES; Shin, J; Shin, MS; Sung, KC; Yoo, BS; Youn, HJ, 2016
)
1.04
" The adverse events (AEs) during both treatment periods were generally mild."( The efficacy and long-term safety of a triple combination of 80 mg telmisartan, 5 mg amlodipine and 12.5 mg hydrochlorothiazide in Japanese patients with essential hypertension: a randomized, double-blind study with open-label extension.
Higaki, J; Ikeda, H; Komuro, I; Kuroki, D; Nishimura, S; Ogihara, T; Shiki, K; Taniguchi, A; Ugai, H, 2017
)
0.68
" Overall, the incidence of adverse events was 20."( Efficacy and safety of sacubitril/valsartan (LCZ696) add-on to amlodipine in Asian patients with systolic hypertension uncontrolled with amlodipine monotherapy.
Hafeez, K; Jia, Y; Sibulo, A; Wang, JG; Yukisada, K; Zhang, J, 2017
)
0.69
" Both treatment regimens were well tolerated regarding adverse events or laboratory testing."( Blood pressure-lowering efficacy and safety of perindopril/indapamide/amlodipine single-pill combination in patients with uncontrolled essential hypertension: a multicenter, randomized, double-blind, controlled trial.
Amodeo, C; Asmar, R; Brzozowska-Villatte, R; de Champvallins, M; Mourad, JJ, 2017
)
0.69
" Adverse reactions were reported by only 13 (0."( Adherence to Treatment, Safety, Tolerance, and Effectiveness of Perindopril/Amlodipine Fixed-Dose Combination in Greek Patients with Hypertension and Stable Coronary Artery Disease: A Pan-Hellenic Prospective Observational Study of Daily Clinical Practice
Kotsis, VT; Liakos, CI; Papadopoulos, DP, 2017
)
0.68
" A systematic review of the literature revealed its most common adverse effects as: peripheral edema (depending on the dose of amlodipine, but attenuated by perindopril), cough, dizziness and hypotension."( Perindopril arginine and amlodipine besylate for hypertension: a safety evaluation.
Bistrika, EA; Elliott, WJ, 2018
)
0.99
" The number of patients with Adverse drug reactions (ADR) were found in 35."( [Pharmacogenetic approaches to predicting the efficiency and safety of amlodipine in patients with arterial hypertension].
Kalle, EG; Morozova, TE; Ryzhikova, KA; Shih, NV; Sychev, DA, 2017
)
0.69
"Most adverse events (AEs) were mild or moderate in intensity, and no deaths or treatment-related serious AEs were reported."( A phase III, open-label, multicenter study to evaluate the safety and efficacy of long-term triple combination therapy with azilsartan, amlodipine, and hydrochlorothiazide in patients with essential hypertension.
Nishiyama, Y; Rakugi, H; Sano, Y; Shimizu, K; Umeda, Y, 2018
)
0.68
" For safety assessments, all adverse events and abnormal laboratory findings were recorded."( Efficacy and Safety of S-Amlodipine 2.5 and 5 mg/d in Hypertensive Patients Who Were Treatment-Naive or Previously Received Antihypertensive Monotherapy.
Demir, M; Şen, S; Üresin, AY; Yiğit, Z, 2018
)
0.78
" Adverse events (AEs), clinical laboratory data, and vital signs were assessed in all patients."( Efficacy and Safety of Triple Therapy With Telmisartan, Amlodipine, and Rosuvastatin in Patients With Dyslipidemia and Hypertension: The Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial.
Ahn, Y; Chang, K; Cho, JM; Hong, SJ; Hyon, MS; Jeong, HS; Kang, WC; Kim, HS; Lee, JH; Pyun, WB, 2019
)
0.76
" No significant differences were found in the incidence of overall AEs and adverse drug reactions, and serious AEs were comparable among 3 groups."( Efficacy and Safety of Triple Therapy With Telmisartan, Amlodipine, and Rosuvastatin in Patients With Dyslipidemia and Hypertension: The Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial.
Ahn, Y; Chang, K; Cho, JM; Hong, SJ; Hyon, MS; Jeong, HS; Kang, WC; Kim, HS; Lee, JH; Pyun, WB, 2019
)
0.76
"Incremental uptitration with dosage-adapted perindopril/amlodipine SPC is a safe and effective strategy for managing hypertension."( Efficacy and Safety of Incremental Dosing of a New Single-Pill Formulation of Perindopril and Amlodipine in the Management of Hypertension.
Dolan, E; Gupta, AK; O'Brien, E; Poulter, NR; Sever, PS; Whitehouse, A, 2019
)
0.98
"7%) patients due to adverse events."( EFFICACY AND SAFETY OF A SINGLE-PILL COMBINATION OF ATORVASTATIN/AMLODIPINE IN PATIENTS WITH ARTERIAL HYPERTENSION AND DYSLIPIDEMIA.
Georgieva Torbova-Gigova, S; Ivanov Manov, E; Margaritov Runev, N; Naydenov Naydenov, S, 2018
)
0.72
" We administered this solution to three animals in order to determine a toxic dose, capable of facilitating a two-arm study of amlodipine toxicity."( Development and Feasibility of a Porcine Model of Amlodipine Toxicity.
Boley, SP; Engebretsen, KM; LeRoy, JM; Mackenzie, RB; Stellpflug, SJ, 2020
)
1.02
"This study demonstrates a potentially repeatable model of amlodipine-induced toxic shock using intravenous administration of amlodipine and several methodological considerations for researchers undertaking similar work."( Development and Feasibility of a Porcine Model of Amlodipine Toxicity.
Boley, SP; Engebretsen, KM; LeRoy, JM; Mackenzie, RB; Stellpflug, SJ, 2020
)
1.06
" No serious adverse events or adverse drug reactions were observed in all groups."( A randomized, double-blind clinical trial to evaluate the efficacy and safety of a fixed-dose combination of amlodipine/rosuvastatin in patients with dyslipidemia and hypertension.
Ahn, JC; Ahn, YK; Chang, K; Cho, EJ; Cho, KI; Kang, DH; Kim, M; Kim, SJ; Kim, SY; Kim, U; Kim, W; Kim, YJ; Lee, CH; Lee, SH; Park, CG; Shin, JH; Yu, CW, 2020
)
0.77
"Chronic hypertension is associated with adverse perinatal outcomes, although the optimal treatment is unclear."( Comparative efficacy and safety of oral antihypertensive agents in pregnant women with chronic hypertension: a network metaanalysis.
Bellos, I; Daskalakis, G; Loutradis, D; Papapanagiotou, A; Pergialiotis, V, 2020
)
0.56
" Safety and tolerability were assessed by the incidence rate of adverse events (AEs) and discontinuation."( Real-World Effectiveness and Safety of a Single-Pill Combination of Olmesartan/Amlodipine/Hydrochlorothiazide in Korean Patients with Essential Hypertension (RESOLVE): A Large, Observational, Retrospective, Cohort Study.
Park, SJ; Rhee, SJ, 2020
)
0.79
" The secondary efficacy variables were changes in MSSBP, mean sitting diastolic blood pressure (MSDBP), LDL cholesterol and other lipid levels at 4 weeks and 8 weeks, as well as observed adverse events during follow-up."( Efficacy and safety of co-administered telmisartan/amlodipine and rosuvastatin in subjects with hypertension and dyslipidemia.
Ahn, JC; Chae, IH; Cho, EJ; Cho, JM; Cho, Y; Choi, SY; Han, KH; Hong, SJ; Hong, SP; Hwang, J; Hyon, MS; Jin, X; Kim, H; Kim, HS; Kim, JH; Kim, MH; Kim, PJ; Kim, WS; Kwon, K; Lee, H; Lee, HC; Lee, JH; Lee, K; Lee, SH; Park, CG; Rhee, MY; Seo, JS; Shin, JH; Sung, JH; Sung, KC; Yoo, BS, 2020
)
0.81
" These results suggest that lipid emulsion inhibits late apoptosis induced by amlodipine at toxic dose via the activation of phosphoinositide-3 kinase and ATP-sensitive potassium channels in the extrinsic apoptotic pathway."( Lipid emulsion attenuates extrinsic apoptosis induced by amlodipine toxicity in rat cardiomyoblasts.
Ahn, SH; Bae, SI; Hwang, Y; Kim, HJ; Lee, SH; Ok, SH; Park, KE; Shin, IW; Sohn, JT; Yoon, S, 2021
)
1.09
" Adverse events, total adverse drug reactions, and serious adverse drug reactions were found in 808 patients (1."( Telmisartan Plus S-Amlodipine Single-Pill Combination Therapy is Safe and Effective in Patients with Hypertension from Large-Scale Nationwide Surveillance Data in Korea (NOVEL) Study.
Hong, GR; Jo, SH; Kim, SW; Park, CG; Park, SJ, 2021
)
0.95
"Telmisartan plus S-amlodipine single-pill combination was safe and effective in patients with hypertension in a large real-world population."( Telmisartan Plus S-Amlodipine Single-Pill Combination Therapy is Safe and Effective in Patients with Hypertension from Large-Scale Nationwide Surveillance Data in Korea (NOVEL) Study.
Hong, GR; Jo, SH; Kim, SW; Park, CG; Park, SJ, 2021
)
1.28
" Safety parameters with adverse events and compliance by traditional pill count method."( An Open Label Prospective Study on Evaluation of Safety and Efficacy of Cilnidipine Over Amlodipine in Stage 1 Hypertensive Patients.
Das, K; Harlalka, S; Majumdar, G; Mandal, P; Roy, UK,
)
0.35
" The blood pressure, pulse rate and adverse effects were monitored in each patient over 12 weeks."( A Randomized Open-Label Parallel-Group Study Comparing the Efficacy and Safety of Cilnidipine and Amlodipine in Hypertensive Adults.
D, DC; Jj, NK; Kavitha, R, 2022
)
0.94
" The patients in the cilnidipine group experienced significantly less adverse effects such as pedal edema and palpitations when compared to those in the amlodipine group (p<0."( A Randomized Open-Label Parallel-Group Study Comparing the Efficacy and Safety of Cilnidipine and Amlodipine in Hypertensive Adults.
D, DC; Jj, NK; Kavitha, R, 2022
)
1.14
"Cilnidipine therapy is an effective and safe alternative in the treatment of essential hypertension."( A Randomized Open-Label Parallel-Group Study Comparing the Efficacy and Safety of Cilnidipine and Amlodipine in Hypertensive Adults.
D, DC; Jj, NK; Kavitha, R, 2022
)
0.94
" Adverse events and laboratory test results will be monitored throughout the trial."( Efficacy and safety of Tengfu Jiangya tablet combined with valsartan/amlodipine in the treatment of stage 2 hypertension: study protocol for a randomized controlled trial.
Chen, W; Hua, Z; Li, Y; Wang, Y; Zhu, Y, 2022
)
0.96
" In terms of safety, no special adverse events and clinically significant results were noted, and all dose groups of the triple combination are considered safe for use in essential hypertension patients."( Efficacy and safety of low-dose antihypertensive combination of amlodipine, telmisartan, and chlorthalidone: A randomized, double-blind, parallel, phase II trial.
Ahn, JC; Cho, EJ; Han, SH; Kang, SM; Kim, KH; Kim, KI; Kim, SY; Kim, W; Kim, YJ; Park, CG; Park, SJ; Park, SM; Shin, J; Shin, JH; Sohn, IS; Sung, JH; Sung, KC, 2022
)
0.96
" As a rare and unique adverse effect of infliximab, hypertension should be paid enough attention in clinical work."( Hypertension as a rare adverse effect caused by infliximab in the treatment of Crohn's disease: a case report.
Mo, J; Tang, J; Zhang, B; Zhao, X, 2022
)
0.72
"Hypertension, as one of the rare adverse reactions of infliximab in the treatment of Crohn's disease, should be paid enough attention."( Hypertension as a rare adverse effect caused by infliximab in the treatment of Crohn's disease: a case report.
Mo, J; Tang, J; Zhang, B; Zhao, X, 2022
)
0.72
"50%) were the most frequent adverse events."( Efficacy and safety of single pill combination of amlodipine and valsartan in hypertensive Saudi patients.
Ahmad, A; Alama, MN; Alharthi, TS; Alkreathy, HM; Alluhabi, SI; Alqarni, F; Alrafiah, AR; Damanhouri, ZA, 2023
)
1.16
" Third-standard-dose triple antihypertensive combination therapy demonstrated early effective BP control compared to third-standard-dose dual combination therapies, without increasing adverse drug reactions in patients with mild-to-moderate hypertension."( Comparison of efficacy and safety between third-dose triple and third-dose dual antihypertensive combination therapies in patients with hypertension.
Cho, DK; Cho, GY; Cho, JM; Heo, JH; Hong, SJ; Jeong, MH; Jung, JA; Kim, DH; Kim, SH; Kim, SY; Kim, W; Kwon, K; Lee, HY; Lee, JB; Lim, SW; Park, K; Park, S; Pyun, WB; Rha, SW; Rhee, MY; Shin, J; Sung, KC, 2023
)
0.91
" The numbers of patients with adverse drug reactions (ADRs) were compared as safety variables."( A Randomized, Multicenter, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Quadruple Combination of Amlodipine, Losartan, Rosuvastatin, and Ezetimibe in Patients with Concomitant Essential Hypertension and Dyslipidemia.
Ahn, Y; Chae, IH; Hong, SJ; Hong, TJ; Kang, DH; Kim, BK; Kim, H; Kim, HS; Kim, MC; Kim, MH; Kim, SH; Kim, SY; Kim, W; Rhee, MY, 2023
)
1.11
" There was no significant difference in the adverse events rates between RSV 10 mg/AML 5 mg, RSV 20 mg/AML 5 mg, and ATV 20 mg/AML 5 mg."( Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia.
Bae, HJ; Cho, EJ; Choi, JY; Han, KR; Hong, BK; Hong, SP; Hyon, MS; Jin, HY; Jung, HW; Kim, CY; Kim, KS; Kim, SY; Kim, U; Lee, JB; Lee, KH; Lee, KJ; Lee, SR; Lee, SY; Nam, CW; Park, CG; Park, SJ; Park, TH; Rhee, MY; Ryu, JK; Seol, SH; Shin, JH; Yang, DH; Yu, GW, 2023
)
1.12
" There are no serious adverse event and no one discontinued medication due to adverse event."( Efficacy and safety of standard dose triple combination of telmisartan 80 mg/amlodipine 5 mg/chlorthalidone 25 mg in primary hypertension: A randomized, double-blind, active-controlled, multicenter phase 3 trial.
Ahn, Y; Cha, KS; Chang, K; Cho, EJ; Choi, DJ; Choi, SY; Doh, JH; Hong, SJ; Hong, SP; Hwang, JY; Hyon, MS; Ihm, SH; Kang, WC; Kim, HS; Kim, MH; Kim, SH; Kim, WS; Kim, YH; Kwon, K; Lee, JH; Lee, N; Lim, SW; Rhee, MY; Shin, J; Son, JW; Yoo, BS, 2023
)
1.14
" The therapy was safe and well tolerated."( Real-World Effectiveness and Safety of a Single-Pill Combination of Olmesartan/Amlodipine/Hydrochlorothiazide in Korean Patients with Hypertension and Cardiovascular Risk Factors.
Hong, JH; Hyun, D; Kim, GH; Kim, HL; Kim, W; Lim, S; Min, KW; Oh, J; Park, SD; Shin, J, 2023
)
1.14

Pharmacokinetics

The study characterizes the single dose pharmacokinetic characteristics of the dihydropyridine calcium antagonist drug amlodipine in a group of 16 elderly subjects, aged 65 to 86 years (8 M:8 F). Pharmacokinetic samples were collected up to 72 hours after the last dose in subjects who received rosuvastatin only.

ExcerptReferenceRelevance
"This study characterizes the single dose pharmacokinetic characteristics of the dihydropyridine calcium antagonist drug amlodipine in a group of 16 elderly subjects, aged 65 to 86 years (8 M:8 F)."( An assessment of the pharmacokinetics and pharmacodynamics of single doses of amlodipine in elderly normotensives.
Elliott, HL; Green, ST; Meredith, PA; Vincent, J,
)
0.57
" Amlodipine is distinct from other calcium antagonists by its pharmacokinetic profile: slower onset of action with less acute vasodilatation associated side effects and a sustained antihypertensive and anti-anginal efficacy over 24 hours."( [Amlodipine: pharmacokinetic and pharmacodynamic profile of a calcium antagonist with prolonged effect].
Heynen, G, 1992
)
2.1
"Amlodipine is a dihydropyridine calcium antagonist drug with distinctive pharmacokinetic characteristics which appear to be attributable to a high degree of ionisation."( Clinical pharmacokinetics of amlodipine.
Elliott, HL; Meredith, PA, 1992
)
2.02
" The slow rate of elimination (elimination half-life of 40-60 h) confers several pharmacokinetic characteristics that are not seen with other calcium-antagonist drugs."( Pharmacokinetics and pharmacodynamics of amlodipine.
Abernethy, DR, 1992
)
0.55
" Thus, amlodipine seems to provide a useful alternative to other agents currently available for the treatment of essential hypertension and chronic stable angina pectoris, with certain pharmacodynamic and tolerability properties that should be advantageous in many patients."( Amlodipine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in cardiovascular disease.
Heel, RC; Murdoch, D, 1991
)
2.18
" In order to document its stability in vitro and to develop a pharmacokinetic model in rabbits, a new reversed-phase liquid chromatography (LC) assay with UV detection was developed."( Liquid chromatography assay for amlodipine: chemical stability and pharmacokinetics in rabbits.
Mosher, SJ; Pollak, PT; Yeung, PK, 1991
)
0.56
" Pharmacokinetic studies were conducted with nonlabeled drug using specific high-pressure liquid chromatography or gas chromatographic procedures."( The metabolism and pharmacokinetics of amlodipine in humans and animals.
Beresford, AP; Humphrey, MJ; Macrae, PV; Stopher, DA, 1988
)
0.54
" The elimination half-life was of the order of 50 h, similar to previously observed values, and did not vary with differences in renal function."( Pharmacokinetics of amlodipine in renal impairment.
Carmody, M; Donohoe, JF; Doyle, GD; Greb, H; Kelly, JG; Laher, MS; Volz, M, 1988
)
0.6
" amlodipine, clearance tended to be decreased in elderly as compared with young patients with resulting prolongation in elimination half-life (64 +/- 20 vs."( Amlodipine in elderly hypertensive patients: pharmacokinetics and pharmacodynamics.
Abernethy, DR; Gutkowska, J; Lambert, MD, 1988
)
2.63
" The elimination half-life was of the order of 50 h, similar to previously reported values and did not vary with renal function."( Pharmacokinetics of amlodipine in renal impairment.
Carmody, M; Donohue, J; Doyle, GD; Greb, H; Laher, M; Volz, M, 1989
)
0.6
"Amlodipine, a dihydropyridine calcium antagonist, was synthesized in an attempt to develop a compound with a pharmacokinetic profile characteristic of this class, which would also have an increased oral bioavailability and extended clearance time."( The pharmacokinetic profile of amlodipine.
Abernethy, DR, 1989
)
2.01
"Intravenous administration of amlodipine (single dose, 10 mg) to 12 volunteers gave a mean plasma half-life of 34 h, mean clearance of 7 ml min-1 kg-1 and a mean apparent volume of distribution of 21 l kg-1."( The pharmacokinetics of amlodipine in healthy volunteers after single intravenous and oral doses and after 14 repeated oral doses given once daily.
Chasseaud, LF; Faulkner, JK; McGibney, D; Perry, JL; Taylor, IW, 1986
)
0.87
" In studies with hypertensive patients in which pharmacokinetic and pharmacodynamic indices have been integrated, we have demonstrated that the intersubject variability in the pharmacokinetics of verapamil, nifedipine, enalapril, and amlodipine is directly related to the variability in blood pressure response at steady state."( Amlodipine; clinical relevance of a unique pharmacokinetic profile.
Elliott, HL; Meredith, PA, 1993
)
1.91
" The mean values of AUC (0-4 h), Cmax and Tmax for benazepril given as combination versus given alone were 161 vs 140 ng."( Pharmacokinetic interaction study between benazepril and amlodipine in healthy subjects.
Chan, K; Cipriano, A; John, VA; Sun, JX, 1994
)
0.53
"Pharmacokinetic and pharmacodynamic data were compared between elderly and young patients with hypertension who received single intravenous doses of amlodipine, a dihydropyridine calcium antagonist, followed by oral administration of amlodipine up to 10 mg once daily for 12 weeks."( An overview of the pharmacokinetics and pharmacodynamics of amlodipine in elderly persons with systemic hypertension.
Abernethy, DR, 1994
)
0.73
"The distinctive pharmacokinetic characteristics of amlodipine, particularly the long half-life, are presumed to translate directly to a prolonged duration of action, but the concentration-effect relationship for the antihypertensive response has not been clearly established."( Pharmacodynamic modeling of the antihypertensive response to amlodipine.
Donnelly, R; Elliott, HL; Howie, CA; Meredith, PA; Miller, SH, 1993
)
0.78
" Cmax values were found to be similar in both groups although Tmax was shorter, and T1/2 was longer, in patients with hepatic insufficiency."( Pharmacokinetics and safety of single oral doses of amlodipine in patients with and without hepatic impairment: an open study.
Darnis, F; Poupon, R, 1993
)
0.54
"When amlodipine was coadministered with grapefruit juice, Cmax was 115% and AUC(0-72 h) was 116% compared with water, but tmax was not significantly changed."( Effect of grapefruit juice on the pharmacokinetics of amlodipine in healthy volunteers.
Ahlner, J; Josefsson, M; Zackrisson, AL, 1996
)
1.06
"Amlodipine, a third-generation dihydropyridine calcium antagonist, has a mode of action and pharmacodynamic profile which are comparable to those of conventional compounds in this series, such as nifedipine."( Amlodipine: an overview of its pharmacodynamic and pharmacokinetic properties.
van Zwieten, PA, 1994
)
3.17
" Significant differences were found between all principal pharmacokinetic variables, when comparing the 2 treatments after both single and repeated dosing."( Crossover comparison of the pharmacokinetics of amlodipine and felodipine ER in hypertensive patients.
Jacobsen, IA; Videbaek, LM, 1997
)
0.55
" The pharmacokinetic behaviour of R-(+)- and S-(-)-amlodipine after single enantiomer administration to healthy male human volunteers together with comparative administration of the racemic mixture of both enantiomers were studied."( Pharmacokinetic behaviour of R-(+)- and S-(-)-amlodipine after single enantiomer administration.
Josic, D; Kopitar, Z; Kremser, M; Luksa, J; Milutinovic, S, 1997
)
0.81
" Pharmacokinetic analysis of drug accumulation showed one-compartment characteristics with an half-life of 76 min."( Amlodipine dynamic effects and myocardial pharmacokinetics in the isolated and perfused guinea-pig heart.
Bruun, J; Jeppesen, P; Nielsen-Kudsk, F, 1998
)
1.74
" Neither AUC nor trough levels of FEL and AML were significantly influenced by transit times, nor was Cmax after any of the three treatments."( The pharmacokinetics of extended-release formulations of calcium antagonists and of amlodipine in subjects with different gastrointestinal transit times.
Laufen, H; Riedel, KD; Scharpf, F; Schumacher, T; Yeates, R; Zimmermann, T, 1999
)
0.53
" Pharmacokinetic parameters of racemic amlodipine (AUC, Cmax, tmax, and kel) were not markedly changed with grapefruit juice coadministration."( Lack of effect of grapefruit juice on the pharmacokinetics and pharmacodynamics of amlodipine.
Dogolo, LC; Foulds, G; Friedman, HL; Harris, SI; Vincent, J; Willavize, S, 2000
)
0.8
" The geometric means of the primary pharmacokinetic parameters at steady state (day 9) for amlodipine when given alone were the following: maximum plasma concentration (Cmax) 17."( Pharmacokinetics of repeated oral doses of amlodipine and amlodipine plus telmisartan in healthy volunteers.
Stangier, J; Su, CA, 2000
)
0.79
" Blood samples were collected after administration of amlodipine and AUC, Cmax, and tmax were determined."( Comparative pharmacokinetics and pharmacodynamics of amlodipine in hypertensive patients with and without type II diabetes mellitus.
Alonso, A; Baltodano, NM; Chung, M; Epstein, M; Gaffney, M; Preston, RA, 2001
)
0.81
" These results suggest that the influence of aging on the pharmacokinetic profiles might differ between the R(+)- and S(-)-isomers of amlodipine."( Stereoselective pharmacokinetics of amlodipine in elderly hypertensive patients.
Arakawa, M; Fujimura, A; Harada, K; Hifumi, S; Miyamori, I; Ohmori, M; Takasaki, H,
)
0.61
" The pharmacokinetic results indicated that the plasma half-life (t1/2) of amlodipine was 38."( Azelnidipine and amlodipine: a comparison of their pharmacokinetics and effects on ambulatory blood pressure.
Hirai, A; Ichikawa, S; Kanada, S; Kuramoto, K; Nakachi, T; Ogihara, T, 2003
)
0.89
" Pharmacokinetic parameters [Cmax, tmax, kel and AUC(0-24)] were calculated for the single dose and for the dose on day 30 and the accumulation index calculated on the basis of AUC(0-24) and Cmax."( Pharmacokinetics of amlodipine in hypertensive patients undergoing haemodialysis.
Kungys, G; Naujoks, H; Wanner, C, 2003
)
0.64
"This study was performed to compare the pharmacokinetic (PK) and pharmacodynamic (PD) properties and safety profiles of a newly developed amlodipine formulation with a conventional formulation in healthy male subjects."( Randomized, open-label, two-period crossover comparison of the pharmacokinetic and pharmacodynamic properties of two amlodipine formulations in healthy adult male Korean subjects.
Kim, KA; Kim, SL; Lee, GS; Lee, YS; Lee, YW; Park, JY; Park, PW; Shin, EK, 2004
)
0.74
"All subjects completed the study and 90% confidence intervals for relevant pharmacokinetic parameters were within the ranges defined by European and US Regulatory Authorities: the geometric mean and the 90% confidence interval test/reference ratios calculated from log-transformed values were 104."( Assessment of sex differences in pharmacokinetics and pharmacodynamics of amlodipine in a bioequivalence study.
Abad-Santos, F; Almeida, S; Gallego-Sandín, S; Gálvez-Múgica, MA; García, AG; Novalbos, J; Vallée, F, 2005
)
0.56
" Although there were no relevant gender-related differences in the pharmacokinetics of amlodipine, women reached higher amlodipine concentrations most likely because of their lower body weight, and therefore, the reported pharmacodynamic effects were higher within this gender group."( Assessment of sex differences in pharmacokinetics and pharmacodynamics of amlodipine in a bioequivalence study.
Abad-Santos, F; Almeida, S; Gallego-Sandín, S; Gálvez-Múgica, MA; García, AG; Novalbos, J; Vallée, F, 2005
)
0.78
" We evaluated potential bidirectional pharmacokinetic interactions between calcium channel blockers and coadministered indinavir and ritonavir."( Pharmacokinetic interactions between indinavir plus ritonavir and calcium channel blockers.
Aberg, JA; Fichtenbaum, CJ; Gerber, JG; Glesby, MJ; Grosskopf, N; Hafner, R; Hall, S; Kendall, MA; Zolopa, AR, 2005
)
0.33
" Twenty-four-hour pharmacokinetic collection was performed on days 7 and 26, with 12-hour collection on day 19."( Pharmacokinetic interactions between indinavir plus ritonavir and calcium channel blockers.
Aberg, JA; Fichtenbaum, CJ; Gerber, JG; Glesby, MJ; Grosskopf, N; Hafner, R; Hall, S; Kendall, MA; Zolopa, AR, 2005
)
0.33
"Structural features of amlodipine give the molecule physicochemical and pharmacokinetic properties that are unique among calcium antagonists."( Amlodipine: pharmacokinetic profile of a low-clearance calcium antagonist.
Abernethy, DR, 1991
)
2.03
" For example, in vagotomized dogs, the total area under the plasma concentration-time curve from time zero to the last measured time, 48 h, in plasma (AUC(0-48 h)) was significantly greater (725 versus 348 ng h/ml) and Tmax was significantly shorter (1."( Pharmacokinetics of oral amlodipine orotate in vagotomized dogs.
Choi, SM; Chung, HK; Kim, JH; Kim, JO; Kwak, HH; Kwon, JW; Lee, JH; Lee, MG; Yoo, M, 2006
)
0.64
"A pharmacokinetic interaction between oral DA-8159 and amlodipine was evaluated in male Sprague-Dawley rats."( Negligible pharmacokinetic interaction between oral DA-8159, a new erectogenic, and amlodipine in rats.
Kim, EJ; Kwon, JW; Lee, JH; Lee, MG; Yoo, M, 2006
)
0.81
" The present method provides an accurate, precise and sensitive tool for buspirone and was successfully applied to a pharmacokinetic study in eight subjects."( Rapid and highly sensitive liquid chromatography/electrospray ionization tandem mass spectrometry method for the quantitation of buspirone in human plasma: application to a pharmacokinetic study.
Cho, SH; Choi, YW; Im, HT; Lee, HW; Lee, KT; Park, WS; Rew, JH, 2006
)
0.33
"A population pharmacokinetic study was conducted in 74 hypertensive children (mean age 10."( Population pharmacokinetics of amlodipine in hypertensive children and adolescents.
Flynn, JT; Mahan, JD; Nahata, MC; Portman, RJ, 2006
)
0.62
" After a single-dose administration of 5 mg amlodipine, plasma concentrations of amlodipine were measured and its pharmacokinetic characteristics were compared according to ABCB1 genotype."( Effect of ABCB1 (MDR1) haplotypes derived from G2677T/C3435T on the pharmacokinetics of amlodipine in healthy subjects.
Kim, KA; Park, JY; Park, PW, 2007
)
0.82
" Four open-label studies investigated the pharmacokinetic interactions between aliskiren 300 mg and the antihypertensive drugs amlodipine 10 mg (n = 18), valsartan 320 mg (n = 18), hydrochlorothiazide 25 mg (HCTZ, n = 22) and ramipril 10 mg (n = 17) in healthy subjects."( Lack of pharmacokinetic interactions of aliskiren, a novel direct renin inhibitor for the treatment of hypertension, with the antihypertensives amlodipine, valsartan, hydrochlorothiazide (HCTZ) and ramipril in healthy volunteers.
Bizot, MN; Denouel, J; Dieterich, HA; Dole, WP; Kemp, C; Vaidyanathan, S; Valencia, J; Yeh, CM; Zhao, C, 2006
)
0.74
"A novel, specific and sensitive ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method was developed for the determination and pharmacokinetic study of amlodipine in human plasma."( Determination and pharmacokinetic study of amlodipine in human plasma by ultra performance liquid chromatography-electrospray ionization mass spectrometry.
Li, F; Lu, X; Ma, Y; Qin, F; Sun, X, 2007
)
0.79
" Blood pressure and pulse rate were also measured for pharmacodynamic analysis."( Effect of CYP3A5*3 genotype on the pharmacokinetics and pharmacodynamics of amlodipine in healthy Korean subjects.
Choi, SH; Chun, BG; Kim, KA; Lee, OJ; Min, BH; Park, JY; Park, PW; Shin, JG; Shin, KH, 2006
)
0.56
" Here, we evaluated the comparative pharmacokinetic and pharmacodynamic characteristics of the nicotinate and besylate forms of amlodipine."( Comparative pharmacokinetic and pharmacodynamic characteristics of amlodipine besylate and amlodipine nicotinate in healthy subjects.
Ha, MC; Kim, JS; Kim, KA; Lee, GH; Lee, OJ; O, MJ; Park, JH; Park, JY; Park, PW; Ryu, JH, 2006
)
0.78
" Blood samples for the pharmacokinetic analysis of amlodipine were obtained over the 144-hour period after administration."( Comparative pharmacokinetic and pharmacodynamic characteristics of amlodipine besylate and amlodipine nicotinate in healthy subjects.
Ha, MC; Kim, JS; Kim, KA; Lee, GH; Lee, OJ; O, MJ; Park, JH; Park, JY; Park, PW; Ryu, JH, 2006
)
0.82
" After administering a single dose of each formulation, mean AUC0-infinity and Cmax values were 190."( Comparative pharmacokinetic and pharmacodynamic characteristics of amlodipine besylate and amlodipine nicotinate in healthy subjects.
Ha, MC; Kim, JS; Kim, KA; Lee, GH; Lee, OJ; O, MJ; Park, JH; Park, JY; Park, PW; Ryu, JH, 2006
)
0.57
"The two amlodipine formulations showed similar pharmacokinetic and pharmacodynamic characteristics and the new amlodipine formulation, amlodipine nicotinate, was found to be equivalent for pharmacokinetics to the currently available amlodipine besylate with respect to the rate and extent of amlodipine absorption."( Comparative pharmacokinetic and pharmacodynamic characteristics of amlodipine besylate and amlodipine nicotinate in healthy subjects.
Ha, MC; Kim, JS; Kim, KA; Lee, GH; Lee, OJ; O, MJ; Park, JH; Park, JY; Park, PW; Ryu, JH, 2006
)
1
"The objective of this study was to compare the pharmacokinetic and pharmacodynamic properties and safety profiles of a newly developed amlodipine formulation, composed wholly of S-amlodipine, with those of the conventionally prescribed racemic formulation."( Pharmacokinetic and pharmacodynamic characteristics of a new S-amlodipine formulation in healthy Korean male subjects: a randomized, open-label, two-period, comparative, crossover study.
Ha, MC; Kang, SW; Kim, JS; Kim, KA; Lee, GH; Lee, KR; Lee, OJ; Park, JY; Park, PW; Ryu, JH, 2006
)
0.78
" Blood samples for pharmacokinetic analysis of S-amlodipine were collected at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 120, 144, and 168 hours after drug administration."( Pharmacokinetic and pharmacodynamic characteristics of a new S-amlodipine formulation in healthy Korean male subjects: a randomized, open-label, two-period, comparative, crossover study.
Ha, MC; Kang, SW; Kim, JS; Kim, KA; Lee, GH; Lee, KR; Lee, OJ; Park, JY; Park, PW; Ryu, JH, 2006
)
0.83
" The mean (SD) values for Cmax AUC from time 0 to the last available measurement (AUC(last)), and AUC from 0 to infinity (AUC(0-infinity)) for the reference formulation (3."( Pharmacokinetic and pharmacodynamic characteristics of a new S-amlodipine formulation in healthy Korean male subjects: a randomized, open-label, two-period, comparative, crossover study.
Ha, MC; Kang, SW; Kim, JS; Kim, KA; Lee, GH; Lee, KR; Lee, OJ; Park, JY; Park, PW; Ryu, JH, 2006
)
0.57
" The newly developed formulation, comprised of only S-amlodipine, had pharmacodynamic profiles comparable to those of the conventional racemic amlodipine formulation in these healthy Korean male subjects."( Pharmacokinetic and pharmacodynamic characteristics of a new S-amlodipine formulation in healthy Korean male subjects: a randomized, open-label, two-period, comparative, crossover study.
Ha, MC; Kang, SW; Kim, JS; Kim, KA; Lee, GH; Lee, KR; Lee, OJ; Park, JY; Park, PW; Ryu, JH, 2006
)
0.82
" Blood samples for pharmacokinetic profiling were taken up to 144 h post-dose, and amlodipine plasma concentrations were determined with a validated LC-MS/MS method."( Pharmacokinetics and bioequivalence study of a generic amlodipine tablet formulation in healthy male volunteers.
Arnold, P; Erenmemişoğlu, A; Hincal, AA; Kanzik, I; Martin, W; Sailer, R; Tamur, U, 2007
)
0.81
"We conducted 3 open-label, multiple-dose, 3-period, randomized, crossover studies in healthy subjects to assess the potential pharmacokinetic interaction between vildagliptin, a novel dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes, and representatives of 3 commonly prescribed antihypertensive drug classes: (1) the calcium channel blocker, amlodipine; (2) the angiotensin receptor blocker, valsartan; and (3) the angiotensin-converting enzyme inhibitor, ramipril."( Vildagliptin, a novel dipeptidyl peptidase IV inhibitor, has no pharmacokinetic interactions with the antihypertensive agents amlodipine, valsartan, and ramipril in healthy subjects.
Campestrini, J; Dole, K; Dole, WP; He, YL; Howard, D; Ligueros-Saylan, M; Marion, A; Pommier, F; Sabo, R; Sunkara, G; Wang, Y; Zhao, C, 2008
)
0.72
" Potential pharmacodynamic interaction between drugs should be investigated as part of developing single-pill combinations."( A randomized, placebo-controlled trial to evaluate the efficacy, safety, and pharmacodynamic interaction of coadministered amlodipine and atorvastatin in 1660 patients with concomitant hypertension and dyslipidemia: the respond trial.
Dykstra, G; Gillen, D; Harvey, P; Herfert, O; Jukema, JW; Preston, RA; Sun, F, 2007
)
0.55
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
"Population pharmacokinetic models for amlodipine and olmesartan were developed using data collected from 4 phase I studies in healthy volunteers and 1 phase III study in subjects with mild to severe hypertension."( Evaluation of population pharmacokinetics and exposure-response relationship with coadministration of amlodipine besylate and olmesartan medoxomil.
Carrothers, TJ; Khariton, T; Kshirsagar, S; Lee, J; Rohatagi, S; Salazar, D, 2008
)
0.83
" The proposed ITP-CZE-DAD method was characterized by favorable performance parameters (sensitivity, linearity, precision, recovery, accuracy, robustness, selectivity) and successfully applied to an enantioselective pharmacokinetic study of AML."( Direct quantitative determination of amlodipine enantiomers in urine samples for pharmacokinetic study using on-line coupled isotachophoresis-capillary zone electrophoresis separation method with diode array detection.
Havránek, E; Marák, J; Maráková, K; Miks, P; Nemec, I; Valásková, Ia, 2008
)
0.62
" Blood samples for pharmacokinetic analysis were collected over a period of 144 h after drug administration."( Comparative pharmacokinetics of a single oral dose of two formulations of amlodipine. A randomized, single-blind, two-period, two-sequence, crossover study.
Caubet, JC; Domínguez, G; Negri, AL; Pico, JC; Terragno, NA, 2008
)
0.58
"194) and R-amlodipine also showed 21% higher Cmax in CYP3A5*1/*3 carriers (3."( Effect of cytochrome P450 3A5*3 genotype on the stereoselective pharmacokinetics of amlodipine in healthy subjects.
Kim, KA; Park, JY; Park, PW, 2009
)
0.97
" From a pharmacokinetic perspective, the 2 drugs are well suited to coadministration in a fixed-dose combination."( Pharmacokinetics of amlodipine and olmesartan after administration of amlodipine besylate and olmesartan medoxomil in separate dosage forms and as a fixed-dose combination.
Allison, M; Bathala, MS; Haworth, S; Heyrman, R; Lee, J; Noveck, R; Rohatagi, S; Rubets, I; Salazar, DE; Shenouda, M, 2008
)
0.67
" This novel method has been applied to human pharmacokinetic study."( Development and validation of a highly sensitive and robust LC-ESI-MS/MS method for simultaneous quantitation of simvastatin acid, amlodipine and valsartan in human plasma: application to a clinical pharmacokinetic study.
Mullangi, R; Ramani, AV; Sengupta, P, 2009
)
0.56
"The aim of this study was to assess and compare the pharmacokinetic properties, bioavailability, and bioequivalence of a newly developed dispersible tablet formulation of amlodipine besylate with those of an established branded formulation in healthy Chinese adult male volunteers."( Pharmacokinetics and bioequivalence evaluation of two formulations of 10-mg amlodipine besylate: an open-label, single-dose, randomized, two-way crossover study in healthy Chinese male volunteers.
Jia, J; Li, S; Liu, G; Liu, Y; Lu, C; Yu, C, 2009
)
0.78
" The amlodipine serum concentration-time curves were used to obtain pharmacokinetic parameters including AUC(0-t), AUC(0-infinity)), and C(max)."( Pharmacokinetics and bioequivalence evaluation of two formulations of 10-mg amlodipine besylate: an open-label, single-dose, randomized, two-way crossover study in healthy Chinese male volunteers.
Jia, J; Li, S; Liu, G; Liu, Y; Lu, C; Yu, C, 2009
)
1.1
" On analysis of variance, no period or sequence effects were observed for any pharmacokinetic property; however, a significant formulation effect was observed for C(max), AUC(0-t), and AUC(0-infinity))."( Pharmacokinetics and bioequivalence evaluation of two formulations of 10-mg amlodipine besylate: an open-label, single-dose, randomized, two-way crossover study in healthy Chinese male volunteers.
Jia, J; Li, S; Liu, G; Liu, Y; Lu, C; Yu, C, 2009
)
0.58
" Bioequivalence was established for all pharmacokinetic parameters."( Pharmacokinetics and safety of olmesartan medoxomil in combination with either amlodipine or atenolol compared to respective monotherapies in healthy subjects.
Bolbrinker, J; Huber, M; Kreutz, R; Scholze, J, 2009
)
0.58
" The method was successfully applied for a pharmacokinetic study and for the determination of commercial amlodipine tablet content."( High-performance liquid chromatographic method for quantitative determination of amlodipine in human plasma and pharmaceutical dosage form and its application to pharmacokinetic studies.
Alsarra, IA,
)
0.57
"This study was conducted to compare the pharmacodynamic (PD) and pharmacokinetic (PK) characteristics of the S-amlodipine formulation (S-amlodipine gentisate) and amlodipine racemate (amlodipine besylate)."( Pharmacodynamic (hemodynamic) and pharmacokinetic comparisons of S-amlodipine gentisate and racemate amlodipine besylate in healthy Korean male volunteers: two double-blind, randomized, two-period, two-treatment, two-sequence, double-dummy, single-dose cr
Jang, IJ; Kim, BH; Kim, JR; Kim, KP; Kim, MG; Lee, BY; Shin, SG; Yu, KS, 2010
)
0.81
" The developed assay method was successfully applied to a pharmacokinetic study in human male volunteers."( Simultaneous determination of atorvastatin, amlodipine, ramipril and benazepril in human plasma by LC-MS/MS and its application to a human pharmacokinetic study.
Inamadugu, JK; Karra, VK; Mullangi, R; Pilli, NR; Rao, JV; Vaidya, JR, 2011
)
0.63
"To explore if non-concurrent amlodipine dosing results in less drug interaction, the pharmacokinetic profiles, safety and efficacy endpoints were assessed following repeated doses of simvastatin, co-administered concurrently or non-concurrently with amlodipine in patients with coexisting hypertension and hyperlipidemia."( Non-concurrent dosing attenuates the pharmacokinetic interaction between amlodipine and simvastatin.
Choi, JW; Kim, SH; Lee, H; Lee, SJ; Lim, HE; Park, CG, 2010
)
0.88
"The Cmax and AUClast and of simvastatin acid in the non-concurrent amlodipine dosing group were 63."( Non-concurrent dosing attenuates the pharmacokinetic interaction between amlodipine and simvastatin.
Choi, JW; Kim, SH; Lee, H; Lee, SJ; Lim, HE; Park, CG, 2010
)
0.83
"The steady-state pharmacokinetic (PK) interaction potential between amlodipine (10 mg), valsartan (320 mg), and hydrochlorothiazide (HCTZ; 25 mg) was evaluated in patients with hypertension in a multicenter, multiple-dose, open-label, 4-cohort, parallel-group study."( Evaluation of pharmacokinetic interactions between amlodipine, valsartan, and hydrochlorothiazide in patients with hypertension.
Ayalasomayajula, S; Bhad, P; Jarugula, V; Karan, R; Leon, S; Riviere, GJ; Sunkara, G, 2011
)
0.86
" In China, where the prevalence of hypertension is increasing the pharmacokinetic study of valsartan, amlodipine assumes significance."( Pharmacokinetics of single and multiple oral doses of valsartan/amlodipine (80/5 mg) in healthy Chinese subjects.
Chen, J; Duan, J; Karan, R; Meiser, K; Smith, HT; Sunkara, G; Yin, Q, 2012
)
0.83
"Following the single-dose oral administration of valsartan/amlodipine 80/5 mg, valsartan and amlodipine plasma concentrations reached peak levels at median tmax of 3 and 6 h, respectively."( Pharmacokinetics of single and multiple oral doses of valsartan/amlodipine (80/5 mg) in healthy Chinese subjects.
Chen, J; Duan, J; Karan, R; Meiser, K; Smith, HT; Sunkara, G; Yin, Q, 2012
)
0.86
"To investigate the effects of coadministration of telmisartan and S-amlodipine on the steady-state pharmacokinetic properties of each drug as a drug-drug interaction study required before developing the fixed-dose combination agent."( Pharmacokinetic interaction of telmisartan with s-amlodipine: an open-label, two-period crossover study in healthy Korean male volunteers.
Bae, KS; Choi, HY; Jin, SJ; Kim, MJ; Kim, YH; Lim, HS; Lim, J; Noh, YH; Sung, HR, 2012
)
0.87
" The pharmacokinetic properties of each drug after coadministration of telmisartan and S-amlodipine were compared with those of each drug administered alone."( Pharmacokinetic interaction of telmisartan with s-amlodipine: an open-label, two-period crossover study in healthy Korean male volunteers.
Bae, KS; Choi, HY; Jin, SJ; Kim, MJ; Kim, YH; Lim, HS; Lim, J; Noh, YH; Sung, HR, 2012
)
0.85
"Following multiple-dose coadministration of high doses of telmisartan and S-amlodipine, the steady-state pharmacokinetic properties of telmisartan were not significantly affected, and telmisartan had no significant effect on the pharmacokinetic properties of S-amlodipine at steady state in these selected groups of healthy volunteers."( Pharmacokinetic interaction of telmisartan with s-amlodipine: an open-label, two-period crossover study in healthy Korean male volunteers.
Bae, KS; Choi, HY; Jin, SJ; Kim, MJ; Kim, YH; Lim, HS; Lim, J; Noh, YH; Sung, HR, 2012
)
0.86
" The method was successfully applied to pharmacokinetic studies of amlodipine and bisoprolol in Sprague-Dawley (SD) rats."( Simultaneous determination of amlodipine and bisoprolol in rat plasma by a liquid chromatography/tandem mass spectrometry method and its application in pharmacokinetic study.
Bi, K; Chang, H; Fan, G; Guan, X; Li, J; Qian, Z; Sun, F, 2012
)
0.9
"Reasonable sampling scheme is the important basis for establishing reliable population pharmacokinetic model."( [Modeling and simulation activities to design sampling scheme for population pharmacokinetic study on amlodipine].
Barrett, JS; Di, W; Guo, R; Huang, ZJ; Jing, NN; Ng, CM; Pei, Q; Yang, GP; Yuan, H; Zhang, BK; Zhou, YN; Zuo, XC, 2012
)
0.59
" Meanwhile, blood pressure and heart rate were repeatedly taken to delineate the pharmacodynamic profiles."( Pharmacokinetic and pharmacodynamic profiles of a fixed-dose combination of olmesartan medoxomil and amlodipine in healthy Chinese males and females.
Chen, X; Hu, P; Jiang, J; Liu, H; Liu, T; Zhao, Q; Zhong, W, 2012
)
0.59
" The elimination half-life of amlodipine is more than twice as long as that of olmesartan."( Pharmacokinetic and pharmacodynamic profiles of a fixed-dose combination of olmesartan medoxomil and amlodipine in healthy Chinese males and females.
Chen, X; Hu, P; Jiang, J; Liu, H; Liu, T; Zhao, Q; Zhong, W, 2012
)
0.88
"After single and multiple doses of olmesartan medoxomil/amlodipine 20 mg/5 mg FDC tablets the pharmacokinetic profiles of olmesartan or amlodipine were comparable to those reported for monotherapy with olmesartan medoxomil or amlodipine, except that the elimination half-life of olmesartan was longer because of the longer time course over which pharmacokinetic blood sampling was carried out in this study."( Pharmacokinetic and pharmacodynamic profiles of a fixed-dose combination of olmesartan medoxomil and amlodipine in healthy Chinese males and females.
Chen, X; Hu, P; Jiang, J; Liu, H; Liu, T; Zhao, Q; Zhong, W, 2012
)
0.84
" There are significant pharmacokinetic interactions between TAC and AML."( Effect of amlodipine on the pharmacokinetics of tacrolimus in rats.
Cheng, ZN; Li, J; Li, PJ; Liu, Z; Tan, HY; Wang, CJ; Yang, GP; Yang, M; Yuan, H; Zhang, BK; Zhou, LY; Zhou, YN; Zuo, XC, 2013
)
0.79
" Pharmacokinetic drug interactions between tacrolimus and amlodipine were evaluated in a randomized, 3-period, 6-sequence crossover study in healthy Chinese volunteers according to CYP3A5 genotype."( Effect of CYP3A5*3 polymorphism on pharmacokinetic drug interaction between tacrolimus and amlodipine.
Barrett, JS; Cheng, ZN; Guo, R; Li, J; Li, PJ; Li, ZJ; Liu, SK; Liu, Z; Ouyang, DS; Tan, HY; Wang, CJ; Wang, JL; Xie, YL; Yang, GP; Yuan, H; Zhang, BK; Zhou, LY; Zhou, YN; Zuo, XC, 2013
)
0.85
"The 90% confidence intervals for the test/reference ratio of the pharmacokinetic parameters in fasting state (mean Cmax, AUC0-t, and AUC0-∞) were within the acceptable range of 80."( A comparative pharmacokinetic study of a fixed dose combination for essential hypertensive patients: a randomized crossover study in healthy human volunteers.
Biswas, E; Choudhury, H; Ghosh, B; Gorain, B; Halder, D; Pal, TK; Sarkar, AK; Sarkar, P, 2013
)
0.39
" The current assay was successfully applied to a pharmacokinetic study to quantitate AML enantiomers following oral administration of 10 mg AML tablet to humans."( Rapid quantification of amlodipine enantiomers in human plasma by LC-MS/MS: application to a clinical pharmacokinetic study.
Hotha, KK; Mullangi, R; Ravindranath, LK; Roychowdhury, S, 2013
)
0.7
"The goal of this study was to compare the pharmacokinetic profiles of single administration of a newly developed FDC tablet containing amlodipine orotate 10 mg and valsartan 160 mg (test formulation) with the conventional FDC tablet of amlodipine besylate 10 mg and valsartan 160 mg (reference formulation) in healthy male Korean volunteers."( Pharmacokinetic comparison of 2 fixed-dose combination tablets of amlodipine and valsartan in healthy male Korean volunteers: a randomized, open-label, 2-period, single-dose, crossover study.
Bahng, MY; Chae, D; Kim, Y; Lee, D; Park, K; Roh, H; Son, H; Son, M, 2013
)
0.83
" Blood samples were collected up to 144 hours after the dose, and pharmacokinetic parameters were determined for amlodipine and valsartan."( Pharmacokinetic comparison of 2 fixed-dose combination tablets of amlodipine and valsartan in healthy male Korean volunteers: a randomized, open-label, 2-period, single-dose, crossover study.
Bahng, MY; Chae, D; Kim, Y; Lee, D; Park, K; Roh, H; Son, H; Son, M, 2013
)
0.84
" In conclusion, this study has quantitatively described the pharmacokinetic interaction between simvastatin and amlodipine using a modeling approach."( Development of a pharmacokinetic interaction model for co-administration of simvastatin and amlodipine.
Jang, SB; Lee, D; Lim, LA; Park, K; Roh, H; Son, H, 2014
)
0.83
" The final population pharmacokinetic model shows that the elimination rate constant for simvastatin acid, the active form by hydrolysis of its lactone prodrug (i."( Genetic algorithm guided population pharmacokinetic model development for simvastatin, concurrently or non-concurrently co-administered with amlodipine.
Chaturvedula, A; Lee, H; Sale, ME, 2014
)
0.6
" Meanwhile, the Cmax of amlodipine, losartan and EXP3174 were reduced by 11."( The influence of food on the pharmacokinetics of amlodipine and losartan after single-dose of its compound tablets in healthy chinese subjects.
Guo, R; Li, R; Lv, C; Wang, B; Wang, X; Wei, C; Yao, H, 2014
)
0.96
" The objective of this study was to compare the pharmacokinetic (PK) characteristics of S-amlodipine and valsartan when administered as one tablet each of Exforge and AGSAV301 to healthy male subjects."( Pharmacokinetics, tolerability, and safety of the single oral administration of AGSAV301 vs Exforge: a randomized crossover study of healthy male volunteers.
Bae, KS; Choi, HY; Kim, MJ; Kim, YH; Lee, SH; Lim, HS; Noh, YH, 2014
)
0.62
" Population pharmacokinetic analyses were performed on data which were collected prospectively from 60 Chinese patients with mild to moderate essential hypertension [age range 40-74 years, males (n = 31), females (n = 29)] receiving oral racemic amlodipine for 4 weeks."( ABCB1 polymorphism and gender affect the pharmacokinetics of amlodipine in Chinese patients with essential hypertension: a population analysis.
Barrett, JS; Guo, CX; Hua, Y; Huang, ZJ; Pei, Q; Wang, JL; Yang, GP; Yuan, H; Zhang, WL; Zhou, HH; Zuo, XC, 2014
)
0.83
"The aim of this study was to compare pharmacokinetic characteristics of fixed-dose combination (FDC) of two different salt form of amlodipine, amlodipine adipate/valsartan and amlodipine besylate/ valsartan, in healthy Korean volunteers under fasting conditions."( Pharmacokinetic comparison of amlodipine adipate/valsartan fixed-dose combination with amlodipine besylate/valsartan fixed-dose combination in healthy volunteers.
Ghim, JL; Han, SK; Kim, EJ; Kim, EY; Kim, HJ; Kim, HS; Nam, JH; Oh, M; Shin, JG; Song, GS, 2015
)
0.91
"This study aimed to quantify the pharmacokinetic drug-drug interaction between CsA and nicardipine, amlodipine, and lacidipine."( Pharmacokinetic drug-drug interaction of calcium channel blockers with cyclosporine in hematopoietic stem cell transplant children.
Bernard, E; Bertrand, Y; Bleyzac, N; Goutelle, S, 2014
)
0.62
" This study was performed to determine the pharmacokinetic (PK) interaction between RG and amlodipine, an antihypertensive drug."( Negligible pharmacokinetic interaction of red ginseng and antihypertensive agent amlodipine in Sprague-Dawley rats.
Cho, YB; Jeong, WS; Kim, JW; Kim, KB; Kim, YG; Kim, YS; Lee, HK; Lee, SH; Ryu, SH, 2014
)
0.85
" The aim of the ROMAN study was to compare the pharmacodynamic effects of ranolazine versus amlodipine on platelet reactivity in clopidogrel treated patients with CAD."( Comparison of the pharmacodynamic effects of ranolazine versus amlodipine on platelet reactivity in stable patients with coronary artery disease treated with dual antiplatelet therapy : The ROMAN (RanOlazine vs. aMlodipine on platelet reactivity in stable
Angiolillo, DJ; Gaudio, C; Greco, C; Marazzi, G; Pelliccia, F; Rollini, F; Rosano, G; Vitale, C, 2015
)
0.88
"Volume of distribution is one of the most important pharmacokinetic properties of a drug candidate."( Volume of Distribution in Drug Design.
Beaumont, K; Di, L; Maurer, TS; Smith, DA, 2015
)
0.42
" We evaluated the pharmacokinetic interactions between lobeglitazone and amlodipine in healthy male Korean subjects."( Pharmacokinetic Interaction Between Amlodipine and Lobeglitazone, a Novel Peroxisome Proliferator-activated Receptor-γ Agonist, in Healthy Subjects.
Kim, C; Kim, CO; Park, MS; Sil Oh, E, 2015
)
0.92
" Thus, 21 participants completed the study schedule to compare the pharmacokinetic parameters of lobeglitazone, and 22 participants completed the study of amlodipine."( Pharmacokinetic Interaction Between Amlodipine and Lobeglitazone, a Novel Peroxisome Proliferator-activated Receptor-γ Agonist, in Healthy Subjects.
Kim, C; Kim, CO; Park, MS; Sil Oh, E, 2015
)
0.89
"To determine whether a potential pharmacokinetic interaction exists between perindopril arginine 5 mg and amlodipine 5 mg, after administration as a fixed-combination of perindopril 5 mg/amlodipine 5 mg (S05985)."( Investigation of a potential pharmacokinetic interaction between perindopril arginine and amlodipine when administered as a single perindopril/amlodipine fixed-dose combination tablet in healthy Chinese male volunteers.
Chen, X; Hu, P; Jiang, J; Liu, T; Zheng, X, 2016
)
0.87
" Serial blood samples were collected in each treatment period for determination of plasma amlodipine, perindopril, and perindoprilat concentrations and for calculation of the respective pharmacokinetic parameters (AUC(0-∞), AUC(0-t), C(max), and t(max))."( Investigation of a potential pharmacokinetic interaction between perindopril arginine and amlodipine when administered as a single perindopril/amlodipine fixed-dose combination tablet in healthy Chinese male volunteers.
Chen, X; Hu, P; Jiang, J; Liu, T; Zheng, X, 2016
)
0.88
" The aim of this study was to study the pharmacokinetics of amlodipine after oral administration of amlodipine and GLT and to investigate the potential for pharmacokinetic herb-drug interactions between GLT and amlodipine in rats."( Effect of Ginkgo Leaf Tablets on the Pharmacokinetics of Amlodipine in Rats.
Chai, Y; Sun, S; Wang, R; Wang, Y; Yuan, Y; Zhang, H, 2016
)
0.92
" Plasma concentrations of amlodipine were determined at the designated time points after oral administration by using the developed LC-MS/MS method, and the main pharmacokinetic parameters were calculated and compared."( Effect of Ginkgo Leaf Tablets on the Pharmacokinetics of Amlodipine in Rats.
Chai, Y; Sun, S; Wang, R; Wang, Y; Yuan, Y; Zhang, H, 2016
)
0.98
" In 3 separate studies, pharmacokinetic drug-drug interactions (DDIs) potential was assessed when LCZ696 was coadministered with hydrochlorothiazide (HCTZ), amlodipine, or carvedilol."( Pharmacokinetic drug-drug interaction assessment between LCZ696, an angiotensin receptor neprilysin inhibitor, and hydrochlorothiazide, amlodipine, or carvedilol.
Greeley, M; Hsiao, HL; Langenickel, TH; Pal, P; Rajman, I; Rebello, S; Roberts, J; Sunkara, G; Zhou, W, 2015
)
0.82
"Our data show a potential pharmacokinetic interaction, most likely via CYP3A4 between amlodipine and RIS, reflected in significantly different C/Ds for RIS, 9-OH-RIS and AM."( Pharmacokinetic considerations in the treatment of hypertension in risperidone-medicated patients - thinking of clinically relevant CYP2D6 interactions.
Gründer, G; Haen, E; Lammertz, SE; Paulzen, M; Schoretsanitis, G; Schruers, KR; Stegmann, B; Walther, S, 2016
)
0.66
" However, the pharmacokinetic interactions among these 3 substances are not well understood."( Pharmacokinetic Interaction Between Rosuvastatin, Telmisartan, and Amlodipine in Healthy Male Korean Subjects: A Randomized, Open-label, Multiple-dose, 2-period Crossover Study.
Guk, J; Heo, YA; Kim, Y; Park, K; Soh, D; Son, M; Woo Chae, D, 2016
)
0.67
" Pharmacokinetic samples were collected up to 72 hours after the last dose in subjects who received rosuvastatin only, and up to 144 hours after the last dose in subjects who received telmisartan/amlodipine with or without rosuvastatin."( Pharmacokinetic Interaction Between Rosuvastatin, Telmisartan, and Amlodipine in Healthy Male Korean Subjects: A Randomized, Open-label, Multiple-dose, 2-period Crossover Study.
Guk, J; Heo, YA; Kim, Y; Park, K; Soh, D; Son, M; Woo Chae, D, 2016
)
0.86
"These results demonstrate that when rosuvastatin, telmisartan, and amlodipine are coadministered to healthy male subjects, pharmacokinetic exposure increases with respect to rosuvastatin and telmisartan, whereas no change occurs with respect to amlodipine."( Pharmacokinetic Interaction Between Rosuvastatin, Telmisartan, and Amlodipine in Healthy Male Korean Subjects: A Randomized, Open-label, Multiple-dose, 2-period Crossover Study.
Guk, J; Heo, YA; Kim, Y; Park, K; Soh, D; Son, M; Woo Chae, D, 2016
)
0.91
" Single oral dose of amlodipine was administered to the hypertensive/normotensive subjects either morning or evening to assess the pharmacokinetic profile after morning dosing or evening dosing, respectively."( Evaluation of the effect of time dependent dosing on pharmacokinetic and pharmacodynamics of amlodipine in normotensive and hypertensive human subjects.
Hs, S; Khodadoustan, S; Kumar, C; Nasri Ashrafi, I; S, C; Vanaja Satheesh, K, 2017
)
0.99
" The aim of the present study was to evaluate in vivo pharmacokinetic (PK) interaction between allopathic drugs tolbutamide (TOLBU), amlodipine (AMLO), and phenacetin (PHENA) at low (L) and high (H) doses with ethanolic extract (EL) from GS."( In vivo pharmacokinetic interaction by ethanolic extract of Gymnema sylvestre with CYP2C9 (Tolbutamide), CYP3A4 (Amlodipine) and CYP1A2 (Phenacetin) in rats.
Kharkar, P; Pandita, N; Sahu, N; Vaghela, M, 2017
)
0.87
"This study compared the pharmacokinetic (PK) and safety profiles of a fixed-dose combination (FDC) formulation of telmisartan and S-amlodipine with those of concomitant administration of the two drugs."( Comparative pharmacokinetics of a fixed-dose combination vs concomitant administration of telmisartan and S-amlodipine in healthy adult volunteers.
Choi, YK; Ghim, JL; Kim, EY; Oh, M; Park, SE; Shim, EJ; Shin, JG, 2017
)
0.87
" Ritonavir (RTV) is a potent mechanism-based and reversible CYP3A inhibitor and moderate inducer that is used as a pharmacokinetic enhancer in several antiviral treatment regimens."( Guiding dose adjustment of amlodipine after co-administration with ritonavir containing regimens using a physiologically-based pharmacokinetic/pharmacodynamic model.
Menon, RM; Mukherjee, D; Shebley, M; Zha, J, 2018
)
0.78
"Amlodipine is rarely used in the treatment of pregnant hypertensive women due to limited pharmacokinetic data during pregnancy and the postpartum period."( Pharmacokinetics of amlodipine besylate at delivery and during lactation.
Kogutt, BK; McIntire, DD; Meek, C; Morgan, JL; Roberts, SW; Sheffield, JS; Stehel, EK, 2018
)
2.25
" A one compartment, first-order model was used to calculate pharmacokinetic estimates for maternal plasma."( Pharmacokinetics of amlodipine besylate at delivery and during lactation.
Kogutt, BK; McIntire, DD; Meek, C; Morgan, JL; Roberts, SW; Sheffield, JS; Stehel, EK, 2018
)
0.8
" In the immediate postpartum period, the amlodipine elimination half-life was 13."( Pharmacokinetics of amlodipine besylate at delivery and during lactation.
Kogutt, BK; McIntire, DD; Meek, C; Morgan, JL; Roberts, SW; Sheffield, JS; Stehel, EK, 2018
)
1.07
" Although of special clinical relevance, data on pharmacokinetic interactions between AMLO, RAMI, and venlafaxine (VEN) are lacking."( How to Treat Hypertension in Venlafaxine-Medicated Patients-Pharmacokinetic Considerations in Prescribing Amlodipine and Ramipril.
Augustin, M; Gründer, G; Haen, E; Paulzen, M; Schoretsanitis, G, 2018
)
0.69
" Pharmacokinetic assessments were performed over 48 hours for candesartan in part 1 and 72 hours for amlodipine in part 2 after drug administration on Day 10."( No pharmacokinetic interactions between candesartan and amlodipine following multiple oral administrations in healthy subjects.
Huh, W; Kim, JR; Kim, S; Ko, JW, 2018
)
0.94
"This study was conducted to compare the pharmacokinetic profiles of the bisoprolol-amlodipine FDC tablet with the bisoprolol tablet and amlodipine tablet administered concomitantly under both fasting and fed conditions."( Bioequivalence and Pharmacokinetics of Bisoprolol-Amlodipine 5 mg/5 mg Combination Tablet versus Bisoprolol 5 mg Tablet and Amlodipine 5 mg Tablet: An Open-Label, Randomized, Two-Sequence Crossover Study in Healthy Chinese Subjects.
Chen, X; Gao, D; Hu, C; Hu, X; Huang, Y; Li, L; Wang, C; Zhang, L; Zhao, Z; Zhou, D, 2018
)
0.96
"To build a physiologically based pharmacokinetic (PBPK) model for fimasartan, amlodipine, and hydrochlorothiazide, and to investigate the drug-drug interaction (DDI) potentials."( Physiologically Based Pharmacokinetic Modeling of Fimasartan, Amlodipine, and Hydrochlorothiazide for the Investigation of Drug-Drug Interaction Potentials.
Jeon, I; Kim, E; Lee, HA; Lee, S; Rhee, SJ; Song, IS; Yu, KS, 2018
)
0.95
"The predicted-to-observed ratios of all the pharmacokinetic parameters met the acceptance criterion."( Physiologically Based Pharmacokinetic Modeling of Fimasartan, Amlodipine, and Hydrochlorothiazide for the Investigation of Drug-Drug Interaction Potentials.
Jeon, I; Kim, E; Lee, HA; Lee, S; Rhee, SJ; Song, IS; Yu, KS, 2018
)
0.72
" The aim of this study was to investigate the possible pharmacokinetic drug-drug interactions between amlodipine, valsartan, and rosuvastatin in healthy Korean male volunteers."( Pharmacokinetic Drug Interactions Between Amlodipine, Valsartan, and Rosuvastatin in Healthy Volunteers.
Cho, S; Gwon, MR; Kang, WY; Kim, BK; Lee, HW; Ohk, B; Seong, SJ; Yang, DH; Yoon, YR, 2019
)
0.99
"When amlodipine, valsartan, and rosuvastatin were coadministered to healthy volunteers, the pharmacokinetic exposure to valsartan was decreased, but no change in exposure to amlodipine and rosuvastatin occurred."( Pharmacokinetic Drug Interactions Between Amlodipine, Valsartan, and Rosuvastatin in Healthy Volunteers.
Cho, S; Gwon, MR; Kang, WY; Kim, BK; Lee, HW; Ohk, B; Seong, SJ; Yang, DH; Yoon, YR, 2019
)
1.29
" The objective of this study was to evaluate the pharmacokinetic interaction between telmisartan/amlodipine fixed dose combination and rosuvastatin in healthy Korean male volunteers."( Pharmacokinetic interactions between telmisartan/amlodipine and rosuvastatin after multiple oral administrations in healthy Korean male subjects.
Jang, K; Jeon, JY; Kim, MG; Lim, Y; Moon, SJ; Yu, KS, 2019
)
0.99
"The pharmacokinetic parameters of telmisartan/amlodipine, but not rosuvastatin, met the pharmacokinetic equivalent criteria."( Pharmacokinetic interactions between telmisartan/amlodipine and rosuvastatin after multiple oral administrations in healthy Korean male subjects.
Jang, K; Jeon, JY; Kim, MG; Lim, Y; Moon, SJ; Yu, KS, 2019
)
1.03
"This study was performed to compare the single-dose pharmacokinetic properties and safety of DP-R212 (FDC of amlodipine and rosuvastatin) to those of each agent co-administered in healthy Korean subjects."( Pharmacokinetic and bioequivalence study of a fixed-dose combination of amlodipine besylate and rosuvastatin calcium compared to co-administration of separate tablets in healthy Korean subjects
.
Jeon, JY; Kim, MG; Park, JS, 2019
)
0.96
"Both drugs were safe and well tolerated, and the pharmacokinetic profiles were comparable between the treatments."( Pharmacokinetic and bioequivalence study of a fixed-dose combination of amlodipine besylate and rosuvastatin calcium compared to co-administration of separate tablets in healthy Korean subjects
.
Jeon, JY; Kim, MG; Park, JS, 2019
)
0.75
" The objective of this study was to evaluate the pharmacokinetic interaction among telmisartan, amlodipine, and hydrochlorothiazide."( Pharmacokinetic Interaction Among Telmisartan, Amlodipine, and Hydrochlorothiazide After a Single Oral Administration in Healthy Male Subjects.
Jeon, JY; Kim, MG; Moon, SJ; Yu, KS, 2019
)
0.99
"The pharmacokinetic parameters of telmisartan, amlodipine, and hydrochlorothiazide when administered separately or co-administered were compared, and all the parameters met the criteria for pharmacokinetic equivalence."( Pharmacokinetic Interaction Among Telmisartan, Amlodipine, and Hydrochlorothiazide After a Single Oral Administration in Healthy Male Subjects.
Jeon, JY; Kim, MG; Moon, SJ; Yu, KS, 2019
)
1.03
" The comparative pharmacokinetic study was performed to compare the profile of an FDC tablet formulation of amlodipine/losartan/rosuvastatin with that of concomitant administration of a currently marketed FDC tablet of amlodipine/losartan with a rosuvastatin tablet."( Comparison of Pharmacokinetics of a Fixed-Dose Combination of Amlodipine/Losartan/Rosuvastatin with Concomitant Administration of Amlodipine/Losartan and Rosuvastatin in Healthy Volunteers.
Chung, JY; Jang, IJ; Jung, JA; Kim, YI; Park, SI; Yoon, DY, 2020
)
1.01
" Blood samples were collected for up to 144 h post dose for pharmacokinetic evaluations."( Comparison of Pharmacokinetics of a Fixed-Dose Combination of Amlodipine/Losartan/Rosuvastatin with Concomitant Administration of Amlodipine/Losartan and Rosuvastatin in Healthy Volunteers.
Chung, JY; Jang, IJ; Jung, JA; Kim, YI; Park, SI; Yoon, DY, 2020
)
0.8
"We confirmed the pharmacokinetic equivalence of the FDC and LC treatments."( Comparison of Pharmacokinetics of a Fixed-Dose Combination of Amlodipine/Losartan/Rosuvastatin with Concomitant Administration of Amlodipine/Losartan and Rosuvastatin in Healthy Volunteers.
Chung, JY; Jang, IJ; Jung, JA; Kim, YI; Park, SI; Yoon, DY, 2020
)
0.8
"The aim of this study was to investigate the effects of P450 oxidoreductase (POR) genetic polymorphisms on the pharmacokinetic parameters of amlodipine."( Effects of cytochrome P450 oxidoreductase genotypes on the pharmacokinetics of amlodipine in healthy Korean subjects.
Chung, JE; Gwak, HS; Han, JM; Lee, KE; Park, K; Yee, J, 2020
)
0.99
"The performance of "trough sampling before reaching steady-state" and "serial sampling beyond the interval between steady-state" in a multiple-dose pharmacokinetic evaluation was compared."( Contribution of Trough Concentration Data in the Evaluation of Multiple-Dose Pharmacokinetics for Drugs with Delayed Distributional Equilibrium and Long Half-Life.
Choi, S; Han, S; Jeon, S; Yim, DS, 2020
)
0.56
"Amlodipine pharmacokinetic data were collected from a human pharmacology study performed in Seoul St."( Contribution of Trough Concentration Data in the Evaluation of Multiple-Dose Pharmacokinetics for Drugs with Delayed Distributional Equilibrium and Long Half-Life.
Choi, S; Han, S; Jeon, S; Yim, DS, 2020
)
2
" With informative trough samples, extended hospitalization for serial sampling (until 3-5 half-lives after the last dose), which is particularly problematic for long half-life drugs, may be avoided."( Contribution of Trough Concentration Data in the Evaluation of Multiple-Dose Pharmacokinetics for Drugs with Delayed Distributional Equilibrium and Long Half-Life.
Choi, S; Han, S; Jeon, S; Yim, DS, 2020
)
0.56
" Repeat dose pharmacokinetic and pharmacodynamic study of the nano-fixed dose combination (FDC) was done in dexamethasone-induced animal model."( Pharmacokinetic and pharmacodynamic evaluation of nano-fixed dose combination for hypertension.
Bhandari, RK; Bhatia, A; Kaur, N; Malhotra, S; Pandey, AK; Rather, IIG; Shafiq, N; Sharma, S, 2020
)
0.56
" In pharmacokinetic analysis a sustained-release for 7 days was observed in nano-FDC group."( Pharmacokinetic and pharmacodynamic evaluation of nano-fixed dose combination for hypertension.
Bhandari, RK; Bhatia, A; Kaur, N; Malhotra, S; Pandey, AK; Rather, IIG; Shafiq, N; Sharma, S, 2020
)
0.56
" sativa with amlodipine improved the pharmacological response of amlodipine in hypertensive rats, though there was no remarkable change in pharmacokinetic parameters (Cmax, Kel, elimination t1/2, and AUC0-t)."( Effect of Nigella sativa and Fenugreek on the Pharmacokinetics and Pharmacodynamics of Amlodipine in Hypertensive Rats.
Ahad, A; Al-Jenoobi, FI; Al-Mohizea, AM; Alam, MA; Bin Jardan, YA; Raish, M, 2020
)
1.15
"A population pharmacokinetic analysis was developed using non-linear mixed effect modelling (NONMEM) and included 163 amlodipine concentrations from 55 PLWH."( Population pharmacokinetic modelling to quantify the magnitude of drug-drug interactions between amlodipine and antiretroviral drugs.
Alves Saldanha, S; Buclin, T; Cavassini, M; Courlet, P; Csajka, C; Decosterd, LA; Guidi, M; Marzolini, C; Stoeckle, M, 2021
)
1.05
" The objective of this study was to compare the pharmacokinetic (PK) profiles of HCP1401, a fixed-dose combination of amlodipine 5 mg, losartan 100 mg, and chlorthalidone 25 mg, with the separate components (loose combination) of amlodipine/losartan 5/100 mg and chlorthalidone 25 mg."( Pharmacokinetics of a Fixed-Dose Combination of Amlodipine/Losartan and Chlorthalidone Compared to Concurrent Administration of the Separate Components.
Choi, Y; Chung, JY; Jeon, I; Jung, J; Moon, SJ; Park, SI; Yu, KS, 2022
)
1.19
" These herbs also influenced the Cmax, AUC0-t, and Tmax of amlodipine."( Effect of Hibiscus sabdariffa and Zingiber officinale on pharmacokinetics and pharmacodynamics of amlodipine.
Ahad, A; Al-Jenoobi, FI; Al-Mohizea, AM; Alam, MA; Alzenaidy, B; Bin Jardan, YA; Raish, M, 2021
)
1.08
" sabdariffa with amlodipine, improves its pharmacodynamic response."( Effect of Hibiscus sabdariffa and Zingiber officinale on pharmacokinetics and pharmacodynamics of amlodipine.
Ahad, A; Al-Jenoobi, FI; Al-Mohizea, AM; Alam, MA; Alzenaidy, B; Bin Jardan, YA; Raish, M, 2021
)
1.18
"This study aimed to evaluate the bioequivalence of 2 amlodipine besylate tablet formulations, a generic formulation and an original formulation, and to investigate their pharmacokinetic and safety profiles."( Pharmacokinetics, Bioequivalence, and Safety Studies of Amlodipine Besylate in Healthy Subjects.
Chen, B; Chen, H; Chen, Z; Lv, D; Sun, Y, 2022
)
1.22
" This study aimed to examine the pharmacokinetic drug interaction between tadalafil and amlodipine and the tolerability of their combined administration in healthy male subjects."( Pharmacokinetic Drug Interaction Between Amlodipine and Tadalafil: An Open-Label, Randomized, Multiple-Dose Crossover Study in Healthy Male Volunteers.
Hong, S; Jung, J; Kim, H; Lee, SH; Lim, HS, 2022
)
1.21
" Pharmacokinetic parameters were calculated using non-compartmental analysis."( Pharmacokinetic Drug Interaction Between Amlodipine and Tadalafil: An Open-Label, Randomized, Multiple-Dose Crossover Study in Healthy Male Volunteers.
Hong, S; Jung, J; Kim, H; Lee, SH; Lim, HS, 2022
)
0.99
"A substantial pharmacokinetic drug interaction between tadalafil and amlodipine was observed with respect to the concentration of tadalafil when administered concomitantly."( Pharmacokinetic Drug Interaction Between Amlodipine and Tadalafil: An Open-Label, Randomized, Multiple-Dose Crossover Study in Healthy Male Volunteers.
Hong, S; Jung, J; Kim, H; Lee, SH; Lim, HS, 2022
)
1.22

Compound-Compound Interactions

Atorvastatin combined with amlodipine therapy improves endothelial function and increases adiponectin levels and insulin sensitivity to a greater extent than monotherapy with either drug.

ExcerptReferenceRelevance
"The antihypertensive and metabolic effects of amlodipine, a new calcium-channel blocker, in combination with hydrochlorothiazide (HCTZ) were compared with those of HCTZ in combination with placebo."( Antihypertensive effectiveness of amlodipine in combination with hydrochlorothiazide.
Chrysant, C; Chrysant, SG; Hitchcock, A; Trus, J, 1989
)
0.81
" Therefore, acute intravenous administration of amlodipine alone or in combination with a beta-blocker does not appear to compromise left ventricular performance, sinus node function, or intracardiac conduction."( Evaluation of the acute hemodynamic and electrophysiologic effects of intravenous amlodipine alone and in combination with a beta-blocker in patients with angina pectoris.
Epstein, AE; Kay, GN; Plumb, V; Vetrovec, GW, 1993
)
0.77
"This prospective, randomized study assessed the safety and efficacy of metoprolol alone or combined with amlodipine on hemodynamic parameters at baseline, 2 hours after the first dose of study medication, and after 12 weeks of therapy in patients receiving background triple therapy for mild to severe heart failure."( Short-term and long-term hemodynamic and clinical effects of metoprolol alone and combined with amlodipine in patients with chronic heart failure.
Buchholz-Varley, C; Freudenberger, RS; Kalman, J; Kukin, ML; Mannino, MM; Ocampo, ON; Steinmetz, M, 1999
)
0.74
"This multicenter study evaluated the efficacy of candesartan cilexetil, an angiotensin II type 1 receptor antagonist, used alone or in combination with amlodipine or in combination with amlodipine and hydrochlorothiazide in the treatment of patients with moderate-to-severe essential hypertension."( Efficacy of candesartan cilexetil alone or in combination with amlodipine and hydrochlorothiazide in moderate-to-severe hypertension. UK and Israel Candesartan Investigators.
Antonios, TF; He, FJ; MacGregor, GA; Viskoper, JR, 2000
)
0.75
"To investigate the effects of the mixed endothelin receptor antagonist, bosentan, combined with the long-acting calcium channel blocker, amlodipine, compared to the angiotensin-converting enzyme inhibitor, cilazapril, on the progressive renal injury in spontaneous hypertensive rats (SHR) with diabetes."( Endothelin receptor antagonist combined with a calcium channel blocker attenuates renal injury in spontaneous hypertensive rats with diabetes.
Chen, J; Gu, Y; Lin, F; Lin, S; Ma, J; Yang, H; Zhu, W, 2002
)
0.52
"Bosentan combined with amlodipine can offer similar renoprotective effects on that of cilazapril and may be a potent therapy to attenuate renal injury by reducing renal protein levels of TGF-beta1 in diabetes with a hypertensive state."( Endothelin receptor antagonist combined with a calcium channel blocker attenuates renal injury in spontaneous hypertensive rats with diabetes.
Chen, J; Gu, Y; Lin, F; Lin, S; Ma, J; Yang, H; Zhu, W, 2002
)
0.63
"The aim of this study was to compare the time-effect profiles of a once-daily administration of valsartan and amlodipine, each given alone or in combination with hydrochlorothiazide, in terms of ambulatory blood pressure (BP) and heart rate in elderly patients with isolated systolic hypertension."( Comparison of the effects on 24-h ambulatory blood pressure of valsartan and amlodipine, alone or in combination with a low-dose diuretic, in elderly patients with isolated systolic hypertension (Val-syst Study).
Ambrosia, GB; Caiazza, A; Malacco, E; Mugellini, A; Palatini, P; Santonastaso, M; Spagnuolo, V, 2004
)
0.76
"These results suggest that olmesartan medoxomil combined with amlodipine is effective and well tolerated in reducing BP in patients with moderate to severe hypertension."( Efficacy and tolerability of olmesartan medoxomil combined with amlodipine in patients with moderate to severe hypertension after amlodipine monotherapy: a randomized, double-blind, parallel-group, multicentre study.
Brommer, P; Haag, U; Miele, C; Volpe, M, 2009
)
0.83
"To investigate the effects of amlodipine, a dihydropyridine calcium-channel blocker, alone or combined with terazosin, on urodynamics in rats with benign prostatic hyperplasia (BPH) and in female rats with detrusor instability (DI)."( Amlodipine alone or combined with terazosin improves lower urinary tract disorder in rat models of benign prostatic hyperplasia or detrusor instability: focus on detrusor overactivity.
Chen, GL; Liu, HP; Liu, P; Xu, XP, 2009
)
2.08
" The rats were intragastrically administered with assigned drugs (amlodipine, terazosin or both combined) for 14 days in three experiments."( Amlodipine alone or combined with terazosin improves lower urinary tract disorder in rat models of benign prostatic hyperplasia or detrusor instability: focus on detrusor overactivity.
Chen, GL; Liu, HP; Liu, P; Xu, XP, 2009
)
2.03
"Amlodipine alone or combined with terazosin might have the potential to alleviate lower urinary tract symptoms (LUTS)."( Amlodipine alone or combined with terazosin improves lower urinary tract disorder in rat models of benign prostatic hyperplasia or detrusor instability: focus on detrusor overactivity.
Chen, GL; Liu, HP; Liu, P; Xu, XP, 2009
)
3.24
"Amlodipine alone or combined with terazosin can improve the PVR of the LUTS patient effectively, but had no significant difference compared with terazosin."( [Amlodipine combined with terazosin reduces postvoid residual and the risk of acute urinary retention].
Fang, J; Li, YL; Liu, HP; Qin, XH; Xu, XP; Yang, C; Zhang, X, 2009
)
2.71
"We hypothesized that atorvastatin combined with amlodipine has additive beneficial vascular and metabolic effects that are superior to monotherapy in patients with hypertension."( Additive beneficial effects of atorvastatin combined with amlodipine in patients with mild-to-moderate hypertension.
Han, SH; Kim, SJ; Koh, KK; Koh, Y; Lee, Y; Park, JB; Quon, MJ; Shin, EK, 2011
)
0.87
"Atorvastatin combined with amlodipine therapy improves endothelial function and increases adiponectin levels and insulin sensitivity to a greater extent than monotherapy with either drug in hypertensive patients."( Additive beneficial effects of atorvastatin combined with amlodipine in patients with mild-to-moderate hypertension.
Han, SH; Kim, SJ; Koh, KK; Koh, Y; Lee, Y; Park, JB; Quon, MJ; Shin, EK, 2011
)
0.91
" We analysed pharmacokinetics and safety of olmesartan medoxomil in combination with either amlodipine or atenolol compared to respective monotherapies in two separate studies."( Pharmacokinetics and safety of olmesartan medoxomil in combination with either amlodipine or atenolol compared to respective monotherapies in healthy subjects.
Bolbrinker, J; Huber, M; Kreutz, R; Scholze, J, 2009
)
0.8
"59 patients with bronchial asthma (BA) combined with hypertension have been observed."( [Level of steroid hormones in patients with bronchial asthma combined with hypertension and their dynamics after using antihypertensive medications].
Altunina, NV; Lyzohub, VH,
)
0.13
" The present study was designed to investigate whether calcium channel blockers (CCBs) in combination with an ARB differentially affect kidney function."( Renoprotective effect of calcium channel blockers in combination with an angiotensin receptor blocker in elderly patients with hypertension. A randomized crossover trial between benidipine and amlodipine.
Dohi, Y; Kimura, G; Miyagawa, K; Nakazawa, A; Sato, K; Sugiura, T; Yamashita, S, 2010
)
0.55
"In patients with hypertension and metabolic syndrome, manidipine, both alone and in combination with the ACE inhibitor lisinopril, is significantly superior to amlodipine for improving insulin sensitivity as well as several metabolic, inflammatory and prothrombotic markers."( Effects of manidipine and its combination with an ACE inhibitor on insulin sensitivity and metabolic, inflammatory and prothrombotic markers in hypertensive patients with metabolic syndrome: the MARCADOR study.
Comi-Diaz, C; Macias-Batista, A; Martinez-Martin, FJ; Pedrianes-Martin, P; Rodriguez-Rosas, H; Soriano-Perera, P, 2011
)
0.57
" The aim of this study was to evaluate the effects of losartan or amlodipine alone or combined with simvastatin on hepatic steatosis degree, and on insulin sensitivity in normocholesterolemic, hypertensive patients with nonalcoholic hepatic steatosis."( Effects of losartan and amlodipine alone or combined with simvastatin in hypertensive patients with nonalcoholic hepatic steatosis.
Derosa, G; Fogari, R; Lazzari, P; Maffioli, P; Mugellini, A; Zoppi, A, 2012
)
0.92
" Mean extraction recoveries of three QCs for the triple drug combination were 76."( Simple RP-HPLC method for determination of triple drug combination of valsartan, amlodipine and hydrochlorothiazide in human plasma.
Pancholi, SS; Sharma, RN, 2012
)
0.61
"To compare the effects of valsartan combined with amlodipine or hydrochlorothiazide regimen on blood pressure variation and plasma nitric oxide (NO) and endothelin (ET) in elderly hypertensive patients."( [Effects of valsartan combined with amlodipine or hydrochlorothiazide regimen on blood pressure variation in elderly hypertensive patients].
Sun, CX; Tao, CW; Wu, ZB; Yu, QG; Zhang, Y, 2012
)
0.91
"Valsartan in combination with amlodipine or hydrochlorothiazide can both effectively lower BPV in elderly hypertensive patients and improve the vascular endothelial function and the former regimen is more suitable for elderly hypertensive patients."( [Effects of valsartan combined with amlodipine or hydrochlorothiazide regimen on blood pressure variation in elderly hypertensive patients].
Sun, CX; Tao, CW; Wu, ZB; Yu, QG; Zhang, Y, 2012
)
0.94
"We compared the effects of exercise alone and in combination with a calcium channel blocker (amlodipine) or an angiotensin receptor blocker (valsartan) in hypertensive patients."( Effects of exercise therapy alone and in combination with a calcium channel blocker or an angiotensin receptor blocker in hypertensive patients.
Ikeda, M; Ohta, M; Tajiri, Y; Yamato, H, 2012
)
0.6
"To investigate the effects and safety of Western medicine combined with Chinese medicine (CM) based on syndrome differentiation in the treatment of elderly polarized hypertension (PHPT), or isolated systolic hypertension with low diastolic blood pressure (DBP)."( Clinical study of western medicine combined with Chinese medicine based on syndrome differentiation in the patients with polarized hypertension.
Chen, SL; Chen, XL; Liu, XY; Mei, WY; Xu, WM, 2012
)
0.38
"A total of 125 elderly patients with PHPT were randomly assigned to two groups: 59 in the control group treated by Western medicine and 66 in the intervention group treated by Western medicine combined with CM treatment."( Clinical study of western medicine combined with Chinese medicine based on syndrome differentiation in the patients with polarized hypertension.
Chen, SL; Chen, XL; Liu, XY; Mei, WY; Xu, WM, 2012
)
0.38
"Western medicine combined with CM treatment based on syndrome differentiation was safer and more effective than Western medicine alone in the treatment of elderly PHPT, because it not only reduced SBP but also improved DBP, which might lower the incidence of the cardiovascular and cerebrovascular events."( Clinical study of western medicine combined with Chinese medicine based on syndrome differentiation in the patients with polarized hypertension.
Chen, SL; Chen, XL; Liu, XY; Mei, WY; Xu, WM, 2012
)
0.38
"The objective of this study was to evaluate the effect of the CYP3A5*3 allele on the pharmacokinetics of tacrolimus and amlodipine, and drug-drug interactions between them in healthy subjects."( Effect of CYP3A5*3 polymorphism on pharmacokinetic drug interaction between tacrolimus and amlodipine.
Barrett, JS; Cheng, ZN; Guo, R; Li, J; Li, PJ; Li, ZJ; Liu, SK; Liu, Z; Ouyang, DS; Tan, HY; Wang, CJ; Wang, JL; Xie, YL; Yang, GP; Yuan, H; Zhang, BK; Zhou, LY; Zhou, YN; Zuo, XC, 2013
)
0.82
" The application of SOHGA for automated model selection, combined with traditional model selection strategies, appears to save time for model development, which also can generate new hypotheses that are biologically more plausible."( Genetic algorithm guided population pharmacokinetic model development for simvastatin, concurrently or non-concurrently co-administered with amlodipine.
Chaturvedula, A; Lee, H; Sale, ME, 2014
)
0.6
"Four simple, accurate, reproducible, and selective methods have been developed and subsequently validated for the determination of Benazepril (BENZ) alone and in combination with Amlodipine (AML) in pharmaceutical dosage form."( Comparative study between univariate spectrophotometry and multivariate calibration as analytical tools for quantitation of Benazepril alone and in combination with Amlodipine.
Elaziz, OA; Farouk, M; Hemdan, A; Shehata, MA; Tawakkol, SM, 2014
)
0.79
"The current study addresses the 24-h antihypertensive efficacy and safety of arotinolol combined with a different calcium channel blocker."( The efficacy and safety of arotinolol combined with a different calcium channel blocker in the treatment of Chinese patients with essential hypertension: a one-year follow-up study.
Chen, W; Fang, H; Liu, X; Xu, W, 2014
)
0.4
"The result showed that the effective rate of one year antihypertensive treatment of arotinolol combined with nifedipine was 51 of 53, significantly effective (p < 0."( The efficacy and safety of arotinolol combined with a different calcium channel blocker in the treatment of Chinese patients with essential hypertension: a one-year follow-up study.
Chen, W; Fang, H; Liu, X; Xu, W, 2014
)
0.4
"The therapy approached of arotinolol combined with nifedipine or amlodipine could be effective and well-tolerated, and they can be used as the better chosen antihypertensive drug."( The efficacy and safety of arotinolol combined with a different calcium channel blocker in the treatment of Chinese patients with essential hypertension: a one-year follow-up study.
Chen, W; Fang, H; Liu, X; Xu, W, 2014
)
0.64
" We have now compared the effects of the ARB valsartan combined with cilnidipine or amlodipine on cardiac pathophysiology in DS rats."( Comparative effects of valsartan in combination with cilnidipine or amlodipine on cardiac remodeling and diastolic dysfunction in Dahl salt-sensitive rats.
Harada, E; Hattori, T; Matsuura, N; Murohara, T; Nagasawa, K; Nagata, K; Niinuma, K; Takahashi, K; Takatsu, M; Watanabe, S, 2015
)
0.88
"This study aimed to quantify the pharmacokinetic drug-drug interaction between CsA and nicardipine, amlodipine, and lacidipine."( Pharmacokinetic drug-drug interaction of calcium channel blockers with cyclosporine in hematopoietic stem cell transplant children.
Bernard, E; Bertrand, Y; Bleyzac, N; Goutelle, S, 2014
)
0.62
"To estimate effectiveness and safety of losartan and its combination with amlodipine in therapy of arterial hypertension."( [Effectiveness and safety of losartan and its combination with amlodipine in therapy of arterial hypertension].
Bazaeva, EV; Boitsov, SA; Drapkina, OM; Luk'ianov, MM; Panov, AV; Shchukina, GN; Terent'ev, BP; Tiurin, VP, 2013
)
0.86
" Losartan was used at a dose of 50-100 mg/24 h for 8 weeks (stage 1) and thereafter from week 9 to 26 (stage 2) in combination with amlodipine (5-10 mg/24 hr) if the desired AP level (< 140/90 mmHg) was not achieved."( [Effectiveness and safety of losartan and its combination with amlodipine in therapy of arterial hypertension].
Bazaeva, EV; Boitsov, SA; Drapkina, OM; Luk'ianov, MM; Panov, AV; Shchukina, GN; Terent'ev, BP; Tiurin, VP, 2013
)
0.83
" In this study, the possibility of drug-drug interactions between amlodipine and coadministered antibiotics (ampicillin) was investigated in rats; thus, changes in the metabolic activities of gut microflora and the consequent pharmacokinetic pattern of amlodipine following ampicillin treatment were characterized."( Effects of orally administered antibiotics on the bioavailability of amlodipine: gut microbiota-mediated drug interaction.
Kim, DH; Kim, IS; Yoo, DH; Yoo, HH, 2016
)
0.91
" Because of interaction between amlodipine and simvastatin, in combination with physical activity, the patient reported: muscle pain, weakness of the muscles, dizziness, and confusion."( [Drug interaction in 63-year-old male sportsman--a case report].
Foerster, J; Schetz, D; Sein Anand, J, 2015
)
0.7
" The study aimed to evaluate the feasibility of different doses of DXM combined with standard AM treatment in clinical hypertension."( Combination With Low-dose Dextromethorphan Improves the Effect of Amlodipine Monotherapy in Clinical Hypertension: A First-in-human, Concept-proven, Prospective, Dose-escalation, Multicenter Study.
Chen, JW; Chen, P; Cheng, SM; Hung, YJ; Tseng, WK; Wang, KY; Wen, MS; Wu, CC; Wu, TC; Yeh, HI; Yin, WH, 2016
)
0.67
" In 3 separate studies, pharmacokinetic drug-drug interactions (DDIs) potential was assessed when LCZ696 was coadministered with hydrochlorothiazide (HCTZ), amlodipine, or carvedilol."( Pharmacokinetic drug-drug interaction assessment between LCZ696, an angiotensin receptor neprilysin inhibitor, and hydrochlorothiazide, amlodipine, or carvedilol.
Greeley, M; Hsiao, HL; Langenickel, TH; Pal, P; Rajman, I; Rebello, S; Roberts, J; Sunkara, G; Zhou, W, 2015
)
0.82
" The drug-drug interaction assay also showed that the concomitant use of kinsenoside has a non-significant effect on the concentration of lovastatin or amlodipine, and their major metabolites."( In Vitro Assessment of CYP-Mediated Drug Interactions for Kinsenoside, an Antihyperlipidemic Candidate.
Choi, MS; Kim, IS; Luo, Z; Rehman, SU; Xue, Y; Yao, G; Yoo, HH; Zhang, Y, 2016
)
0.63
"The aims of this study are to find the prevalence of potential drug-drug interactions (DDIs) in patients with Hemodialysis and identify factors associated with these interactions if present."( Evaluation of potential drug- drug interactions among Palestinian hemodialysis patients.
Abu-Ghazaleh, D; Al-Ramahi, R; Bsharat, A; Raddad, AR; Rashed, AO; Shehab, O; Yasin, E, 2016
)
0.43
" The new model is useful for estimating the risk of drug interaction in clinical practice when AST-120 is used in combination with other drugs."( Prediction of drug interaction between oral adsorbent AST-120 and concomitant drugs based on the in vitro dissolution and in vivo absorption behavior of the drugs.
Kotegawa, T; Koya, Y; Machi, Y; Namiki, N; Shobu, Y; Uchida, S, 2016
)
0.43
"To build a physiologically based pharmacokinetic (PBPK) model for fimasartan, amlodipine, and hydrochlorothiazide, and to investigate the drug-drug interaction (DDI) potentials."( Physiologically Based Pharmacokinetic Modeling of Fimasartan, Amlodipine, and Hydrochlorothiazide for the Investigation of Drug-Drug Interaction Potentials.
Jeon, I; Kim, E; Lee, HA; Lee, S; Rhee, SJ; Song, IS; Yu, KS, 2018
)
0.95
"To study the effect and molecular mechanisms of amlodipine besylate combined with acupoint application of traditional Chinese medicine nursing on the treatment methods of renal failure and hypertension."( Effect of amlodipine besylate combined with acupoint application of traditional Chinese medicine nursing on the treatment of renal failure and hypertension by the PI3K/AKT pathway.
Chi, R; Feng, L; Liang, W; Lv, S; Su, J; Zhu, Q, 2019
)
1.17
" The aim of this study was to investigate the possible pharmacokinetic drug-drug interactions between amlodipine, valsartan, and rosuvastatin in healthy Korean male volunteers."( Pharmacokinetic Drug Interactions Between Amlodipine, Valsartan, and Rosuvastatin in Healthy Volunteers.
Cho, S; Gwon, MR; Kang, WY; Kim, BK; Lee, HW; Ohk, B; Seong, SJ; Yang, DH; Yoon, YR, 2019
)
0.99
" As the management of drug-drug interactions (DDIs) constitutes a key aspect of the care of PLWH, the magnitude of pharmacokinetic DDIs between cardiovascular and anti-HIV drugs needs to be more thoroughly characterized."( UHPLC-MS/MS assay for simultaneous determination of amlodipine, metoprolol, pravastatin, rosuvastatin, atorvastatin with its active metabolites in human plasma, for population-scale drug-drug interactions studies in people living with HIV.
Alves Saldanha, S; Buclin, T; Cavassini, M; Courlet, P; Csajka, C; Decosterd, LA; Desfontaine, V; Marzolini, C; Spaggiari, D, 2019
)
0.76
" Participants were divided into six treatment groups based on the hypertensive drug therapy they were using; lisinopril, losartan or valsartan alone or in combination with hydrochlorothiazide (A, B and C group respectively) or combination of lisinopril, losartan or valsartan with/without hydrochlorothiazide together with amlodipine (D, E and F respectively)."( Effects of Different Antihypertensive Drug Combinations on Blood Pressure and Arterial Stiffness.
Hebibovic, S; Jatic, Z; Rustempasic, E; Skopljak, A; Sukalo, A; Valjevac, A, 2019
)
0.69
"These data suggest that lisinopril/lisinopril + hydrochlorothiazide, losartan/losartan + hydrochlorothiazide and valsartan/valsartan + hydrochlorothiazide alone or in combination with amlodipine are equally effective and well tolerated for the reduction of both systolic and diastolic blood pressure and improve arterial stiffness in patients with essential hypertension."( Effects of Different Antihypertensive Drug Combinations on Blood Pressure and Arterial Stiffness.
Hebibovic, S; Jatic, Z; Rustempasic, E; Skopljak, A; Sukalo, A; Valjevac, A, 2019
)
0.71
" SIGNIFICANCE AND IMPACT OF THE STUDY: Drug combination is an effective approach for the treatment of resistant bacterial infection."( In vitro interactions of ambroxol hydrochloride or amlodipine in combination with antibacterial agents against carbapenem-resistant Acinetobacter baumannii.
Li, X; Lu, C; Sun, S; Wang, D; Wang, Y, 2020
)
0.81
": The risk of drug-drug interactions (DDIs) is elevated in aging people living with HIV (PLWH) because of highly prevalent age-related comorbidities leading to more comedications."( Aging does not impact drug--drug interaction magnitudes with antiretrovirals.
Battegay, M; Cavassini, M; Courlet, P; Decosterd, L; Marzolini, C; Saldanha, SA; Stader, F; Stoeckle, M, 2020
)
0.56
" In order to determine which combination was better as the next-step therapy for standard-dose combination of ARBs and CCBs, a combination with high-dose CCBs or a triple combination with diuretics, the authors conducted a prospective, randomized, open-label trial to determine which of the following combination is better as the next-step treatment: a combination with high-dose CCBs or a triple combination with diuretics."( Assessment of suitable antihypertensive therapies: Combination with high-dose amlodipine/irbesartan vs triple combination with amlodipine/irbesartan/indapamide (ASAHI-AI study).
Hasebe, N; Koyama, S; Maruyama, J; Morimoto, H; Nakagawa, N; Nakamura, Y; Ogawa, Y; Ohta, T; Saijo, Y; Sato, N; Takeuchi, T; Uekita, K, 2020
)
0.79
"Objectives For revealing the peculiarities of the drug-drug interaction of rivaroxaban (substrate CYP3A4 and P-gp) and calcium channel blockers (CCBs) (verapamil - inhibitor CYP3A4 and P-gp and amlodipine - substrate CYP3A4) in patients 80 years and older with nonvalvular atrial fibrillation (NAF) we studied 128 patients."( Drug-drug interaction of rivaroxaban and calcium channel blockers in patients aged 80 years and older with nonvalvular atrial fibrillation.
Bahteeva, D; Bochkov, P; Cherniaeva, M; Golovina, O; Gorbatenkova, S; Kulikova, M; Mirzaev, K; Ostroumova, O; Rytkin, E; Shevchenko, R; Sychev, D, 2020
)
0.75
"This open-label, repeat-dose, fixed-sequence study in healthy subjects examined pharmacokinetic drug-drug interactions between the components of a novel fixed-dose combination product containing ramipril, amlodipine, and atorvastatin."( Mechanistic Considerations About an Unexpected Ramipril Drug-Drug Interaction in the Development of a Triple Fixed-Dose Combination Product Containing Ramipril, Amlodipine, and Atorvastatin.
Gundlach, K; Hermann, R; Seiler, D, 2021
)
1.01
"Conclusion      Patients with IHD and AH in combination with early CKD have pronounced impairment of the condition of arterial blood vessels and the heart."( [Vasoprotective effects hypotensive therapy in patients with coronary heart disease combined with chronic kidney disease stage 2-3 after coronary stenting].
Barbashina, TA; Gavriljuk, EV; Mal, GS; Pribylov, CA; Pribylov, VS; Pribylova, NN; Yakovleva, MV, 2021
)
0.62
" The aim of this study was to evaluate the efficacy and safety of TJT combined with Val/Aml in the treatment of stage 2 hypertension with hyperactivity of liver yang."( Efficacy and safety of Tengfu Jiangya tablet combined with valsartan/amlodipine in the treatment of stage 2 hypertension: study protocol for a randomized controlled trial.
Chen, W; Hua, Z; Li, Y; Wang, Y; Zhu, Y, 2022
)
0.96
" Eligible patients will be randomly assigned (1:1) into groups receiving either TJT or placebo three times daily for 28 days, both combined with Val/Aml 80/5 mg."( Efficacy and safety of Tengfu Jiangya tablet combined with valsartan/amlodipine in the treatment of stage 2 hypertension: study protocol for a randomized controlled trial.
Chen, W; Hua, Z; Li, Y; Wang, Y; Zhu, Y, 2022
)
0.96
"This is the first placebo-controlled randomized trial conducted to evaluate the efficacy and safety of a Chinese herbal extract combined with Val/Aml in patients with stage 2 hypertension."( Efficacy and safety of Tengfu Jiangya tablet combined with valsartan/amlodipine in the treatment of stage 2 hypertension: study protocol for a randomized controlled trial.
Chen, W; Hua, Z; Li, Y; Wang, Y; Zhu, Y, 2022
)
0.96
" The availability of OM combined with HCTZ, AML or both at different dosages makes it a valuable option to customize therapy based on the levels of BP and the clinical characteristics of hypertensive patients."( Single-Pill Combination with Three Antihypertensive Agents to Improve Blood Pressure Control in Hypertension: Focus on Olmesartan-Based Combinations.
Burnier, M; Redon, J; Volpe, M, 2023
)
0.91
" However, there are few studies on the regulation and efficacy of atorvastatin combined with amlodipine on Th17/Treg balance in hypertension combined with carotid atherosclerosis."( Effects of amlodipine combined with atorvastatin on Th17/Treg imbalance and vascular microcirculation in hypertensive patients with atherosclerosis: A double-blind, single-center randomized controlled trial.
Qiu, Y; Yang, G, 2023
)
1.52
"These data indicate that amlodipine combined with atorvastatin can improve Th17/Treg imbalance, vascular endothelial function and efficacy in patients with hypertension and atherosclerosis."( Effects of amlodipine combined with atorvastatin on Th17/Treg imbalance and vascular microcirculation in hypertensive patients with atherosclerosis: A double-blind, single-center randomized controlled trial.
Qiu, Y; Yang, G, 2023
)
1.6
" Therefore, the results of valsartan and amlodipine tablets combined with alpha-lipoic acid on total antioxidant capacity (T-AOC) need to be investigated."( Effects of Valsartan and Amlodipine Tablets Combined with α-Lipoic Acid on T-AOC, IL-6 and β2-MG Levels in Patients with Diabetic Nephropathy.
Su, F; Xia, Q, 2023
)
1.48
"To observe the effect of amlodipine besylate combined with metoprolol in treating hypertension and heart failure."( Improvement in hemodynamics of amlodipine besylate combined with metoprolol in patients with hypertension complicated by heart failure.
Chen, C; Jiao, D; Shen, J; Zhang, W; Zhang, X; Zhu, G, 2023
)
1.5

Bioavailability

The present study was conducted to find out whether the bioavailability of a 10 mg amlodipine (CAS 88150-42-9) tablet (Intervask, "test") was equivalent to that of a reference formulation ("reference") Bioavailability enhancement by grapefruit juice, noted with other dihydropyridine calcium antagonists, does not occur with amlODIPine.

ExcerptReferenceRelevance
" Following oral administration, bioavailability is 60 to 65% and plasma concentrations rise gradually to peak 6 to 8h after administration."( Clinical pharmacokinetics of amlodipine.
Elliott, HL; Meredith, PA, 1992
)
0.57
" It has high oral bioavailability (60-80%) and accumulates to a steady-state with once-daily administration over a period of 1-1 1/2 weeks."( Pharmacokinetics and pharmacodynamics of amlodipine.
Abernethy, DR, 1992
)
0.55
" A high oral bioavailability of amlodipine has been demonstrated in a number of animal species and man, together with a long elimination half-life."( Amlodipine: a once daily calcium antagonist.
Burges, RA, 1991
)
2.01
" Bioavailability of unchanged drug after oral administration was high with values of 63, 88, 100, and 100% in humans, dogs, mice, and rats, respectively."( The metabolism and pharmacokinetics of amlodipine in humans and animals.
Beresford, AP; Humphrey, MJ; Macrae, PV; Stopher, DA, 1988
)
0.54
"The oral bioavailability of amlodipine in healthy volunteers was compared in two separate studies after solution and capsule doses, and after capsule doses in fed and fasting states."( Absorption of amlodipine unaffected by food. Solid dose equivalent to solution dose.
Chasseaud, LF; Faulkner, JK; Hayden, ML; Taylor, T, 1989
)
0.93
"Amlodipine, a dihydropyridine calcium antagonist, was synthesized in an attempt to develop a compound with a pharmacokinetic profile characteristic of this class, which would also have an increased oral bioavailability and extended clearance time."( The pharmacokinetic profile of amlodipine.
Abernethy, DR, 1989
)
2.01
" Amlodipine, a new member of this family of dihydropyridines, has a unique pharmacokinetic profile with high bioavailability and an extended period of pharmacodynamic activity."( The efficacy of amlodipine in myocardial ischemia.
Taylor, SH, 1989
)
1.53
" Oral bioavailability approached 100%, and hemodynamic responses were gradual in onset and long-lasting in effect."( Long-acting dihydropyridine calcium antagonists. 1. 2-Alkoxymethyl derivatives incorporating basic substituents.
Arrowsmith, JE; Blackburn, KJ; Burges, RA; Campbell, SF; Cross, PE; Gardiner, DG; Stubbs, JK, 1986
)
0.27
" The drug was well absorbed by the oral route while the mean oral bioavailability for unchanged drug was 62."( Metabolism and kinetics of amlodipine in man.
Beresford, AP; Humphrey, MJ; Macrae, PV; McGibney, D; Stopher, DA, 1988
)
0.57
"In the present study we investigated the pharmacokinetics and comparative bioavailability of three oral doses of amlodipine in 12 healthy male volunteers."( Amlodipine pharmacokinetics in healthy volunteers.
Cubeddu, LX; Williams, DM, 1988
)
1.93
" Nifedipine, diltiazem, and verapamil are all high-clearance agents with significant hepatic extraction and rapid clearance, leading to limited and short-lived bioavailability necessitating frequent daily administration."( Amlodipine once a day in stable angina: double-blind crossover comparison with placebo.
Cheitlin, MD; Das, SK; Deedwania, PC; Pasternak, RC; Pool, PE; Singh, JB, 1993
)
1.73
" They are very liposoluble molecules which are well absorbed after oral prescription (90-100%); they show an important effect in their first step, they join the serum proteins in a high proportion, present a wide tissue distribution, they are quickly biotransformed in the liver and only a minimum proportion is discharged by urine without any modification."( [Clinical pharmacokinetics of calcium antagonists].
Sesin, J; Tamargo, J, 1997
)
0.3
" Amlodipine once-daily, a calcium channel blocker structurally related to nifedipine with an excellent bioavailability and a long elimination half-time, has been shown to reduce blood pressure in adults."( Amlodipine once-daily in systemic hypertension.
Bianchetti, MG; Busch, K; Clericetti-Affolter, C; Laux-End, R; Pfammatter, JP; Truttmann, AC, 1998
)
2.65
"The quantitative structure-bioavailability relationship of 232 structurally diverse drugs was studied to evaluate the feasibility of constructing a predictive model for the human oral bioavailability of prospective new medicinal agents."( QSAR model for drug human oral bioavailability.
Topliss, JG; Yoshida, F, 2000
)
0.31
" Bioavailability enhancement by grapefruit juice, noted with other dihydropyridine calcium antagonists, does not occur with amlodipine."( Lack of effect of grapefruit juice on the pharmacokinetics and pharmacodynamics of amlodipine.
Dogolo, LC; Foulds, G; Friedman, HL; Harris, SI; Vincent, J; Willavize, S, 2000
)
0.74
"To determine the effects of the angiotensin II receptor antagonist irbesartan, the calcium-channel blocker amlodipine, and hydrochlorothiazide/hydralazine on superoxide, NAD(P)H oxidase and nitric oxide bioavailability in spontaneously hypertensive stroke-prone rats (SHRSP)."( Irbesartan lowers superoxide levels and increases nitric oxide bioavailability in blood vessels from spontaneously hypertensive stroke-prone rats.
Brosnan, MJ; Dominiczak, AF; Graham, D; Hamilton, CA; Jardine, E; Lygate, CA, 2002
)
0.53
" In vitro the effects of exposure to drugs and vehicle for 30 min and 4 h on superoxide levels and nitric oxide bioavailability were examined."( Irbesartan lowers superoxide levels and increases nitric oxide bioavailability in blood vessels from spontaneously hypertensive stroke-prone rats.
Brosnan, MJ; Dominiczak, AF; Graham, D; Hamilton, CA; Jardine, E; Lygate, CA, 2002
)
0.31
"62 nmoles/mg per min and increased nitric oxide bioavailability in carotid arteries."( Irbesartan lowers superoxide levels and increases nitric oxide bioavailability in blood vessels from spontaneously hypertensive stroke-prone rats.
Brosnan, MJ; Dominiczak, AF; Graham, D; Hamilton, CA; Jardine, E; Lygate, CA, 2002
)
0.31
"These studies support the hypothesis that AT1 receptor blockade has beneficial effects on superoxide production and nitric oxide bioavailability above that of other classes of antihypertensive agents."( Irbesartan lowers superoxide levels and increases nitric oxide bioavailability in blood vessels from spontaneously hypertensive stroke-prone rats.
Brosnan, MJ; Dominiczak, AF; Graham, D; Hamilton, CA; Jardine, E; Lygate, CA, 2002
)
0.31
" A comparative bioavailability study of a tablet and suspension formulation of amlodipine was completed in 20 healthy adult volunteers."( Bioavailability of a pediatric amlodipine suspension.
Hard, M; Koren, G; Kozer, E; Levichek, Z; Lyszkiewicz, DA; Moretti, M; Yagev, Y, 2003
)
0.83
" Many factors, including P-glycoprotein (PGP), influence the oral bioavailability and interpatient variability of CsA."( Amlodipine, but not MDR1 polymorphisms, alters the pharmacokinetics of cyclosporine A in Japanese kidney transplant recipients.
Kobayashi, T; Kuzuya, T; Moriyama, N; Nabeshima, T; Nagasaka, T; Nakao, A; Uchida, K; Yokoyama, I, 2003
)
1.76
"05), whereas the response to an NO donor was unaffected, suggesting decreased bioavailability of NO."( Oxidant stress leads to impaired regulation of renal cortical oxygen consumption by nitric oxide in the aging kidney.
Adler, S; Huang, H; Kaminski, PM; Wolin, MS, 2004
)
0.32
" The rate of absorption reflected by tmax had a difference of -0."( Bioequivalence study of generic amlodipine in healthy Thai male volunteers.
Arnold, P; Chaichana, N; Gaupp, M; Jakob, K; Martin, W; Rojanasthien, N; Teekachunhatean, S, 2004
)
0.61
" On average, bioavailability of amlodipine was slightly higher in females than in males, but these differences could be explained by the lower body weight of women."( Assessment of sex differences in pharmacokinetics and pharmacodynamics of amlodipine in a bioequivalence study.
Abad-Santos, F; Almeida, S; Gallego-Sandín, S; Gálvez-Múgica, MA; García, AG; Novalbos, J; Vallée, F, 2005
)
0.84
" Amlodipine is absorbed gradually after oral administration (peak plasma levels 6-12 h postdose) and has an absolute bioavailability of 64%."( Amlodipine: pharmacokinetic profile of a low-clearance calcium antagonist.
Abernethy, DR, 1991
)
2.63
" Damage to the endothelium leads to reduced NO bioavailability and facilitates vessel wall permeability to low-density lipoprotein."( A rationale for combination therapy in risk factor management: a mechanistic perspective.
Mason, RP, 2005
)
0.33
" The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability or bioequivalence studies."( Sensitive and rapid liquid chromatography/tandem mass spectrometry assay for the quantification of amlodipine in human plasma.
Kandikere, VN; Maurya, S; Mudigonda, K; Nirogi, RV; Shukla, M, 2006
)
0.55
"To improve the bioavailability and photostability of poorly water-soluble and photosensitive amlodipine, dry emulsion (DE) was prepared by spray-drying the oil-in-water emulsion of amlodipine."( Improvement of bioavailability and photostability of amlodipine using redispersible dry emulsion.
Jang, DJ; Jeong, EJ; Kim, BC; Kim, CK; Lee, HM; Lim, SJ, 2006
)
0.8
"Two different tablets containing amlodipine besylate (CAS 111470-99-6) (Vazkor 10 mg tablet as test preparation and 10 mg tablet of the originator product as reference preparation) were investigated in 18 healthy male volunteers in order to compare the bioavailability and prove the bioequivalence between both treatments after oral single dose administration."( Pharmacokinetics and bioequivalence study of a generic amlodipine tablet formulation in healthy male volunteers.
Arnold, P; Erenmemişoğlu, A; Hincal, AA; Kanzik, I; Martin, W; Sailer, R; Tamur, U, 2007
)
0.87
"The present study was conducted to find out whether the bioavailability of a 10 mg amlodipine (CAS 88150-42-9) tablet (Intervask, "test") was equivalent to that that of a reference formulation ("reference")."( Comparative bioavailability cf two amlodipine formulation in healthy volunteers.
Deniati, SH; Handayani, LR; Harinanto, G; Santoso, ID; Setiawati, E; Yunaidi, DA, 2007
)
0.84
"Salt-sensitive (SS) hypertension is a vascular diathesis characterized by reduced cardiovascular and renal nitric oxide bioavailability and local upregulation of ANG II."( Upregulation of cortical COX-2 in salt-sensitive hypertension: role of angiotensin II and reactive oxygen species.
Jaimes, EA; Pearse, DD; Puzis, L; Raij, L; Zhou, MS, 2008
)
0.35
"Chronic kidney disease (CKD) and hypertension have been associated with decreased bioavailability of nitric oxide (NO) and endothelial dysfunction."( Plasma asymmetric dimethylarginine, symmetric dimethylarginine, l-arginine, and nitrite/nitrate concentrations in cats with chronic kidney disease and hypertension.
Elliott, J; Jepson, RE; Syme, HM; Vallance, C,
)
0.13
" In particular, reduced bioavailability of endothelial-dependent nitric oxide production as a result of enhanced oxidative stress represents a common pathological mechanism of cardiovascular risk factors."( Scientific rationale for combination of a calcium channel antagonist and an HMG-CoA reductase inhibitor: a new approach to risk factor management.
Mason, RP, 2008
)
0.35
" The relative bioavailability of a newly developed dispersible tablet as compared with an established branded formulation has not been reported in a Chinese population."( Pharmacokinetics and bioequivalence evaluation of two formulations of 10-mg amlodipine besylate: an open-label, single-dose, randomized, two-way crossover study in healthy Chinese male volunteers.
Jia, J; Li, S; Liu, G; Liu, Y; Lu, C; Yu, C, 2009
)
0.58
" The relative bioavailability of the test formulation was 90."( Pharmacokinetics and bioequivalence evaluation of two formulations of 10-mg amlodipine besylate: an open-label, single-dose, randomized, two-way crossover study in healthy Chinese male volunteers.
Jia, J; Li, S; Liu, G; Liu, Y; Lu, C; Yu, C, 2009
)
0.58
" After transdermal administration to rats, the absolute bioavailability was 88."( A drug-in-adhesive transdermal patch for S-amlodipine free base: in vitro and in vivo characterization.
Fang, L; He, Z; Li, L; Li, W; Meng, P; Sun, Y; Zhu, M, 2009
)
0.62
" The relative bioavailability was 103."( Liquid chromatography-mass spectrometry method for the determination of amlodipine in human plasma and its application in a bioequivalence study.
Ge, Z; Ouyang, P; Wei, P; Zhan, Y; Zou, Q, 2009
)
0.59
"Pioglitazone improved endothelial function in hypertensive patients with IGT through an increase in nitric oxide bioavailability by, in part, a decrease in oxidative stress."( Pioglitazone improves endothelium-dependent vasodilation in hypertensive patients with impaired glucose tolerance in part through a decrease in oxidative stress.
Chayama, K; Fujii, Y; Fujimura, N; Goto, C; Hata, T; Hidaka, T; Higashi, Y; Idei, N; Kihara, Y; Nakagawa, K; Soga, J, 2010
)
0.36
"Oral bioavailability (F) is a product of fraction absorbed (Fa), fraction escaping gut-wall elimination (Fg), and fraction escaping hepatic elimination (Fh)."( Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
Chang, G; El-Kattan, A; Miller, HR; Obach, RS; Rotter, C; Steyn, SJ; Troutman, MD; Varma, MV, 2010
)
0.36
" The bioavailability of amlodipine and atorvastatin with a single-tablet, fixed-dose amlodipine/atorvastatin combination was not significantly different to that with coadministered separate amlodipine and atorvastatin tablets."( Amlodipine/Atorvastatin: a review of its use in the treatment of hypertension and dyslipidaemia and the prevention of cardiovascular disease.
Curran, MP, 2010
)
2.11
"Nanoemulsion (NE) of amlodipine besilate (AB) was developed by spontaneous emulsification method with the aim to enhance the solubility and oral bioavailability of AB and to achieve localized delivery of drug at target site."( Design and development of nanoemulsion drug delivery system of amlodipine besilate for improvement of oral bioavailability.
Chhabra, G; Chuttani, K; Mishra, AK; Pathak, K, 2011
)
0.93
" The aim of this study was to estimate the influence of hypotensive drugs (angiotensine converting enzyme inhibitors (ACE-I), β-blockers, Ca-antagonists, diuretics) on the potential bioavailability of magnesium, iron, zinc and copper from buckwheat groats in vitro enzymatic digestion."( The influence of selected hypotensive drugs on the bioavailability of minerals from buckwheat groats in vitro enzymatic digestion.
Bogdański, P; Chiniewicz, B; Suliburska, J,
)
0.13
"25, indicating that the extent of bioavailability of S-amlodipine was not affected by telmisartan."( Pharmacokinetic interaction of telmisartan with s-amlodipine: an open-label, two-period crossover study in healthy Korean male volunteers.
Bae, KS; Choi, HY; Jin, SJ; Kim, MJ; Kim, YH; Lim, HS; Lim, J; Noh, YH; Sung, HR, 2012
)
0.88
"In this study, the authors compared the effects of amlodipine (AML) on the bioavailability of cephalexin (LEX) and cefuroxime axetil (CXM)."( Effects of amlodipine on the oral bioavailability of cephalexin and cefuroxime axetil in healthy volunteers.
Ding, L; Ding, Y; Jia, Y; Jin, X; Liu, W; Lu, C; Song, Y; Wen, A; Yang, J; Yang, L; Zhu, Y, 2013
)
1.03
"This study was aimed to investigate the relative bioavailability of fixed-dose-combination (FDC) product of amlodipine, telmisartan and hydrochlorothiazide with individual marketed products in healthy male volunteers."( A comparative pharmacokinetic study of a fixed dose combination for essential hypertensive patients: a randomized crossover study in healthy human volunteers.
Biswas, E; Choudhury, H; Ghosh, B; Gorain, B; Halder, D; Pal, TK; Sarkar, AK; Sarkar, P, 2013
)
0.6
"The authors investigated the relative bioavailability under a fasting state of the 3 drugs in a randomized, open-label, 2-treatment, 2-period, 2-sequence, crossover bioequivalence study with a washout period of 21 days."( A comparative pharmacokinetic study of a fixed dose combination for essential hypertensive patients: a randomized crossover study in healthy human volunteers.
Biswas, E; Choudhury, H; Ghosh, B; Gorain, B; Halder, D; Pal, TK; Sarkar, AK; Sarkar, P, 2013
)
0.39
" Amlodipine concentrations were assumed to influence the clearance of simvastatin and simvastatin acid, which as well as the oral bioavailability was allowed to vary depending on genetic polymorphisms of metabolic enzymes."( Development of a pharmacokinetic interaction model for co-administration of simvastatin and amlodipine.
Jang, SB; Lee, D; Lim, LA; Park, K; Roh, H; Son, H, 2014
)
1.53
" In this study, we elucidated the effect of amlodipine on nitric oxide (NO) bioavailability and cytotoxic peroxynitrite (ONOO(-)) and blood pressure (BP)."( Amlodipine increased endothelial nitric oxide and decreased nitroxidative stress disproportionately to blood pressure changes.
Corbalan, JJ; Jacob, RF; Kaliszan, R; Malinski, T; Mason, RP, 2014
)
2.11
"Amlodipine increased NO bioavailability and decreased nitroxidative stress in SHRs with EC dysfunction disproportionately to BP changes."( Amlodipine increased endothelial nitric oxide and decreased nitroxidative stress disproportionately to blood pressure changes.
Corbalan, JJ; Jacob, RF; Kaliszan, R; Malinski, T; Mason, RP, 2014
)
3.29
"These results showed that antibiotic intake might increase the bioavailability of amlodipine by suppressing gut microbial metabolic activities, which could be followed by changes in therapeutic potency."( Effects of orally administered antibiotics on the bioavailability of amlodipine: gut microbiota-mediated drug interaction.
Kim, DH; Kim, IS; Yoo, DH; Yoo, HH, 2016
)
0.89
" The study (NCT02075619) evaluated the bioavailability of 2 prototype FDC tablet formulations (FDC1 and FDC2) of amlodipine/rosuvastatin (10 mg/20 mg) compared with coadministered reference tablets."( The relative bioavailability of 2 prototype fixed-dose combination formulations for amlodipine and rosuvastatin in healthy white and Chinese subjects.
Bullman, JN; Joshi, SM; Kapsi, SG; Nwe, HH; Stylianou, A, 2016
)
0.87
"Pharmacokinetic analyses revealed an increase in the bioavailability of simvastatin when co-administered with amlodipine [Nishio S et al."( Analysis of secondary care data to evaluate the clinical relevance of the drug-drug interaction between amlodipine and simvastatin.
Fuhrmann, S; Knoth, H; Koppen, A; Schröder, J; Seeling, A, 2019
)
0.94
" The elution of AML from prepared PGA gels was complete within an hour and the gel did not appear to influence the bioavailability of AML."( Preparation and Evaluation of Poly-γ-glutamic Acid Hydrogel Mixtures with Amlodipine Besylate: Effect on Ease of Swallowing and Taste Masking.
Haraguchi, T; Ikegami, S; Kawasaki, I; Kojima, H; Nishikawa, H; Ozeki, M; Uchida, T; Yoshida, M, 2019
)
0.74
"Transdermal drug delivery has been developed to increase drug bioavailability and improve patient compliance."( Microneedle-assisted transdermal delivery of amlodipine besylate loaded nanoparticles.
Al-Nemrawi, NK; Nasereddin, J; Nimrawi, S; Zaid Alkilani, A, 2022
)
0.98

Dosage Studied

Four new, simple, and reproducible spectrophotometric methods were developed. Telmisartan (40, 80, and 120 mg) provided greater decreases in mean hourly systolic and diastolic blood pressure throughout the 24-hour dosing interval than amlodipine (5 and 10 mg)

ExcerptRelevanceReference
" However, amlodipine reduced ambulatory systolic (SBP) and DBP almost every hour over the whole circadian cycle, whereas the antihypertensive effect of captopril was attenuated during the final 3 hours of each dosing interval."( Comparison of the effects of amlodipine and captopril on clinic and ambulatory blood pressure.
Lacourcière, Y; Poirier, L; Provencher, P, 1992
)
0.98
" This study used sphygmomanometric and intra-arterial ambulatory blood pressure (BP) monitoring to confirm the antihypertensive effect of a once-daily dose of amlodipine over the dosing interval."( Intra-arterial monitoring of the antihypertensive effects of once-daily amlodipine.
al-Khawaja, I; Brigden, G; Broadhurst, P; Heber, ME; Raftery, EB, 1992
)
0.71
" This study demonstrates that once-daily administration of amlodipine or atenolol to mild-to-moderate hypertensive patients was well-tolerated and provided adequate blood pressure control throughout the 24-h dosing interval."( A randomized, placebo-controlled, double-blind comparison of amlodipine and atenolol in patients with essential hypertension.
Brobyn, R; Brown, RD; Frishman, WH; Johnson, BF; Reeves, RL; Wombolt, DG, 1992
)
0.77
" Due to the low incidence of side effects and the once-daily dosage regimen, an improvement in patient compliance can be expected."( [Effectiveness and tolerance of amlodipine in treatment of patients with mild to moderate hypertension. Results of a long-term study with a new calcium antagonist].
Ganzinger, U; Habeler, G; Lenzhofer, R; Pall, H; Tomaschek, A; Ziebart-Schroth, A; Zirm, B, 1992
)
0.57
" Amlodipine shows linear dose-related pharmacokinetic characteristics and, at steady-state, there are relatively small fluctuations in plasma concentrations across a dosage interval."( Clinical pharmacokinetics of amlodipine.
Elliott, HL; Meredith, PA, 1992
)
1.49
" Fluctuation of plasma drug concentration between doses is between 20 and 25% when once-daily dosing is used."( Pharmacokinetics and pharmacodynamics of amlodipine.
Abernethy, DR, 1992
)
0.55
" Dose-response curves were obtained with intravenous injection of the four drugs."( Hemodynamic profile of Ro 40-5967 in conscious rats: comparison with diltiazem, verapamil, and amlodipine.
Clozel, JP; Hess, P; Véniant, M; Wolfgang, R, 1991
)
0.5
"Sixty patients (31 male, 29 female) were studied in a 4-week double-blind parallel dose-response study."( A double-blind dose-response study of amlodipine in patients with stable angina pectoris.
Alfiero, R; Cocco, G, 1991
)
0.55
"2 mg/kg/day for 20 days) chronically receiving AML, there was an enhancement of the antihypertensive effect of AML within a few days after starting chronic dosing, and thereafter a significant reduction of BP at 24 hr after dosing and constant effects of AML during subsequent treatment."( [Antihypertensive effects of amlodipine, a new calcium antagonist].
Ishiko, J; Munehasu, S; Suzuki, M; Yamanaka, K, 1991
)
0.57
" The pharmacokinetics of the molecule mean that effective blood levels and hence good control of blood pressure are maintained throughout the dosing interval."( Amlodipine: an effective once-daily antihypertensive agent.
Tyler, HM, 1991
)
1.72
" Ambulatory monitoring studies have confirmed that once-daily dosing provides 24-h control of blood pressure."( Amlodipine in the treatment of hypertension.
Kaplan, NM, 1991
)
1.72
" It is concluded that once-daily dosing with either amlodipine or atenolol significantly reduces blood pressures."( Multicenter placebo-controlled comparison of amlodipine and atenolol in mild to moderate hypertension.
Cocco, G; de Bruijn, B; Tyler, HM, 1988
)
0.79
" After intravenous administration, the percentages of the dosed radioactivity recovered in urine were 62% in humans, 45% in dogs, 38% in rats, and 25% in mice."( The metabolism and pharmacokinetics of amlodipine in humans and animals.
Beresford, AP; Humphrey, MJ; Macrae, PV; Stopher, DA, 1988
)
0.54
" These results suggest that once-daily administration of amlodipine is suitable for all degrees of renal function and that dosage adjustment is not necessary in renal impairment."( Pharmacokinetics of amlodipine in renal impairment.
Carmody, M; Donohoe, JF; Doyle, GD; Greb, H; Kelly, JG; Laher, MS; Volz, M, 1988
)
0.84
" Ambulatory blood pressure recordings revealed adequate blood pressure control throughout the 24-h dosing interval."( A double-blind evaluation of the effect of amlodipine on ambulatory blood pressure in hypertensive patients.
Allenby, KS; Burris, JF; Mroczek, WJ, 1988
)
0.54
"The antihypertensive efficacy and suitability for once daily dosing of amlodipine, a new calcium antagonist, was studied in a series of 205 patients with mild to moderate hypertension."( A dose-response study of amlodipine in mild to moderate hypertension.
Frick, MH; McGibney, D; Tyler, HM, 1989
)
0.81
" These results suggest that once daily administration of amlodipine is suitable for all degrees of renal function and that dosage adjustment is not necessary in renal impairment."( Pharmacokinetics of amlodipine in renal impairment.
Carmody, M; Donohue, J; Doyle, GD; Greb, H; Laher, M; Volz, M, 1989
)
0.85
" With chronic oral dosing of amlodipine once daily for 14 days, support was provided for the linearity of amlodipine's pharmacokinetics and absence of such with chronic oral dosing with verapamil, diltiazem, and nifedipine."( The pharmacokinetic profile of amlodipine.
Abernethy, DR, 1989
)
0.85
" Dosage modifications are unnecessary in renal impairment, but the dosage regimen for patients with hepatic impairment is not yet established."( The safety of amlodipine.
Osterloh, I, 1989
)
0.64
"The haemodynamic dose-response effects of a new long-acting slow-calcium channel blocking agent, amlodipine were evaluated in 20 patients with angiographically confirmed coronary heart disease."( A haemodynamic dose finding study with a new slow-calcium channel blocker (amlodipine) in coronary artery disease.
Frais, MA; Jackson, NC; Reynolds, G; Sharma, SK; Silke, B; Taylor, SH; Verma, SP, 1986
)
0.72
" After a stable control period, dose-response curves were constructed for each drug with hemodynamics measured 10 minutes after intravenous boluses."( Comparative hemodynamic dose-response effects of five slow calcium channel-blocking agents in coronary artery disease.
Frais, MA; Jackson, N; Midtbo, KA; Reynolds, G; Sharma, S; Silke, B; Taylor, SH; Verma, SP, 1987
)
0.27
" Renal elimination was the major route of excretion with about 60% of the dosed radioactivity recovered in urine."( Metabolism and kinetics of amlodipine in man.
Beresford, AP; Humphrey, MJ; Macrae, PV; McGibney, D; Stopher, DA, 1988
)
0.57
" However, the concentrations at which these calcium channel blockers elicit antiproliferative effects may not be attainable during therapeutic dosing in humans."( Effect of calcium channel blockers on the growth of human vascular smooth muscle cells derived from saphenous vein and vascular graft stenoses.
Betteridge, L; Chan, P; Gallagher, K; Munro, E; Patel, M; Schachter, M; Sever, P; Wolfe, J, 1994
)
0.29
" In contrast, however, the effects of captopril were no longer evident during the final 3 h of the dosing interval."( Comparison of amlodipine and captopril in hypertension based on 24-hour ambulatory monitoring.
Lacourcière, Y; Poirier, L; Provencher, P, 1993
)
0.65
"01), although the once-daily dosing of enalapril and the maximum dose of 20 mg might not have been optimal for this agent."( Low-dose drug combination therapy: an alternative first-line approach to hypertension treatment.
Adegbile, IA; Alemayehu, D; Carr, AA; Lefkowitz, MP; Papademetriou, V; Prisant, LM; Weber, MA; Weir, MR, 1995
)
0.29
" If office diastolic pressure was greater than or equal to 90 mm Hg after 4 weeks, the dosage was doubled and continued for another 4 weeks."( Comparison of perindopril and amlodipine in cyclosporine-treated renal allograft recipients.
Lamote, J; Sennesael, J; Tasse, S; Verbeelen, D; Violet, I, 1995
)
0.58
" The effects of three long-acting calcium antagonists, amlodipine, lacidipine and nifedipine GITS (gastrointestinal therapeutic system), on vascular reactivity were assessed over 24h and 48h dosage intervals."( Vascular reactivity: a measurement of calcium channel blockade.
Elliott, HL, 1995
)
0.54
" Blood pressure measurements were taken at the end of the dosing interval to assess the antihypertensive efficacy of the two drugs."( At equipotent doses, isradipine is better tolerated than amlodipine in patients with mild-to-moderate hypertension: a double-blind, randomized, parallel-group study.
De Keyser, P; Deblander, A; Hermans, L; Lesaffre, E; Scheys, I; Westelinck, KJ, 1994
)
0.53
" Exercise tests and blood sampling for plasma concentrations of amlodipine were performed at 8 and at 24 h after dosing on both days of acute testing as well as on day 18 of chronic treatment."( Pharmacokinetics and additional anti-ischaemic effectiveness of amlodipine, a once-daily calcium antagonist, during acute and long-term therapy of stable angina pectoris in patients pre-treated with a beta-blocker.
Beyerle, A; Lehmann, G; Reiniger, G; Rudolph, W, 1993
)
0.76
" About 8% of patients had a low compliance rate, irrespective of the dosage regimen."( [Time of drug intake in hypertension and angina pectoris. A controlled monitoring study].
Erne, P; Heynen, G; Saxenhofer, H; Waeber, B, 1994
)
0.29
" Correspondingly there was less variability with amlodipine in the blood pressure reductions across the dosage interval."( A comparative assessment of amlodipine and felodipine ER: pharmacokinetic and pharmacodynamic indices.
Bainbridge, AD; Elliott, HL; Herlihy, O; Meredith, PA, 1993
)
0.83
" The number of days with missed medication was thus significantly higher for the evening dosing regimen."( The use of self-measured blood pressure determinations in assessing dynamics of drug compliance in a study with amlodipine once a day, morning versus evening.
Binswanger, B; Mengden, T; Spühler, T; Vetter, W; Weisser, B, 1993
)
0.5
" Furthermore, the use of self-measurement and the MEMS may provide useful additional information on the pharmacodynamic impact of different dosing patterns in hypertensive patients."( The use of self-measured blood pressure determinations in assessing dynamics of drug compliance in a study with amlodipine once a day, morning versus evening.
Binswanger, B; Mengden, T; Spühler, T; Vetter, W; Weisser, B, 1993
)
0.5
" Gingival changes occurred within 3 months of dosage and appeared to be compounded by the patient's existing periodontal condition."( Amlodipine-induced gingival overgrowth.
Ellis, JS; Idle, JR; Monkman, S; Seymour, RA; Thomason, JM, 1994
)
1.73
" Amlodipine maintained blood pressure reduction throughout the 24-hours dosing interval with a once-daily dose."( Amlodipine in mild and moderate hypertension: initial Indian experience.
Ailiani, R; Bajan, KD; Chawla, KP; Chopra, P; Joseph, TA; Karnik, ND; Khokhani, RC; Waknis, SS, 1993
)
2.64
" Results of temporal and dose-response studies showed that memory enhancement (significant increase in step-through latency) occurred when amlodipine (5, 7, 9, 15, and 30 mg/kg) was given either immediately post-training or (15 mg/kg) 15 min pretesting."( Effect of the calcium channel blocker amlodipine on memory in mice.
Ermita, B; Hawxhurst, A; Puente, J; Quartermain, D, 1993
)
0.76
" In comparison with other antianginal drugs, once-daily amlodipine at a dosage range of 5-10 mg demonstrated antianginal activity comparable to thrice-daily diltiazem and once-daily nadolol."( Usefulness of amlodipine for angina pectoris.
Taylor, SH, 1994
)
0.9
"m-2] had been on prior treatment with a thiazide diuretic in low dosage and/or a beta-adrenoceptor blocker (group A), and 10 matched patients [BMI 31."( Lack of effect of long-term amlodipine on insulin sensitivity and plasma insulin in obese patients with essential hypertension.
Böhlen, L; de Courten, M; Ferrari, P; Heynen, G; Riesen, W; Schneider, M; Shaw, S; Weidmann, P, 1993
)
0.58
"To determine the dose-response efficacy of once-daily administration of placebo or a new long-acting calcium channel blocker amlodipine in patients with mild to moderate hypertension, a randomized, multicenter, placebo-controlled, double-blind trial was conducted."( Double-blind evaluation of the dose-response relationship of amlodipine in essential hypertension.
Garland, WT; Gradman, AH; Lopez, LM; Mehta, JL; Nash, DT; O'Connell, MT; Pickering, BI; Vlachakis, ND, 1993
)
0.73
" After two weeks, the dosage was able to be increased (according to clinical efficacy) to 10 mg of amlodipine as a single dose or 240 mg of diltiazem in four divided doses."( [Evaluation of amlodipine in stable effort angina. Comparison with diltiazem in terms of efficacy, tolerability and maintenance of the anti-ischemic action 24 hours after the last dose].
Bernaud, C; Marchand, X; Morand, P; Tibi, T, 1996
)
0.86
" The dosage of amlodipine was 5 to 10 mg/day."( -Efficacy and safety of using amlodipine in treatment of mild and moderate essential hypertension-.
Kokot, F; Kokot, M; Raszewska, J; Rychlik, G; Witkowicz, J, 1995
)
0.93
" Newer calcium channel blockers of the dihydropyridine group have longer elimination half-lives (t1/2) that permit once-daily dosage and are generally better tolerated than their parent compound."( Relative efficacy and tolerability of lacidipine and amlodipine in patients with mild-to-moderate hypertension: a randomized double-blind study.
Cheung, BM; Lau, CP, 1996
)
0.54
" From these results, the optimal dosage of amlodipine in the treatment of angina pectoris is 10 mg for the initial 3 days followed by 5 mg thereafter."( Clinical evaluation of serum amlodipine level in patients with angina pectoris.
Inomata, T; Izumi, T; Miyakita, Y; Nagatomo, T; Ochiai, Y; Qu, YL; Shiba, M; Shibata, A; Washizuka, T; Watanabe, K, 1996
)
0.85
" An analysis was also performed on 84 outpatients with stable angina pectoris, who were included in an open, parallel study and received the same dosing regimen of either amlodipine or nifedipine SR as the patients in the hypertension arm of the study."( Patient compliance and therapeutic coverage: amlodipine versus nifedipine SR in the treatment of hypertension and angina: interim results. Steering Committee and Cardiologists and General Practitioners involved in the Belgium Multicentre Study on Patient
Detry, JM, 1994
)
0.74
"To date, the clinical utility of first-generation, shortacting calcium antagonists has not been optimal due to their multiple dosing requirements."( A double-blind evaluation of amlodipine in patients with chronic, stable angina: sustained efficacy and lack of "withdrawal phenomenon" upon abrupt discontinuation.
Lopez, LM; Mehta, JL, 1994
)
0.58
" The slow elimination of amlodipine explains the long duration of action, which allows a convenient once-daily dosage schedule."( Amlodipine: an overview of its pharmacodynamic and pharmacokinetic properties.
van Zwieten, PA, 1994
)
2.03
" We have compared the pulmonary vasodilator effects, dose-response characteristics, and tolerability of two calcium channel blockers, amlodipine and extended-release (ER) felodipine, in 10 patients (seven men, age 68+/-4."( A comparison of two long-acting vasoselective calcium antagonists in pulmonary hypertension secondary to COPD.
Alpers, JA; Bune, AJ; Frith, PA; McEvoy, RD; Sajkov, D; Wang, T, 1997
)
0.5
" Their dose-response characteristics are similar, but amlodipine treatment was associated with fewer side effects."( A comparison of two long-acting vasoselective calcium antagonists in pulmonary hypertension secondary to COPD.
Alpers, JA; Bune, AJ; Frith, PA; McEvoy, RD; Sajkov, D; Wang, T, 1997
)
0.55
" The results suggest that the negative consequences of partial compliance for blood pressure control can be offset by choosing agents with a duration of action well beyond the dosing interval."( Patterns of compliance with once versus twice daily antihypertensive drug therapy in primary care: a randomized clinical trial using electronic monitoring.
Boileau, G; Bolli, P; Handa, SP; Larochelle, P; Leenen, FH; Myers, M; Tanner, J; Wilson, TW, 1997
)
0.3
" The good anti-anginal and hypotensive efficacy and safety of amiodipine with once daily dosage regimen makes this drug an excellent choice of treatment for hypertensive patients with severe coronary artery disease."( [Comparative study to assess the efficacy and adverse effects of amlodipine and nifedipine retard in patients with stable exertional angina and hypertension].
Hlawaty, M; Kubler, G; Negrusz-Kawecka, M; Olszowska, M; Salamon, P; Tracz, W; Witkowska, M, 1997
)
0.53
" The coefficients of variation of maximal drug concentration and AUC after single dosing and at steady-state were significantly higher for felodipine ER than for amlodipine."( Crossover comparison of the pharmacokinetics of amlodipine and felodipine ER in hypertensive patients.
Jacobsen, IA; Videbaek, LM, 1997
)
0.75
" In patients whose trough SDBP was greater than 90 mm Hg after 4 or 8 weeks of double-masked therapy, the dosage was titrated upward to mibefradil 100 mg or amlodipine 10 mg for the remainder of the 12-week active treatment period."( Comparative efficacy and tolerability of two long-acting calcium antagonists, mibefradil and amlodipine, in essential hypertension. Mibefradil Hypertension Study Group.
Benz, JR; Carr, A; Karch, FE; Lunde, NM; Marbury, T; Pordy, R; Tarro, JN,
)
0.55
"The calcium antagonist amlodipine may have the potential for expanded use in children owing to its physiochemistry and pharmacokinetic profile that facilitates once-daily dosing in a liquid formulation."( Efficacy of amlodipine in pediatric bone marrow transplant patients.
Arbus, GS; Khattak, S; Koren, G; Rogan, JW; Saunders, EF; Theis, JG, 1998
)
0.99
"Anginal patients who remain symptomatic despite optimally dosed beta blockade may also be given dihydropyridine calcium antagonists."( Value of the addition of amlodipine to atenolol in patients with angina pectoris despite adequate beta blockade.
Bernink, PJ; Bouwens, LH; Dunselman, PH; Herweijer, AH; Holwerda, KJ; van Kempen, LH, 1998
)
0.6
" injection of amlodipine (1, 3, 10 mg/kg body weight) either at 8:00 or at 20:00 h dose-dependently reduced blood pressure irrespective of the dosing time."( Effects of amlodipine once or twice daily on circadian blood pressure profile, myocardial hypertrophy, and beta-adrenergic signaling in transgenic hypertensive TGR(mREN2)27 rats.
Lemmer, B; Schmidt, T; Schnecko, A; Voll, C; Witte, K, 1998
)
1.05
" Once-daily dosing improves compliance, but 24-h antihypertensive activity should be provided."( Compliance and antihypertensive efficacy of amlodipine compared with nifedipine slow-release.
Bernaud, C; Carré, A; Charpentier, JC; Hotton, JM; Lequeuche, B; Mounier-Vehier, C, 1998
)
0.56
" Amlodipine seems to be more effective than felodipine when the drugs are compared in the same dose, with regard to the effect on clinic BP 24 h after dosing and to ambulatory BP during the night."( Effect of amlodipine versus felodipine extended release on 24-hour ambulatory blood pressure in hypertension.
Brodin, U; Isaksson, H; Ohman, KP; Ostergren, J; Schwan, A, 1998
)
1.61
" The procedures refer to situations when detailed comparisons make sense only if the sensitivity of the trial has been shown, for example, if a dose-response relationship or a difference between active control and placebo has been established."( Testing strategies in multi-dose experiments including active control.
Bauer, P; Hothorn, L; Maurer, W; Röhmel, J, 1998
)
0.3
" Furthermore, amlodipine has the advantage of once-daily dosing and so may also be beneficial in ensuring good patient compliance."( A comparative study of once-daily amlodipine versus twice-daily diltiazem controlled release (CR) in the treatment of stable angina pectoris. Amlodipine Study Group.
van Kesteren, HA; Withagen, AJ, 1998
)
0.94
" The impact of these agents will also be compared during irregular dosing periods."( Amlodipine versus diltiazem CR in the reduction of the total ischemic burden: the Circadian Anti-Ischemia Program in Europe (CAPE) II trial--clinical rationale and methodology.
Deanfield, JE, 1998
)
1.74
" The amlodipine dosage was increased."( Severe neuromuscular complications possibly associated with amlodipine.
Muller, BA; Phillips, BB, 1998
)
1.06
"To evaluate the appropriate dosing of amlodipine when converting patients from nifedipine extended-release (nifedipine ER) to amlodipine in the treatment of hypertension."( Evaluation of amlodipine dosing for conversion of nifedipine extended-release to amlodipine in the treatment of hypertension.
Enlow, AM; Halverson, VJ; Kilpatrick, DM; Lower, DL; Montopoli, G; Yamreudeewong, W, 1999
)
0.94
" Dosing titration of amlodipine was required in 16 of 27 patients after the switch."( Evaluation of amlodipine dosing for conversion of nifedipine extended-release to amlodipine in the treatment of hypertension.
Enlow, AM; Halverson, VJ; Kilpatrick, DM; Lower, DL; Montopoli, G; Yamreudeewong, W, 1999
)
0.98
"This study indicates the amlodipine dosage of 5 or 10 mg once daily can be used when nifedipine ER is converted to amlodipine in the treatment of hypertension."( Evaluation of amlodipine dosing for conversion of nifedipine extended-release to amlodipine in the treatment of hypertension.
Enlow, AM; Halverson, VJ; Kilpatrick, DM; Lower, DL; Montopoli, G; Yamreudeewong, W, 1999
)
0.97
"This multicenter, randomized, double-blind, parallel group, placebo lead-in, placebo-controlled study compared the antianginal and anti-ischemic effects of once-daily bedtime dosing of controlled-onset extended-release (COER-24) verapamil to a once-daily morning dosing of amlodipine +/- atenolol in patients with chronic stable angina."( Comparison of controlled-onset, extended-release verapamil with amlodipine and amlodipine plus atenolol on exercise performance and ambulatory ischemia in patients with chronic stable angina pectoris.
Deedwania, PC; Fakouhi, TD; Frishman, WH; Glasser, S; Johnson, M; Stone, P, 1999
)
0.72
" The aim of the study reported here was to determine whether an early increase in dosage of amlodipine provided an advantage in terms of antihypertensive effect."( Is initial dose titration of amlodipine worthwhile in patients with mild to moderate hypertension?
Adamczak, M; Hayduk, K; Nowitzki, G, 1999
)
0.81
" Clinical inputs include agent efficacy, side effects, and compliance with dosing schedules."( An economic evaluation of the JNC hypertension guidelines using data from a randomized controlled trial. Joint National Committee.
Neil, N; Perfetto, E; Ramsey, SD; Sullivan, SD,
)
0.13
"To determine the stability of amlodipine besylate in two liquid dosage forms under refrigeration and at room temperature."( Stability of amlodipine besylate in two liquid dosage forms.
Hipple, TF; Morosco, RS; Nahata, MC,
)
0.79
" The liquid dosage form would also permit accurate administration of amlodipine doses to infants and young children based on their body weight."( Stability of amlodipine besylate in two liquid dosage forms.
Hipple, TF; Morosco, RS; Nahata, MC,
)
0.74
"Amlodipine is a calcium antagonist with a long elimination half-life (35 to 50 h) allowing a once daily dosing in the treatment of hypertension."( Prolonged antihypertensive effect of amlodipine: a prospective double-blind randomized study.
Biston, P; Clement, D; Degaute, JP; Mélot, C; Quoidbach, A, 1999
)
2.02
" Dosage was doubled after 4 weeks when diastolic blood pressure was > 90 mmHg in sitting position, the treatment was continued for 12 weeks."( Effects of amlodipine and enalapril on platelet function in patients with mild to moderate hypertension.
Armas de Hernández, MJ; Armas-Padilla, MC; Carvajal, AR; Guerrero-Pajuelo, J; Hernández-Hernández, R; Pacheco, B; Velasco, M, 1999
)
0.69
"3% of hypertensive patients with an average dosage of 31."( Effects of amlodipine and enalapril on platelet function in patients with mild to moderate hypertension.
Armas de Hernández, MJ; Armas-Padilla, MC; Carvajal, AR; Guerrero-Pajuelo, J; Hernández-Hernández, R; Pacheco, B; Velasco, M, 1999
)
0.69
" Ambulatory blood pressure monitoring showed that blood pressure control was sustained over the 24-h dosing interval."( Amlodipine lowers blood pressure without affecting cerebral blood flow as measured by single photon emission computed tomography in elderly hypertensive subjects.
Clarke, SE; Pandita-Gunawardena, ND, 1999
)
1.75
" To evaluate the dose-response relation between this pharmacological interference and dependent edema, a frequent side effect of CCBs during antihypertensive treatment, skin blood flow (laser Doppler flowmetry) at the dorsum of the foot, both supine and with the limb passively placed 50 cm below the heart level, and leg weight (Archimedes principle) were measured at baseline, during increasing doses of the dihydropyridine amlodipine (5 and 10 mg UID each for 2 weeks), and after drug withdrawal in 10 hypertensive men."( Amlodipine, enalapril, and dependent leg edema in essential hypertension.
Dell'Omo, G; Mariani, M; Melillo, E; Pedrinelli, R, 2000
)
1.91
" The age, gender, current drug regimen and dosage were recorded for each participant and alginate impressions taken of both arches."( The calcium channel blocker used with cyclosporin has an effect on gingival overgrowth.
Boomer, S; Campbell, BA; Hull, PS; Irwin, CR; Jamal, S; James, JA; Johnson, RW; Linden, GJ; Marley, JJ; Maxwell, AP; Short, CD; Spratt, H, 2000
)
0.31
" Earlier studies combining short acting drugs from these classes require multiple dosing and were associated with poor compliance."( Evaluation of amlodipine, lisinopril, and a combination in the treatment of essential hypertension.
Naidu, MU; Rao, TR; Shobha, JC; Usha, PR, 2000
)
0.67
"Various studies have indicated that acute ethanol dosage perturbs cardiac function and/or structure with concomitant reductions in protein synthesis."( Alcohol-induced reductions in cardiac protein synthesis in vivo are not ameliorated by treatment with the dihydropyridine calcium channel blocker amlodipine.
Patel, VB; Preedy, VR; Richardson, PJ; Siddiq, T, 2000
)
0.51
" Acute alcohol dosage reduced cardiac protein synthesis in mixed, myofibrillary, and sarcoplasmic protein fractions."( Alcohol-induced reductions in cardiac protein synthesis in vivo are not ameliorated by treatment with the dihydropyridine calcium channel blocker amlodipine.
Patel, VB; Preedy, VR; Richardson, PJ; Siddiq, T, 2000
)
0.51
" In addition, data were collected and analyzed with regard to adverse drug reactions, average dosage of the alternative calcium channel blocker, number of additional antihypertensives begun or discontinued, and number of dosage changes in antihypertensives within the two visits after conversion, and the overall cost impact of conversion."( Retrospective evaluation of the conversion of amlodipine to alternative calcium channel blockers.
Beckey, NP; Korman, L; Parra, D, 2000
)
0.57
" Conversion to calcium channel antagonists other than felodipine or less than equal dosages of felodipine may require dosage titration."( Retrospective evaluation of the conversion of amlodipine to alternative calcium channel blockers.
Beckey, NP; Korman, L; Parra, D, 2000
)
0.57
" Twice-daily dosing may be required in many children to achieve BP control."( Treatment of hypertensive children with amlodipine.
Bunchman, TE; Flynn, JT; Smoyer, WE, 2000
)
0.57
" However, it is difficult clinically to pinpoint the maximum dosage for antihypertensive activity of the drug without having parallel data on the plasma drug concentrations."( Enzyme linked immunosorbent assay for determination of amlodipine in plasma.
Arafat, T; Badwan, A; El-Thaher, T; Jehanli, A; Matalka, K; Saleem, M, 2001
)
0.56
" Morning rather than evening dosing appeared to confer a slight advantage."( Treatment of hypertension in patients > or =65 years of age: experience with amlodipine.
Langdon, C, 2000
)
0.54
" Given the lower incidence of adverse events with amlodipine and its convenient once daily dosing regimen, however, amlodipine may help to enhance patient compliance."( [Amlodipine versus nifedipine retard. A randomized double-blind comparative study on long-term efficacy and safety of amlodipine and nifedipine retard in the monotherapy of chronic stable angina pectoris].
Kupper, W; Sauerbrey-Wullkopf, N, 2001
)
1.47
" A possible use of the technique is shown using the example of the effect of varying the drug dosage on the contraction of the arteriole muscle."( A rapid procedure for initial drug evaluation.
Macpherson, AK; Macpherson, PA; Neti, S, 2001
)
0.31
" In 11 patients concomitantly treated with cyclosporine the dosage and the trough-level of this agent were stable throughout the trial."( Antihypertensive efficacy of amlodipine in children with chronic kidney diseases.
Bianchetti, MG; Bianda, ND; Casaulta Aebischer, C; Franscini, LM; Pfister, R; von Vigier, RO, 2001
)
0.6
" Responders continued on the same dosage for 16 additional weeks, while non-responders were titrated to 60 mg NI or 10 mg AM."( Efficacy, tolerability and influence on "quality of life" of nifedipine GITS versus amlodipine in elderly patients with mild-moderate hypertension.
Boari, L; De Dominicis, E; Giusti, C; Kilama, MO; Marchesi, M; Marelli, G; Mattarei, M; Mos, L; Novo, S; Pessina, AC; Pirrelli, A; Santini, M; Santonastaso, M; Semeraro, S; Uslenghi, E, 2001
)
0.54
" The proposed method has been applied successfully to the analysis of the bulk drug and its dosage forms."( Spectrophotometric method for the determination of amlodipine besylate with ninhydrin in drug formulations.
Azmi, SN; Rahman, N, 2001
)
0.56
" SHRSP were exposed to high dietary salt intake (1% NaCl in drinking solution) from 8 to 14 weeks of age, with or without amlodipine or lacidipine at three dosage regimens producing similar effects on blood pressure."( Effects of amlodipine and lacidipine on cardiac remodelling and renin production in salt-loaded stroke-prone hypertensive rats.
Godfraind, T; Krenek, P; Kyselovic, J; Wibo, M, 2001
)
0.91
" Telmisartan (40, 80, and 120 mg) provided greater decreases in mean hourly systolic and diastolic blood pressure throughout the 24-hour dosing interval, including the last 4 hours of the dosing period, than amlodipine (5 and 10 mg)."( Comparative effects of telmisartan in the treatment of hypertension.
White, WB,
)
0.32
"The optimal medical therapy for ischemia suppression and the impact of irregular dosing using agents with different pharmacologic properties has not been established in patients with coronary disease."( Medical treatment of myocardial ischemia in coronary artery disease: effect of drug regime and irregular dosing in the CAPE II trial.
Beckerman, B; Brennan, C; Bultas, J; Deanfield, JE; Detry, JM; Lichtlen, PR; Sellier, P; Thaulow, E; Young, ST, 2002
)
0.31
" Nevertheless, physicians are often reluctant to prescribe multiple anti-hypertensive drugs due to concerns over side-effects, inconvenient dosing regimens and costs."( A new fixed-dose combination for added blood pressure control: telmisartan plus hydrochlorothiazide.
Lacourcière, Y,
)
0.13
" Of these 708 patients 643 patients received once daily dosage of the combination whereas 10 patients received 1/2 daily, 13 patients received 1 1/2 daily and 42 patients received 1 twice daily dosage of the combination."( Efficacy and safety of losartan-amplodipine combination--an Indian postmarketing surveillance experience.
Gokhale, N; Pawar, D; Shahani, S, 2002
)
0.31
" Of those who received a dosage adjustment, a significantly greater percentage of amlodipine-treated patients (59%) than losartan/HCTZ-treated patients (42%) reached BP goal at the last visit (p=0."( The effects of amlodipine compared to losartan in patients with mild to moderately severe hypertension.
Grimm, RH; Kloner, RA; Phillips, RA; Weinberger, M,
)
0.71
" Both the methods were applied successfully for the analysis of amlodipine besylate in dosage forms."( Validated spectrophotometric methods for the determination of amlodipine besylate in drug formulations using 2,3-dichloro 5,6-dicyano 1,4-benzoquinone and ascorbic acid.
Nasrul Hoda, M; Rahman, N, 2003
)
0.8
"Although fitting orders to renal function avoids overdosage and therefore iatrogenic risk, dosage adjustment is rarely made."( Assessing residents' prescribing behavior in renal impairment.
Brücker, G; Deray, G; Launay-Vacher, V; Levu, S; Ravaud, P; Salomon, L, 2003
)
0.32
" Although no adjustment to renal function was required, 28% of the residents decreased the dosage of amlodipine and ordered an underdose."( Assessing residents' prescribing behavior in renal impairment.
Brücker, G; Deray, G; Launay-Vacher, V; Levu, S; Ravaud, P; Salomon, L, 2003
)
0.53
"Considering the iatrogenic risk related to the lack of dosage adjustment, attention should be drawn to increasing residents' awareness of dosage adjustment in renal impairment and to providing them with better information on patients' renal function."( Assessing residents' prescribing behavior in renal impairment.
Brücker, G; Deray, G; Launay-Vacher, V; Levu, S; Ravaud, P; Salomon, L, 2003
)
0.32
" at the same dosage for 6 weeks in three crossover periods each separated by a 2-week placebo wash-out period (3x3 latin square)."( Effect of benazepril amlodipine combination on fibrinolysis in hypertensive diabetic patients.
Corradi, L; Fogari, E; Fogari, R; Lazzari, P; Mugellini, A; Preti, P; Zoppi, A, 2003
)
0.64
"3-fold in the dose-response curves."( A comparative assessment of the duration of action of amlodipine and nifedipine GITS in normotensive subjects.
Elliott, HL; Howie, CA; Meredith, PA; Ueda, S, 1993
)
0.53
" The dosage was doubled if necessary."( Better renoprotective effect of angiotensin II antagonist compared to dihydropyridine calcium channel blocker in childhood.
Bianchetti, MG; Edefonti, A; Fossali, E; Gartenmann, AC; Schmidtko, J; Simonetti, GD; von Vigier, RO, 2003
)
0.32
" Dosage of both drugs was increased to irbesartan 300 mg once daily or amlodipine 10 mg once daily in case of sitting diastolic BP still >90 mm Hg after the first 2 weeks of treatment."( Comparative effects of irbesartan versus amlodipine on left ventricular mass index in hypertensive patients with left ventricular hypertrophy.
Fedele, F; Fera, MS; Ferri, FM; Gaudio, C; Giovannini, M; Pannarale, G; Puddu, PE; Vittore, A; Vizza, CD, 2003
)
0.82
"To compare the effects of morning and evening dosing of amlodipine on both circadian blood pressure (BP) and heart rate (HR) in mild-to-moderate essential hypertension."( Differential effects of morning or evening dosing of amlodipine on circadian blood pressure and heart rate.
Chen, JZ; Qiu, YG; Yao, XY; Zhu, JH, 2003
)
0.81
" After 2 weeks of double-blind therapy, patients with a seated diastolic blood pressure > or =90 mm Hg had their doses titrated upward to 10 mg, while the other patients remained on their original 5 mg doses for another 4 weeks period, than crossover to the alternate dosing regimen for 6 additional weeks."( Differential effects of morning or evening dosing of amlodipine on circadian blood pressure and heart rate.
Chen, JZ; Qiu, YG; Yao, XY; Zhu, JH, 2003
)
0.57
"05) were significantly greater with evening dosing compared with morning dosing."( Differential effects of morning or evening dosing of amlodipine on circadian blood pressure and heart rate.
Chen, JZ; Qiu, YG; Yao, XY; Zhu, JH, 2003
)
0.57
" Treadmill exercise 12 hours (trough) and 4 hours (peak) after dosing was assessed after 2, 6 (trough only), and 12 weeks of treatment."( Effects of ranolazine with atenolol, amlodipine, or diltiazem on exercise tolerance and angina frequency in patients with severe chronic angina: a randomized controlled trial.
Chaitman, BR; Chumakova, G; Kuch, J; Parker, JO; Pepine, CJ; Skettino, SL; Skopal, J; Wang, W; Wolff, AA, 2004
)
0.6
" The influence of CsA dosage and its trough level, HLA phenotype, gender and the administered calcium channel blocker on incidence and severity of overgrowth were studied."( Risk factors of gingival overgrowth in kidney transplant recipients treated with cyclosporine A.
Boratyńska, M; Klinger, M; Radwan-Oczko, M; Zietek, M, 2003
)
0.32
" Total yearly CsA dosage was significantly higher in patients with overgrowth."( Risk factors of gingival overgrowth in kidney transplant recipients treated with cyclosporine A.
Boratyńska, M; Klinger, M; Radwan-Oczko, M; Zietek, M, 2003
)
0.32
" CCBs were increased in dosage or other drugs were added until blood pressure decreased below 140/90 mmHg, but no inhibitors of the renin-angiotensin (RA) system were added or changed in dosage."( Comparison between cilnidipine and amlodipine besilate with respect to proteinuria in hypertensive patients with renal diseases.
Kojima, S; Shida, M; Yokoyama, H, 2004
)
0.6
" There was a significant dose-response effect of amlodipine on both systolic and diastolic BP beginning at doses > or =0."( A randomized, placebo-controlled trial of amlodipine in children with hypertension.
Daniels, SR; Flynn, JT; Hogg, RJ; Newburger, JW; Portman, RJ; Sanders, SP; Saul, JP, 2004
)
0.84
" Combination therapy of amlodipine besylate (Norvasc, Pfizer Ltd) with atorvastatin calcium (Lipitor, Pfizer Ltd), marketed as Caduet (Pfizer Ltd) is the first dual-therapy compound designed to treat hypertension and/or angina and dyslipidemia concurrently with a single daily pill in the full range of dosing combinations."( Amlodipine/atorvastatin: the first cross risk factor polypill for the prevention and treatment of cardiovascular disease.
Frishman, WH; Zuckerman, AL, 2004
)
2.07
"5) After a 4-week wash-out period, they were randomized to amlodipine (5 mg) or atorvastatin (20 mg) or their combination at the same oral dosage for 12 weeks in three cross-over periods each separated by a 4-week placebo period (3 by 3 latin square design)."( Effect of amlodipine-atorvastatin combination on fibrinolysis in hypertensive hypercholesterolemic patients with insulin resistance.
Derosa, G; Fogari, E; Fogari, R; Lazzari, P; Mugellini, A; Rinaldi, A; Zoppi, A, 2004
)
0.97
" 24-hour efficacy with once daily dosing was given as the most important argument for using Amlodipine besylate."( [Safety and antihypertensive efficacy of the dihydropyridine calcium antagonist Amlodipine besylate--results from an observational study in 9,672 patients].
Clemens, A; Keck, M; Regourd, E; Sauerbrey-Wullkopf, N, 2004
)
0.77
" In addition to recommending lifestyle modifications, eight dosage strengths of amlodipine/atorvastatin single pill (5/10, 5/20, 5/40, 5/80, 10/10, 10/20, 10/40, and 10/80 mg) were electively titrated to improve blood pressure and lipid control."( Single-pill therapy in the treatment of concomitant hypertension and dyslipidemia (the amlodipine/atorvastatin gemini study).
Blank, R; LaSalle, J; Maroni, J; Reeves, R; Sun, F; Tarasenko, L, 2005
)
0.78
" This study has shown that amlodipine effectively reduced blood pressure for 24 h after once-daily dosing and was well tolerated."( 24-hour blood pressure control with the once-daily calcium antagonist amlodipine.
Al-Khawaja, I; Brigden, G; Heber, ME; Raftery, EB, 1991
)
0.81
" Exercise testing before and 6 h after dosing showed that an acute 10 mg dose of amlodipine reduced BP without modifying the physiologic response to dynamic exercise."( Amlodipine in hypertension: its effects on platelet aggregation and dynamic exercise.
Armas-de Hernande, MJ; Armas-Padilla, MC; Barragan, O; Carvajal, AR; Guerrero-Pajuelo, J; Hernández, R; Machado-de Alvarado, I, 1991
)
1.95
"A placebo-controlled, double-blind, dose-response study of amlodipine (1."( A double-blind, placebo-controlled, parallel dose-response study of amlodipine in stable exertional angina pectoris.
Cocco, G; Jackson, N; Lee, P; Taylor, SH, 1991
)
0.76
" It is concluded that amlodipine is an antihypertensive and anti-ischemic agent that has the combined advantages of a good safety profile with once-daily dosage and a smooth onset and long duration of action."( An update on the safety of amlodipine.
Osterloh, IH, 1991
)
0.89
" Moreover, mice receiving morphine for 8 days demonstrated a significant rightward shift of the morphine antinociceptive dose-response curve, indicative of antinociceptive tolerance, whereas those that also received amlodipine along with morphine did not demonstrate tolerance."( Spinal L-type calcium channel blockade abolishes opioid-induced sensory hypersensitivity and antinociceptive tolerance.
Bilsky, EJ; Dogrul, A; Lai, J; Ossipov, MH; Porreca, F, 2005
)
0.51
" Twenty-four-hour ambulatory blood pressure monitoring showed that telmisartan plus HCTZ (n=448) and amlodipine plus HCTZ (n=424) changed systolic blood pressure for the last 6 hours of the dosing interval by -18."( Telmisartan plus HCTZ vs. amlodipine plus HCTZ in older patients with systolic hypertension: results from a large ambulatory blood pressure monitoring study.
Edwards, C; Neldam, S,
)
0.65
" Our data suggest that the DE may be a potential oral dosage form for amlodipine to improve its bioavailability."( Improvement of bioavailability and photostability of amlodipine using redispersible dry emulsion.
Jang, DJ; Jeong, EJ; Kim, BC; Kim, CK; Lee, HM; Lim, SJ, 2006
)
0.82
" Amlodipine concentrations were similar in subjects dosed either once or twice daily."( Population pharmacokinetics of amlodipine in hypertensive children and adolescents.
Flynn, JT; Mahan, JD; Nahata, MC; Portman, RJ, 2006
)
1.53
"Stable patients with coronary disease and > or =3 anginal attacks per week despite maximum recommended dosage of amlodipine (10 mg/day) were randomized to 1,000 mg ranolazine or placebo twice a day for 6 weeks."( Antianginal efficacy of ranolazine when added to treatment with amlodipine: the ERICA (Efficacy of Ranolazine in Chronic Angina) trial.
Blokhin, A; Gratsiansky, NA; Huang, IZ; Meng, L; Stone, PH, 2006
)
0.78
" In each study, subjects received multiple once-daily doses of aliskiren and the test antihypertensive drug alone or in combination in two dosing periods separated by a drug-free washout period."( Lack of pharmacokinetic interactions of aliskiren, a novel direct renin inhibitor for the treatment of hypertension, with the antihypertensives amlodipine, valsartan, hydrochlorothiazide (HCTZ) and ramipril in healthy volunteers.
Bizot, MN; Denouel, J; Dieterich, HA; Dole, WP; Kemp, C; Vaidyanathan, S; Valencia, J; Yeh, CM; Zhao, C, 2006
)
0.53
"5 mg; n=22), captopril (50 mg twice daily; n=22) or a capsule containing each of the 4 above at one-quarter dosage (n=22) in a parallel group design for 4 weeks."( Low-dose quadruple antihypertensive combination: more efficacious than individual agents--a preliminary report.
Feely, J; Mahmud, A, 2007
)
0.34
" However, during the first 7 h after dosing, ABP was lower on VAL, whereas AML exerted a significantly stronger effect during the last 4 h of the dosing interval--possibly influencing the differences in office BP found in the main study."( Ambulatory blood pressure monitoring after 1 year on valsartan or amlodipine-based treatment: a VALUE substudy.
Høegholm, A; Julius, S; Kjeldsen, SE; Mancia, G; Nielsen, ES; Pedersen, OL; Pickering, T; Refsgaard, J; Weber, M, 2007
)
0.58
" Different dosing regimens have been employed."( Acute amlodipine overdose treated by high dose intravenous calcium in a patient with severe renal insufficiency.
Hung, YM; Olson, KR, 2007
)
0.82
" The proposed method was successfully applied to the pharmaceutical dosage forms containing the above-mentioned drug combination without any interference by the excipients."( Simultaneous high-performance liquid chromatographic determination of atenolol and amlodipine in pharmaceutical-dosage form.
Ahmed, M; Barman, RK; Hossain, MB; Ibne Wahed, MI; Islam, MA; Islam, R; Khan, A; Rahman, BM, 2007
)
0.56
" The proposed methods were successfully applied to the analysis of AML in pure and pharmaceutical dosage forms with good accuracy; the recovery percentages ranged from 100."( Validated spectrofluorometric methods for determination of amlodipine besylate in tablets.
Abdel-Wadood, HM; Mahmoud, AM; Mohamed, NA, 2008
)
0.59
" No adjustment in dosage based on pharmacokinetic considerations is required should vildagliptin be coadministered with amlodipine, valsartan, or ramipril in patients with type 2 diabetes and hypertension."( Vildagliptin, a novel dipeptidyl peptidase IV inhibitor, has no pharmacokinetic interactions with the antihypertensive agents amlodipine, valsartan, and ramipril in healthy subjects.
Campestrini, J; Dole, K; Dole, WP; He, YL; Howard, D; Ligueros-Saylan, M; Marion, A; Pommier, F; Sabo, R; Sunkara, G; Wang, Y; Zhao, C, 2008
)
0.76
"A simple, precise, specific and accurate reverse phase HPLC method has been developed for the simultaneous determination of metoprolol succinate (MS) and amlodipine besylate (AB) in tablet dosage form."( Simultaneous determination of metoprolol succinate and amlodipine besylate in pharmaceutical dosage form by HPLC.
Dongre, VG; Jadhav, VK; Karmuse, PP; Phadke, M; Shah, SB, 2008
)
0.79
" Eight dosage strengths of single-pill amlodipine/atorvastatin were flexibly titrated."( Improved attainment of blood pressure and cholesterol goals using single-pill amlodipine/atorvastatin in African Americans: the CAPABLE trial.
Bruschi, P; Ferdinand, KC; Flack, JM; Jamieson, MJ; Saunders, E; Shi, H; Tarasenko, L; Victor, R; Watson, K, 2008
)
0.84
" The aim of this study was to clarify the add-on effects of bedtime dosing of the alpha(1)-adrenergic receptor antagonist doxazosin on morning blood pressure in patients with essential hypertension who were under long-acting calcium channel blocker amlodipine monotherapy."( Add-on effect of bedtime dosing of the alpha(1)-adrenergic receptor antagonist doxazosin on morning hypertension and left ventricular hypertrophy in patients undergoing long-term amlodipine monotherapy.
Gomi, T; Ikeda, T; Matsuda, N; Shibuya, Y; Shinozaki, S; Suzuki, Y, 2007
)
0.71
" Amlodipine/valsartan, at approved dosage regimens, achieved significantly greater reductions in mean sitting diastolic and systolic blood pressure (BP) than amlodipine or valsartan monotherapy, or placebo in two randomized, double-blind, factorial trials in patients with mild to moderate hypertension."( Amlodipine/Valsartan: fixed-dose combination in hypertension.
Plosker, GL; Robinson, DM, 2008
)
2.7
"Treatment regimens that require fewer dosage units and less frequent dosing to decrease the complexity and cost of care are among the strategies recommended to improve compliance with antihypertensive therapy."( Compliance with antihypertensive therapy in the elderly: a comparison of fixed-dose combination amlodipine/benazepril versus component-based free-combination therapy.
Dickson, M; Plauschinat, CA, 2008
)
0.56
" Likewise, few studies have directly compared more than two agents or ARB/hydrochlorothiazide fixed-dose combinations, and most ARBs have not been compared across their full recommended dosage ranges."( Comparison of angiotensin II type 1 receptor antagonists in the treatment of essential hypertension.
Smith, DH, 2008
)
0.35
" Eight dosage strengths of single-pill amlodipine/atorvastatin (5/10, 10/10, 5/20, 10/20, 5/40, 10/40, 5/80 and 10/80 mg) were titrated to improve blood pressure and lipid control."( Single-pill amlodipine/atorvastatin helps patients of diverse ethnicity attain recommended goals for blood pressure and lipids (the Gemini-AALA study).
Aguilar-Salinas, CA; Chaves, H; Chopra, P; Erdine, S; Guindy, R; Howes, LG; Moller, RA; Ro, YM; Schou, IM; Tse, HF, 2009
)
1
"The pharmacokinetics of amlodipine and olmesartan in healthy volunteers after coadministration of amlodipine besylate and olmesartan medoxomil concomitantly as separate dosage forms and together in a fixed-dose combination tablet were characterized in 5 phase I, randomized, crossover studies."( Pharmacokinetics of amlodipine and olmesartan after administration of amlodipine besylate and olmesartan medoxomil in separate dosage forms and as a fixed-dose combination.
Allison, M; Bathala, MS; Haworth, S; Heyrman, R; Lee, J; Noveck, R; Rohatagi, S; Rubets, I; Salazar, DE; Shenouda, M, 2008
)
0.98
" Real plasma samples from hypertensive patients receiving a dosing of 5mg antagonists were examined by using the proposed method."( Determination of nicardipine and amlodipine in human plasma using on-line solid-phase extraction with a monolithic weak cation-exchange column.
Chen, Y; Qi, L; Wei, X; Yang, G, 2009
)
0.63
" black triangle In the comparison with amlodipine monotherapy, >70% of olmesartan medoxomil/amlodipine recipients, some requiring upwards dosage adjustment, met BP goals."( Olmesartan medoxomil/amlodipine.
Keam, SJ; Sanford, M, 2009
)
0.94
" After a 4-week wash-out period, 209 patients were randomized to either CC 8 mg or AML 5 mg once daily for a minimum of 1 month, after which, if BP was not normalized, the dosage was doubled, followed by the addition of hydrochlorothiazide 12."( Effects of candesartan cilexetil on carotid remodeling in hypertensive diabetic patients: the MITEC study.
Asmar, R; Baguet, JP; Mallion, JM; Nisse-Durgeat, S; Valensi, P, 2009
)
0.35
"The purposes of this study were to describe amlodipine poisoning in children and to determine whether a dose-response relationship could be detected in this population using standardized call data from United States (US) poison centers."( Amlodipine toxicity in children less than 6 years of age: a dose-response analysis using national poison data system data.
Bakhireva, LN; Benson, BE; Spyker, DA; Troutman, WG; Watson, WA, 2010
)
2.06
" Ingestions reported as a "taste or lick" (n = 53) were included as a dose of 1/10 of the dosage form involved."( Amlodipine toxicity in children less than 6 years of age: a dose-response analysis using national poison data system data.
Bakhireva, LN; Benson, BE; Spyker, DA; Troutman, WG; Watson, WA, 2010
)
1.8
" In each subgroup, > or =1 dosage combination of amlodipine + OM significantly reduced SeDBP and SeSBP compared with constituent monotherapies."( Subgroup analyses of an efficacy and safety study of concomitant administration of amlodipine besylate and olmesartan medoxomil: evaluation by baseline hypertension stage and prior antihypertensive medication use.
Karki, S; Lee, J; Melino, M; Oparil, S, 2009
)
0.83
"A rapid, precise, specific, and accurate ultra performance liquid chromatography (UPLC) method has been developed and subsequently validated for simultaneous determination of amlodipine present as amlodipine basylate (AB) and benazepril hydrochloride (BH) in capsule dosage form."( Simultaneous determination of amlodipine besylate and benazepril hydrochloride in pharmaceutical dosage form by LC.
Farooqui, MN; Kasawar, GB, 2009
)
0.83
" Blood pressure (BP) and heart rate were measured in the sitting position before dosing and at 1, 2, 4, 5, 6, 7, 8, 10, 12, 14, 24, 48, and 72 hours after oral administration of S-amlodipine or amlodipine racemate."( Pharmacodynamic (hemodynamic) and pharmacokinetic comparisons of S-amlodipine gentisate and racemate amlodipine besylate in healthy Korean male volunteers: two double-blind, randomized, two-period, two-treatment, two-sequence, double-dummy, single-dose cr
Jang, IJ; Kim, BH; Kim, JR; Kim, KP; Kim, MG; Lee, BY; Shin, SG; Yu, KS, 2010
)
0.79
" h/mL after dosing with S-amlodipine and 129."( Pharmacodynamic (hemodynamic) and pharmacokinetic comparisons of S-amlodipine gentisate and racemate amlodipine besylate in healthy Korean male volunteers: two double-blind, randomized, two-period, two-treatment, two-sequence, double-dummy, single-dose cr
Jang, IJ; Kim, BH; Kim, JR; Kim, KP; Kim, MG; Lee, BY; Shin, SG; Yu, KS, 2010
)
0.9
" Oral dosing of amlodipine (0."( Protective effect of amlodipine against osteoporosis in stroke-prone spontaneously hypertensive rats.
Ando, H; Fujimura, A; Ishikawa, E; Liu, Y; Maekawa, T; Motosugi, Y; Tsuruoka, S; Ushijima, K, 2010
)
1.03
" We present a case of iatrogenic lipid emulsion overdose because of a dosing error."( Iatrogenic lipid emulsion overdose in a case of amlodipine poisoning.
Hendrickson, RG; McKeown, NJ; West, PL, 2010
)
0.62
"The aim of the present study was to use ambulatory blood pressure (BP) monitoring (ABPM) to determine the efficacy of a fixed-dose combination of amlodipine (AML) and olmesartan medoxomil (OM) over the 24-hour dosing interval."( Efficacy of amlodipine and olmesartan medoxomil in patients with hypertension: the AZOR Trial Evaluating Blood Pressure Reductions and Control (AZTEC) study.
Dubiel, R; Kereiakes, DJ; Maa, JF; Neutel, JM; Punzi, H; Shojaee, A; Waverczak, WF, 2010
)
0.94
" Our data demonstrate the potential of SRS microscopy in high-speed screening of pharmaceutical solid dosage forms."( Vibrational imaging of tablets by epi-detected stimulated Raman scattering microscopy.
Carvajal, MT; Chen, H; Cheng, JX; Ely, DR; Jung, Y; Slipchenko, MN, 2010
)
0.36
" They were successfully applied to the determination of AML and VAL in synthetic mixtures and in a pharmaceutical dosage form."( High-performance liquid chromatographic and first derivative of the ratio spectrophotometric determination of amlodipine and valsartan in their binary mixtures.
Dogan-Topal, B; Kul, D; Kutucu, T; Ozkan, SA; Uslu, B,
)
0.34
"To explore if non-concurrent amlodipine dosing results in less drug interaction, the pharmacokinetic profiles, safety and efficacy endpoints were assessed following repeated doses of simvastatin, co-administered concurrently or non-concurrently with amlodipine in patients with coexisting hypertension and hyperlipidemia."( Non-concurrent dosing attenuates the pharmacokinetic interaction between amlodipine and simvastatin.
Choi, JW; Kim, SH; Lee, H; Lee, SJ; Lim, HE; Park, CG, 2010
)
0.88
"The Cmax and AUClast and of simvastatin acid in the non-concurrent amlodipine dosing group were 63."( Non-concurrent dosing attenuates the pharmacokinetic interaction between amlodipine and simvastatin.
Choi, JW; Kim, SH; Lee, H; Lee, SJ; Lim, HE; Park, CG, 2010
)
0.83
"Non-concurrent dosing may be a useful and safe therapeutic option for patients who require two or more drugs administered concomitantly, but who are likely to develop unwanted drug interactions."( Non-concurrent dosing attenuates the pharmacokinetic interaction between amlodipine and simvastatin.
Choi, JW; Kim, SH; Lee, H; Lee, SJ; Lim, HE; Park, CG, 2010
)
0.59
" Amlodipine, however, has been shown to be effective in reducing BP throughout the day and night, independent of dosing time."( Chronotherapy with valsartan/amlodipine fixed combination: improved blood pressure control of essential hypertension with bedtime dosing.
Ayala, DE; Fernández, JR; Fontao, MJ; Hermida, RC; Mojón, A, 2010
)
1.56
"A simple, rapid, and precise method is developed for the quantitative simultaneous estimation of amlodipine (AM) and olmesartan (OL) in combined pharmaceutical dosage form."( Stability indicating LC method for the simultaneous determination of amlodipine and olmesartan in dosage form.
Patil, KR; Rane, VP; Sangshetti, JN; Shinde, DB; Yeole, RD, 2010
)
0.81
" The bedtime dosing of amlodipine and olmesartan seems more apt than the morning dose to obtain the therapeutic goal."( The bedtime administration ameliorates blood pressure variability and reduces urinary albumin excretion in amlodipine-olmesartan combination therapy.
Hoshino, A; Matsubara, H; Nakamura, T, 2010
)
0.88
" In the young subjects, the first dose of either DHP did not decrease BP and chronic dosing decreased BP by approximately 10 mm Hg, which had disappeared by 24 hours."( Pharmacokinetic and antihypertensive profile of amlodipine and felodipine-ER in younger versus older patients with hypertension.
Coletta, E; Leenen, FH, 2010
)
0.62
" In particular, mean 24-h BP and BP variability both correlate closely with hypertension end-organ damage and rate of CV events, which suggests that antihypertensive therapy should provide smooth BP control over the full 24-h dosing interval."( Efficacy and tolerability of olmesartan/amlodipine combination therapy in patients with mild-to-severe hypertension: focus on 24-h blood pressure control.
Bilo, G; Hoshide, S; Lonati, L; Ochoa, JE; Parati, G; Ramos, C, 2010
)
0.63
" Once-daily treatment with amlodipine/valsartan/hydrochlorothiazide (10/320/25 mg) reduces ABP to a significantly greater extent than component-based dual therapy and maintains its effectiveness over the entire 24-h dosing period."( 24-Hour ambulatory blood pressure control with triple-therapy amlodipine, valsartan and hydrochlorothiazide in patients with moderate to severe hypertension.
Calhoun, DA; Crikelair, N; Glazer, RD; Lacourcière, Y; Yen, J, 2011
)
0.91
" The present study indicated that the implemention of both 5 mg and 10 mg dosage could enable accurate predictions of AUC(0-24 h) by the same LSS model."( [Limited sampling strategy models for estimating AUC for amlodipine in Chinese healthy volunteers].
He, YC; Sheng, YC; Shi, JM; Wang, K; Xu, L; Yang, J; Zhang, M; Zheng, QS, 2010
)
0.61
"This study compared the effects of morning and evening dosing of amlodipine/valsartan combination on 24-h blood pressure (BP) in patients uncontrolled by amlodipine (5 mg)."( Efficacy of morning and evening dosing of amlodipine/valsartan combination in hypertensive patients uncontrolled by 5 mg of amlodipine.
Achouba, A; Asmar, R; Gosse, P; Queré, S, 2011
)
0.87
"Morning and evening dosing with amlodipine/valsartan had equivalent effects on systolic BP (mean 24 h, daytime, night-time, and 24-30 h) and diastolic BP (mean 24 h, daytime, night-time, and 24-30 h)."( Efficacy of morning and evening dosing of amlodipine/valsartan combination in hypertensive patients uncontrolled by 5 mg of amlodipine.
Achouba, A; Asmar, R; Gosse, P; Queré, S, 2011
)
0.92
"In this first randomized trial evaluating the effects of intensive versus moderate dosing of the combination of amlodipine/valsartan, our data suggest that ABPM was a better method for assessing between-treatment differences than clinic or home BP recordings, although measurement of home BP as a single recording was a limitation of our trial."( The role of ambulatory blood pressure monitoring compared with clinic and home blood pressure measures in evaluating moderate versus intensive treatment of hypertension with amlodipine/valsartan for patients uncontrolled on angiotensin receptor blocker mo
Giles, TD; Hilkert, R; Ofili, EO; Oparil, S; Pitt, B; Purkayastha, D; Samuel, R; Sowers, JR, 2011
)
0.77
" In the two groups the patients with SeDBP ≥ 90 mm Hg were doubled the dosage of the initial regimen at the end of 4-week treatment for additional 4 weeks, and the patients with SeDBP < 90 mm Hg remained the initial regimen for additional 4 weeks."( [Comparison of benazepril monotherapy to amlodipine plus benazepril in the treatment of patients with mild and moderate hypertension: a multicentre, randomized, double-blind, parallel-controlled study].
Fan, CM; Gao, MM; Li, CX; Li, YQ; Li, YS; Lu, XL; Pang, HM; Tao, YK; Wang, L; Wang, XW; Wang, YN; Yan, LR, 2011
)
0.64
" Moreover, consistent reductions in BP were observed over the 24-hour dosing interval using ambulatory measurements."( Olmesartan/amlodipine: a review of its use in the management of hypertension.
Kreutz, R, 2011
)
0.76
" In conclusion, this amlodipine/OM-based titration regimen was well tolerated and effectively lowered BP throughout the 24-hour dosing interval in patients with hypertension and type 2 diabetes."( Management of hypertension in patients with diabetes using an amlodipine-, olmesartan medoxomil-, and hydrochlorothiazide-based titration regimen.
Littlejohn, T; Neutel, JM; Qian, C; Ram, CV; Sachson, R; Shojaee, A; Stoakes, KA, 2011
)
0.93
" Twenty-two dogs were treated with amlodipine, at a median daily dosage of 0·38 mg/kg (interquartile range 0·28 to 0·49) divided in one to two applications per day."( Occurrence of systemic hypertension in dogs with acute kidney injury and treatment with amlodipine besylate.
Doherr, M; Francey, T; Geigy, CA; Schweighauser, A, 2011
)
0.87
" The primary objective of the study was to determine the effect of once-daily dosing of a combination therapy for blood pressure (BP) and dyslipidemia using home BP monitoring on reaching clinical BP and the effect of daily dosing of combination therapy on reaching lipid goals."( Improving adherence with amlodipine/atorvastatin therapy: IMPACT study.
Crabbe, A; Delkhah, Y; Jones, J; Leonard, D; Nesbitt, S; Oliver, S, 2011
)
0.67
"Three simple, specific, accurate and precise spectrophotometric methods manipulating ratio spectra are developed for the simultaneous determination of Amlodipine besylate (AM) and Atorvastatin calcium (AT) in tablet dosage forms."( Three different spectrophotometric methods manipulating ratio spectra for determination of binary mixture of Amlodipine and Atorvastatin.
Darwish, HW; El-Zeiny, BA; Hassan, SA; Salem, MY, 2011
)
0.78
" The combination of amlodipine and atorvastatin in 8 different dosage strengths were flexibly titrated over a period of 14 weeks."( Impact of combination therapy with amlodipine and atorvastatin on plasma adiponectin levels in hypertensive patients with coronary artery disease: combination therapy and adiponectin.
Cheung, BM; Lam, KS; Li, M; Tse, HF; Xu, A, 2011
)
0.97
" The preparation was prescribed in different fixed dosage depending on duration of hypertension, quantity of taken hypertension groups of preparations and blood pressure level."( [Estimation of antihypertension efficiency and use of fixed combination perindopril+amlodipin by uncontrollable hypertension patients within the limits of routine treatment].
Ishmurzin, GP, 2011
)
0.37
" Greater efficacy was also found during daytime and nighttime hours and during the last 6, 4, or 2 hours of the dosing interval."( 24-hour efficacy and safety of Triple-Combination Therapy With Olmesartan, Amlodipine, and Hydrochlorothiazide: the TRINITY ambulatory blood pressure substudy.
Chrysant, SG; Fernandez, V; Heyrman, R; Izzo, JL; Kereiakes, DJ; Lee, J; Littlejohn Iii, T; Melino, M; Oparil, S, 2011
)
0.6
"6 mmHg), ABP in the last 4 hours of the dosing period (-21."( Ambulatory blood pressure response to triple therapy with an angiotensin-receptor blocker (ARB), calcium-channel blocker (CCB), and HCTZ versus dual therapy with an ARB and HCTZ.
Duprez, D; Ferdinand, K; Purkayastha, D; Samuel, R; Wright, R, 2011
)
0.37
"The aim of this study was to determine the dose-response relationship and assess the efficacy and safety of amlodipine or losartan monotherapy and amlodipine camsylate/losartan combination therapy in patients with essential hypertension."( Evaluation of the dose-response relationship of amlodipine and losartan combination in patients with essential hypertension: an 8-week, randomized, double-blind, factorial, phase II, multicenter study.
Chae, SC; Cho, SY; Choi, YJ; Hong, BK; Hong, TJ; Jeong, JW; Kim, CH; Kim, JJ; Kim, MH; Kwan, J; Park, CG; Park, SH; Yang, JY; Youn, HJ, 2012
)
0.85
" Clinical assessment of GO was correlated with patient's age, gender, drug dosage (2."( Prevalence of gingival overgrowth among elderly patients under amlodipine therapy at a large Indian teaching hospital.
Bhat, GS; Bhat, KM; Karnik, R, 2012
)
0.62
" Plaque and gingival inflammation were highly correlated with this condition, while demographic characteristics and drug dosage did not relate significantly."( Prevalence of gingival overgrowth among elderly patients under amlodipine therapy at a large Indian teaching hospital.
Bhat, GS; Bhat, KM; Karnik, R, 2012
)
0.62
"A simple, specific, accurate and precise stability-indicating reversed-phase high-performance liquid chromatographic method was developed for simultaneous estimation of olmesartan medoxomile (OLME), amlodipine besylate (AMLO) and hydrochlorothiazide (HCTZ) in tablet dosage form."( Stability-indicating method for simultaneous estimation of olmesartan medoxomile, amlodipine besylate and hydrochlorothiazide by RP-HPLC in tablet dosage form.
Chaudhari, AJ; Gorle, AP; Jain, PS; Patel, MK; Surana, SJ, 2012
)
0.79
" In the intervention group, Shiyiwei Shenqi Capsule was given additionally to the subgroup of yang-qi deficiency at the dosage of 3-5 capsules, thrice a day, while Dengzhan Shengmai Capsule was given additionally to the subgroup of yin-qi deficiency at the dosage of 2 capsules, 2-3 times per day."( Clinical study of western medicine combined with Chinese medicine based on syndrome differentiation in the patients with polarized hypertension.
Chen, SL; Chen, XL; Liu, XY; Mei, WY; Xu, WM, 2012
)
0.38
" First, optimized sample scenarios were designed using WinPOPT software according to the aim, dosage regimen and visit schedule of the clinical study protocol, and the amlodipine population model reported by Rohatagi et al."( [Modeling and simulation activities to design sampling scheme for population pharmacokinetic study on amlodipine].
Barrett, JS; Di, W; Guo, R; Huang, ZJ; Jing, NN; Ng, CM; Pei, Q; Yang, GP; Yuan, H; Zhang, BK; Zhou, YN; Zuo, XC, 2012
)
0.79
" The single pill triple combination of aliskiren, amlodipine, and hydrochlorothiazide offers five different formulations of escalating dosages of the three agents, allowing dosing flexibility."( The single pill triple combination of aliskiren, amlodipine, and hydrochlorothiazide in the treatment of hypertension.
Huan, Y; Townsend, R, 2012
)
0.89
" BP reductions were maintained throughout the 24 h dosing period, and 24 h goal rates were obtained in a high proportion of patients."( Telmisartan plus amlodipine single-pill combination for the management of hypertensive patients with a metabolic risk profile (added-risk patients).
Ley, L; Schumacher, H, 2013
)
0.73
" Steady states of both compounds were attained after once-daily dosing for 8 days."( Pharmacokinetic and pharmacodynamic profiles of a fixed-dose combination of olmesartan medoxomil and amlodipine in healthy Chinese males and females.
Chen, X; Hu, P; Jiang, J; Liu, H; Liu, T; Zhao, Q; Zhong, W, 2012
)
0.59
"Three simple, specific, accurate and precise spectrophotometric methods depending on the proper selection of two wavelengths are developed for the simultaneous determination of Amlodipine besylate (AML) and Atorvastatin calcium (ATV) in tablet dosage forms."( Three different methods for determination of binary mixture of Amlodipine and Atorvastatin using dual wavelength spectrophotometry.
Darwish, HW; El-Zeany, BA; Hassan, SA; Salem, MY, 2013
)
0.82
"Accurate, sensitive and reproducible reversed-phase high-performance liquid chromatography (RP-HPLC), high-performance thin-layer chromatography (HPTLC) and ultraviolet (UV) spectrophopometric methods were developed for the concurrent estimation of amlodipine besylate (AMLO), hydrochlorothiazide (HCTZ) and valsartan (VALS) in bulk and combined tablet dosage forms."( Concurrent estimation of amlodipine besylate, hydrochlorothiazide and valsartan by RP-HPLC, HPTLC and UV-spectrophotometry.
Kothari, C; Mehta, P; Sharma, M; Sherikar, O, 2014
)
0.89
" Control of blood pressure with fixed dose combination of the above drugs acting through different mechanism have a benefit of convenient dosing in terms of compliance, lower the dose and subsequently reduce the side effects."( A comparative pharmacokinetic study of a fixed dose combination for essential hypertensive patients: a randomized crossover study in healthy human volunteers.
Biswas, E; Choudhury, H; Ghosh, B; Gorain, B; Halder, D; Pal, TK; Sarkar, AK; Sarkar, P, 2013
)
0.39
"5 mg) (ARB+D; n = 72) or a combination of amlodipine (5 mg) and the typical dosage of ARBs (ARB+C; n = 68) to evaluate the change in the BP, laboratory values and cognitive function."( Combination of antihypertensive therapy in the elderly, multicenter investigation (CAMUI) trial: results after 1 year.
Hasebe, N; Kikuchi, K; Koyama, S; Maruyama, J; Morimoto, H; Morita, K; Saijo, Y; Sano, H; Sasagawa, Y; Sato, N; Sumitomo, K; Takehara, N; Takeuchi, T, 2013
)
0.65
" Antihypertensive efficacy was maintained throughout the 24-hour dosing interval."( Efficacy/safety of a fixed-dose amlodipine/olmesartan medoxomil-based treatment regimen in hypertensive blacks and non-blacks with uncontrolled BP on prior antihypertensive monotherapy.
Maa, JF; Nesbitt, S; Shojaee, A, 2013
)
0.67
" At inclusion, previous angiotensin-converting enzyme (ACE) inhibitors and/or calcium channel blockers (CCBs) were replaced by a perindopril/amlodipine fixed-dose combination at a dosage (5/5, 5/10, 10/5, or 10/10 mg) chosen by the physician and uptitrated at month 1, if required."( Twenty-four-hour ambulatory blood pressure reduction with a perindopril/amlodipine fixed-dose combination.
Nagy, VL, 2013
)
0.82
" Amlodipine is often favored clinically over other calcium channel blockers for its vascular selectivity and relative lack of negative ionotropy, once daily dosing and prolonged duration of effect."( Postoperative hypotension associated with amlodipine.
Kadam, PG; Shah, VR, 2013
)
1.56
" The proposed method was successfully applied to amlodipine besylate and aliskiren hemifumarate in pharmaceutical dosage mixtures without any interference from the excipients."( Simultaneous determination of amlodipine and aliskren in tablets by high-performance liquid chromatography.
Akyüz, A; Özdemir, FA, 2014
)
0.95
" A fixed-dose combination (FDC) drug is a formulation including fixed amounts of active drug ingredients combined in a single dosage form that is expected to improve medication compliance."( Pharmacokinetic comparison of 2 fixed-dose combination tablets of amlodipine and valsartan in healthy male Korean volunteers: a randomized, open-label, 2-period, single-dose, crossover study.
Bahng, MY; Chae, D; Kim, Y; Lee, D; Park, K; Roh, H; Son, H; Son, M, 2013
)
0.63
" The developed method is applicable for the determination of related substances in bulk drugs and simultaneous assay in a tablet pharmaceutical dosage form."( A validated stability-indicating RP-LC method for the simultaneous determination of amlodipine and perindopril in tablet dosage form and their stress degradation behavior under ICH-recommended stress conditions.
Gumustas, M; Ozkan, SA,
)
0.36
"In the observation program AESCULAP using the fixed-dose combination of amlodipine/valsartan as different dosage regimens (5/160 and 10/160 mg) and/or a diuretic, there was a marked antihypertensive effect in different subgroups of patients with previously uncontrolled hypertension and the BP goals being achieved in 79."( [On the way to achieve hypertension treatment goals: results of the open observational program AESCULAP (exforge--clinical safety and efficiency of using a double combination of antihypertensive drugs in patients with uncontrolled blood pressure)].
Chazova, IE; Martynyuk, TV, 2013
)
0.62
" The smoothness index (SI) provides a useful measure of antihypertensive treatment efficacy over the 24 h dosing period, its values being highest with antihypertensive agents that have large and consistent effects across 24 h."( Blood pressure variability over 24 h: prognostic implications and treatment perspectives. An assessment using the smoothness index with telmisartan-amlodipine monotherapy and combination.
Parati, G; Schumacher, H, 2014
)
0.6
" The methods were used for the quantitative analysis of the drugs in raw materials and pharmaceutical dosage form via handling the UV spectral data."( Different approaches in Partial Least Squares and Artificial Neural Network models applied for the analysis of a ternary mixture of Amlodipine, Valsartan and Hydrochlorothiazide.
Darwish, HW; El-Zeany, BA; Hassan, SA; Salem, MY, 2014
)
0.61
"Four simple, accurate, reproducible, and selective methods have been developed and subsequently validated for the determination of Benazepril (BENZ) alone and in combination with Amlodipine (AML) in pharmaceutical dosage form."( Comparative study between univariate spectrophotometry and multivariate calibration as analytical tools for quantitation of Benazepril alone and in combination with Amlodipine.
Elaziz, OA; Farouk, M; Hemdan, A; Shehata, MA; Tawakkol, SM, 2014
)
0.79
" The specificity of the developed methods is investigated by analyzing laboratory prepared mixtures containing different ratios of the three drugs and their combined dosage form."( Spectrophotometric methods for simultaneous determination of ternary mixture of amlodipine besylate, olmesartan medoxomil and hydrochlorothiazide.
Diab, SS; Merey, HA; Moustafa, AA; Ramadan, NK, 2014
)
0.63
"A novel, specific, reliable, and accurate capillary zone electrophoretic method was developed and validated for the simultaneous determination of aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide in their triple mixture dosage form."( Simultaneous determination of aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide in their triple mixture dosage form by capillary zone electrophoresis.
Belal, F; Ebeid, WM; El-Enany, N; Patonay, G; Salim, MM; Walash, M, 2014
)
0.85
" There were no differences between 4 dosing regimens in laboratory and clinical parameters of safety and tolerability."( [Fixed irbesartan/amlodipine combination: efficacy and safety of the use of four dosing regimens in patients with arterial hypertension].
Kobalava, ZhD, 2014
)
0.74
" We investigated the relevant impact of different dosing times of antihypertensive drugs beyond CPAP application."( Evening versus morning dosing of antihypertensive drugs in hypertensive patients with sleep apnoea: a cross-over study.
Andrikou, I; Aragiannis, D; Bilo, G; Dimitriadis, K; Filis, K; Kasiakogias, A; Parati, G; Sideris, S; Stefanadis, C; Thomopoulos, C; Tsiachris, D; Tsioufis, C, 2015
)
0.42
"Evening dosing of antihypertensive drugs improves night-time BP and dipping status in nonsleepy patients with OSA, irrespective of CPAP application."( Evening versus morning dosing of antihypertensive drugs in hypertensive patients with sleep apnoea: a cross-over study.
Andrikou, I; Aragiannis, D; Bilo, G; Dimitriadis, K; Filis, K; Kasiakogias, A; Parati, G; Sideris, S; Stefanadis, C; Thomopoulos, C; Tsiachris, D; Tsioufis, C, 2015
)
0.42
" In June 2011, the US FDA released a Drug Safety Communication that provided updated product labeling with dosing restrictions for simvastatin to minimize the risk of myopathies."( Simvastatin prescribing patterns before and after FDA dosing restrictions: a retrospective analysis of a large healthcare claims database.
Ghushchyan, V; Nair, K; Saseen, JJ; Tuchscherer, RM, 2015
)
0.42
"Our objective was to describe prescribing patterns of simvastatin in combination with medications known to increase the risk of myopathies following updated product labeling dosing restrictions in June 2011."( Simvastatin prescribing patterns before and after FDA dosing restrictions: a retrospective analysis of a large healthcare claims database.
Ghushchyan, V; Nair, K; Saseen, JJ; Tuchscherer, RM, 2015
)
0.42
" The patients were treated with a fixed combination of dosage forms ofp erindopril and amlodipine at 10/5 mg/days or 10/10 mg/days for 24 weeks."( [Organoprotective effects of the combination of perindopril and amlodipine depending on the renal functional state in patients with arterial hypertension].
Budagovskaia, ZM; Iskenderov, BG; Sisina, ON, 2013
)
0.85
"A new rapid stability-indicating UPLC method for separation and determination of impurities in amlodipine besylate, valsartan and hydrochlorothiazide in their combined tablet dosage form was developed."( A new, rapid, stability-indicating UPLC method for separation and determination of impurities in amlodipine besylate, valsartan and hydrochlorothiazide in their combined tablet dosage form.
Coufal, P; Janečková, L; Jedlička, A; Vojta, J, 2015
)
0.85
" It is a major determinant of half-life and dosing frequency of a drug."( Volume of Distribution in Drug Design.
Beaumont, K; Di, L; Maurer, TS; Smith, DA, 2015
)
0.42
" This study aims to investigate whether calcium channel blockers plus low dosage aspirin therapy can reduce the incidence of complications during pregnancy with chronic hypertension and improve the prognosis of neonates."( The effect of calcium channel blockers on prevention of preeclampsia in pregnant women with chronic hypertension.
Jiang, N; Liu, L; Liu, Q; Yang, WW; Zeng, Y, 2015
)
0.42
" The ANCOVA showed that changes in patients' HRQoL was likely to have been influenced by patients' achievement of blood pressure control, the amount of concomitant medication and patients' last used dosage strength of antihypertensive."( Health-related quality of life impact of a triple combination of olmesartan medoxomil, amlodipine besylate and hydrochlorotiazide in subjects with hypertension.
Brazier, JE; Guest, JF; Haag, U; Marques da Silva, P; Soro, M, 2015
)
0.64
" Achieving blood pressure control, amount of concomitant medication and dosage strength of antihypertensive impacted on patients' HRQoL."( Health-related quality of life impact of a triple combination of olmesartan medoxomil, amlodipine besylate and hydrochlorotiazide in subjects with hypertension.
Brazier, JE; Guest, JF; Haag, U; Marques da Silva, P; Soro, M, 2015
)
0.64
" Commercially available tablet formulations were successfully analysed using the developed methods without interference from other dosage form additives except PLS model, which failed to determine both drugs in their pharmaceutical dosage form."( Conventional univariate versus multivariate spectrophotometric assisted techniques for simultaneous determination of perindopril arginin and amlodipine besylate in presence of their degradation products.
Abbas, SS; Essam, HM; Hegazy, MA; Zaazaa, HE, 2015
)
0.62
"Two advanced, accurate and precise chemometric methods are developed for the simultaneous determination of amlodipine besylate (AML) and atorvastatin calcium (ATV) in the presence of their acidic degradation products in tablet dosage forms."( Advanced stability indicating chemometric methods for quantitation of amlodipine and atorvastatin in their quinary mixture with acidic degradation products.
Darwish, HW; El-Zeany, BA; Hassan, SA; Salem, MY, 2016
)
0.88
" Specificity was investigated by analyzing the synthetic mixtures containing different ratios of the three studied drugs and their tablets dosage form."( Application and validation of superior spectrophotometric methods for simultaneous determination of ternary mixture used for hypertension management.
Lamie, NT; Mohamed, HM, 2016
)
0.43
"Hypertensive patients who had not achieved their target blood pressure with at least 4 weeks of ARB therapy were randomly assigned to receive either a fixed-dose combination of losartan and HCTZ (losartan/HCTZ; n=110) or a combination of amlodipine and a typical ARB dosage (CCB/ARB; n=121) and followed for 24 weeks."( Effect of Diuretic or Calcium-Channel Blocker Plus Angiotensin-Receptor Blocker on Diastolic Function in Hypertensive Patients.
Ishii, K; Ito, H; Iwakura, K; Kihara, H; Toh, N; Watanabe, H; Yoshikawa, J, 2016
)
0.62
"Simultaneous spectrophotometric analysis of a multi-component dosage form of olmesartan, amlodipine and hydrochlorothiazide used for the treatment of hypertension has been carried out using various chemometric methods."( Simultaneous quantitative analysis of olmesartan, amlodipine and hydrochlorothiazide in their combined dosage form utilizing classical and alternating least squares based chemometric methods.
Abdelhameed, AS; Bakheit, AH; Darwish, HW, 2016
)
0.91
" The specificity of the developed methods is investigated by analyzing laboratory prepared mixtures of the two drugs and their combined dosage form."( Spectrophotometric Methods for Simultaneous Determination of Amlodipine Besylate and Atenolol in Their Tablet Dosage Form.
Lamie, NT, 2015
)
0.66
"Three simple, selective, and accurate spectrophotometric methods have been developed and then validated for the analysis of Benazepril (BENZ) and Amlodipine (AML) in bulk powder and pharmaceutical dosage form."( Development and validation of different methods manipulating zero order and first order spectra for determination of the partially overlapped mixture benazepril and amlodipine: A comparative study.
Hemdan, A, 2016
)
0.83
"Four new spectrophotometric methods were developed, applied to resolve the overlapped spectra of a ternary mixture of [aliskiren hemifumarate (ALS)-amlodipine besylate (AM)-hydrochlorothiazide (HCT)] and to determine the three drugs in pure form and in combined dosage form."( Resolution of overlapped spectra for the determination of ternary mixture using different and modified spectrophotometric methods.
Ahmed, MS; El-Zaher, AA; Mahrouse, MA; Moussa, BA, 2016
)
0.63
" The commercially available tablets of 5 and 10mg do not provide the necessary flexibility in dosing needed for treating children."( Design and stability study of an oral solution of amlodipine besylate for pediatric patients.
Hanff, LM; Koch, BC; Postma, DJ; Smeets, OS; van der Velde, I; van der Vossen, AC; Vermes, A; Vulto, AG, 2016
)
0.69
" Microbiological quality was studied in an 18-week in-use test based on a two-times daily dosing schedule."( Design and stability study of an oral solution of amlodipine besylate for pediatric patients.
Hanff, LM; Koch, BC; Postma, DJ; Smeets, OS; van der Velde, I; van der Vossen, AC; Vermes, A; Vulto, AG, 2016
)
0.69
" This liquid formulation is preferred over manipulated commercial dosage forms or non-standardized extemporaneously compounded formulations."( Design and stability study of an oral solution of amlodipine besylate for pediatric patients.
Hanff, LM; Koch, BC; Postma, DJ; Smeets, OS; van der Velde, I; van der Vossen, AC; Vermes, A; Vulto, AG, 2016
)
0.69
"The median daily dosage of RIS did not differ between the groups (p=0."( Pharmacokinetic considerations in the treatment of hypertension in risperidone-medicated patients - thinking of clinically relevant CYP2D6 interactions.
Gründer, G; Haen, E; Lammertz, SE; Paulzen, M; Schoretsanitis, G; Schruers, KR; Stegmann, B; Walther, S, 2016
)
0.43
"BACKGROUND Is the timing of dosing for amlodipine and atorvastatin important with regard to therapeutic efficacy? To answer this question, we designed an outpatient, practice-based, case-control study lasting 8 weeks."( Is Time an Important Problem in Management of Hypertension and Hypercholesterolemia by Using an Amlodipine-Atorvastatin Single Pill Combination?
Wang, M; Zeng, R; Zhang, L, 2016
)
0.92
"A total of 108 mild-to-moderate essential hypertension patients in Chinese Han nationality were treated with amlodipine for 8 weeks at a dosage of 5 mg/d."( [Association between gene polymorphism of calcium/calmodulin-dependent kinase 4 and efficacy of amlodipine in the treatment of hypertension in Chinese Han nationality].
Chen, Y; Liu, L; Liu, Y; Luo, Y; Yang, L; Yao, J; Zhong, G, 2016
)
0.86
" The case for fixed-dose combination (FDC) oral dosage forms and orally disintegrating tablet (ODT) technology to enhance outcomes and compliance is strong."( Fixed-dose combination orally disintegrating tablets to treat cardiovascular disease: formulation, in vitro characterization and physiologically based pharmacokinetic modeling to assess bioavailability.
Badhan, RK; Dennison, TJ; Mohammed, AR; Smith, JC, 2017
)
0.46
" These advantages inform their uses in the design of drug dosage forms."( Formulation and Evaluation of Oral Dissolving Films of Amlodipine Besylate Using Blends of Starches With Hydroxypropyl Methyl Cellulose.
Ayorinde, JO; Balogun-Agbaje, O; Odeniyi, MA,
)
0.38
" Hence, the present study was undertaken to study the chronopharmacokinetic and chronopharmacodynamic phenomena of amlodipine and evaluate the effect of time of dosage in hypertensive subjects."( Evaluation of the effect of time dependent dosing on pharmacokinetic and pharmacodynamics of amlodipine in normotensive and hypertensive human subjects.
Hs, S; Khodadoustan, S; Kumar, C; Nasri Ashrafi, I; S, C; Vanaja Satheesh, K, 2017
)
0.88
" The primary objective of the PETRA study was to evaluate the efficacy of blood pressure (BP) control with once daily administration of the different dosage strengths of the once-daily, triple fixed combination of perindopril, indapamide, and amlodipine."( The Antihypertensive Efficacy of the Triple Fixed Combination of Perindopril, Indapamide, and Amlodipine: The Results of the PETRA Study.
Ábrahám, G; Dézsi, CA, 2017
)
0.86
" Here, we hypothesized different efficacy of morning versus evening dosing of VA in spontaneously hypertensive rats (SHR) and the involvement of circadian clock genes Bmal1 and Per2."( mRNA levels of circadian clock components Bmal1 and Per2 alter independently from dosing time-dependent efficacy of combination treatment with valsartan and amlodipine in spontaneously hypertensive rats.
Doka, G; Klimas, J; Kralova, E; Krenek, P; Potucek, P; Radik, M, 2017
)
0.65
" The purpose of this study was to explore the optimal dosage of a fixed-dose combination of candesartan cilexetil (CAN) and amlodipine besylate (AML), by examining the tolerability and efficacy of CAN/AML combination therapy compared with those of monotherapy with either drug in patients with essential hypertension."( Efficacy and Tolerability of Combination Therapy Versus Monotherapy with Candesartan and/or Amlodipine for Dose Finding in Essential Hypertension: A Phase II Multicenter, Randomized, Double-blind Clinical Trial.
Ahn, T; Chae, SC; Cho, EJ; Cho, JH; Choi, JY; Chung, WB; Hong, TJ; Ihm, SH; Jeon, HK; Jeong, MH; Kim, CJ; Kim, WS; Kim, YK; Lee, HY; Lee, JH; Nam, CW; Park, JI; Park, SM; Shin, ES; Sohn, IS; Yang, TH; Yoon, JH; Youn, HJ, 2017
)
0.88
"Drug half-life has important implications for dosing regimen and peak-to-trough ratio at the steady state."( Relevance of Half-Life in Drug Design.
Beaumont, K; Di, L; Maurer, TS; Smith, DA, 2018
)
0.48
"The objective of this study was to evaluate non-crystalline cellulose (NCC) as a novel tablet excipient in solid oral dosage forms in comparison with microcrystalline cellulose (MCC) and silicified microcrystalline cellulose (Prosolv®, SMCC)."( Evaluation of non-crystalline cellulose as a novel excipient in solid dose products.
Babu, RJ; Lee, Y; Pawar, K; Rangari, V; Render, D, 2018
)
0.48
"Based on the data, it can be concluded that NCC can serve as a cheaper and better alternative to MCC as excipient in solid dosage forms."( Evaluation of non-crystalline cellulose as a novel excipient in solid dose products.
Babu, RJ; Lee, Y; Pawar, K; Rangari, V; Render, D, 2018
)
0.48
"For both candesartan and amlodipine, the 90% confidence intervals for the geometric mean ratios of area under the concentration-time curve from time zero to the time of dosing interval of 24 hours and maximum concentration after drug administration fell within the bioequivalence acceptance criteria."( No pharmacokinetic interactions between candesartan and amlodipine following multiple oral administrations in healthy subjects.
Huh, W; Kim, JR; Kim, S; Ko, JW, 2018
)
1.03
" It was confirmed that the degradation product was formed by the reaction of amlodipine with formaldehyde originating from the excipients present in the dosage form."( Identification and structure elucidation of a new degradation impurity in the multi-component tablets of amlodipine besylate.
Břicháč, J; Douša, M; Gibala, P; Kalášek, S; Kalužíková, A; Štefko, M; Tkadlecová, M, 2019
)
0.96
" Multiple blood and milk samples were obtained from the mothers over a 24 hours dosing interval."( Low Levels of Amlodipine in Breast Milk and Plasma.
Aoki, H; Ito, N; Ito, S; Kaniwa, N; Murashima, A; Nakajima, K; Okamoto, A; Sago, H; Saito, Y; Wada, Y, 2018
)
0.84
"Four new, simple, and reproducible spectrophotometric methods were developed and validated for the simultaneous determination of Amlodipine (AML) and Atorvastatin (AT) in bulk powder and pharmaceutical dosage form."( Determination of amlodipine and atorvastatin mixture by different spectrophotometric methods with or without regression equations.
Fares, NV; Farouk, M; Hemdan, A; Magdy, R, 2019
)
1.06
"Significant increases in BP control were observed with each dosage increment of perindopril/amlodipine, which was well tolerated, rising from 21% (3."( Efficacy and Safety of Incremental Dosing of a New Single-Pill Formulation of Perindopril and Amlodipine in the Management of Hypertension.
Dolan, E; Gupta, AK; O'Brien, E; Poulter, NR; Sever, PS; Whitehouse, A, 2019
)
0.95
" Edema resulting from chronic dosing may be explained by the aforementioned effects."( Amlodipine alters hemorheological parameters: Increased efficacy at the cost of edema?
Arunkumar, S; Lokhandwala, Y; Padgaonkar, K; Panicker, G; Puniyani, RR; Ravindra, RP; Sharma, R; Vadivelu, R,
)
1.57
" In the absence of AH, patients received scheme I -(Mertenil® at initial dosage of 10 mg/day)."( ANICHKOV study: the effect of combined hypotensive and lipid-lowering therapy on cardiovascular complications in patients of high and very high risk.
Ansheles, AA; Boytsov, SA; Drapkina, ОМ; Gornyakova, NB; Kuharchuk, VV; Sergienko, IV; Shepel, RN; Zubareva, MY, 2019
)
0.51
"5%) were adherent to the therapy (PDC ≥ 80%); among them, a small percentage required dosage modification."( Treatment with Free Triple Combination Therapy of Atorvastatin, Perindopril, Amlodipine in Hypertensive Patients: A Real-World Population Study in Italy.
Degli Esposti, L; Gambera, M; Nati, G; Perone, F; Perrone, V; Tagliabue, PF; Veronesi, C; Volpe, M, 2019
)
0.74
"5-mg, 5-mg, and 10-mg amlodipine besylate tablets do not provide the necessary flexibility in dosing needed for treating children."( Physicochemical Stability of Compounded Amlodipine Besylate Suspensions in PCCA Base, SuspendIt.
Bostanian, LA; Graves, RA; Mandal, TK; Morris, TC; Nguyen, AT; Pramar, YV; Swopes, D,
)
0.71
" The significance of using drug combination is that it can reduce drug dosage requirements, reduce the toxic effects of agents and prevent or delay the emergence of drug resistance."( In vitro interactions of ambroxol hydrochloride or amlodipine in combination with antibacterial agents against carbapenem-resistant Acinetobacter baumannii.
Li, X; Lu, C; Sun, S; Wang, D; Wang, Y, 2020
)
0.81
" A major barrier to entry of this technology is the lack of non-destructive quality control methods capable of verifying the dosage of multiple drugs in polyprintlets at the point of dispensing."( Non-destructive dose verification of two drugs within 3D printed polyprintlets.
Basit, AW; Gaisford, S; Goyanes, A; Rowland, M; Tan, HX; Trenfield, SJ; Wilsdon, D, 2020
)
0.56
" Drugs with long half-lives, following multi-compartment pharmacokinetics, and whose distribution-related characteristics are less likely to be assessed within one dosing interval are focused."( Contribution of Trough Concentration Data in the Evaluation of Multiple-Dose Pharmacokinetics for Drugs with Delayed Distributional Equilibrium and Long Half-Life.
Choi, S; Han, S; Jeon, S; Yim, DS, 2020
)
0.56
"In multiple-dose studies on drugs with delayed distributional equilibrium, information from a few trough samples can augment the limit of serial sampling within the dosing interval for parameter estimation."( Contribution of Trough Concentration Data in the Evaluation of Multiple-Dose Pharmacokinetics for Drugs with Delayed Distributional Equilibrium and Long Half-Life.
Choi, S; Han, S; Jeon, S; Yim, DS, 2020
)
0.56
" Once weekly oral dosing of nano-FDC of amlodipine, CNDT and hydrochlorothiazide provided adequate antihypertensive effect which was not statistically different from daily dosing of free drugs in dexamethasone-induced animal model."( Pharmacokinetic and pharmacodynamic evaluation of nano-fixed dose combination for hypertension.
Bhandari, RK; Bhatia, A; Kaur, N; Malhotra, S; Pandey, AK; Rather, IIG; Shafiq, N; Sharma, S, 2020
)
0.83
"Once weekly oral dosing of nano-FDC of amlodipine, CNDT and hydrochlorothiazide provided adequate antihypertensive effect and was not statistically different from daily dosing of free drugs in dexamethasone-induced animal model."( Pharmacokinetic and pharmacodynamic evaluation of nano-fixed dose combination for hypertension.
Bhandari, RK; Bhatia, A; Kaur, N; Malhotra, S; Pandey, AK; Rather, IIG; Shafiq, N; Sharma, S, 2020
)
0.83
" Insulin was infused for a total of approximately 37 hours, most of which was dosed at 10 U/kg/hour; following discontinuation, serial serum insulin levels were drawn and remained at supraphysiologic levels for at least 24 hours and well above reference range for multiple days thereafter."( Persistent Hyperinsulinemia Following High-Dose Insulin Therapy: A Case Report.
Bangh, SA; Cole, JB; Corcoran, JN; Jacoby, KJ; Olives, TD, 2020
)
0.56
" If BP is not at goal during 4 week's visit, dosage of antihypertensive agents will be doubled."( A comparative study for the effects of nifedipine GITS and amlodipine besylate administrated in daytime or at nighttime on recovery of blood pressure rhythm and arterial stiffness in the young and middle-aged subjects with non-dipper hypertension (NARRAS)
Liu, J, 2020
)
0.8
" The current work presents three newly developed UV spectrophotometric methods depending on minimal mathematical manipulations on the zero-order spectrum namely: absorption correction, induced dual-wavelength, and Fourier self deconvoluted method; for the simultaneous determination of celecoxib and ramipril in their pharmaceutical combined dosage forms with amlodipine."( Smart UV spectrophotometric methods based on simple mathematical filtration for the simultaneous determination of celecoxib and ramipril in their pharmaceutical mixtures with amlodipine: A comparative statistical study.
Attala, K; Elsonbaty, A, 2021
)
0.98
" The method was successfully used for quality control laboratories and the determination of these drugs combinations in pharmaceutical dosage forms."( Development and Validation of a UPLC-DAD Method for the Simultaneous Quantification of Eight Antihypertensive Drugs in the Pharmaceutical Matrix.
Abousalih, FZ; Azougagh, M; Benchekroun, YH; Bennani, I; Bouatia, M; El Karbane, M; Saffaj, T, 2021
)
0.62
" This study aimed at characterizing the magnitude of DDIs between amlodipine and ARV drugs in order to establish dosing recommendations."( Population pharmacokinetic modelling to quantify the magnitude of drug-drug interactions between amlodipine and antiretroviral drugs.
Alves Saldanha, S; Buclin, T; Cavassini, M; Courlet, P; Csajka, C; Decosterd, LA; Guidi, M; Marzolini, C; Stoeckle, M, 2021
)
1.08
" Clinicians should adjust amlodipine dosage accordingly, by halving the dosage in PLWH receiving ARV with inhibitory properties (mainly ritonavir-boosted darunavir), whereas they should double amlodipine doses when coadministering it with efavirenz, under appropriate monitoring of clinical response and tolerance."( Population pharmacokinetic modelling to quantify the magnitude of drug-drug interactions between amlodipine and antiretroviral drugs.
Alves Saldanha, S; Buclin, T; Cavassini, M; Courlet, P; Csajka, C; Decosterd, LA; Guidi, M; Marzolini, C; Stoeckle, M, 2021
)
1.14
" Blood samples were taken over the dosing intervals and drug concentrations quantified by high-performance liquid chromatography-mass spectrometry."( Mechanistic Considerations About an Unexpected Ramipril Drug-Drug Interaction in the Development of a Triple Fixed-Dose Combination Product Containing Ramipril, Amlodipine, and Atorvastatin.
Gundlach, K; Hermann, R; Seiler, D, 2021
)
0.82
"4 with the evening dosing (р<0."( Psychological Continuum of Elderly Patients Suffering from Arterial Hypertension with Metabolic Syndrome, Against the Background of Chronotherapy with a Fixed Combination of Amlodipine, Lisinopril and Rosuvastatin.
Agarkov, NM; Kolomiets, VI; Korneeva, SI; Markelova, AM; Markelova, EA; Moskalev, AA; Moskaleva, EO; Okhotnikov, OI, 2021
)
0.81
" This work presents novel and green spectrophotometric methods for the concurrent analysis of Amlodipine (AML), Telmisartan (TEL), Hydrochlorothiazide (HCTZ), and Chlorthalidone (CLO) in their pharmaceutical dosage form."( Advanced eco-friendly UV spectrophotometric approach for resolving overlapped spectral signals of antihypertensive agents in their binary and tertiary pharmaceutical dosage form.
Attala, K; Elsonbaty, A, 2021
)
0.84
" The former dosage of ACEis/ARBs was continued in one group while in another group, the ACEis/ARBs were replaced by amlodipine ± carvedilol according to the dose equivalents."( Effects of Renin-Angiotensin-Aldosterone Inhibitors on Early Outcomes of Hypertensive COVID-19 Patients: A Randomized Triple-Blind Clinical Trial.
Ashraf, H; Bahreini, M; Ghoghaei, M; Najmeddin, F; Rasooli, F; Salehi, M; Soleimani, A; Solhjoo, M, 2021
)
0.83
" Amlodipine is a long-acting dihydropyridine and inappropriate dosage poses a great threat for profound vasodilation, hypotension, and refractory vasopressor-resistant shock."( Refractory Shock from Amlodipine Overdose Overcomed with Hyperinsulinemia.
Kakava, K; Koliastasis, L; Lampadakis, I; Milkas, A; Papaioannou, S; Sourides, V; Strempelas, P; Tsioufis, P, 2022
)
1.95
"Pleural effusion resolved within 24 h of reducing the dosage of amlodipine."( Unusual case of pleural effusion caused by amlodipine in a dog with systemic hypertension.
An, JH; Chae, HK; Choi, M; Hwang, SY; Jang, HW; Kang, K; Oh, YI; Park, SM; Youn, HY, 2022
)
1.22
"5 hours before dosing to 168 hours after dosing."( Pharmacokinetics and Bioequivalence Evaluation of 2 Olmesartan Medoxomil and Amlodipine Besylate Fixed-Dose Combination Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions.
Chen, L; Li, X; Mo, E, 2022
)
0.95
"The future of dosage form design is expected to move towards the production of personalized dosage forms tailored to each patient."( Molding as Innovative Technology for Personalized Tablet Production.
Al-Shoubki, AA; Donia, AA; Hagag, Y; Ibrahim, B; Mady, OY,
)
0.13
" We also discuss several challenges encountered related to dosing and concentration of medications, which led to fluid overload."( Single-Pass Albumin Dialysis as Rescue Therapy for Pediatric Calcium Channel Blocker Overdose.
Berg, S; Essink, J; Montange, J; Salomon, J; Sankey, A; Taylor, V,
)
0.13
"Comparative study of different spectrophotometric approaches used for the simultaneous determination of perindopril, indapamide, and amlodipine in bulk powder and in dosage form Triplixam."( In Vitro Dissolution Profile of Antihypertensive Mixture: Comparison Between Multivariate Methods and Statistical and Graphical Representation of Different Univariate Spectrophotometric Data.
Fares, NV; Farouk, M; Hemdan, A; Magdy, R, 2023
)
1.11
"The methods were applied for the analysis of the mixture in the pharmaceutical dosage form Triplixam and in vitro release at intestinal pH (7."( In Vitro Dissolution Profile of Antihypertensive Mixture: Comparison Between Multivariate Methods and Statistical and Graphical Representation of Different Univariate Spectrophotometric Data.
Fares, NV; Farouk, M; Hemdan, A; Magdy, R, 2023
)
0.91
"Pedal oedema is a well-known adverse effect of amlodipine, but significantly less frequent if only half of the maximum recommended dosage is used."(
Christensen, B; Helgestad, OK; Henriksen, JN; Oxlund, CS; Skovbjerg, BK, 2023
)
1.17
" Along with gingival and plaque index, medication dosage and duration were also assessed."( Prevalence and Severity of Amlodipine-induced Gingival Enlargement.
Dahal, S; Ghimire, P; Rajkarnikar, J; Vaidya, S, 2023
)
1.21
"Fixed-dose combinations for treatment of hypertension are observed in many dosages in the global market because of their high efficacy compared to single component dosage forms."( Derivatization-free conventional and synchronous spectrofluorimetric estimation of atenolol and amlodipine.
Abd El-Aziz, H; Zeid, AM, 2024
)
1.66
" During follow-up, the OA dosage is adjusted according to the ABPM and OBPM results."( The effects of Olmesartan/amlodipine administered in the Morning or At Night on nocturnal blood pressure reduction in Chinese patients with mild-moderate essential hypertension (OMAN Trial): study protocol for a prospective, multicenter, randomized, open-
Chen, X; Jia, S; Li, X; Liao, H; Liu, K; Liu, X; Meng, Q; Shi, R; Sun, L; Wang, S; Wang, Z; Xu, M; Ye, R; Zhang, X; Zhang, Z, 2023
)
1.21
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (3)

RoleDescription
antihypertensive agentAny drug used in the treatment of acute or chronic vascular hypertension regardless of pharmacological mechanism.
calcium channel blockerOne of a class of drugs that acts by selective inhibition of calcium influx through cell membranes or on the release and binding of calcium in intracellular pools.
vasodilator agentA drug used to cause dilation of the blood vessels.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (5)

ClassDescription
dihydropyridine
monochlorobenzenesAny member of the class of chlorobenzenes containing a mono- or poly-substituted benzene ring in which only one substituent is chlorine.
ethyl esterAny carboxylic ester resulting from the formal condensation of the carboxy group of a carboxylic acid with ethanol.
methyl esterAny carboxylic ester resulting from the formal condensation of a carboxy group with methanol.
primary amino compoundA compound formally derived from ammonia by replacing one hydrogen atom by an organyl group.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (1)

PathwayProteinsCompounds
Amlodipine Action Pathway478

Protein Targets (39)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, Ferritin light chainEquus caballus (horse)Potency50.11875.623417.292931.6228AID485281
acid sphingomyelinaseHomo sapiens (human)Potency31.622814.125424.061339.8107AID504937
TDP1 proteinHomo sapiens (human)Potency19.73470.000811.382244.6684AID686978; AID686979
Smad3Homo sapiens (human)Potency35.48130.00527.809829.0929AID588855
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency0.08490.01237.983543.2770AID1645841
GVesicular stomatitis virusPotency2.68370.01238.964839.8107AID1645842
cytochrome P450 2D6Homo sapiens (human)Potency16.93300.00108.379861.1304AID1645840
IDH1Homo sapiens (human)Potency29.09290.005210.865235.4813AID686970
chromobox protein homolog 1Homo sapiens (human)Potency89.12510.006026.168889.1251AID540317
nuclear receptor ROR-gamma isoform 1Mus musculus (house mouse)Potency12.58930.00798.23321,122.0200AID2551
gemininHomo sapiens (human)Potency21.04410.004611.374133.4983AID624296; AID624297
histone acetyltransferase KAT2A isoform 1Homo sapiens (human)Potency39.81070.251215.843239.8107AID504327
Interferon betaHomo sapiens (human)Potency2.68370.00339.158239.8107AID1645842
HLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)Potency2.68370.01238.964839.8107AID1645842
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusPotency6.30960.009610.525035.4813AID1479145
Inositol hexakisphosphate kinase 1Homo sapiens (human)Potency2.68370.01238.964839.8107AID1645842
cytochrome P450 2C9, partialHomo sapiens (human)Potency2.68370.01238.964839.8107AID1645842
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Voltage-dependent L-type calcium channel subunit alpha-1CCavia porcellus (domestic guinea pig)IC50 (µMol)1.20000.02201.64228.9000AID1207608
Potassium channel subfamily K member 2Homo sapiens (human)IC50 (µMol)0.40000.40003.92279.0000AID726094
Bile salt export pumpHomo sapiens (human)IC50 (µMol)74.50000.11007.190310.0000AID1449628; AID1473738
ATP-dependent translocase ABCB1Homo sapiens (human)IC50 (µMol)22.00000.00022.318510.0000AID678836
Alpha-2A adrenergic receptorHomo sapiens (human)IC50 (µMol)0.60200.00001.44217.3470AID625201
Alpha-2A adrenergic receptorHomo sapiens (human)Ki0.22600.00010.807410.0000AID625201
Alpha-2C adrenergic receptorHomo sapiens (human)IC50 (µMol)1.80000.00001.47257.8980AID625203
Alpha-2C adrenergic receptorHomo sapiens (human)Ki0.26100.00030.483410.0000AID625203
Alpha-2B adrenergic receptorRattus norvegicus (Norway rat)Ki5.37000.00000.929610.0000AID35892
Voltage-dependent L-type calcium channel subunit alpha-1CRattus norvegicus (Norway rat)Ki0.00200.00080.57965.4000AID42528
Alpha-2C adrenergic receptorRattus norvegicus (Norway rat)Ki5.37000.00000.970810.0000AID35892
Alpha-2A adrenergic receptorRattus norvegicus (Norway rat)Ki5.37000.00000.937510.0000AID35892
Alpha-1D adrenergic receptorHomo sapiens (human)Ki5.37000.00000.360910.0000AID35892
Alpha-1A adrenergic receptorHomo sapiens (human)Ki2.34400.00000.272610.0000AID35755
Alpha-1B adrenergic receptorHomo sapiens (human)Ki7.94300.00000.471310.0000AID35883
5-hydroxytryptamine receptor 6Homo sapiens (human)IC50 (µMol)2.89800.00170.83815.4200AID625221
5-hydroxytryptamine receptor 6Homo sapiens (human)Ki1.34600.00020.522910.0000AID625221
Sodium-dependent dopamine transporter Homo sapiens (human)IC50 (µMol)5.52100.00071.841946.0000AID625256
Sodium-dependent dopamine transporter Homo sapiens (human)Ki4.38700.00021.11158.0280AID625256
Voltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)IC50 (µMol)2.70000.00032.25459.6000AID1207607; AID1207608
Potassium channel subfamily K member 2 Bos taurus (cattle)IC50 (µMol)0.43000.43002.57608.2000AID1307729
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Potassium channel subfamily K member 2Homo sapiens (human)EC50 (µMol)0.43000.18702.72248.1800AID1802150
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (230)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cardiac ventricle developmentPotassium channel subfamily K member 2Homo sapiens (human)
G protein-coupled receptor signaling pathwayPotassium channel subfamily K member 2Homo sapiens (human)
memoryPotassium channel subfamily K member 2Homo sapiens (human)
response to mechanical stimulusPotassium channel subfamily K member 2Homo sapiens (human)
response to axon injuryPotassium channel subfamily K member 2Homo sapiens (human)
negative regulation of cardiac muscle cell proliferationPotassium channel subfamily K member 2Homo sapiens (human)
cellular response to hypoxiaPotassium channel subfamily K member 2Homo sapiens (human)
potassium ion transmembrane transportPotassium channel subfamily K member 2Homo sapiens (human)
cochlea developmentPotassium channel subfamily K member 2Homo sapiens (human)
positive regulation of cellular response to hypoxiaPotassium channel subfamily K member 2Homo sapiens (human)
negative regulation of DNA biosynthetic processPotassium channel subfamily K member 2Homo sapiens (human)
stabilization of membrane potentialPotassium channel subfamily K member 2Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell activation involved in immune responseInterferon betaHomo sapiens (human)
cell surface receptor signaling pathwayInterferon betaHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to virusInterferon betaHomo sapiens (human)
positive regulation of autophagyInterferon betaHomo sapiens (human)
cytokine-mediated signaling pathwayInterferon betaHomo sapiens (human)
natural killer cell activationInterferon betaHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT proteinInterferon betaHomo sapiens (human)
cellular response to interferon-betaInterferon betaHomo sapiens (human)
B cell proliferationInterferon betaHomo sapiens (human)
negative regulation of viral genome replicationInterferon betaHomo sapiens (human)
innate immune responseInterferon betaHomo sapiens (human)
positive regulation of innate immune responseInterferon betaHomo sapiens (human)
regulation of MHC class I biosynthetic processInterferon betaHomo sapiens (human)
negative regulation of T cell differentiationInterferon betaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIInterferon betaHomo sapiens (human)
defense response to virusInterferon betaHomo sapiens (human)
type I interferon-mediated signaling pathwayInterferon betaHomo sapiens (human)
neuron cellular homeostasisInterferon betaHomo sapiens (human)
cellular response to exogenous dsRNAInterferon betaHomo sapiens (human)
cellular response to virusInterferon betaHomo sapiens (human)
negative regulation of Lewy body formationInterferon betaHomo sapiens (human)
negative regulation of T-helper 2 cell cytokine productionInterferon betaHomo sapiens (human)
positive regulation of apoptotic signaling pathwayInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell differentiationInterferon betaHomo sapiens (human)
natural killer cell activation involved in immune responseInterferon betaHomo sapiens (human)
adaptive immune responseInterferon betaHomo sapiens (human)
T cell activation involved in immune responseInterferon betaHomo sapiens (human)
humoral immune responseInterferon betaHomo sapiens (human)
positive regulation of T cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
adaptive immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class I via ER pathway, TAP-independentHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of T cell anergyHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
defense responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
detection of bacteriumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-12 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-6 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protection from natural killer cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
innate immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of dendritic cell differentiationHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class IbHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
G2/M transition of mitotic cell cycleATP-dependent translocase ABCB1Homo sapiens (human)
xenobiotic metabolic processATP-dependent translocase ABCB1Homo sapiens (human)
response to xenobiotic stimulusATP-dependent translocase ABCB1Homo sapiens (human)
phospholipid translocationATP-dependent translocase ABCB1Homo sapiens (human)
terpenoid transportATP-dependent translocase ABCB1Homo sapiens (human)
regulation of response to osmotic stressATP-dependent translocase ABCB1Homo sapiens (human)
transmembrane transportATP-dependent translocase ABCB1Homo sapiens (human)
transepithelial transportATP-dependent translocase ABCB1Homo sapiens (human)
stem cell proliferationATP-dependent translocase ABCB1Homo sapiens (human)
ceramide translocationATP-dependent translocase ABCB1Homo sapiens (human)
export across plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
transport across blood-brain barrierATP-dependent translocase ABCB1Homo sapiens (human)
positive regulation of anion channel activityATP-dependent translocase ABCB1Homo sapiens (human)
carboxylic acid transmembrane transportATP-dependent translocase ABCB1Homo sapiens (human)
xenobiotic detoxification by transmembrane export across the plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
xenobiotic transport across blood-brain barrierATP-dependent translocase ABCB1Homo sapiens (human)
regulation of chloride transportATP-dependent translocase ABCB1Homo sapiens (human)
positive regulation of cytokine productionAlpha-2A adrenergic receptorHomo sapiens (human)
DNA replicationAlpha-2A adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
Ras protein signal transductionAlpha-2A adrenergic receptorHomo sapiens (human)
Rho protein signal transductionAlpha-2A adrenergic receptorHomo sapiens (human)
female pregnancyAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of cell population proliferationAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of norepinephrine secretionAlpha-2A adrenergic receptorHomo sapiens (human)
regulation of vasoconstrictionAlpha-2A adrenergic receptorHomo sapiens (human)
actin cytoskeleton organizationAlpha-2A adrenergic receptorHomo sapiens (human)
platelet activationAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of cell migrationAlpha-2A adrenergic receptorHomo sapiens (human)
activation of protein kinase activityAlpha-2A adrenergic receptorHomo sapiens (human)
activation of protein kinase B activityAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of epinephrine secretionAlpha-2A adrenergic receptorHomo sapiens (human)
cellular response to hormone stimulusAlpha-2A adrenergic receptorHomo sapiens (human)
receptor transactivationAlpha-2A adrenergic receptorHomo sapiens (human)
vasodilationAlpha-2A adrenergic receptorHomo sapiens (human)
glucose homeostasisAlpha-2A adrenergic receptorHomo sapiens (human)
fear responseAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of potassium ion transportAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of MAP kinase activityAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of epidermal growth factor receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of calcium ion-dependent exocytosisAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of insulin secretionAlpha-2A adrenergic receptorHomo sapiens (human)
intestinal absorptionAlpha-2A adrenergic receptorHomo sapiens (human)
thermoceptionAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of lipid catabolic processAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of membrane protein ectodomain proteolysisAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of calcium ion transportAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of insulin secretion involved in cellular response to glucose stimulusAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of uterine smooth muscle contractionAlpha-2A adrenergic receptorHomo sapiens (human)
adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-inhibiting adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
phospholipase C-activating adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of wound healingAlpha-2A adrenergic receptorHomo sapiens (human)
presynaptic modulation of chemical synaptic transmissionAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of calcium ion transmembrane transporter activityAlpha-2A adrenergic receptorHomo sapiens (human)
regulation of smooth muscle contractionAlpha-2C adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of norepinephrine secretionAlpha-2C adrenergic receptorHomo sapiens (human)
regulation of vasoconstrictionAlpha-2C adrenergic receptorHomo sapiens (human)
platelet activationAlpha-2C adrenergic receptorHomo sapiens (human)
activation of protein kinase B activityAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of epinephrine secretionAlpha-2C adrenergic receptorHomo sapiens (human)
receptor transactivationAlpha-2C adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-2C adrenergic receptorHomo sapiens (human)
positive regulation of neuron differentiationAlpha-2C adrenergic receptorHomo sapiens (human)
adrenergic receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of insulin secretionAlpha-2C adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-1D adrenergic receptorHomo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayAlpha-1D adrenergic receptorHomo sapiens (human)
positive regulation of cell population proliferationAlpha-1D adrenergic receptorHomo sapiens (human)
neuron-glial cell signalingAlpha-1D adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-1D adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-1D adrenergic receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayAlpha-1D adrenergic receptorHomo sapiens (human)
positive regulation of cytosolic calcium ion concentrationAlpha-1D adrenergic receptorHomo sapiens (human)
positive regulation of vasoconstrictionAlpha-1D adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-1D adrenergic receptorHomo sapiens (human)
MAPK cascadeAlpha-1A adrenergic receptorHomo sapiens (human)
negative regulation of heart rate involved in baroreceptor response to increased systemic arterial blood pressureAlpha-1A adrenergic receptorHomo sapiens (human)
norepinephrine-epinephrine vasoconstriction involved in regulation of systemic arterial blood pressureAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of heart rate by epinephrine-norepinephrineAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of the force of heart contraction by epinephrine-norepinephrineAlpha-1A adrenergic receptorHomo sapiens (human)
apoptotic processAlpha-1A adrenergic receptorHomo sapiens (human)
smooth muscle contractionAlpha-1A adrenergic receptorHomo sapiens (human)
signal transductionAlpha-1A adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-1A adrenergic receptorHomo sapiens (human)
activation of phospholipase C activityAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of cytosolic calcium ion concentrationAlpha-1A adrenergic receptorHomo sapiens (human)
adult heart developmentAlpha-1A adrenergic receptorHomo sapiens (human)
negative regulation of cell population proliferationAlpha-1A adrenergic receptorHomo sapiens (human)
response to xenobiotic stimulusAlpha-1A adrenergic receptorHomo sapiens (human)
response to hormoneAlpha-1A adrenergic receptorHomo sapiens (human)
negative regulation of autophagyAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of cardiac muscle hypertrophyAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of synaptic transmission, GABAergicAlpha-1A adrenergic receptorHomo sapiens (human)
intracellular signal transductionAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of action potentialAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of vasoconstrictionAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of smooth muscle contractionAlpha-1A adrenergic receptorHomo sapiens (human)
calcium ion transport into cytosolAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of cardiac muscle contractionAlpha-1A adrenergic receptorHomo sapiens (human)
cell growth involved in cardiac muscle cell developmentAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of protein kinase C signalingAlpha-1A adrenergic receptorHomo sapiens (human)
pilomotor reflexAlpha-1A adrenergic receptorHomo sapiens (human)
neuron-glial cell signalingAlpha-1A adrenergic receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayAlpha-1A adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-1A adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-1A adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-1B adrenergic receptorHomo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayAlpha-1B adrenergic receptorHomo sapiens (human)
regulation of vasoconstrictionAlpha-1B adrenergic receptorHomo sapiens (human)
intracellular signal transductionAlpha-1B adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-1B adrenergic receptorHomo sapiens (human)
regulation of cardiac muscle contractionAlpha-1B adrenergic receptorHomo sapiens (human)
neuron-glial cell signalingAlpha-1B adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-1B adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-1B adrenergic receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayAlpha-1B adrenergic receptorHomo sapiens (human)
positive regulation of cytosolic calcium ion concentrationAlpha-1B adrenergic receptorHomo sapiens (human)
cerebral cortex cell migration5-hydroxytryptamine receptor 6Homo sapiens (human)
positive regulation of TOR signaling5-hydroxytryptamine receptor 6Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 6Homo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 6Homo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 6Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 6Homo sapiens (human)
monoamine transportSodium-dependent dopamine transporter Homo sapiens (human)
neurotransmitter transportSodium-dependent dopamine transporter Homo sapiens (human)
lactationSodium-dependent dopamine transporter Homo sapiens (human)
sensory perception of smellSodium-dependent dopamine transporter Homo sapiens (human)
locomotory behaviorSodium-dependent dopamine transporter Homo sapiens (human)
response to xenobiotic stimulusSodium-dependent dopamine transporter Homo sapiens (human)
response to iron ionSodium-dependent dopamine transporter Homo sapiens (human)
dopamine transportSodium-dependent dopamine transporter Homo sapiens (human)
adenohypophysis developmentSodium-dependent dopamine transporter Homo sapiens (human)
response to nicotineSodium-dependent dopamine transporter Homo sapiens (human)
positive regulation of multicellular organism growthSodium-dependent dopamine transporter Homo sapiens (human)
regulation of dopamine metabolic processSodium-dependent dopamine transporter Homo sapiens (human)
response to cocaineSodium-dependent dopamine transporter Homo sapiens (human)
dopamine biosynthetic processSodium-dependent dopamine transporter Homo sapiens (human)
dopamine catabolic processSodium-dependent dopamine transporter Homo sapiens (human)
response to ethanolSodium-dependent dopamine transporter Homo sapiens (human)
cognitionSodium-dependent dopamine transporter Homo sapiens (human)
dopamine uptake involved in synaptic transmissionSodium-dependent dopamine transporter Homo sapiens (human)
response to cAMPSodium-dependent dopamine transporter Homo sapiens (human)
norepinephrine uptakeSodium-dependent dopamine transporter Homo sapiens (human)
prepulse inhibitionSodium-dependent dopamine transporter Homo sapiens (human)
dopamine uptakeSodium-dependent dopamine transporter Homo sapiens (human)
hyaloid vascular plexus regressionSodium-dependent dopamine transporter Homo sapiens (human)
amino acid transportSodium-dependent dopamine transporter Homo sapiens (human)
norepinephrine transportSodium-dependent dopamine transporter Homo sapiens (human)
sodium ion transmembrane transportSodium-dependent dopamine transporter Homo sapiens (human)
immune system developmentVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
positive regulation of cytosolic calcium ion concentrationVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
heart developmentVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
regulation of cardiac muscle contraction by regulation of the release of sequestered calcium ionVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
embryonic forelimb morphogenesisVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
camera-type eye developmentVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
positive regulation of adenylate cyclase activityVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
positive regulation of muscle contractionVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
calcium ion transport into cytosolVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
cardiac conductionVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
calcium ion transmembrane transport via high voltage-gated calcium channelVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
calcium ion transmembrane transportVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
cardiac muscle cell action potential involved in contractionVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
membrane depolarization during cardiac muscle cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
membrane depolarization during AV node cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
cell communication by electrical coupling involved in cardiac conductionVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
regulation of heart rate by cardiac conductionVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
regulation of ventricular cardiac muscle cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
membrane depolarization during atrial cardiac muscle cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
calcium ion import across plasma membraneVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
inositol phosphate metabolic processInositol hexakisphosphate kinase 1Homo sapiens (human)
phosphatidylinositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
negative regulation of cold-induced thermogenesisInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (83)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
outward rectifier potassium channel activityPotassium channel subfamily K member 2Homo sapiens (human)
potassium ion leak channel activityPotassium channel subfamily K member 2Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
cytokine activityInterferon betaHomo sapiens (human)
cytokine receptor bindingInterferon betaHomo sapiens (human)
type I interferon receptor bindingInterferon betaHomo sapiens (human)
protein bindingInterferon betaHomo sapiens (human)
chloramphenicol O-acetyltransferase activityInterferon betaHomo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
signaling receptor bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
peptide antigen bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein-folding chaperone bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein bindingATP-dependent translocase ABCB1Homo sapiens (human)
ATP bindingATP-dependent translocase ABCB1Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
efflux transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
ATP hydrolysis activityATP-dependent translocase ABCB1Homo sapiens (human)
transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
ubiquitin protein ligase bindingATP-dependent translocase ABCB1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
carboxylic acid transmembrane transporter activityATP-dependent translocase ABCB1Homo sapiens (human)
phosphatidylcholine floppase activityATP-dependent translocase ABCB1Homo sapiens (human)
phosphatidylethanolamine flippase activityATP-dependent translocase ABCB1Homo sapiens (human)
ceramide floppase activityATP-dependent translocase ABCB1Homo sapiens (human)
floppase activityATP-dependent translocase ABCB1Homo sapiens (human)
alpha2-adrenergic receptor activityAlpha-2A adrenergic receptorHomo sapiens (human)
protein bindingAlpha-2A adrenergic receptorHomo sapiens (human)
protein kinase bindingAlpha-2A adrenergic receptorHomo sapiens (human)
alpha-1B adrenergic receptor bindingAlpha-2A adrenergic receptorHomo sapiens (human)
alpha-2C adrenergic receptor bindingAlpha-2A adrenergic receptorHomo sapiens (human)
thioesterase bindingAlpha-2A adrenergic receptorHomo sapiens (human)
heterotrimeric G-protein bindingAlpha-2A adrenergic receptorHomo sapiens (human)
protein homodimerization activityAlpha-2A adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-2A adrenergic receptorHomo sapiens (human)
epinephrine bindingAlpha-2A adrenergic receptorHomo sapiens (human)
norepinephrine bindingAlpha-2A adrenergic receptorHomo sapiens (human)
guanyl-nucleotide exchange factor activityAlpha-2A adrenergic receptorHomo sapiens (human)
alpha2-adrenergic receptor activityAlpha-2C adrenergic receptorHomo sapiens (human)
protein bindingAlpha-2C adrenergic receptorHomo sapiens (human)
alpha-2A adrenergic receptor bindingAlpha-2C adrenergic receptorHomo sapiens (human)
protein homodimerization activityAlpha-2C adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-2C adrenergic receptorHomo sapiens (human)
epinephrine bindingAlpha-2C adrenergic receptorHomo sapiens (human)
guanyl-nucleotide exchange factor activityAlpha-2C adrenergic receptorHomo sapiens (human)
protein bindingAlpha-1D adrenergic receptorHomo sapiens (human)
identical protein bindingAlpha-1D adrenergic receptorHomo sapiens (human)
alpha1-adrenergic receptor activityAlpha-1D adrenergic receptorHomo sapiens (human)
alpha1-adrenergic receptor activityAlpha-1A adrenergic receptorHomo sapiens (human)
protein bindingAlpha-1A adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-1A adrenergic receptorHomo sapiens (human)
protein bindingAlpha-1B adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-1B adrenergic receptorHomo sapiens (human)
alpha1-adrenergic receptor activityAlpha-1B adrenergic receptorHomo sapiens (human)
histamine receptor activity5-hydroxytryptamine receptor 6Homo sapiens (human)
protein binding5-hydroxytryptamine receptor 6Homo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 6Homo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 6Homo sapiens (human)
protease bindingSodium-dependent dopamine transporter Homo sapiens (human)
signaling receptor bindingSodium-dependent dopamine transporter Homo sapiens (human)
neurotransmitter transmembrane transporter activitySodium-dependent dopamine transporter Homo sapiens (human)
dopamine:sodium symporter activitySodium-dependent dopamine transporter Homo sapiens (human)
protein bindingSodium-dependent dopamine transporter Homo sapiens (human)
monoamine transmembrane transporter activitySodium-dependent dopamine transporter Homo sapiens (human)
dopamine bindingSodium-dependent dopamine transporter Homo sapiens (human)
amine bindingSodium-dependent dopamine transporter Homo sapiens (human)
protein-containing complex bindingSodium-dependent dopamine transporter Homo sapiens (human)
metal ion bindingSodium-dependent dopamine transporter Homo sapiens (human)
protein phosphatase 2A bindingSodium-dependent dopamine transporter Homo sapiens (human)
heterocyclic compound bindingSodium-dependent dopamine transporter Homo sapiens (human)
norepinephrine:sodium symporter activitySodium-dependent dopamine transporter Homo sapiens (human)
high voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
voltage-gated calcium channel activity involved in cardiac muscle cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
protein bindingVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
calmodulin bindingVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
high voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
metal ion bindingVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
alpha-actinin bindingVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
voltage-gated calcium channel activity involved in cardiac muscle cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
voltage-gated calcium channel activity involved in AV node cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
inositol-1,3,4,5,6-pentakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol heptakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
protein bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
ATP bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 1-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 3-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol 5-diphosphate pentakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol diphosphate tetrakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (63)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
endoplasmic reticulum membranePotassium channel subfamily K member 2Homo sapiens (human)
plasma membranePotassium channel subfamily K member 2Homo sapiens (human)
cell surfacePotassium channel subfamily K member 2Homo sapiens (human)
apical plasma membranePotassium channel subfamily K member 2Homo sapiens (human)
neuronal cell bodyPotassium channel subfamily K member 2Homo sapiens (human)
calyx of HeldPotassium channel subfamily K member 2Homo sapiens (human)
astrocyte projectionPotassium channel subfamily K member 2Homo sapiens (human)
voltage-gated potassium channel complexPotassium channel subfamily K member 2Homo sapiens (human)
plasma membranePotassium channel subfamily K member 2Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
extracellular spaceInterferon betaHomo sapiens (human)
extracellular regionInterferon betaHomo sapiens (human)
Golgi membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
endoplasmic reticulumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
Golgi apparatusHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
cell surfaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
ER to Golgi transport vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
secretory granule membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
phagocytic vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
early endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
recycling endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular exosomeHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
lumenal side of endoplasmic reticulum membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
MHC class I protein complexHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular spaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
external side of plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
cytoplasmATP-dependent translocase ABCB1Homo sapiens (human)
plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
cell surfaceATP-dependent translocase ABCB1Homo sapiens (human)
membraneATP-dependent translocase ABCB1Homo sapiens (human)
apical plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
extracellular exosomeATP-dependent translocase ABCB1Homo sapiens (human)
external side of apical plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
plasma membraneATP-dependent translocase ABCB1Homo sapiens (human)
cytoplasmAlpha-2A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2A adrenergic receptorHomo sapiens (human)
basolateral plasma membraneAlpha-2A adrenergic receptorHomo sapiens (human)
neuronal cell bodyAlpha-2A adrenergic receptorHomo sapiens (human)
axon terminusAlpha-2A adrenergic receptorHomo sapiens (human)
presynaptic active zone membraneAlpha-2A adrenergic receptorHomo sapiens (human)
dopaminergic synapseAlpha-2A adrenergic receptorHomo sapiens (human)
postsynaptic density membraneAlpha-2A adrenergic receptorHomo sapiens (human)
glutamatergic synapseAlpha-2A adrenergic receptorHomo sapiens (human)
GABA-ergic synapseAlpha-2A adrenergic receptorHomo sapiens (human)
receptor complexAlpha-2A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2A adrenergic receptorHomo sapiens (human)
cytoplasmAlpha-2C adrenergic receptorHomo sapiens (human)
endosomeAlpha-2C adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2C adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2C adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-1D adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-1D adrenergic receptorHomo sapiens (human)
nucleusAlpha-1A adrenergic receptorHomo sapiens (human)
nucleoplasmAlpha-1A adrenergic receptorHomo sapiens (human)
cytoplasmAlpha-1A adrenergic receptorHomo sapiens (human)
cytosolAlpha-1A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-1A adrenergic receptorHomo sapiens (human)
caveolaAlpha-1A adrenergic receptorHomo sapiens (human)
nuclear membraneAlpha-1A adrenergic receptorHomo sapiens (human)
intracellular membrane-bounded organelleAlpha-1A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-1A adrenergic receptorHomo sapiens (human)
nucleusAlpha-1B adrenergic receptorHomo sapiens (human)
cytoplasmAlpha-1B adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-1B adrenergic receptorHomo sapiens (human)
caveolaAlpha-1B adrenergic receptorHomo sapiens (human)
nuclear membraneAlpha-1B adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-1B adrenergic receptorHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 6Homo sapiens (human)
cilium5-hydroxytryptamine receptor 6Homo sapiens (human)
synapse5-hydroxytryptamine receptor 6Homo sapiens (human)
dendrite5-hydroxytryptamine receptor 6Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 6Homo sapiens (human)
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
cytoplasmSodium-dependent dopamine transporter Homo sapiens (human)
plasma membraneSodium-dependent dopamine transporter Homo sapiens (human)
cell surfaceSodium-dependent dopamine transporter Homo sapiens (human)
membraneSodium-dependent dopamine transporter Homo sapiens (human)
axonSodium-dependent dopamine transporter Homo sapiens (human)
neuron projectionSodium-dependent dopamine transporter Homo sapiens (human)
neuronal cell bodySodium-dependent dopamine transporter Homo sapiens (human)
axon terminusSodium-dependent dopamine transporter Homo sapiens (human)
membrane raftSodium-dependent dopamine transporter Homo sapiens (human)
postsynaptic membraneSodium-dependent dopamine transporter Homo sapiens (human)
dopaminergic synapseSodium-dependent dopamine transporter Homo sapiens (human)
flotillin complexSodium-dependent dopamine transporter Homo sapiens (human)
axonSodium-dependent dopamine transporter Homo sapiens (human)
presynaptic membraneSodium-dependent dopamine transporter Homo sapiens (human)
plasma membraneSodium-dependent dopamine transporter Homo sapiens (human)
neuronal cell body membraneSodium-dependent dopamine transporter Homo sapiens (human)
cytoplasmVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
plasma membraneVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
postsynaptic densityVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
membraneVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
Z discVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
dendriteVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
perikaryonVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
postsynaptic density membraneVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
L-type voltage-gated calcium channel complexVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
voltage-gated calcium channel complexVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
fibrillar centerInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
cytosolInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleusInositol hexakisphosphate kinase 1Homo sapiens (human)
cytoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (230)

Assay IDTitleYearJournalArticle
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID224235In vivo evaluation for the antihypertensive effect in the spontaneously hypertensive rat is % decrease in blood pressure during post drug administration at 15 uM/kg peroral; 34/201992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Dihydropyrimidine calcium channel blockers. 4. Basic 3-substituted-4-aryl-1,4-dihydropyrimidine-5-carboxylic acid esters. Potent antihypertensive agents.
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID444052Hepatic clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID197523Evaluated for the negative logarithm of the molar concentration required to block [Ca2+] induced contraction of K+ depolarized rat aorta by 50%.1991Journal of medicinal chemistry, Jan, Volume: 34, Issue:1
Long-acting dihydropyridine calcium antagonists. 6. Structure-activity relationships around 4-(2,3-dichlorophenyl)-3-(ethoxycarbonyl)-2-[(2-hydroxyethoxy)methyl]-5 -(methoxycarbonyl)-6-methyl-1,4-dihydropyridine.
AID60643Percent decrease in coronary vascular resistance in dogs after intravenous dosage of 450 ug/kg compound1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Long-acting dihydropyridine calcium antagonists. 1. 2-Alkoxymethyl derivatives incorporating basic substituents.
AID467611Dissociation constant, pKa of the compound2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID427818Toxicity in BALB/c mouse assessed as heart function at 10 mg/kg, po2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Oral Therapy with Amlodipine and Lacidipine, 1,4-Dihydropyridine Derivatives Showing Activity against Experimental Visceral Leishmaniasis.
AID42528Binding affinity against rat L-type calcium channel1999Bioorganic & medicinal chemistry letters, Oct-04, Volume: 9, Issue:19
Design and synthesis of novel dihydropyridine alpha-1a antagonists.
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID496825Antimicrobial activity against Leishmania mexicana2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496824Antimicrobial activity against Toxoplasma gondii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1217717Time dependent inhibition of CYP2C9 (unknown origin) at 30 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID23635Plasma half-life in dogs after intravenous administration1990Journal of medicinal chemistry, Feb, Volume: 33, Issue:2
Long-acting dihydropyridine calcium antagonists. 4. Synthesis and structure-activity relationships for a series of basic and nonbasic derivatives of 2-[(2-aminoethoxy)methyl]-1,4-dihydropyridine calcium antagonists.
AID537133Antileishmanial activity against promastigotes of Leishmania major MHOM/1L/80/Fredlin after 18 hrs by MTT assay2010Bioorganic & medicinal chemistry, Nov-15, Volume: 18, Issue:22
Anti-leishmanial and anti-trypanosomal activities of 1,4-dihydropyridines: In vitro evaluation and structure-activity relationship study.
AID444051Total clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID73832Negative inotropy measured as the concentration required to depress contraction in the isolated Langendorff-perfused guinea pig heart by 25%1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Long-acting dihydropyridine calcium antagonists. 1. 2-Alkoxymethyl derivatives incorporating basic substituents.
AID427808Antileishmanial activity against Leishmania donovani MHOH/IN/1983/AD83 amastigotes infected in BALB/c mouse peritoneal macrophage at 3 ug/mL treated 6 hrs after infection measured after 48 hrs using Giemsa staining relative to control2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Oral Therapy with Amlodipine and Lacidipine, 1,4-Dihydropyridine Derivatives Showing Activity against Experimental Visceral Leishmaniasis.
AID409956Inhibition of mouse brain MAOB2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID1217729Intrinsic clearance for reactive metabolites formation assessed as summation of [3H]GSH adduct formation rate-based reactive metabolites formation and cytochrome P450 (unknown origin) inactivation rate-based reactive metabolites formation2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID22995Volume of distribution in dogs after intravenous administration1990Journal of medicinal chemistry, Feb, Volume: 33, Issue:2
Long-acting dihydropyridine calcium antagonists. 4. Synthesis and structure-activity relationships for a series of basic and nonbasic derivatives of 2-[(2-aminoethoxy)methyl]-1,4-dihydropyridine calcium antagonists.
AID427806Antileishmanial activity against Leishmania donovani MHOH/IN/1983/AD83 promastigotes assessed as growth inhibition after 3 days by MTT assay2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Oral Therapy with Amlodipine and Lacidipine, 1,4-Dihydropyridine Derivatives Showing Activity against Experimental Visceral Leishmaniasis.
AID678713Inhibition of human CYP2C9 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-methoxy-4-trifluoromethylcoumarin-3-acetic acid as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID496826Antimicrobial activity against Entamoeba histolytica2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1207608Inhibition of L-type calcium channel measured using 2-electrode voltage-clamp in Xenopus oocyte heterologically expressing alpha-1C subunit2012Journal of applied toxicology : JAT, Oct, Volume: 32, Issue:10
Predictive model for L-type channel inhibition: multichannel block in QT prolongation risk assessment.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID678836TP_TRANSPORTER: inhibition of Daunorubicin transepithelial transport (basal to apical) (Daunorubicin: 0.035 uM) in MDR1-expressing LLC-PK1 cells2000Pharmaceutical research, Oct, Volume: 17, Issue:10
Inhibitory potencies of 1,4-dihydropyridine calcium antagonists to P-glycoprotein-mediated transport: comparison with the effects on CYP3A4.
AID427805Antileishmanial activity against Leishmania donovani MHOH/IN/1983/AD83 promastigotes assessed as cell killing at 30 ug/mL after 2 hrs by MTT assay relative to control2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Oral Therapy with Amlodipine and Lacidipine, 1,4-Dihydropyridine Derivatives Showing Activity against Experimental Visceral Leishmaniasis.
AID678714Inhibition of human CYP2C19 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 3-butyryl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID669779Inhibition of norA-mediated ethidium bromide efflux in Staphylococcus aureus SA-1199B harboring grlA A116E mutant at 50 uM after 5 mins by fluorometric analysis2012ACS medicinal chemistry letters, Mar-08, Volume: 3, Issue:3
Ligand Promiscuity between the Efflux Pumps Human P-Glycoprotein and S. aureus NorA.
AID1232306Dissociation constant of the compound2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Volume of Distribution in Drug Design.
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID427813Antileishmanial activity against Leishmania donovani MHOH/IN/1983/AD83 promastigotes assessed as increase in caspase 3 like activation in parasite cytosol at 3 to 30 ug/mL after 2 hrs by spectrofluorimetric analysis2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Oral Therapy with Amlodipine and Lacidipine, 1,4-Dihydropyridine Derivatives Showing Activity against Experimental Visceral Leishmaniasis.
AID29854Compound was evaluated for the plasma half-life to investigate its pharmacokinetic profile in dogs after intravenous administration. 1991Journal of medicinal chemistry, Jan, Volume: 34, Issue:1
Long-acting dihydropyridine calcium antagonists. 6. Structure-activity relationships around 4-(2,3-dichlorophenyl)-3-(ethoxycarbonyl)-2-[(2-hydroxyethoxy)methyl]-5 -(methoxycarbonyl)-6-methyl-1,4-dihydropyridine.
AID781326pKa (acid-base dissociation constant) as determined by Avdeef ref: DOI: 10.1002/047145026X2014Pharmaceutical research, Apr, Volume: 31, Issue:4
Comparison of the accuracy of experimental and predicted pKa values of basic and acidic compounds.
AID28681Partition coefficient (logD6.5)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID311932Inhibition of ASM in human H4 cells assessed as residual activity at 10 uM2008Journal of medicinal chemistry, Jan-24, Volume: 51, Issue:2
Identification of new functional inhibitors of acid sphingomyelinase using a structure-property-activity relation model.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID169100In vitro calcium antagonist activity was assessed against calcium induced constriction of potassium-depolarized rat aorta1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Long-acting dihydropyridine calcium antagonists. 1. 2-Alkoxymethyl derivatives incorporating basic substituents.
AID496818Antimicrobial activity against Trypanosoma brucei brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1207607Inhibition of L-type calcium channel measured using 2-electrode voltage-clamp in Xenopus oocyte heterologically expressing alpha-1C subunit2012Journal of applied toxicology : JAT, Oct, Volume: 32, Issue:10
Predictive model for L-type channel inhibition: multichannel block in QT prolongation risk assessment.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID640615Clearance in human liver microsomes at 1 uM measured after 60 mins by HPLC analysis2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Capture hydrolysis signals in the microsomal stability assay: molecular mechanisms of the alkyl ester drug and prodrug metabolism.
AID231283Ratio of binding affinity against human alpha 2a-adrenoceptor by human alpha 1A-adrenoceptor1999Bioorganic & medicinal chemistry letters, Oct-04, Volume: 9, Issue:19
Design and synthesis of novel dihydropyridine alpha-1a antagonists.
AID1217709Time dependent inhibition of CYP3A4 (unknown origin) at 100 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID537135Antitrypanosomal activity against trypomastigotes of Trypanosoma cruzi infected in rhesus monkey LLC-MK2 cells after 48 hrs by MTT assay2010Bioorganic & medicinal chemistry, Nov-15, Volume: 18, Issue:22
Anti-leishmanial and anti-trypanosomal activities of 1,4-dihydropyridines: In vitro evaluation and structure-activity relationship study.
AID237474Percentage of drug bound in bovine plasma albumin2004Journal of medicinal chemistry, Jul-29, Volume: 47, Issue:16
Contribution of ionization and lipophilicity to drug binding to albumin: a preliminary step toward biodistribution prediction.
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID231282Ratio of binding affinity against human alpha 1d-adrenoceptor by human alpha 1A-adrenoceptor1999Bioorganic & medicinal chemistry letters, Oct-04, Volume: 9, Issue:19
Design and synthesis of novel dihydropyridine alpha-1a antagonists.
AID537136Cytotoxicity against rhesus monkey LLC-MK2 cells after 48 hrs by MTT assay2010Bioorganic & medicinal chemistry, Nov-15, Volume: 18, Issue:22
Anti-leishmanial and anti-trypanosomal activities of 1,4-dihydropyridines: In vitro evaluation and structure-activity relationship study.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID496828Antimicrobial activity against Leishmania donovani2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID444057Fraction escaping hepatic elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID467612Fraction unbound in human plasma2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1217704Time dependent inhibition of CYP1A2 (unknown origin) at 100 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID1232307Lipophilicity, log P of the compound2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Volume of Distribution in Drug Design.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID227699Virtual screen for compounds with anticonvulsant activity2003Bioorganic & medicinal chemistry letters, Aug-18, Volume: 13, Issue:16
Topological virtual screening: a way to find new anticonvulsant drugs from chemical diversity.
AID60642Percent decrease in coronary vascular resistance in dogs after intravenous dosage of 1500 ug/kg compound1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Long-acting dihydropyridine calcium antagonists. 1. 2-Alkoxymethyl derivatives incorporating basic substituents.
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID35755Binding affinity against human Alpha-1a adrenergic receptor1999Bioorganic & medicinal chemistry letters, Oct-04, Volume: 9, Issue:19
Design and synthesis of novel dihydropyridine alpha-1a antagonists.
AID30135Volume of distribution of the compound2001Journal of medicinal chemistry, Apr-26, Volume: 44, Issue:9
Property-based design: optimization of drug absorption and pharmacokinetics.
AID1207606Inhibition of L-type calcium channel measured using whole-cell patch clamp in guinea pig ventricular myocytes2012Journal of applied toxicology : JAT, Oct, Volume: 32, Issue:10
Predictive model for L-type channel inhibition: multichannel block in QT prolongation risk assessment.
AID21474Compound was tested for the plasma half life in dogs1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Long-acting dihydropyridine calcium antagonists. 1. 2-Alkoxymethyl derivatives incorporating basic substituents.
AID678717Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-benzyloxyquinoline as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID235901Selectivity index calculated as the ratio of Calcium pIC50 to that of negative inotropy IC251991Journal of medicinal chemistry, Jan, Volume: 34, Issue:1
Long-acting dihydropyridine calcium antagonists. 6. Structure-activity relationships around 4-(2,3-dichlorophenyl)-3-(ethoxycarbonyl)-2-[(2-hydroxyethoxy)methyl]-5 -(methoxycarbonyl)-6-methyl-1,4-dihydropyridine.
AID444050Fraction unbound in human plasma2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1217707Time dependent inhibition of CYP2C19 in human liver microsomes at 100 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID239884pKa value of the compound2004Journal of medicinal chemistry, Jul-29, Volume: 47, Issue:16
Contribution of ionization and lipophilicity to drug binding to albumin: a preliminary step toward biodistribution prediction.
AID444058Volume of distribution at steady state in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID181533Antihypertensive activity when administered orally to spontaneously hypertensive rats1991Journal of medicinal chemistry, Feb, Volume: 34, Issue:2
Dihydropyrimidine calcium channel blockers. 3. 3-Carbamoyl-4-aryl-1,2,3,4-tetrahydro-6-methyl-5-pyrimidinecarboxylic acid esters as orally effective antihypertensive agents.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID427809Antileishmanial activity against Leishmania donovani MHOH/IN/1983/AD83 amastigotes infected in BALB/c mouse peritoneal macrophage treated 6 hrs after infection measured after 48 hrs using Giemsa staining relative to control2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Oral Therapy with Amlodipine and Lacidipine, 1,4-Dihydropyridine Derivatives Showing Activity against Experimental Visceral Leishmaniasis.
AID496830Antimicrobial activity against Leishmania major2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID29359Ionization constant (pKa)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID19424Partition coefficient (logD7.4)2001Journal of medicinal chemistry, Jul-19, Volume: 44, Issue:15
ElogD(oct): a tool for lipophilicity determination in drug discovery. 2. Basic and neutral compounds.
AID427807Antileishmanial activity against Leishmania donovani MHOH/IN/1983/AD83 amastigotes infected in BALB/c mouse peritoneal macrophage assessed as cell killing at 15 ug/mL treated 6 hrs after infection measured after 48 hrs using Giemsa staining relative to co2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Oral Therapy with Amlodipine and Lacidipine, 1,4-Dihydropyridine Derivatives Showing Activity against Experimental Visceral Leishmaniasis.
AID496827Antimicrobial activity against Leishmania amazonensis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1217708Time dependent inhibition of CYP2D6 (unknown origin) at 100 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID311935Partition coefficient, log P of the compound2008Journal of medicinal chemistry, Jan-24, Volume: 51, Issue:2
Identification of new functional inhibitors of acid sphingomyelinase using a structure-property-activity relation model.
AID427810Toxicity in BALB/c mouse peritoneal macrophage assessed as toxic dose2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Oral Therapy with Amlodipine and Lacidipine, 1,4-Dihydropyridine Derivatives Showing Activity against Experimental Visceral Leishmaniasis.
AID1217710Covalent binding in human liver microsomes measured per mg of protein using radiolabelled compound at 10 uM after 1 hr incubation by liquid scintillation counting2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID669780Inhibition of human recombinant MDR1 expressed in mouse L5178Y cells assessed as inhibition of rhodamine-123 efflux at 10'-5 M preincubated for 10 mins measured after 20 mins by FACS analysis2012ACS medicinal chemistry letters, Mar-08, Volume: 3, Issue:3
Ligand Promiscuity between the Efflux Pumps Human P-Glycoprotein and S. aureus NorA.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID1217728Intrinsic clearance for reactive metabolites formation per mg of protein based on cytochrome P450 (unknown origin) inactivation rate by TDI assay2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID195355Concentration required to block Ca+2-induced contraction of K+ depolarized rat aorta1990Journal of medicinal chemistry, Jun, Volume: 33, Issue:6
Long-acting dihydropyridine calcium antagonists. 5. Synthesis and structure-activity relationships for a series of 2-[[(N-substituted-heterocyclyl)ethoxy]methyl]-1,4-dihydropyridine calcium antagonists.
AID537137Selectivity index, ratio of IC50 for rhesus monkey LLC-MK2 cells to IC50 for amastigotes of Leishmania chagasi MHOM/BR/1972/LD2010Bioorganic & medicinal chemistry, Nov-15, Volume: 18, Issue:22
Anti-leishmanial and anti-trypanosomal activities of 1,4-dihydropyridines: In vitro evaluation and structure-activity relationship study.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID467613Volume of distribution at steady state in human2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID496819Antimicrobial activity against Plasmodium falciparum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID167819In vitro inhibition of potassium-contracted rabbit aorta strips1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Dihydropyrimidine calcium channel blockers. 4. Basic 3-substituted-4-aryl-1,4-dihydropyrimidine-5-carboxylic acid esters. Potent antihypertensive agents.
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID678722Covalent binding affinity to human liver microsomes assessed per mg of protein at 10 uM after 60 mins presence of NADPH2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID726094Inhibition of TREK-1 (unknown origin)2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Ion channels as therapeutic targets: a drug discovery perspective.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID21233Partition coefficient of compound in to biological membranes1991Journal of medicinal chemistry, Mar, Volume: 34, Issue:3
Reevaluating equilibrium and kinetic binding parameters for lipophilic drugs based on a structural model for drug interaction with biological membranes.
AID1217727Intrinsic clearance for reactive metabolites formation per mg of protein in human liver microsomes based on [3H]GSH adduct formation rate at 100 uM by [3H]GSH trapping assay2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID1217731Time dependent inhibition of CYP2B6 (unknown origin) at 3 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID1232312Clearance in human2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Volume of Distribution in Drug Design.
AID231284Ratio of binding affinity against human alpha 2b-adrenoceptor by human alpha 1A-adrenoceptor1999Bioorganic & medicinal chemistry letters, Oct-04, Volume: 9, Issue:19
Design and synthesis of novel dihydropyridine alpha-1a antagonists.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID235556Ratio of pIC50 of rat aorta to pIC25 of guinea pig1990Journal of medicinal chemistry, Jun, Volume: 33, Issue:6
Long-acting dihydropyridine calcium antagonists. 5. Synthesis and structure-activity relationships for a series of 2-[[(N-substituted-heterocyclyl)ethoxy]methyl]-1,4-dihydropyridine calcium antagonists.
AID537130Antileishmanial activity against promastigotes of Leishmania chagasi MHOM/BR/1972/LD after 18 hrs by MTT assay2010Bioorganic & medicinal chemistry, Nov-15, Volume: 18, Issue:22
Anti-leishmanial and anti-trypanosomal activities of 1,4-dihydropyridines: In vitro evaluation and structure-activity relationship study.
AID29813Oral bioavailability in human2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID444056Fraction escaping gut-wall elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID1057863Cytotoxicity against mouse dividing ScN2a-cl3 cells assessed as cell viability after 5 days by calcein-AM staining-based fluorescence assay2013Bioorganic & medicinal chemistry, Dec-15, Volume: 21, Issue:24
Antiprion compounds that reduce PrP(Sc) levels in dividing and stationary-phase cells.
AID311934Dissociation constant, pKa of the compound2008Journal of medicinal chemistry, Jan-24, Volume: 51, Issue:2
Identification of new functional inhibitors of acid sphingomyelinase using a structure-property-activity relation model.
AID427814Antileishmanial activity against Leishmania donovani MHOH/IN/1983/AD83 promastigotes assessed as inhibition of calcium uptake2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Oral Therapy with Amlodipine and Lacidipine, 1,4-Dihydropyridine Derivatives Showing Activity against Experimental Visceral Leishmaniasis.
AID17662Equilibrium dissociation constant based on aqueous concentration in rat smooth muscle1991Journal of medicinal chemistry, Mar, Volume: 34, Issue:3
Reevaluating equilibrium and kinetic binding parameters for lipophilic drugs based on a structural model for drug interaction with biological membranes.
AID35883Binding affinity against human Alpha-1b adrenergic receptor1999Bioorganic & medicinal chemistry letters, Oct-04, Volume: 9, Issue:19
Design and synthesis of novel dihydropyridine alpha-1a antagonists.
AID21434Plasma clearance in dogs after intravenous administration1990Journal of medicinal chemistry, Feb, Volume: 33, Issue:2
Long-acting dihydropyridine calcium antagonists. 4. Synthesis and structure-activity relationships for a series of basic and nonbasic derivatives of 2-[(2-aminoethoxy)methyl]-1,4-dihydropyridine calcium antagonists.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID21438Compound was tested for the plasma clearance in dogs1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Long-acting dihydropyridine calcium antagonists. 1. 2-Alkoxymethyl derivatives incorporating basic substituents.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID1380098Inhibition of Cch1 in Candida albicans isolate 16 assessed as potentiation of fluconazole-induced antifungal activity by measuring fractional inhibitory concentration index after 24 hrs by checkerboard assay2018Journal of medicinal chemistry, 07-12, Volume: 61, Issue:13
Emerging New Targets for the Treatment of Resistant Fungal Infections.
AID537139Cytotoxicity in BALB/c mouse erythrocytes assessed as hemolysis at 50 uM after 3 hrs2010Bioorganic & medicinal chemistry, Nov-15, Volume: 18, Issue:22
Anti-leishmanial and anti-trypanosomal activities of 1,4-dihydropyridines: In vitro evaluation and structure-activity relationship study.
AID1217724Time dependent inhibition of CYP2D6 (unknown origin) at 30 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID1057862Inhibition of RML prion protein infected in mouse dividing ScN2a-cl3 cells expressing full length mouse PrP assessed as reduction of PrPsc level after 5 days by ELISA2013Bioorganic & medicinal chemistry, Dec-15, Volume: 21, Issue:24
Antiprion compounds that reduce PrP(Sc) levels in dividing and stationary-phase cells.
AID427804Antileishmanial activity against Leishmania donovani MHOH/IN/1983/AD83 promastigotes assessed as viability after 2 hrs by MTT assay2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Oral Therapy with Amlodipine and Lacidipine, 1,4-Dihydropyridine Derivatives Showing Activity against Experimental Visceral Leishmaniasis.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID678712Inhibition of human CYP1A2 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using ethoxyresorufin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID231285Ratio of binding affinity against human alpha 2c-adrenoceptor by human alpha 1A-adrenoceptor1999Bioorganic & medicinal chemistry letters, Oct-04, Volume: 9, Issue:19
Design and synthesis of novel dihydropyridine alpha-1a antagonists.
AID22992Compound was tested for the volume of distribution in dogs1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Long-acting dihydropyridine calcium antagonists. 1. 2-Alkoxymethyl derivatives incorporating basic substituents.
AID227119In vivo evaluation for the antihypertensive effect in the spontaneously hypertensive rat is % decrease in blood pressure during post drug administration at 5 umol/kg peroral; 23/111992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Dihydropyrimidine calcium channel blockers. 4. Basic 3-substituted-4-aryl-1,4-dihydropyrimidine-5-carboxylic acid esters. Potent antihypertensive agents.
AID496817Antimicrobial activity against Trypanosoma cruzi2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID79826Evaluated for the negative ionotropy logarithm of the molar concentration required to depress contraction in the Langendorff-perfused guinea pig heart by 25%1991Journal of medicinal chemistry, Jan, Volume: 34, Issue:1
Long-acting dihydropyridine calcium antagonists. 6. Structure-activity relationships around 4-(2,3-dichlorophenyl)-3-(ethoxycarbonyl)-2-[(2-hydroxyethoxy)methyl]-5 -(methoxycarbonyl)-6-methyl-1,4-dihydropyridine.
AID678716Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using diethoxyfluorescein as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID496821Antimicrobial activity against Leishmania2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1057864Ratio of LC50 for dividing mouse ScN2a-cl3 cells to EC50 for inhibition of RML prion protein2013Bioorganic & medicinal chemistry, Dec-15, Volume: 21, Issue:24
Antiprion compounds that reduce PrP(Sc) levels in dividing and stationary-phase cells.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID27900Plasma clearance of the compound2001Journal of medicinal chemistry, Apr-26, Volume: 44, Issue:9
Property-based design: optimization of drug absorption and pharmacokinetics.
AID27167Delta logD (logD6.5 - logD7.4)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID537138Selectivity index, ratio of IC50 for rhesus monkey LLC-MK2 cells to IC50 for trypomastigotes of Trypanosoma cruzi2010Bioorganic & medicinal chemistry, Nov-15, Volume: 18, Issue:22
Anti-leishmanial and anti-trypanosomal activities of 1,4-dihydropyridines: In vitro evaluation and structure-activity relationship study.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID1367794Half life in human at 5 to 10 mg, qd2018Journal of medicinal chemistry, 05-24, Volume: 61, Issue:10
Relevance of Half-Life in Drug Design.
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1217711Metabolic activation in human liver microsomes assessed as [3H]GSH adduct formation rate measured per mg of protein at 100 uM by [3H]GSH trapping assay2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID223060Concentration required to depress contraction in the Langendorff-perfused guinea pig heart1990Journal of medicinal chemistry, Jun, Volume: 33, Issue:6
Long-acting dihydropyridine calcium antagonists. 5. Synthesis and structure-activity relationships for a series of 2-[[(N-substituted-heterocyclyl)ethoxy]methyl]-1,4-dihydropyridine calcium antagonists.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID237416Distribution coeeficient for the compound at pH7.4 (Log D7.4) 2004Journal of medicinal chemistry, Jul-29, Volume: 47, Issue:16
Contribution of ionization and lipophilicity to drug binding to albumin: a preliminary step toward biodistribution prediction.
AID1232310Volume of distribution at steady state in human2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Volume of Distribution in Drug Design.
AID1367796Unbound intrinsic clearance in human at 5 to 10 mg, qd2018Journal of medicinal chemistry, 05-24, Volume: 61, Issue:10
Relevance of Half-Life in Drug Design.
AID21234Partition coefficient of compound in to octanol/buffer1991Journal of medicinal chemistry, Mar, Volume: 34, Issue:3
Reevaluating equilibrium and kinetic binding parameters for lipophilic drugs based on a structural model for drug interaction with biological membranes.
AID427815Toxicity in BALB/c mouse at 10 mg/kg, po2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Oral Therapy with Amlodipine and Lacidipine, 1,4-Dihydropyridine Derivatives Showing Activity against Experimental Visceral Leishmaniasis.
AID1380097Inhibition of Cch1 in Candida albicans isolate 10 assessed as potentiation of fluconazole-induced antifungal activity by measuring fractional inhibitory concentration index after 24 hrs by checkerboard assay2018Journal of medicinal chemistry, 07-12, Volume: 61, Issue:13
Emerging New Targets for the Treatment of Resistant Fungal Infections.
AID444054Oral bioavailability in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID537131Antileishmanial activity against amastigotes of Leishmania chagasi MHOM/BR/1972/LD after 24 hrs by MTT assay2010Bioorganic & medicinal chemistry, Nov-15, Volume: 18, Issue:22
Anti-leishmanial and anti-trypanosomal activities of 1,4-dihydropyridines: In vitro evaluation and structure-activity relationship study.
AID1217713Time dependent inhibition of CYP3A4 (unknown origin) at 10 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID497005Antimicrobial activity against Pneumocystis carinii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID427819Antileishmanial activity against Leishmania donovani MHOH/IN/1983/AD83 promastigotes assessed as decrease in rate of oxygen consumption at 30 ug/mL after 2 hrs by polarographically with Clark electrode2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Oral Therapy with Amlodipine and Lacidipine, 1,4-Dihydropyridine Derivatives Showing Activity against Experimental Visceral Leishmaniasis.
AID227110In vivo evaluation for the antihypertensive effect in the spontaneously hypertensive rat is % decrease in blood pressure during post drug administration at 45 umol/kg peroral; 46/371992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Dihydropyrimidine calcium channel blockers. 4. Basic 3-substituted-4-aryl-1,4-dihydropyrimidine-5-carboxylic acid esters. Potent antihypertensive agents.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1307729Activation of bovine TREK1 expressed in AZT cells assessed as reduction in channel currents2016Journal of medicinal chemistry, 06-09, Volume: 59, Issue:11
Perspectives on the Two-Pore Domain Potassium Channel TREK-1 (TWIK-Related K(+) Channel 1). A Novel Therapeutic Target?
AID427812Antileishmanial activity against Leishmania donovani MHOH/IN/1983/AD83 promastigotes assessed as suppression of oxygen consumption after 2 hrs by polarographically with Clark electrode2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Oral Therapy with Amlodipine and Lacidipine, 1,4-Dihydropyridine Derivatives Showing Activity against Experimental Visceral Leishmaniasis.
AID28677Partition coefficient (logD)2001Journal of medicinal chemistry, Apr-26, Volume: 44, Issue:9
Property-based design: optimization of drug absorption and pharmacokinetics.
AID73833Negative inotropy measured as the concentration required to depress contraction in the isolated Langendorff-perfused guinea pig heart by 25%; Not tested1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Long-acting dihydropyridine calcium antagonists. 1. 2-Alkoxymethyl derivatives incorporating basic substituents.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID409954Inhibition of mouse brain MAOA2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID1232313Elimination half life in human2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Volume of Distribution in Drug Design.
AID29851Half life was measured as time taken to decrease half of its initial concentration2001Journal of medicinal chemistry, Apr-26, Volume: 44, Issue:9
Property-based design: optimization of drug absorption and pharmacokinetics.
AID678715Inhibition of human CYP2D6 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 4-methylaminoethyl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1367790Inhibition of human calcium channel2018Journal of medicinal chemistry, 05-24, Volume: 61, Issue:10
Relevance of Half-Life in Drug Design.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID427816Toxicity in BALB/c mouse assessed as liver function at 10 mg/kg, po2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Oral Therapy with Amlodipine and Lacidipine, 1,4-Dihydropyridine Derivatives Showing Activity against Experimental Visceral Leishmaniasis.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID444053Renal clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1449628Inhibition of human BSEP expressed in baculovirus transfected fall armyworm Sf21 cell membranes vesicles assessed as reduction in ATP-dependent [3H]-taurocholate transport into vesicles incubated for 5 mins by Topcount based rapid filtration method2012Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 40, Issue:12
Mitigating the inhibition of human bile salt export pump by drugs: opportunities provided by physicochemical property modulation, in silico modeling, and structural modification.
AID496832Antimicrobial activity against Trypanosoma brucei rhodesiense2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1367792Unbound concentration in human at 5 to 10 mg, qd2018Journal of medicinal chemistry, 05-24, Volume: 61, Issue:10
Relevance of Half-Life in Drug Design.
AID231281Ratio of binding affinity against human alpha 1b-adrenoceptor by human alpha 1A-adrenoceptor1999Bioorganic & medicinal chemistry letters, Oct-04, Volume: 9, Issue:19
Design and synthesis of novel dihydropyridine alpha-1a antagonists.
AID231286Ratio of binding affinity against rat L-type calcium channel by human alpha 1A-adrenoceptor1999Bioorganic & medicinal chemistry letters, Oct-04, Volume: 9, Issue:19
Design and synthesis of novel dihydropyridine alpha-1a antagonists.
AID35892Binding affinity against human Alpha-1d adrenergic receptor1999Bioorganic & medicinal chemistry letters, Oct-04, Volume: 9, Issue:19
Design and synthesis of novel dihydropyridine alpha-1a antagonists.
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID496829Antimicrobial activity against Leishmania infantum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID537134Antileishmanial activity against promastigotes of Leishmania braziliensis MHO/BR/75/M2903 after 18 hrs by MTT assay2010Bioorganic & medicinal chemistry, Nov-15, Volume: 18, Issue:22
Anti-leishmanial and anti-trypanosomal activities of 1,4-dihydropyridines: In vitro evaluation and structure-activity relationship study.
AID444055Fraction absorbed in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID17659Equilibrium dissociation constant based on membrane concentration in rat smooth muscle1991Journal of medicinal chemistry, Mar, Volume: 34, Issue:3
Reevaluating equilibrium and kinetic binding parameters for lipophilic drugs based on a structural model for drug interaction with biological membranes.
AID1070215Inhibition of Trichomonas vaginalis uridine nucleoside ribohydrolase using 5-fluorouridine as substrate at 0.04 to 200 uM after 40 mins by NMR spectrometric analysis2014Bioorganic & medicinal chemistry letters, Feb-15, Volume: 24, Issue:4
Identification of proton-pump inhibitor drugs that inhibit Trichomonas vaginalis uridine nucleoside ribohydrolase.
AID496823Antimicrobial activity against Trichomonas vaginalis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496820Antimicrobial activity against Trypanosoma brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID28412Compound was evaluated for the plasma clearance to investigate its pharmacokinetic profile in dogs after intravenous administration. 1991Journal of medicinal chemistry, Jan, Volume: 34, Issue:1
Long-acting dihydropyridine calcium antagonists. 6. Structure-activity relationships around 4-(2,3-dichlorophenyl)-3-(ethoxycarbonyl)-2-[(2-hydroxyethoxy)methyl]-5 -(methoxycarbonyl)-6-methyl-1,4-dihydropyridine.
AID30133Compound was evaluated for the volume of distribution to investigate its pharmacokinetic profile in dogs after intravenous administration. 1991Journal of medicinal chemistry, Jan, Volume: 34, Issue:1
Long-acting dihydropyridine calcium antagonists. 6. Structure-activity relationships around 4-(2,3-dichlorophenyl)-3-(ethoxycarbonyl)-2-[(2-hydroxyethoxy)methyl]-5 -(methoxycarbonyl)-6-methyl-1,4-dihydropyridine.
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID427817Toxicity in BALB/c mouse assessed as kidney function at 10 mg/kg, po2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Oral Therapy with Amlodipine and Lacidipine, 1,4-Dihydropyridine Derivatives Showing Activity against Experimental Visceral Leishmaniasis.
AID1232308Distribution coefficient, log D of the compound2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Volume of Distribution in Drug Design.
AID537132Antileishmanial activity against promastigotes of Leishmania amazonensis WHO/BR/00/LT0016 after 18 hrs by MTT assay2010Bioorganic & medicinal chemistry, Nov-15, Volume: 18, Issue:22
Anti-leishmanial and anti-trypanosomal activities of 1,4-dihydropyridines: In vitro evaluation and structure-activity relationship study.
AID1217712Time dependent inhibition of CYP2C8 (unknown origin) at 100 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID496831Antimicrobial activity against Cryptosporidium parvum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID60644Percent decrease in coronary vascular resistance in dogs after intravenous dosage of 50 ug/kg compound1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Long-acting dihydropyridine calcium antagonists. 1. 2-Alkoxymethyl derivatives incorporating basic substituents.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1346650Human Cav1.3 (Voltage-gated calcium channels)2009Molecular pharmacology, Feb, Volume: 75, Issue:2
Expression and 1,4-dihydropyridine-binding properties of brain L-type calcium channel isoforms.
AID1802150TREK1 Assay from Article 10.1111/cbdd.12810: \\Identification of the first in silico-designed TREK1 antagonists that block channel currents dose dependently.\\2016Chemical biology & drug design, Dec, Volume: 88, Issue:6
Identification of the first in silico-designed TREK1 antagonists that block channel currents dose dependently.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (3,938)

TimeframeStudies, This Drug (%)All Drugs %
pre-199085 (2.16)18.7374
1990's690 (17.52)18.2507
2000's1334 (33.88)29.6817
2010's1459 (37.05)24.3611
2020's370 (9.40)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 140.75

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index140.75 (24.57)
Research Supply Index8.65 (2.92)
Research Growth Index5.47 (4.65)
Search Engine Demand Index267.27 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (140.75)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials1,504 (35.81%)5.53%
Reviews319 (7.60%)6.00%
Case Studies359 (8.55%)4.05%
Observational60 (1.43%)0.25%
Other1,958 (46.62%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (541)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 1, Open Label, Non-randomized, Two-cohort, Single-sequence, Crossover Study to Investigate the Pharmacokinetic Drug-drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers [NCT02233218]Phase 160 participants (Actual)Interventional2014-07-31Completed
Salt Sensitive Hypertension and Striatin [NCT03683069]Phase 4400 participants (Actual)Interventional2019-01-15Active, not recruiting
Amlodipine Use in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major [NCT01125254]Phase 2/Phase 310 participants (Actual)Interventional2008-09-30Completed
A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study of Amlodipine and Losartan Versus Two Co-administration of Amlodipine and Losartan in Healthy Caucasian Subjects [NCT01197014]Phase 172 participants (Anticipated)Interventional2010-09-30Completed
Phase IV Study for Effect of Intensive Blood-Pressure Control Using Anti-hypertensive Agents in Essential Hypertension With History of Stroke [NCT01198496]Phase 45,000 participants (Anticipated)Interventional2010-10-31Recruiting
An Open-label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Two Way Crossover, Single Oral Dose Comparative Pharmacokinetic Study of Amlodipine Besylate Controlled-release Tablets, EQ 5mg Base of Overseas Pharmaceuticals Ltd., China and [NCT05667818]Phase 116 participants (Anticipated)Interventional2023-01-28Not yet recruiting
Exercise and Intensive Vascular Risk Reduction in Preventing Dementia [NCT02913664]Phase 2/Phase 3513 participants (Actual)Interventional2017-02-02Completed
A Phase I, Double-Blind, Randomized, Placebo-Controlled, Two-Period, Two-Cohort Crossover Study to Assess the Potential Interaction of Avanafil on the Pharmacokinetic and/or Hemodynamic Effects of Enalapril or Amlodipine in Male Subjects [NCT01117038]Phase 148 participants (Actual)Interventional2010-04-30Completed
A Randomized, Controlled, Multicenter Trial of Levamlodipine Besylate Versus Amlodipine Maleate in Patients With Essential Hypertension [NCT01131546]Phase 41,080 participants (Anticipated)Interventional2009-12-31Completed
An Open-Label Randomized Single-Dose Bioequivalence Study of Amlodipine 10 mg Tablets and Norvasc ® 10 mg Tablets Under Fed Conditions [NCT01131936]Phase 124 participants (Actual)Interventional2002-08-31Completed
A Randomized, Double-blind, Multi-center, Phase III Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Amlodipine Besylate and Candesartan Cilexetil Combination in Patients With Essential Hypertension Who Are Not Adequately Controlled [NCT02368665]Phase 3180 participants (Actual)Interventional2014-12-31Completed
A Randomized, Double-blind, Multi-center, Phase III Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Amlodipine Besylate and Candesartan Cilexetil Combination in Patients With Essential Hypertension Who Are Not Adequately Controlled [NCT02368652]Phase 3181 participants (Actual)Interventional2014-12-31Completed
A Multi-center, Double-blind, Randomized, Placebo- and Active-controlled, Parallel-group, Proof-of-concept Study to Evaluate the Efficacy, Safety, and Tolerability of 10 mg of ACT-280778 in Patients With Mild to Moderate Essential Hypertension [NCT01264692]Phase 2196 participants (Actual)Interventional2011-02-28Completed
Effects and Safety of Clonidine Patch on Young and Middle-aged Smokers With Mild Hypertension: a Randomized Controlled Trial (ECLIPSE) [NCT05416840]Phase 480 participants (Anticipated)Interventional2022-08-31Not yet recruiting
Effect of Amlodipine on Platelet Inhibition by Clopidogrel in Patients With Ischemic Heart Disease- a Prospective Randomized Controlled Trial [NCT01203696]Phase 497 participants (Actual)Interventional2010-07-31Completed
Short-term Effects of Perindopril-amlodipine Versus Perindopril-indapamide on Blood Pressure Control in Newly Diagnosed Type 2 Diabetes Individuals With Hypertension [NCT03747978]Phase 430 participants (Actual)Interventional2016-10-01Completed
Evaluation of spironolactoNe Versus Indapamide on Target Organ Damage in Patients With Obesity and hYpertension(ENVOY) [NCT03626506]400 participants (Anticipated)Interventional2019-02-13Recruiting
A Double-blind, Randomized, Multi-center Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of CJ-30061 Compared With Amlodipine/Valsartan Combination Therapy and Valsartan/Atorvastatin Combination Therapy in Hypertensive Patients With Hyperlipide [NCT03639480]Phase 3180 participants (Anticipated)Interventional2017-10-13Enrolling by invitation
A Cohort Study of Telmisartan on Metabolic Components and Left Ventricular Remodeling in Obese Patients With Hypertension [NCT03956823]300 participants (Anticipated)Interventional2019-08-01Recruiting
Efficacy of Sevikar® Compared to the Combination of Perindopril/ Amlodipine on Central Arterial Blood Pressure in Patients With Moderate to Severe Hypertension- [NCT01101009]Phase 4486 participants (Actual)Interventional2010-04-30Completed
A Randomized, Open-label, Single Dose, Replicate Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers [NCT03662620]Phase 167 participants (Actual)Interventional2018-10-05Completed
Randomized Open-label Single-Dose Two-Way Crossover Study to Assess the Relative Bioavailability of 5mg Levamlodipine Tablet vs. 10mg Amlodipine Besylate Tablet in Healthy Subjects Followed by a Phase to Study Food Effect on the PK of Levamlodipine [NCT03657550]Phase 136 participants (Actual)Interventional2018-05-31Completed
Efficacy and Safety of Two Fixed-combination Antihypertensive Regimens, Amtrel® and Co-Diovan® in Type 2 Diabetes Hypertension Patients With Microalbuminuria [NCT01375322]Phase 4226 participants (Actual)Interventional2007-06-30Completed
The Multicenter, Randomized, Double Blind Phase 3 Clinical Trial to Compare Efficacy and Safety of Combination of Amlodipine and Losartan Compared to Amlodipine Monotherapy in Patients With Stage 2 Hypertension [NCT01127217]Phase 3149 participants (Actual)Interventional2009-05-31Completed
Relative Bioavailability of Telmisartan 40 mg/Amlodipine 5 mg Fixed-dose Combination Tablet Compared to Concomitant Use of Its Mono-components (i.e., Telmisartan 40 mg Tablet and Amlodipine 5 mg Tablet in Concomitant Use) Following Oral Administration in [NCT02259790]Phase 130 participants (Actual)Interventional2007-07-31Completed
Pharmacokinetic and Hemodynamic Interactions Between Amlodipine and Losartan in Humans [NCT03912285]Phase 124 participants (Actual)Interventional2008-01-10Completed
Effects of Intensive Vasodilating add-on Therapy on Peripheral Vascular Resistance and Coronary Flow Reserve in Patients With Essential Hypertension [NCT01180413]Phase 448 participants (Actual)Interventional2010-12-31Completed
A 24-week Open-label Clinical Trial to Assess Tolerability and Antihypertensive Effect and in Hemodynamic Parameters and Arterial Stiffness of Fimasartan 60 mg Plus Amlodipine Besylate 5 mg Given Once a Day in Patients With Hypertension in Stadiums 2/3 [NCT03294070]Phase 453 participants (Anticipated)Interventional2017-09-30Not yet recruiting
A Randomised Double-blind Cross-over Single-centre Study on Molecular Genetics of Drug Responsiveness in Essential Hypertension [NCT03276598]Phase 4233 participants (Actual)Interventional1999-11-25Completed
A Randomized, Double-blind, Multi-center, Phase Ⅳ Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety Between Amlodipine Besylate/Candesartan Cilexetil Combination Tablets and Co-administration of Amlodipine Besylate and Candesartan Cilexe [NCT03231982]Phase 4210 participants (Anticipated)Interventional2017-04-17Recruiting
An Open-label, Fixed-sequence, Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety After Multiple Oral Doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects [NCT02397538]Phase 150 participants (Actual)Interventional2015-02-28Completed
An Open Label, Randomized, Single-dose, 4-period Cross-over Study to Compare the Pharmacokinetics and Safety Following Administration of JLP-1401 and Co-administration of Telmisartan/Amlodipine and Rosuvastatin in Healthy Adult Volunteers [NCT03707899]Phase 149 participants (Actual)Interventional2018-12-13Completed
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication [NCT05103332]Phase 2672 participants (Actual)Interventional2021-11-05Active, not recruiting
A Multicenter Trial to Evaluate the Safety and Efficacy of the Combination of Valsartan/Amlodipine 160/10 mg Versus Amlodipine 10 mg Alone for 8 Weeks in Hypertensive Patients Who Are Not Adequately Controlled on Amlodipine 10 mg Monotherapy [NCT00171002]Phase 3936 participants (Actual)Interventional2004-11-30Completed
Evaluation of Amlodipine Pharmacokinetics in Patients Receiving Hi Flux Hemodialysis [NCT03722381]0 participants (Actual)Observational2020-01-31Withdrawn(stopped due to Study activities were not initiated, and we do not plan to initiate them in the future.)
A Randomized Clinical Trial of the N-of-1 Approach in Children With Hypertension [NCT03461003]Phase 449 participants (Actual)Interventional2018-04-02Completed
Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia [NCT02671695]40 participants (Actual)Interventional2015-04-30Completed
EffecTs of Amlodipine and Other Blood PREssure Lowering Agents on Microvascular FuncTion in Small Vessel Diseases [NCT03082014]Phase 3101 participants (Actual)Interventional2018-02-22Terminated(stopped due to completed for the primary study group of sporadic SVD patients, halted prematurely for the additional study group due to slow recruitment at 26 of 30 CADASIL patients in December 2022)
An Observational Study to Evaluate the Efficacy and Safety of Amosartan Plus Tablet in Uncontrolled Essential Hypertension Patients [NCT05462535]4,785 participants (Actual)Observational2018-02-26Completed
DescripTion of the Effectiveness, Safety, Tolerability and Adherence to Amlodipine/atoRvastatin/Perindopril sinGle Pill Combination trEatmenT in Patients With Arterial Hypertension and Dyslipidemia in the Daily Clinical Practice. (TARGET) [NCT05764317]400 participants (Anticipated)Observational2023-04-30Not yet recruiting
Effect of Fixed Triple Combination With Losartan-Amlodipin-HCTZ vs. Free Triple Combination on Blood Pressure Control [NCT03578042]Phase 4100 participants (Anticipated)Interventional2017-04-01Recruiting
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) Cognitive Sub-Study [NCT03785067]Phase 31 participants (Actual)Interventional2020-02-27Terminated(stopped due to Contractual and financial issues.)
Effect of L-type Calcium Channel Blocker (Amlodipine) on Myocardial Iron Deposition in Thalassemic Patients With Moderate to Severe Myocardial Iron Deposition: A Randomized Pilot Study [NCT02065492]Phase 2/Phase 320 participants (Actual)Interventional2014-02-28Completed
An Open-label, Randomized, 2X2 Crossover Study to Compare the Pharmacokinetics and Safety Between DWJ1351 and Co-administration of Amlodipine/Olmesartan and Rosuvastatin in Healthy Male Subjects [NCT03753477]Phase 164 participants (Actual)Interventional2017-12-22Completed
A Randomized, Open-label, Multiple Doses, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction and Safety of Amlodipine Between Free Combination of Amlodipine and Candesartan and Amlodipine Monotherapy in Healthy Male Volunteers [NCT02064556]Phase 124 participants (Actual)Interventional2014-05-31Completed
A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia [NCT03009487]Phase 3265 participants (Actual)Interventional2017-01-31Completed
A Randomized, Double-blind, Multi-center, PhaseⅡ Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Candesartan Cilexetil and Amlodipine Besylate for the Dose Selection in Patients With Essential Hypertension [NCT02059616]Phase 2384 participants (Anticipated)Interventional2014-02-28Recruiting
An Open-label, Postmarketing Study of Amlodipine/Valsartan Single-Pill Combination for the Treatment of Hypertension [NCT02058446]Phase 436 participants (Actual)Interventional2013-10-31Completed
A Randomized, Open-label, Multiple Doses, Crossover Study to Evaluate the Pharmacokinetic Drug Interaction and Safety of S-amlodipine Between Free Combination of S-amlodipine and Telmisartan and S-amlodipine Monotherapy in Healthy Male Volunteers [NCT01356043]Phase 124 participants (Actual)Interventional2011-05-31Completed
A Randomized, Double-Blind, Multicenter, Phase 2/3 Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB (Fix-dose Combination of Azilsartan and Amlodipine) and Hydrochlorothiazide in Comparison With TAK-536CCB or Hydrochlorot [NCT02072330]Phase 2/Phase 3353 participants (Actual)Interventional2013-03-31Completed
A Comparative Study for the Effects of Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness in the Young and Middle-aged Subjects With Non-dipper Hypertension [NCT02940548]Phase 499 participants (Actual)Interventional2016-12-31Terminated(stopped due to The patient recruitment and follow-ups were influenced with the pandemic of COVID-19)
Reduced Contractile Reserve: a Therapeutic Target in Heart Failure With Preserved Ejection Fraction [NCT01354613]14 participants (Actual)Interventional2011-04-30Completed
A 12-week, Multi-Center, Randomized Double-Blind, Active Control Parallel Group Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertens [NCT01368536]Phase 4975 participants (Actual)Interventional2011-05-31Terminated(stopped due to Based on results from an ALTITUDE study interim analysis, testing aliskiren concomitantly with an ACE inhibitor or ARB, in diabetics with renal impairment)
Effect of the Administration of Losartan / Amlodipine in Fixed Combination Versus Losartan on Hemodynamic and Arterial Stiffness Parameters in Patients With Systemic Hypertension Grade 1 and 2 [NCT03626259]Phase 428 participants (Anticipated)Interventional2018-08-06Recruiting
A Randomized, Open-label, Multiple Doses, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction and Safety of Telmisartan Between Free Combination of Telmisartan and S-amlodipine and Telmisartan Monotherapy in Healthy Male Volunteers [NCT01356017]Phase 132 participants (Anticipated)Interventional2011-06-30Completed
Pharmacokinetics of Repeated Oral Doses of 80 mg Telmisartan (Micardis®) at Steady State Alone and in Combination With Repeated Oral Doses of Amlodipine 10 mg (Norvasc®) at Steady State. A Two-way Crossover, Open, Randomised Design Study [NCT02259816]Phase 138 participants (Actual)Interventional2006-05-31Completed
Randomized, Double-blind, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine and Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia [NCT03566316]Phase 3134 participants (Actual)Interventional2015-11-24Completed
"Multinational Observational Uncontrolled Open Programme The Use of TRIple Fixed-dose COmbination in the Treatment of arteriaL Hypertension: Opportunity for Effective BP Control With cOmbined Antihypertensive Therapy" [NCT03722524]1,247 participants (Actual)Observational2018-10-01Completed
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) MRI Sub-study [NCT03783754]4 participants (Actual)Interventional2018-08-09Terminated(stopped due to Not feasible to continue)
Assessment of Immediate Postoperative Delirium (IPD) in Adult Patients: Incidence, Implication of Type of Anesthesia and Identification of Other Etiological Factors [NCT03967496]402 participants (Actual)Observational [Patient Registry]2019-01-01Completed
A Cluster Randomized Trial On Cardiovascular Risk Factor Management: Caduet Versus Usual Care In Subjects With Hypertension And Additional Cardiovascular Risk Factors In Clinical Practice [NCT00407537]Phase 41,531 participants (Actual)Interventional2007-03-31Completed
Study to Evaluate the Safety and Efficacy of Two Fixed Dose Combinations of Irbesartan / Amlodipine and Monotherapy After Eight Weeks of Treatment in Subjects With Uncomplicated Mild to Moderate Essential Hypertension [NCT00950066]Phase 2270 participants (Actual)Interventional2009-07-31Completed
ACCESS STUDY (Angiotensin Receptor Blocker Combined With Calcium Antagonist Evaluation of Safety and Lowering of Systolic Blood Pressure Study) ARB/CCB Combination Therapy: Efficacy vs an ACE-inhibitor/CCB Combination and Use as First Line Therapy. [NCT01089452]Phase 40 participants (Actual)InterventionalWithdrawn(stopped due to Study not started due to administrative reasons.)
A Prospective Randomized Open-Label, Blinded-Endpoint (PROBE) Trial Comparing MICARDIS® (Telmisartan) (80 mg QD) and Amlodipine (5 mg QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring. [NCT02177409]Phase 3431 participants (Actual)Interventional1998-04-30Completed
The Use of the Calcium Channel Blocker Amlodipine as an Adjuvant Treatment to Iron Chelation for the Prevention of Iron Overload Cardiomyopathy in Patients With Thalassemia [NCT02474420]60 participants (Anticipated)Interventional2015-06-30Recruiting
A Two-Way Crossover, Open-Label, Single-Dose, Fed, Bioequivalence Study of Amlodipine 10 mg Tablets Versus Norvasc® 10 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects [NCT00841815]Phase 128 participants (Actual)Interventional2003-04-30Completed
Evaluation of the Efficacy and Safety of S-amlodipine+Chlorthalidone Combination Therapy and S-amlodipine+Telmisartan Combination Therapy in Hypertensive Patients Inadequately Controlled With Calcium Channel Blocker Monotherapy [NCT03226340]Phase 4170 participants (Anticipated)Interventional2015-12-02Recruiting
A Double-Blind, Comparative Study Between Amlodipine 5mg And 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective [NCT00415623]Phase 3305 participants (Actual)Interventional2007-01-31Completed
A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers [NCT03116516]Phase 162 participants (Actual)Interventional2017-04-21Completed
Open Label, Randomized, Two-treatment, Two-period, Two-sequence, Oral Bioequivalence Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10mg/80mg Under Fed Condition [NCT02292069]Phase 190 participants (Actual)Interventional2011-09-30Completed
A Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-828(Telmisartan 80mg/S-amlodipine 5mg Combination Tablet) to Coadministration of Telmisartan 80mg and S-amlodipine 5mg in Healthy Male Volunteers [NCT02358824]Phase 148 participants (Actual)Interventional2015-02-28Completed
A Prospective Randomized Placebo Controlled Study to Evaluate the Effect of Celecoxib on the Efficacy and Safety of Amlodipine on Renal and Vascular Function in Subjects With Existing Hypertension Requiring Antihypertensive Therapy [NCT02979197]Phase 3105 participants (Actual)Interventional2016-11-03Completed
The Effects of Renin Angiotensin System Blockage (RAS), Calcium Channel Blocker and Combine Drugs on TWEAK, PTX3 and FMD Levels in Diabetic Proteinuric Patients With Hypertension [NCT00921570]Phase 4105 participants (Actual)Interventional2008-02-29Completed
Folic Acid and Intensive Antihypertensive Therapy for Cerebrovascular and Cardiovascular Events Prevention Among Patients With Hypertension and Cerebral Small Vascular Diseases (FAITH)----A Multicenter, Randomized, Controlled, Open-label, 2x2 Factorial, B [NCT05169021]Phase 415,000 participants (Anticipated)Interventional2021-12-31Not yet recruiting
An Open-label, Randomized, Single Dose, 6-Sequence, 3-Period, Cross-over Study to Evaluate a Drug Interaction Between Fixed-dose Combination of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male Subjects [NCT03390465]Phase 136 participants (Actual)Interventional2017-12-15Completed
An Open-Label, Superiority, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination Versus Telmisartan, Amlodipine, and Hydrochlorothiazide in Elderly Patients With Essential [NCT06041529]Phase 4250 participants (Anticipated)Interventional2023-09-14Not yet recruiting
Open Label, Randomized, Two-treatment, Two-period, Two-sequence,Crossover, Single Dose, Oral Bioequivalence Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10mg/80mg Under Fasting Condition [NCT02295046]Phase 180 participants (Actual)Interventional2011-10-31Completed
Bioequivalence of 80 mg Telmisartan / 10 mg Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Male and Female Volunteers. An Open-label, Randomised, Single-dose, Two Sequence, Two-period Crossover Study [NCT02193308]Phase 184 participants (Actual)Interventional2007-09-30Completed
Comparison of Tandospirone, Amlodipine and Their Combination in Adults With Hypertension and Anxiety: a Multicentre, Randomized, Double-blind, Double-dummy, Placebo-controlled Trial [NCT03667677]Phase 4256 participants (Anticipated)Interventional2019-02-01Not yet recruiting
Multicenter, Randomized, Open-label Trial to Assess the Efficacy of Sacubitril/Valsartan vs. Amlodipine/Losartan on Left Ventricular Remodeling in Patients With Chronic Severe Aortic Regurgitation [NCT05212597]Phase 2100 participants (Anticipated)Interventional2022-01-12Recruiting
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of 10 mg Amlodipine Besylate/20 mg Benazepril Hydrochloride Capsules in Healthy Adult Male Volunteers Under Non-fasting (Fed) Conditions [NCT01155908]Phase 148 participants (Actual)Interventional2005-04-30Completed
Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects [NCT03648333]Phase 127 participants (Actual)Interventional2013-12-31Completed
An Observational Study to Evaluate the Effects of Twynsta Tablets (Telmisartan and Amlodipine FDC, q.d.) With Life Style Modifications on Blood Pressure, Quality of Life, and Other Risk Factors in Korean Patients With Hypertension [NCT01316419]2,089 participants (Actual)Observational2011-03-31Completed
Influence of Food on the Bioavailability of Telmisartan 40 mg/Amlodipine 5 mg Fixed-dose Combination and of Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination in Healthy Japanese Male Volunteers (a Phase I, Open-label, Randomised, Single-dose, Two-w [NCT02261064]Phase 132 participants (Actual)Interventional2008-12-31Completed
Influence of Food on the Bioavailability of 80 mg Telmisartan/10 mg Amlodipine Fixed Dose Combination in Healthy Male and Female Volunteers. An Open-label, Randomised, Single-dose, Two Period, Crossover Study [NCT02259777]Phase 140 participants (Actual)Interventional2007-09-30Completed
Impact of Intensive Treatment of Systolic Blood Pressure on Brain Perfusion, Amyloid, and Tau in Older Adults (IPAT Study) [NCT05331144]Phase 2180 participants (Anticipated)Interventional2022-10-25Recruiting
A Double-blind, Randomized, Multi-center Phase III Clinical Trial to Evaluate the Safety and Efficacy of CJ-30060 Compared With Amlodipine/Valsartan Combination Therapy and Valsartan/Rosuvastatin Combination Therapy in Hypertensive Patients With Hyperlipi [NCT03536598]Phase 3203 participants (Actual)Interventional2016-10-14Completed
A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-330 (Fixed-dose Combination of Candesartan 8 mg and Amlodipine 5 mg) With Coadministration of the Two Separate Drugs in Healthy Male Volunteers [NCT02186496]Phase 132 participants (Actual)Interventional2014-07-31Completed
Bariatric Surgery and Pharmacokinetics Amlodipine: BAR-MEDS Amlodipine [NCT02904291]12 participants (Anticipated)Observational2016-11-30Recruiting
A Phase III, Randomized, Double-Blind, Placebo Controlled Clinical Trial Evaluating the Benefits and Mechanism Of Action Of Angiotensin-II Receptor Blocker On Cardiovascular Remodeling In Patients With Repaired Coarctation Of Aorta [NCT06150560]Phase 3120 participants (Anticipated)Interventional2023-12-31Not yet recruiting
A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Amlodipine 10 mg Tablets Versus Norvasc® 10 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects [NCT00841542]Phase 128 participants (Actual)Interventional2003-04-30Completed
A Randomized, Open-label, Multiple Doses, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction and Safety of Candesartan Between Free Combination of Candesartan and Amlodipine and Candesartan Monotherapy in Healthy Male Volunteers [NCT02064621]Phase 124 participants (Actual)Interventional2014-06-30Completed
An Open-label, Randomized, Single Dose, Three-way Crossover, Six Sequence Pilot Study to Evaluate the Relative Bioavailability of One Amlodipine 10mg Tablet and Rosuvastatin 20mg Tablet to Two Fixed Dose Combination Tablet Formulations of Amlodipine (10mg [NCT02075619]Phase 124 participants (Actual)Interventional2014-03-24Completed
A Randomized, Double-blind, Multi-center, Multi-factorial, Phase 2 Trial to Evaluate the Efficacy and Safety of S-Amlodipine/Telmisartan Combined or Alone and Select Better Dose of CKD-828 in Patients With Essential Hypertension [NCT01128322]Phase 2430 participants (Anticipated)Interventional2010-07-31Completed
Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety Following Administration of CJ-30059 and Co-administration of Candesartan Cilexetil and Amlodipine Besylate in Healthy Volunteers. [NCT02173912]Phase 132 participants (Anticipated)Interventional2014-06-30Recruiting
A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial to Evaluate the Efficacy of Telmisartan/S-Amlodipine(Telminuvo® Tab. 40/2.5mg) on 24-hour Ambulatory BP Control Compared With Telmisartan Monotherapy in Hypertensive Patients Inadequately C [NCT02231788]Phase 4217 participants (Actual)Interventional2014-06-30Completed
A Study to Evaluate the Co-Administration of MK-4618 With Antihypertensive Agents [NCT01337674]Phase 126 participants (Actual)Interventional2011-04-01Completed
Effect of Nocturnal Administration of Anti-hypertensive Medications in NoN-dippers [NCT01091753]Phase 428 participants (Actual)Interventional2008-03-31Completed
Trial of Amlodipine Combined With Botulinum Toxin Injections for Focal Dystonia [NCT00015457]Phase 216 participants (Actual)Interventional2001-04-30Completed
Single-Dose Fasting In Vivo Bioequivalence Study of Amlodipine and Benazepril HCl Capsules (10 mg/20 mg; Mylan) to Lotrel® Capsules (10 mg/20 mg; Novartis) in Healthy Volunteers [NCT00649519]Phase 154 participants (Actual)Interventional2004-05-31Completed
A 16-week Double-blind, Randomized, Multicenter, Force-titration Study to Evaluate the Antihypertensive Efficacy of Valsartan/Hydrochlorothiazide (HCTZ) Therapy Compared to HCTZ Based Therapy in Obese, Hypertensive Patients [NCT00439738]Phase 4412 participants (Actual)Interventional2006-12-31Completed
A Randomized, Open-label, Multiple Dose, Three-treatment, Three-period, Six-sequence Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between CKD-501 and Amlodipine After Oral Administration in Healthy Male Volunteers [NCT01341392]Phase 125 participants (Actual)Interventional2011-04-30Completed
A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients [NCT01120327]Phase 4212 participants (Anticipated)Interventional2010-07-31Not yet recruiting
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of 10 mg Amlodipine Besylate/20 mg Benazepril Hydrochloride Capsules in Healthy Adult Male Volunteers Under Fasting Conditions [NCT01155895]Phase 154 participants (Actual)Interventional2004-03-31Completed
A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study of Amlodipine and Losartan Versus Two Co-administration of Amlodipine and Losartan in Healthy Caucasian Subjects [NCT01197001]Phase 172 participants (Anticipated)Interventional2010-08-31Completed
An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of a 4 Week Therapy With the Single Pill (SPC) Combination of Aliskiren 300 mg / Amlodipine 10 mg in Hypertensive Patients Not Adequately Respond to an Uptitrated 4 Week Therapy With the [NCT01113047]Phase 3347 participants (Actual)Interventional2010-05-31Completed
A Randomized, Open Label, Multiple Dose, Crossover Study to Investigate Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide(HCTZ) in Subjects With (Pre)Hypertension [NCT01198249]Phase 123 participants (Actual)Interventional2010-09-30Completed
An Open-Label Randomized Single-Dose Bioequivalence Study of Amlodipine 10 mg Tablets and Norvasc ® 10 mg Tablets Under Fasting Conditions [NCT01131923]Phase 126 participants (Actual)Interventional2002-10-31Completed
Effect of Blood Pressure Reduction in Patients With Chronic Heart Failure - Randomized, Double-blind, Placebo-controlled Trial [NCT01255475]Phase 2/Phase 321 participants (Actual)Interventional2011-01-31Completed
A Randomized, Open-label, Single Dose, 3-way Crossover Study to Evaluate the Drug-drugs Interaction Between Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers [NCT03889145]Phase 130 participants (Actual)Interventional2013-12-19Completed
A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial Designed to Evaluate the Efficacy of a Telmisartan/S-Amlodipine(Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled [NCT02526875]Phase 4208 participants (Anticipated)Interventional2015-04-30Recruiting
A Randomized, Two-period Crossover Trial Examining Bioequivalence of Bisoprolol-Amlodipine 5 mg/5 mg Combination Tablets Versus Bisoprolol 5 mg Tablets and Amlodipine 5 mg Tablets Given Concomitantly in Healthy Subjects in Fasting and Fed State [NCT03226275]Phase 132 participants (Actual)Interventional2017-08-09Completed
A TElmisartan and AMlodipine STudy to Assess the Cardiovascular PROTECTive Effects as Measured by Endothelial Dysfunction in Hypertensive at Risk Patients Beyond Blood Pressure [NCT01180205]Phase 4576 participants (Anticipated)Interventional2010-08-31Active, not recruiting
An Open-label PET-observer-blinded Pilot Study of the Effect of Aliskiren- Versus Amlodipine-based Antihypertensive Treatment in Patients With Small Abdominal Aortic Aneurysm and Mild to Moderate Hypertension on Aneurysmal FDG-uptake [NCT01425242]3 participants (Actual)Interventional2011-09-30Terminated(stopped due to Insufficient number of participants)
A Randomized,Open-label,Single Dose,Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Comparison to the Co-administration of Twynsta and Hygroton in Healthy Volunteers [NCT02496910]Phase 1180 participants (Anticipated)Interventional2015-06-30Completed
Role of LSD1 in Hypertension in Blacks [NCT04840342]Phase 4300 participants (Anticipated)Interventional2022-02-03Recruiting
NORVASC10MG DRUG USE INVESTIGATION [NCT01252563]14,141 participants (Actual)Observational2010-12-31Completed
Double Blind, Randomized, Parallel Group, Multicentre Study to Evaluate the Effects of Manidipine 20 MG Vs. Amlodipine 10 MG and the Combination of Manidipine 10 MG Plus Delapril 30 MG Vs. Amlodipine 5 MG Plus Delapril 30 MG on Intraglomerular Pressure in [NCT00627952]Phase 3100 participants (Actual)Interventional2007-11-30Completed
An Open, Randomized, Parallel-Cohort, 2-Periods, Crossover, Single Dose Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet In Healthy Male Subjects [NCT01004614]Phase 148 participants (Actual)Interventional2009-11-30Completed
A Multi-national, Multi-center, Double-blind, Randomized, Parallel Study Comparing the Efficacy and Safety of Valsartan/Amlodipine 160/5 mg to Valsartan 160 mg Alone in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With V [NCT01001572]Phase 3932 participants (Actual)Interventional2009-09-30Completed
A Randomized, Eight-week Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (300/5 mg and 300/10 mg) in Comparison With Aliskiren 300 mg in Patients With Essential Hypertension [NCT00777946]Phase 3818 participants (Actual)Interventional2008-10-31Completed
Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg [NCT00687973]Phase 4393 participants (Actual)Interventional2008-01-31Completed
The Effect of Losartan Versus Amlodipine-based Antihypertensive Therapy on Atherosclerotic Inflammatory Markers and Cerebrovascular Regulation in Ischemic Stroke Patients [NCT00754429]Phase 440 participants (Actual)Interventional2004-06-30Completed
A 6-Week, Prospective, Randomized, Double-Blind, Double-Dummy Phase IV Clinical Trial Designed to Evaluate the Efficacy of an Aggressive Multi-Risk Factor Management Strategy With Caduet (A3841045) Versus a Guideline-Based Approach in Achieving Blood Pres [NCT00412113]Phase 4245 participants (Actual)Interventional2007-01-31Completed
An 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 + Amlodipine 10mg Versus Amlodipine 10 mg Monotherapy as First Line Therapy in Type 2 Diabetes Patients With Hypertension. [NCT00877929]Phase 3706 participants (Actual)Interventional2009-02-28Completed
A Phase 1, Open Label, Two-cohort, Single-Sequence, Crossover Study to Investigate the Pharmacokinetic Drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers [NCT02951962]Phase 160 participants (Anticipated)Interventional2016-08-31Completed
A Prospective, Open-label, Ambulatory Blood Pressure Monitoring (ABPM) Dose Titration Study to Evaluate the Safety and Efficacy of an Olmesartan Medoxomil and Amlodipine Based Treatment Regimen in Hypertensive, Type 2 Diabetic Subjects [NCT00654745]Phase 4207 participants (Actual)Interventional2008-05-31Completed
Comparison of Optimal Hypertension Regimens (Part of the Ancestry Informative Markers in Hypertension (AIMHY) Programme - AIMHY-INFORM) [NCT02847338]Phase 41,320 participants (Anticipated)Interventional2016-11-30Recruiting
Reduction Efficacy of OLOMAX for Blood Pressure and Low-density Lipoprotein Cholesterol in Hypertensive Patients With Dyslipidemia: a Multi-center-database Real-world Study [NCT05660135]4,000 participants (Anticipated)Observational2022-06-20Recruiting
A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-330 (Fixed-dose Combination of Candesartan 16 mg and Amlodipine 5 mg) With Coadministration of the Two Separate Drugs in Healthy Male Volunteers [NCT02801526]Phase 132 participants (Actual)Interventional2015-04-30Completed
Comparative, Randomized, Single Dose, 2-way Crossover Bioavailability Study of Actavis Group hf and Pfizer Inc. (Norvasc®)10 mg Amlodipine Besylate Tablets in Healthy Adult Volunteers Under Fed Conditions. [NCT00870571]Phase 126 participants (Actual)Interventional2005-04-30Completed
A Randomized, Double-blind, Multi-center Clinical Trial to Evaluate Efficacy and Safety of Ezetimibe/Rosuvastatin Combination Tablets and Candesartan Cilexetil/Amlodipine Besylate Combination Tablets [NCT03847506]Phase 4127 participants (Actual)Interventional2018-07-05Completed
An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets in Healthy Male Volunteers [NCT02205151]Phase 186 participants (Actual)Interventional2014-07-31Completed
A Randomized, Double-blind, Multi-center, Phase 2 Trial to Evaluate the Efficacy and Safety of Candesartan/Amlodipine Combined or Alone and Select Better Dose of CKD-330 in Patients With Essential Hypertension [NCT02206165]Phase 2456 participants (Anticipated)Interventional2014-03-31Recruiting
A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine in Healthy Male Volunteers [NCT02387619]Phase 141 participants (Actual)Interventional2015-02-28Completed
Morning Versus Bedtime Dosing of Antihypertensive Medication in Grade 1 Day-night Hypertension: a Multicenter Randomized Controlled Trial (Dosing-Time Trial) [NCT05089448]Phase 4300 participants (Anticipated)Interventional2021-01-28Recruiting
Bioequivalence of 40 mg Telmisartan/5 mg Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Male and Female Volunteers. An Open-label, Randomised, Single-dose, Two-period Crossover Study [NCT02259829]Phase 184 participants (Actual)Interventional2007-09-30Completed
Cardiovascular and Metabolic Physiological Adaptations to Intermittent Hypoxia. Physiological Aspects and Expression of Receptors and Cellular Mediators [NCT02058823]Phase 412 participants (Actual)Interventional2013-08-07Terminated(stopped due to budget constraints)
Sympathetic Mechanisms in the Cardiovascular and Metabolic Alterations of Obesity [NCT04329806]Phase 172 participants (Anticipated)Interventional2021-02-23Suspended(stopped due to Study being replaced by crossover design)
Calcium Channel Blockade in Primary Aldosteronism [NCT04179019]Phase 215 participants (Anticipated)Interventional2020-09-01Active, not recruiting
Relative Bioavailability of Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet Compared to Concomitant Use of Its Mono-components (i.e., Two Telmisartan 40 mg Tablets and Amlodipine 5 mg Tablet in Concomitant Use) Following Oral Administratio [NCT02259803]Phase 130 participants (Actual)Interventional2007-10-31Completed
A Randomized, Double-blind, Active-controlled, Multicenter Phase3 Trial to Evaluate the Efficacy and Safety of Co-administrated Temisartan/Amlodipine and Rosuvastatin in Subjects With Hypertension and Hyperlipidemia [NCT03067688]Phase 3202 participants (Actual)Interventional2017-04-11Completed
An Open-label, Multiple-dose, Two-arm Clinical Study to Evaluate the Drug-drug Interaction and Safety of Telmisartan, Amlodipine and/or Chlorthalidone in Healthy Adult Volunteers [NCT02152969]Phase 166 participants (Actual)Interventional2014-05-31Completed
To Compare the Pharmacokinetics and Safety of CKD-828 80/5mg to Coadministration of Telmisartan 80mg and S-amlodipine 5mg in Healthy Male Volunteers [NCT02250833]Phase 169 participants (Actual)Interventional2014-09-30Completed
Clinical Phase Ib/II Trial of L-NMMA Plus Taxane Chemotherapy in the Treatment of Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients [NCT02834403]Phase 1/Phase 237 participants (Actual)Interventional2016-11-30Completed
A Multicenter, Double-blind, Controlled, Randomized Trial to Evaluate the Association Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension [NCT05920005]Phase 3698 participants (Anticipated)Interventional2023-08-22Recruiting
Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of 40 mg Telmisartan/5 mg Amlodipine and 80 mg Telmisartan/5 mg Amlodipine (Free Dose Combination) in Healthy Male Volunteers [NCT02194309]Phase 124 participants (Actual)Interventional2006-09-30Completed
Investigating the Relevance of Skin Sodium and Salt Sensitivity of Blood Pressure in Determining the Response to Anti-Hypertensive Drugs (INTREPID) [NCT05976438]60 participants (Anticipated)Interventional2023-08-31Not yet recruiting
A Phase III, 8-week, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Amlodipine 5mg+Losartan 100mg Versus Losartan 100mg in Patients With Essential Hypertension Not Controlled on Losartan Monotherapy [NCT00940680]Phase 3142 participants (Actual)Interventional2008-04-30Completed
A Randomized, Double-Blind, Parallel, Placebo or Amlodipine-Controlled Study of the Effects of Losartan on Proteinuria in Pediatric Patients With or Without Hypertension [NCT00568178]Phase 3306 participants (Actual)Interventional2007-06-01Completed
Efficacy and Safety of Amlodipine Used as add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 20 mg Monotherapy [NCT00220220]Phase 3429 participants (Anticipated)Interventional2005-04-30Completed
An 8-week, Multicenter, Randomized, Double-blind, Factorial Phase II Study to Evaluate Dose-response Relationship of Amlodipine and Losartan Combination in Patients With Essential Hypertension. [NCT00942344]Phase 2320 participants (Actual)Interventional2007-05-31Completed
Efficacy and Safety of Irbesartan/Amlodipine Fixed Combination Therapy Compared With Irbesartan Monotherapy in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy [NCT00957554]Phase 3435 participants (Actual)Interventional2009-07-31Completed
Double Blind Study of Irbesartan vs. Amlodipine in Obese Hypertensive Subjects- The OBI Study [NCT00987662]Phase 40 participants (Actual)Interventional2012-01-31Withdrawn(stopped due to no funding)
The Objective of This Study Was to Compare the Rate and Extent of Absorption of Ranbaxy Amlodipine 10 mg Tablet to That of Norvasc® 10 mg Tablet After a Single, One Tablet Dose in Fed State Subjects. [NCT00775151]40 participants (Actual)Interventional2005-07-31Completed
Vascular Improvement With Olmesartan Medoxomil Study [NCT00772499]Phase 4100 participants (Actual)Interventional2002-11-30Completed
A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled, Factorial Study to Evaluate the Efficacy and Safety of 8-week Treatment With Valsartan (40 and 80 mg) and Amlodipine (2.5 and 5 mg) Combined and Alone in Essential Hypertensive [NCT00425373]Phase 2/Phase 31,474 participants (Actual)Interventional2006-11-30Completed
A Multi-Center, Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin In The Treatment Of Concurrent Hypertension And Hyper-LDL-Cholesterolemia [NCT00530946]Phase 3165 participants (Actual)Interventional2007-09-30Completed
A Double-blind, Randomized, Multicenter, Parallel Group Study to Evaluate the Efficacy, Tolerability, and Safety of Treatment With the Combination of Valsartan/Amlodipine 160/5 mg Compared to Amlodipine 10 mg in Patients With Essential Hypertension Not Ad [NCT00437645]Phase 31,183 participants (Actual)Interventional2007-01-31Completed
Association Between Angiotensin Converting Enzyme Inhibitor or Angiotensin Receptor Blocker Use and COVID-19 Severity and Mortality Among US Veterans [NCT04467931]22,213 participants (Actual)Observational2020-01-19Completed
Comparison of Effects Between Calcium Channel Blocker and Diuretics in Combination With Angiotensin II Receptor Blocker on 24-hr Central Blood Pressure and Vascular Hemodynamic Parameters in Hypertensive Patients Multicenter, Double-blind, Active-controll [NCT02294539]Phase 4231 participants (Actual)Interventional2014-08-31Completed
The Precision Hypertension Care Study [NCT02774460]Phase 4280 participants (Actual)Interventional2017-02-20Completed
A Randomized, Double-Blind, Parallel, Multi-Center, Phase 2 Clinical Trial to Determine the Optimal Dose of AD-209 in Patients With Essential Hypertension [NCT04218552]Phase 2176 participants (Actual)Interventional2020-02-25Completed
DP-R212 Pharmacokinetic Study Pharmacokinetic Characteristics of DP-R212 in Comparison to Each Component Coadministered in Healthy Volunteers [NCT02814500]Phase 136 participants (Anticipated)Interventional2016-07-31Not yet recruiting
A Randomized, Open-label, Single Dose, Replicate Crossover Clinical Trial to Compare the Pharmacokinetics of TAH Tablet in Comparison to the Co-administration of Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers [NCT02739672]Phase 140 participants (Actual)Interventional2016-01-02Completed
Open Label, Comparative, Multiple-dose, Fixed-sequence Steady State Trial in Healthy Volunteers to Assess the Pharmacokinetic Interaction of Ramipril, Atorvastatin and Amlodipine After a Multiple Oral Dose Administration [NCT04262765]Phase 118 participants (Actual)Interventional2019-02-23Completed
Pharmacological Association of the Angiotensin-Converting Enzyme Insertion/Deletion Polymorphism on Blood Pressure and Cardiovascular Risk in Relation to Anti-hypertensive Treatment [NCT00006294]37,939 participants (Actual)Observational1999-09-30Completed
An Open-label, Multiple-dosing, and Crossover Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers [NCT00938197]Phase 134 participants (Anticipated)Interventional2009-06-30Completed
A Pilot Study of N-of-1 Trials of Blood Pressure Medications in Adults With Hypertension [NCT02744456]Early Phase 110 participants (Actual)Interventional2014-08-01Completed
Thiazide Diuretics for Hypertension in Kidney Transplant Recipients Using Tacrolimus [NCT02644395]Phase 349 participants (Actual)Interventional2013-01-18Completed
Effects Of Losartan On Myocardial Structure And Function And On Epicardial Fat Deposition In Diabetic Hypertensive Patients With Left Ventricular: Qualitative And Quantitative Alteration [NCT00659451]Phase 3100 participants (Anticipated)Interventional2008-04-30Recruiting
Ultrasonographic Modification of Liver Steatosis and Visceral Fat Induced by Treatment With Losartan and Simvastatin in Hypertensive Normocholesterolemic Obese Patients [NCT00669435]Phase 475 participants (Anticipated)Interventional2008-04-30Recruiting
Effects of Intensive Antihypertensive Therapies on the Risk of Stroke in Hypertensive Adults: A Prospective Randomized Open-Label Blinded-Endpoint Trial, a Feasibility Study [NCT02817503]Phase 4100 participants (Anticipated)Interventional2015-12-31Enrolling by invitation
A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-330(Fixed-dose Combination of Candesartan 16 mg and Amlodipine 5 mg) With Coadministration of the Two Separate Drugs in Healthy Male Volunteers [NCT02811731]Phase 132 participants (Actual)Interventional2015-04-30Completed
A Randomized, Open-label, Single-Dose, 2-Way Cross-over Study To Compare the Safety and Pharmacokinetic Characteristics of Combination of Amlodipine, Olmesartan and Rosuvastatin and DWJ1351 in Healthy Male Volunteers [NCT02665832]Phase 158 participants (Anticipated)Interventional2016-01-31Not yet recruiting
A Twelve Week, Randomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren/Ramipril/Amlodipine (300/10/5-10 mg) Compared to the Combinations of Ramipril/Amlodipine (10/5-10 mg) and Aliski [NCT00542269]Phase 4178 participants (Actual)Interventional2008-03-31Terminated(stopped due to Early termination of the study due to slow recruitment.)
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy [NCT02651870]Phase 3135 participants (Actual)Interventional2015-04-22Completed
Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans [NCT02742467]Phase 4702 participants (Actual)Interventional2017-06-07Completed
A Prospective, Open-label Study to Assess the Efficacy and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Subjects With Stage 1 and Stage 2 Hypertension [NCT00527514]Phase 3185 participants (Actual)Interventional2007-09-30Completed
Pilot Study to Assess Blockade of Calcium Channels and Sodium Chloride Cotransporters for Physiologic Abnormalities in Liver Transplant Associated Hypertension [NCT05275907]Phase 40 participants (Actual)Interventional2022-07-12Withdrawn(stopped due to Screened participants did not meet inclusion criteria prior to study completion date)
Phase 4 Study of Effects of ARB Compared With Diuretics in Hypertension Patients With High Cardiovascular Risks [NCT01011660]Phase 413,542 participants (Anticipated)Interventional2007-10-31Recruiting
A Phase III, 8-week, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Amlodipine 5mg+Losartan 50mg Versus Amlodipine 10mg in Patients With Essential Hypertension Not Controlled on Amlodipine Monotherapy [NCT00940667]Phase 3185 participants (Actual)Interventional2008-05-31Completed
A Multi-national, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel Study Comparing the Efficacy and Safety of Valsartan/Amlodipine 80/5 mg to Amlodipine 5 mg Alone Once Daily in Patients With Mild to Moderate Essential Hype [NCT00413049]Phase 3698 participants (Actual)Interventional2007-01-31Completed
[NCT01048047]Phase 488 participants (Anticipated)Interventional2009-11-30Active, not recruiting
A 36 Week Randomized, Double-blind, Parallel Group, Multi-center, Active-controlled, Optional Titration Study Comparing an Aliskiren-based Regimen to a Ramipril-based Regimen in Patients ≥ 65 Years Old With Systolic Essential Hypertension [NCT00368277]Phase 3901 participants (Actual)Interventional2006-09-30Completed
A Randomized, Double-blind Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination of Fimasartan/Amlodipine Versus Fimasartan Monotherapy in Patients With Essential Hypertension Who Fail to Respond Adequately to Fimasartan Monother [NCT02152306]Phase 3143 participants (Actual)Interventional2014-04-30Completed
Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes [NCT03264352]Phase 411,414 participants (Anticipated)Interventional2018-02-01Recruiting
An Open Label Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 40mg + Amlodipine 10mg or Fixed Dose Combination of Telmisartan 80mg + Amlodipine 10mg Tablets Alone or in Combination With Other Antihyp [NCT00624052]Phase 3838 participants (Actual)Interventional2008-03-31Completed
Lack of Effect of Antihypertensive Treatment With Amlodipine and Lisinopril on Retinal Autoregulation in Patients With Type 1 Diabetes and Mild Diabetic Retinopathy. A Prospective Randomized Clinical Trial. [NCT00337298]25 participants (Actual)Interventional2006-07-31Completed
Part 1: An Open Label Pilot Study to Determine Interstitial and Tissue Concentrations of Aliskiren and Effects on the Renin- Angiotensin System (RAS) in Fat and Skeletal Muscle of Hypertensive Patients With Abdominal Obesity. Part 2: A Randomized, Double [NCT00498433]Phase 246 participants (Actual)Interventional2007-06-30Terminated(stopped due to Early termination resulted from interim analysis of the ALTITUDE trial)
An 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 mg & Amlodipine 10mg Versus Telmisartan 80 mg Monotherapy or Amlodipine 10 mg Monotherapy as First Line Therapy in Patients With Severe Hypertension (Grade 3) [NCT00860262]Phase 3858 participants (Actual)Interventional2009-03-31Completed
Prospective, Non-interventional Study for the Recording of Adherence to Treatment With Perindopril/Indapamide/Amlodipine Fixed Dose Combination, in a Greek Population With Hypertension [NCT02655029]2,285 participants (Actual)Observational [Patient Registry]2015-11-25Completed
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 When Co-administered With Amlodipine 5 mg in Subjects With Essential Hypertension [NCT00591266]Phase 3566 participants (Actual)Interventional2007-10-31Completed
An 8 Week Prospective, Multicenter, Randomized, Double-Blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ Versus Amlodipine in African American Patients With Stage 2 Hypertension [NCT00739596]Phase 4332 participants (Actual)Interventional2008-07-31Completed
A Prospective, Open-Label, Titration Study to Evaluate the Efficacy and Safety Safety of AZOR in Multiple Subgroups of Hypertensive Subjects Who Are Non-Responders to Anti-Hypertensive Monotherapy [NCT00791258]Phase 4999 participants (Actual)Interventional2008-11-30Completed
An 8 Week, Double-blind, Randomized, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate to Severe Hypertension [NCT00765674]Phase 31,191 participants (Actual)Interventional2008-09-30Completed
A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22189 in Comparison to Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers [NCT02608242]Phase 1123 participants (Actual)Interventional2015-11-30Terminated(stopped due to sponsor decision)
Effect of Amlodipine Versus Bisoprolol on Hypertensive Patients With End-stage Renal Disease on Maintenance Hemodialysis. [NCT04085562]Phase 446 participants (Actual)Interventional2019-09-01Completed
A Randomized Clinical Trial to Evaluate the Effects of Multiple Doses of Amlodipine 10 mg on Pedal Edema Measurements in Middle-Aged and Elderly Healthy Subjects and Patient With Hypertension [NCT00789321]Phase 147 participants (Actual)Interventional2008-07-31Completed
An 8-week Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ (300/25 mg) Compared to Amlodipine (10 mg) in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus [NCT00787605]Phase 4860 participants (Actual)Interventional2008-11-30Completed
An Open-label, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Amlodipine in Combination With Valsartan Compared to Losartan in Combination With Hydrochlorothiazide Given for 52 Weeks on the Regression of Left Ventricular Hypertrophy [NCT00446563]Phase 390 participants (Actual)Interventional2007-03-31Completed
Prognostic Value of the Circadian Pattern of Ambulatory Blood Pressure for Multiple Risk Assessment [NCT00741585]Phase 421,983 participants (Actual)Interventional2008-09-01Completed
A Randomized, 32 Week Double-blind, Parallel-group, Multicenter Study to Compare the Efficacy and Safety of Initiating Treatment With Combination (Aliskiren/Amlodipine) Therapy in Comparison With the Sequential add-on Treatment Strategies in Patients With [NCT00797862]Phase 31,254 participants (Actual)Interventional2008-11-30Completed
Comparison of the Medication Adherence of Patients Treated With Telmisartan/Hydrochlorothiazide or Telmisartan/Amlodipine Fixed Dose Combination (FDC) Versus Double-pill Combination Therapy Based on Database Data in Real-world Japanese Therapeutic Practic [NCT03205137]0 participants (Actual)Observational2022-06-01Withdrawn(stopped due to Sponsor decision)
The Objective of This Study Was to Compare the Rate and Extent of Absorption of Ranbaxy Amlodipine 10 mg Tablet to That of Norvasc® 10 mg Tablet After a Single, One Tablet Dose in Fasted Subjects. [NCT00775905]40 participants (Actual)Interventional2005-07-31Completed
A 28 to 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren / Amlodipine / Hydrochlorothiazide in Patients With Essential Hypertension [NCT00667719]Phase 3564 participants (Actual)Interventional2008-06-05Completed
Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension [NCT00139555]Phase 4125 participants (Actual)Interventional2004-07-31Completed
A Randomized Controlled Phase Ⅳ Trial With Two Equally Sized Treatment Groups: Amlodipine And Nifedipine GITS [NCT01030081]Phase 4510 participants (Actual)Interventional2009-10-31Completed
Real Life Experience With Caduet Evaluating Effectiveness, Safety and Tolerability in the Management of Cardiovascular Risk Factors (EXCEL Study) [NCT00579254]112 participants (Actual)Observational2007-12-31Terminated(stopped due to See the termination reason in detailed description.)
An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80 mg+ Amlodipine 5 mg Fixed-dose Combination vs. Telmisartan 80 mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Te [NCT01222520]Phase 3174 participants (Actual)Interventional2010-10-31Completed
Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor (ARNI) With Amlodipine on Ventricular Remodeling in Hypertension and Left Ventricular Hypertrophy. [NCT04929600]Phase 4120 participants (Anticipated)Interventional2021-11-28Recruiting
An Evaluation of the Effect of an Angiotensin-converting Enzyme (ACE) Inhibitor on the Growth Rate of Small Abdominal Aortic Aneurysms. [NCT01118520]Phase 2224 participants (Actual)Interventional2011-09-30Completed
[NCT02569814]Phase 1100 participants (Actual)Interventional2015-09-30Completed
Additive Beneficial Effects of Atorvastatin Combined With Amlodipine In Treatment of Hypertension [NCT00741078]Phase 40 participants Interventional2004-12-31Completed
A Multi-center, Randomized, Double-Blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWJ1451 in Patients With Hypertension and Dyslipidemia [NCT04161001]Phase 3237 participants (Anticipated)Interventional2019-11-20Recruiting
Open Label, Comparative, Multiple-dose, Fixed-sequence Steady State Trial in Healthy Volunteers to Assess the Pharmacokinetic Interaction of Candesartan, Atorvastatin and Amlodipine After a Multiple Oral Dose Administration [NCT04245046]Phase 118 participants (Actual)Interventional2019-01-18Completed
An Open Label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Combination of Telmisartan 40mg + Amlodipine 5mg or the Combination of Telmisartan 80mg + Amlodipine 5mg Tablets Alone or in Combination With Other Antihypertensive [NCT00614380]Phase 3976 participants (Actual)Interventional2008-01-31Completed
A Multi-national, Multicenter, Double-blind, Double-dummy, Randomized, Active-controled, Parallel Study, Comparing Efficacy and Safety of Valsartan/Amlodipine 80/5 mg to Valsartan 80 mg and Valsartan 160 mg Alone Once Daily in Patients With Mild to Modera [NCT00413413]Phase 31,134 participants (Actual)Interventional2007-01-31Completed
A Randomized, Double-Blind, Parallel Group Study Evaluating the Efficacy and Safety of Co-Administration of a Triple Combination Therapy of Olmesartan Medoxomil, Amlodipine Besylate and Hydrochlorothiazide in Subjects With Hypertension [NCT00649389]Phase 32,500 participants (Actual)Interventional2008-05-31Completed
A Multicenter, Open-label, 18 Month Study to Evaluate the Long-term Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age With Hypertension and With or Without Chronic Kidney Disease [NCT01365481]Phase 3150 participants (Actual)Interventional2011-08-31Completed
A Multicenter, Double-blind, Randomized, Parallel-group Study to Evaluate the Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 mg as Compared to Amlodipine/Valsartan 5/40 mg or to Amlodipine 5 mg Once Daily in Elderly Patients Wi [NCT00699192]Phase 3965 participants (Actual)Interventional2008-05-31Completed
Randomized, Double-Blind, Multi-Center, Phase 3 Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Hydrochlorothiazide Combination in Comparison With Telmisartan/Amlodipine Combination for Essential Hypertension Patients Not Controlled by [NCT02738632]Phase 3300 participants (Anticipated)Interventional2015-05-31Completed
Randomized Comparison of Fixed Low-dose Combination of THREE Antihypertensive Drugs Versus Fixed High-dose Combination of Two Antihypertensive Drugs in Arterial Hypertension (the 3D Trial) [NCT02710552]Phase 4100 participants (Anticipated)Interventional2016-04-30Not yet recruiting
Caduet® Drug Use Investigation (Regulatory Post Marketing Commitment Plan) [NCT01107743]1,291 participants (Actual)Observational2010-06-30Completed
Evaluation of a Primary Treatment Algorithm Using Combination Therapy for the Management of Patients With Hypertension and Hypercholesterolemia [NCT00637078]Phase 41,000 participants (Actual)Interventional2008-02-29Completed
Randomised, Double-Blind, Parallel-Group Study Evaluating Efficacy and Safety of Co-Administration of Triple Combinations of Olmesartan Medoxomil, Amlodipine Besylate, and Hydrochlorothiazide Compared With Corresponding Olmesartan - Amlodipine Combination [NCT00923091]Phase 32,689 participants (Actual)Interventional2009-06-30Completed
An 8-week Multicenter, Randomized, Double-blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine (150/5 mg, 300/10 mg) Versus Amlodipine Alone (5 mg, 10 mg) in African Ameri [NCT00853957]Phase 4443 participants (Actual)Interventional2009-02-28Completed
Effects of Direct Renin Inhibition on Atherosclerotic Biomarkers in Patients With Stable Coronary Heart Disease and Type 2 Diabetes Mellitus [NCT00818779]Phase 438 participants (Actual)Interventional2008-01-31Completed
Efficacy and Safety of Irbesartan/Amlodipine Fixed Combination Therapy Compared With Amlodipine Monotherapy in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy [NCT00956644]Phase 3406 participants (Anticipated)Interventional2009-07-31Completed
A Prospective Multicenter Randomized Controlled Trial of Efficacy and Safety of Renal Denervation for Resistant Hypertension [NCT02900729]Phase 3254 participants (Anticipated)Interventional2016-10-31Not yet recruiting
Cardiovascular Events in Hypertensive Hemodialysed Patients: Aliskiren Versus Amlodipine. A Randomized, Double-blind Study. [NCT01394770]Phase 4350 participants (Anticipated)Interventional2009-09-30Active, not recruiting
Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major: a Randomized, Controlled Trial [NCT01395199]Phase 362 participants (Actual)Interventional2012-08-31Completed
Comparison Between Amlodipine and Aliskiren in Diabetic Hypertensive Patient With Blood Pressure Not Controlled by Losartan: Effects on Endothelial Function and Renin Concentration and Activity [NCT01409408]Phase 40 participants (Actual)Interventional2011-04-30Withdrawn(stopped due to Due to preliminary results of Altitude Trial.)
Effect of Amlodipine and Clomid on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients [NCT02544776]60 participants (Actual)Interventional2015-01-31Completed
Effect of Olmesartan Medoxomil on Vascular Markers in Hypertensive Patients With Metabolic Syndrome [NCT00891267]Phase 360 participants (Anticipated)Interventional2008-10-31Completed
Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India [NCT05683301]Phase 41,968 participants (Anticipated)Interventional2022-08-30Recruiting
A Randomized, Double-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia [NCT04074551]Phase 3145 participants (Actual)Interventional2019-07-16Completed
8 Week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80mg+ Amlodipine 5 mg vs. Amlodipine 5mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy [NCT01103960]Phase 3324 participants (Actual)Interventional2010-07-31Completed
A Randomized, Parallel, Double Blind Study of Losartan Versus Amlodipine in Patients With Mild to Moderate Hypertension and Chronic Nondiabetic Proteinuric Nephropathy: Evaluation of the Effect on Proteinuria and on the Plasmatic Levels of Growth Factors [NCT00140985]Phase 497 participants (Actual)Interventional2000-02-29Completed
A 12-week Multicenter, Randomized, Double-blind, Parallel-group, Active-control Study to Evaluate the Antihypertensive Efficacy and Safety of Valsartan/Amlodipine-based Regimen Versus a Losartan-based Regimen in Patients With Stage 2 Systolic Hypertension [NCT00931710]Phase 4488 participants (Actual)Interventional2009-07-31Completed
An Open-Label, Randomized, Two-Way Crossover, Single Dose Study to Evaluate the Bioavailability of the Test Formulation of Amlodipine 10 mg Tablets (Torrent Pharmaceuticals Limited, India) Compared to a 10 mg Dose of Norvasc® (Pfizer, USA) in 22 Fasted, H [NCT00932763]Phase 10 participants InterventionalCompleted
A Randomized, Eight Week Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (150/10 mg and 300/10 mg) in Comparison With Amlodipine 10 mg in Patients With Essential Hypertension [NCT00778921]Phase 3847 participants (Actual)Interventional2008-10-31Completed
An 8-week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Amlodipine 10 mg Compared to Amlodipine 10 mg in Patients [NCT00841672]Phase 3485 participants (Actual)Interventional2009-01-31Completed
[NCT02789475]Phase 138 participants (Anticipated)Interventional2016-05-31Recruiting
Add-on Study of Hydrochlorothiazide in Patients With Moderate to Severe Hypertension Not Achieving Target Blood Pressure on Olmesartan/Amlodipine Alone [NCT00902538]Phase 32,204 participants (Actual)Interventional2009-04-30Completed
A 6-Week Multi-center, Randomized, Double-Blind, Parallel Group Study Comparing the Efficacy of Amlodipine Besylate/Benazepril Versus Amlodipine in the Treatment of Severe Hypertension [NCT00136851]Phase 4259 participants (Actual)Interventional2004-12-31Completed
Efficacy of Amlodipine-folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine in Patients With Mild to Moderate Hypertension and Hyperhomocysteinemia :a Double-blind Randomized Controlled Trial [NCT01848873]Phase 2/Phase 3756 participants (Anticipated)Interventional2013-01-31Recruiting
An 8-week Randomized, Double-blind, Placebo-controlled Factorial Study to Evaluate the Efficacy and Safety of LCZ696 Alone and in Combination With Amlodipine in Patients With Essential Hypertension [NCT01865188]Phase 30 participants (Actual)Interventional2014-04-30Withdrawn
An Open-label, Multicenter Study to Evaluate the Efficacy and Tolerability of a 4 Week Therapy With the Fixed Dose Combination of Amlodipine 10 mg Plus Valsartan 160 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With the Free C [NCT00523744]Phase 3257 participants (Actual)Interventional2007-07-31Completed
Treat-to-Target Study of Olmesartan Medoxomil and an Add-on Treatment Algorithm Consisting of Hydrochlorothiazide and Amlodipine Besylate in Patients With Mild to Moderate Hypertension [NCT00311155]Phase 4694 participants (Actual)Interventional2006-03-31Completed
A Clinical Trial of Renin Profiling in Selection of Initial Antihypertensive Drug [NCT00834600]185 participants (Actual)Interventional2005-12-31Completed
A Randomized, Open-label, Multiple-dose, Two-arm, One-sequence • Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration Telmisartan/S-amlodipine and Rosuvastatin in Healthy Volunteers [NCT02047175]Phase 164 participants (Actual)Interventional2014-02-28Completed
A Multicenter, Randomized, Double Blind, Parallel Design Trial to Evaluate the Blood Pressure Lowering Efficacy Comparing Moderate Versus Aggressive Treatment Regimen of Valsartan + Amlodipine in Patients Uncontrolled on ARB Monotherapy [NCT00666536]Phase 4728 participants (Actual)Interventional2008-03-31Completed
An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination [NCT00618774]Phase 3259 participants (Actual)Interventional2008-01-31Completed
[NCT00000522]Phase 20 participants Interventional1985-08-31Completed
Open-laBel, Multicenter, multinatiOnal, inTerventional Clinical Trial to Assess effIcacy and Safety of the Extemporaneous Combination of nEbivoLol and amLodipine in Grade 1-2 Hypertensive patIents Versus Each Monotherapy [NCT05513937]Phase 4291 participants (Actual)Interventional2022-05-12Completed
An 8-week Double-blind, Multicenter, Randomized, Multifactorial, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Amlodipine in Patients With Essential Hypertension [NCT00739973]Phase 32,694 participants (Actual)Interventional2008-09-30Completed
Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression [NCT00518479]42 participants (Actual)Interventional2003-09-30Completed
A Multi-Center, Randomized, Open-Label Study To Evaluate Efficacy And Safety Of Dual Therapy With Atorvastatin Plus Amlodipine When Compared Amlodipine Therapy Alone In The Treatment Of Subjects With Concurrent Hyperlipidemia And Hypertension. [NCT00174330]Phase 4330 participants Interventional2005-05-31Completed
A 54 Week, Extension to the Double-blind, Multicenter, Multifactorial, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Valsartan (160 mg and 320 mg) and Amlodipine (10 mg) Combined and Alone in Hypertensive Patients [NCT00170976]Phase 3403 participants (Actual)Interventional2004-04-30Completed
A Multicenter, Group Study to Evaluate the Safety and Efficacy of Amlodipine and Benazepril Administered in Combination Compared to Amlodipine Monotherapy in Hypertensive Patients Not Adequately Controlled With Amlodipine Alone [NCT00171366]Phase 31,422 participants (Actual)Interventional2004-07-31Completed
Effect of Amlodipine on the Lipid Profile of Newly Diagnosed Hypertensive Patients [NCT05467384]Phase 480 participants (Actual)Interventional2016-03-01Completed
Regional and Systemic Hemodynamic Effects of a Long-term Administration of Amlodipine in Patients With Chronic Heart Failure Treated With a Combination of Enalapril, Furosemide and Digoxin [NCT00151619]Phase 27 participants (Actual)Interventional1999-02-10Terminated
Effect of Active Telephone Calls in the Compliance of Hypertensive Patients With Treatment: An Open and Randomized Clinical Trial [NCT00813722]Phase 4400 participants (Actual)Interventional1999-03-31Active, not recruiting
A Five-arm, Randomised, Open Label, Multi-centre, Prospective Study to Compare the Efficacy, Safety and Tolerability of Metoprolol XL Plus Amlodipine Combination (Selomax TM) With Metoprolol XL and Amlodipine as Individual Components in Management of Hype [NCT00819104]Phase 4402 participants (Actual)Interventional2008-11-30Completed
A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS [NCT04686643]Phase 3306 participants (Anticipated)Interventional2021-02-01Not yet recruiting
Which is the Best Treatment for Non-diabetic Hypertension With Obesity: Telmisartan, Amlodipine or Candesartan, Alone or Plus MEtformin? (HOT-ACME 1) [NCT00538486]Phase 4360 participants (Actual)Interventional2008-02-29Completed
Comparative Open-label,Randomized, Fasting/Fed, Single Dose, Three-way Crossover Bioequivalence Study of Valsartan and Amlodipine Tablets (Hua Yuan Pharmaceutical LLC, China) and Valsartan and Amlodipine Tablets (Ⅰ) (Novartis Pharma Schweiz AG, Switzerlan [NCT04085627]Phase 184 participants (Actual)Interventional2018-10-08Active, not recruiting
A Multi-Center, Randomized, Double-Blind, Double-Dummy Study Evaluating The Safety and Efficacy Of The Addition Of Amlodipine To Quinapril Or Losartan In The Treatment Of Diabetic Hypertensive Subjects [NCT00159692]Phase 4739 participants (Actual)Interventional2003-03-31Completed
An Open-Label, Randomized, Two-Way Crossover, Single Dose Study to Evaluate the Bioavailability of the Test Formulation of Amlodipine 10 mg Tablets [Torrent Pharmaceuticals Limited,India] Compared to a 10 mg Dose of Norvasc®, [Pfizer, USA] in 18 Fed, Heal [NCT00932880]Phase 10 participants InterventionalCompleted
Long-Term Study For Amlodipine 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective [NCT00443456]Phase 3134 participants (Actual)Interventional2007-05-31Completed
Investigation of Reduction of Blood Pressure and Metabolic Rate in Obese Hypertensive Patients Using Eplerenone: Implications for Treatment of Hypertension and Heart Failure [NCT00825188]10 participants (Actual)Interventional2009-01-31Terminated(stopped due to funding to complete was inadequate)
Valsartan Versus Amlodipine Effect on Left Ventricular Multidirectional Deformation and Adipocytokines Level in Hypertensive Patients: Speckle Tracking Echocardiography [NCT03990480]Phase 4230 participants (Actual)Interventional2018-12-01Completed
A Double-blind, Double Dummy, Randomized Parallel Design Trial to Study the Effects of 12 Weeks of Treatment With 300mg Aliskiren vs. 5mg Amlodipine on Insulin Resistance and Endothelial Dysfunction in Hypertensive Patients With Metabolic Syndrome [NCT00417170]Phase 248 participants (Actual)Interventional2007-10-31Completed
A Prospective, Multinational, Multicenter Trial to Compare the Effects of Amlodipine/Benazepril to Benazepril and Hydrochlorothiazide Combined on the Reduction of Cardiovascular Morbidity and Mortality in Patients With High Risk Hypertension [NCT00170950]Phase 311,506 participants (Actual)Interventional2003-10-31Terminated(stopped due to The study was terminated early because of significant efficacy results for the primary endpoint in favor of benazepril/amlodipine treatment.)
Efficacy and Safety of GMRx2 (a Single Pill Combination Containing Telmisartan/Amlodipine/Indapamide) Compared to Dual Combinations for the Treatment of Hypertension [NCT04518293]Phase 31,385 participants (Actual)Interventional2021-06-26Completed
A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of BR1010 in Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination [NCT03991442]Phase 3257 participants (Actual)Interventional2019-06-17Completed
An Open Label, Single Arm Prospective Study to Evaluate Efficacy and Safety of Losartan Based Therapy Reslio® (Losartan) and Resilo-h® (Losartan+Hydrochlorthiazide) in Diabetic and Uncontrolled Hypertensive Patients [NCT03978884]Phase 40 participants (Actual)Interventional2019-06-01Withdrawn(stopped due to Unable to effective arrange trial logistics)
A Randomized, Double-blind, Double-dummy, Placebo-controlled, 4x4 Factorial Design Trial to Evaluate Telmisartan 20, 40 and 80 mg Tablets in Combination With Amlodipine 2.5, 5 and 10 mg Capsules After Eight Weeks of Treatment in Patients With Stage I or I [NCT00281580]Phase 31,461 participants (Actual)Interventional2006-04-30Completed
Multi-center, Open Label, 18-week Study to Demonstrate the Efficacy and Safety of Combination Therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Stage II HT [NCT01070030]Phase 4230 participants (Actual)Interventional2010-01-31Completed
An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of FDC of Olmesaartan Medoxomil, Amlopdipine and Hydrochlorothiazide (40+10+25) mg Tab [Torrent,India] Vs Tribenzor(40+10+25) mg Tab [ Daichi Sankyo, Inc USA] in Health [NCT02962336]Phase 134 participants (Actual)Interventional2011-05-31Completed
A Randomized, Double-blind, Multicenter, Placebo-control, Parallel Group Phase 3 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients [NCT05476354]Phase 3271 participants (Actual)Interventional2022-07-05Completed
Glucose Optimisation With Angiotensin II Antagonist Losartan in Patients With Hypertension and Other Risk Factors for Metabolic Syndrome (GOAAL) [NCT00237588]Phase 425 participants Interventional2004-12-31Completed
A Comparison of Telmisartan 80 mg + Hydrochlorothiazide 12.5 mg With Amlodipine 10 mg + Hydrochlorothiazide 12.5 mg in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension. A Prospective, Randomised, Open-label, Blinded [NCT00240474]Phase 41,000 participants Interventional2002-12-31Completed
Efficacy of Amlodipine-Folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine in Patients With Mild to Moderate Hypertension, Hyperhomocysteinemia and Angiotension-Converting Enzyme Inhibitor Intolerance [NCT01956786]Phase 2/Phase 3540 participants (Anticipated)Interventional2013-09-30Recruiting
The COMPAriSon of Systolic Blood Pressure Variability and Central Blood Pressure of Calcium Channel Blocker (Amlodipine) in Comparison With Angiotensin Receptor Blocker (Losartan) in Patients With Essential Hypertension [NCT01964079]Phase 4144 participants (Actual)Interventional2013-04-30Completed
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Telmisartan and S-Amlodipine(TELMINUVO TAB.) Versus S-Amlodipine Monotherapy in Patients With Stage 2 Hypertension [NCT01983735]Phase 3200 participants (Anticipated)Interventional2014-01-31Not yet recruiting
The Usefulness of Non-invasive Assessment of Haemodynamic Profile in the Diagnosis and Treatment of Hypertension [NCT01996085]144 participants (Actual)Interventional2013-01-31Completed
Management of Resistant Hypertension -Pharmacokinetic Assessment of Different Antihypertensive Regimen -Comparison of Two Treatment Strategies: Increase Sodium Depletion or Combined Blockage of Renin-angiotensin System (RAS) [NCT00224549]Phase 4180 participants (Actual)Interventional2005-04-30Completed
Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation [NCT02353806]Phase 416 participants (Actual)Interventional2015-01-31Completed
Phase 1, Open-Label, Randomized, Single-Dose, 2-Treatment, 2-Period Crossover Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablets, Manufactured By Aurobindo Pharma Ltd., India To 10 Mg Amlodipine Besylate Capsules, Manu [NCT01177293]Phase 114 participants (Actual)Interventional2010-03-31Completed
An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80mg Plus Amlodipine 5 mg Fixed-dose Combination vs. Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination in Patients With Hypertension [NCT01286558]Phase 3225 participants (Actual)Interventional2011-01-31Completed
The Reduction of Microalbuminuria in Japanese Hypertensive Subjects With Type 2 Diabetes Mellitus Treated With Valsartan or Amlodipine: Study Design for the Shiga Microalbuminuria Reduction Trial (SMART) [NCT00202618]Phase 4160 participants Interventional2003-12-31Recruiting
Open-label Randomized Crossover Two Period Single Dose Bioequivalence Study of Two Formulations of Perindopril Erbumine/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg Tablets (Pharmtechnology LLC, Republic of Belarus) and Triplixam® 10 mg/2.5 mg/10 mg Tablets (L [NCT05940909]Phase 150 participants (Anticipated)Interventional2023-06-24Recruiting
Sympathetic Mechanisms in the Cardiovascular and Metabolic Alterations of Obesity, Crossover Design Study. [NCT05312892]Phase 1/Phase 212 participants (Anticipated)Interventional2022-05-20Recruiting
A Double Blind, Randomized, Parallel Study to Assess the Effects of Aliskiren/Amlodipine and Amlodipine Monotherapy on Ankle Foot Volume (AFV) in Patients naïve to Trial Drugs With Mild to Moderate Hypertension [NCT01080768]Phase 231 participants (Actual)Interventional2010-02-28Terminated(stopped due to Publication of data from a similar study made the current study redundant.)
A 12 Weeks, Multi-center, Randomized, Open Label, Active Control, Phase IV Clinical Trial to Compare Evaluated Improvement of Edema Index, Safety and Efficacy of Amlodipine Versus S Amlodipine in Patients With Essential Hypertension [NCT04554303]80 participants (Anticipated)Observational2020-10-28Recruiting
A Randomized, Double-blind, Parallel Group, Active-controlled, 38-week Study to Evaluate the Efficacy of Valsartan Versus Amlodipine on the Arterial Properties of Postmenopausal Women With Mild to Moderate Hypertension [NCT00171054]Phase 4125 participants (Actual)Interventional2003-09-30Completed
A Single-centre, Randomized, Open-label, Three-period Crossover Pharmacokinetic Study of 80 mg Telmisartan / 5 mg Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Chinese Subjects [NCT01181011]Phase 128 participants (Actual)Interventional2010-08-31Completed
Newer vs Older Antihypertensive Agents in African Hypertensive Patients Trial [NCT01030458]Phase 4183 participants (Actual)Interventional2010-09-30Completed
A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 10 mg Amlodipine Besylate Tablets Under Fed Conditions [NCT00601302]40 participants (Actual)Interventional2004-04-30Completed
Evaluation of Carotid Intima Media Thickness by Treatment of Vascular and Metabolic Factors With Combined Antihypertensive and Hypolipidemic Therapy [NCT04306627]Phase 4200 participants (Anticipated)Interventional2020-04-15Not yet recruiting
Carotid Endarterectomy Versus Optimal Medical Treatment of Asymptomatic High Grade Carotid Artery Stenosis [NCT00805311]Phase 4400 participants (Actual)Interventional2009-04-30Terminated(stopped due to Due to the clear advantage of carotid endarterectomy)
Comparative, Randomized, Single Dose, 2-way Crossover Bioavailability Study of Actavis Group hf and Pfizer Inc. (Norvasc®)10 mg Amlodipine Besylate Tablets in Healthy Adult Volunteers Under Fasting Conditions. [NCT00870142]Phase 126 participants (Actual)Interventional2005-04-30Completed
A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Safety and Efficacy of YH22162 in Subjects With Essential Hypertension Inappropriately Controlled on Telmisartan/Amlodipine Treatment [NCT02620163]Phase 3381 participants (Actual)Interventional2015-12-31Completed
A 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren 300 mg / Amlodipine 10 mg in Patients With Essential Hypertension [NCT00402103]Phase 3556 participants (Actual)Interventional2006-11-30Completed
ANALYSIS OF THE EFFECTIVENESS OF A STAGED MANAGEMENT PROGRAM AIMED AT CONTROLLING BLOOD PRESSURE AND BLOOD GLUCOSE OF TYPE 2 DIABETIC PATIENTS USING EXCLUSIVELY THE RESOURCES AVAILABLE IN A PRIMARY CARE SETTING IN BRAZIL [NCT00935805]124 participants (Anticipated)Observational2006-07-31Active, not recruiting
A Randomized, Open-label, Single-dosing, Crossover Study to Compare the Safety and Pharmacokinetics of CKD-330(Fixed-dose Combination of Candesartan Cilexetil 8 mg and Amlodipine 5 mg) With Coadministration of the Two Separate Drugs in Healthy Male Volunt [NCT02548286]Phase 153 participants (Actual)Interventional2015-08-31Completed
Clinical Bioequivalence Study on Two Amlodipine Tablet 10mg Formulations [NCT02707913]Phase 117 participants (Actual)Interventional2016-03-31Completed
A Multi-center, Prospective, Randomized, Open-label Study With Blinded Outcome Evaluation to Evaluate the Effects of Systolic Blood Pressure Lowering to Different Targets (Less Than 130 mmHg vs. Less Than 140 mmHg) on Diastolic Function Using Valsartan + [NCT00523549]Phase 4229 participants (Actual)Interventional2006-11-30Completed
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT), Substudies: MRI, Cognitive [NCT02699645]Phase 31,500 participants (Anticipated)Interventional2017-09-28Recruiting
An 8-week Multicenter, Randomized, Double-blind, Active Controlled, Parallel Group, Forced Titration Study to Evaluate the Efficacy and Safety of Aliskiren/Amlodipine/HCTZ Compared to Aliskiren/Amlodipine in US Minority Patients With Stage 2 Hypertension [NCT00942994]Phase 4412 participants (Actual)Interventional2009-06-30Completed
AN OPEN LABEL, NON-INTERVENTIONAL STUDY OF THE SAFETY, TOLERABILITY, AND EFFICACY OF AMLODIPINE AND OLMESARTAN MEDOXOMIL (NORMETECTM) IN FILIPINO PATIENTS WITH HYPERTENSION: A POST MARKETING SURVEILLANCE STUDY [NCT01200407]615 participants (Actual)Observational2010-06-09Terminated(stopped due to The requirement for Post Marketing Surveillance was lifted by the Philippine FDA)
[NCT00693199]360 participants (Actual)Interventional2006-07-31Completed
"The ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling (ALLMARK) Study" [NCT01176032]Phase 474 participants (Actual)Interventional2010-06-30Completed
An Open-label Study to Evaluate the Antihypertensive Effects of the Fixed-dose Combination of Telmisartan 80 mg and Amlodipine 5 mg (T80/A5) Given Once Daily by 24 h ABPM in Patients With Moderate to Severe Hypertension [NCT01204398]Phase 327 participants (Actual)Interventional2010-11-30Completed
Single-Dose Food in Vivo Bioequivalence Study of Amlodipine and Benazepril HCl Capsules (10 mg/20 mg; Mylan) to Lotrel® Capsules (10 mg/20 mg; Novartis) in Healthy Volunteers [NCT00649402]Phase 164 participants (Actual)Interventional2004-05-31Completed
Assessment of Renin Inhibition on Insulin Sensitivity, Diastolic Function and Aortic Compliance [NCT01252238]24 participants (Actual)Interventional2010-06-30Terminated(stopped due to Study sponsor terminated study due to AE's reported with valsartan and aliskiren)
An 8-week Double-blind, Multicenter, Randomized, 6-arm, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in Patients With Essential Hypertension [NCT01237223]Phase 31,342 participants (Actual)Interventional2010-10-31Completed
A Double-Blind, Randomized, Placebo-Controlled, 3-Period, Crossover Study to Evaluate the Effects of Antihypertensive Agents on Central Blood Pressure in Healthy Subjects and Patients With Hypertension [NCT01130168]Phase 138 participants (Actual)Interventional2010-05-31Completed
A Randomized, Double-blind, Active-controlled, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of Co-administrated AD-2071 and AD-2073 in Patients With Primary Hypercholesterolemia and Essential Hypertension [NCT04158076]Phase 3131 participants (Actual)Interventional2020-01-23Completed
A Single Center, Randomized, Double-blind, Active Controlled, Parallel Group Study to Demonstrate Non-inferiority of a Fixed Dose Combination of 5 mg Amlodipine and 80 mg Valsartan to 160 mg Valsartan in the Treatment of Hypertension [NCT01070043]Phase 460 participants (Actual)Interventional2009-06-30Completed
Antihypertensive Effects of a Fixed-dose Combination of Losartan and Hydrochlorothiazide Plus Amlodipine Versus a Hydrochlorothiazide and Atenolol Combination Plus Amlodipine in Subjects With Ambulatory Systolic Hypertension. [NCT00140959]Phase 4120 participants Interventional2003-02-01Completed
Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 6-Sequence, 3-Period Crossover Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablets, Manufactured By Aurobindo Pharma Ltd., India To Amlodipine Besylate 10 Mg Ta [NCT01138826]Phase 118 participants (Actual)Interventional2010-05-31Completed
A Randomized, Double-blind, Placebo-controlled Factorial Study Evaluating the Efficacy and Safety of Co-administration of Olmesartan Medoxomil Plus Amlodipine Compared to Monotherapy in Patients With Mild to Severe Hypertension [NCT00185133]Phase 31,900 participants Interventional2005-05-31Completed
Treatment of Early Hypertension Among Persons Living With HIV in Haiti [NCT04692467]Phase 2250 participants (Actual)Interventional2021-02-26Active, not recruiting
Effect of Antihypertensive Agents on Diastolic Function in Patients With Sleep Apnea: Protocol for a Randomized Controlled Trial [NCT02896621]Phase 369 participants (Actual)Interventional2014-12-07Completed
Valsartan/Amlodipine 160/5 mg or 160/10 mg Versus Valsartan 160 mg Alone for 8 Weeks in Hypertensive Patients Who Are Not Adequately Controlled on Valsartan 160 mg Monotherapy [NCT00170963]Phase 31,018 participants (Actual)Interventional2004-10-31Completed
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a CKD-330 Versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy [NCT02586311]Phase 3160 participants (Actual)Interventional2016-01-31Completed
An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of a 4 Week Therapy With Aliskiren 300 mg Plus Hydrochlorothiazide 25 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With Candesartan 32 mg Plus Hydrochlorothi [NCT00867490]Phase 3186 participants (Actual)Interventional2009-03-31Completed
A Phase IV Clinical Trial of Intensified Blood Pressure Management in Primary Care Using Valsartan Alone and as Combination Anti-Hypertensive Therapy [NCT00902304]Phase 42,337 participants (Actual)Interventional2009-07-31Completed
Randomized Comparison of Once-daily Fixed combiNation vErsus freE-drug cOmbination of Three aNtihypertensive Agents in arteriaL hYpertension (the ONE&ONLY Trial) [NCT02710539]Phase 4100 participants (Anticipated)Interventional2016-04-30Not yet recruiting
Double Blind Atorvastatin Amlodipine Study (DUAAL) Effect Of Amlodipine, Atorvastatin And The Combination On Transient Myocardia Ischemia In Coronary Artery Disease. [NCT00159718]Phase 4360 participants Interventional2001-07-31Completed
ONgoing Evaluation of Depressor Effect And Safety of Combination Therapy With Telmisartan and Low-dose Hydrochlorothiazide in Patients With Hypertension Uncontrolled on Amlodipine Treatment [NCT00509470]Phase 475 participants (Actual)Interventional2007-07-31Completed
A Randomized, Double-blind, Parallel Group, Single-Centre Study to Evaluate the Efficacy and Safety of Lacidipine and Amlodipine Once-daily Treatment in Hypertensive Adult Patients [NCT00338338]Phase 470 participants Interventional2005-11-07Completed
Clinical Utility Of Caduet In Simultaneously Achieving Blood Pressure And Lipid Endpoints In A Specific Patient Population (CAPABLE) [NCT00150384]Phase 4500 participants Interventional2004-07-31Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of PletaalÒ(Cilostazol) in Subjects With Vasospastic Angina (STELLA) [NCT01444885]Phase 250 participants (Actual)Interventional2011-10-31Completed
A Study on the Efficacy and Safety of Olmesartan Medoxomil and Its Combination With Hydrochlorothiazide Compared With an ACE Inhibitor and Its Combination With a Calcium Channel Blocker in Patients With Stage 2 Hypertension [NCT00185120]Phase 4152 participants Interventional2005-09-30Completed
Add-on Study of Olmesartan Medoxomil in Patients With Moderate to Severe Hypertension Not Achieving Target Blood Pressure on Amlodipine 5 mg Alone [NCT00220233]Phase 3632 participants Interventional2005-04-30Completed
Clinical Trial to Investigate the Influence of SK3530 on the Blood Pressure of Patients With Hypertension Taking Amlodipine [NCT00626743]Phase 113 participants (Actual)Interventional2008-05-31Completed
Multi-Omics to Predict the Blood Pressure Response to Antihypertensives [NCT05917275]Phase 496 participants (Anticipated)Interventional2023-10-31Not yet recruiting
Comparison of Phosphodiesterase-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon, Double Blind, Randomized, Cross-over Trial [NCT01280266]Phase 2/Phase 329 participants (Actual)Interventional2011-01-31Completed
A Multi-center, Multiple Dose, Open-label, Four-cohort, Parallel Study to Assess the Pharmacokinetic Drug Interaction Following Co-administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension. [NCT00548067]Phase 3111 participants (Actual)Interventional2007-09-30Completed
A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605 [NCT02916602]Phase 3340 participants (Actual)Interventional2015-04-30Completed
Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue [NCT02996916]Phase 4100 participants (Anticipated)Interventional2015-12-31Recruiting
Comparison of the Pharmacodynamic Effects of RanOlazine Versus aMlodipine on Platelet Reactivity in Stable Patients With Coronary Artery Disease Treated With Dual ANtiplatelet Therapy - The ROMAN Randomized Study [NCT01490255]Phase 4100 participants (Anticipated)Interventional2012-01-31Recruiting
A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet After a Single Oral Administration in Healthy Male Volu [NCT01494727]Phase 148 participants (Anticipated)Interventional2012-02-29Completed
Combination of OLMesartan and Calcium Channel Blocker or Low Dose Diuretics in High Risk Elderly Hypertensive Patients Study (COLM-Study) [NCT00454662]Phase 45,141 participants (Actual)Interventional2007-04-30Completed
An 8-week Multicenter Study to Evaluate the Efficacy and Safety of Orally Administered Valsartan/Amlodipine Combination Based Therapy Versus Amlodipine Monotherapy in Patients With Stage II Hypertension [NCT00350168]Phase 3647 participants (Actual)Interventional2006-06-30Completed
A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 10 mg Amlodipine Besylate Tablets Under Fasting Conditions [NCT00602017]40 participants (Actual)Interventional2004-04-30Completed
A Phase III, Randomized, Active-Comparator Controlled Clinical Trial to Study the Efficacy and Safety of MK-0954E in Japanese Patients With Essential Hypertension Uncontrolled With Losartan and Amlodipine Co-administration [NCT01302691]Phase 3327 participants (Actual)Interventional2011-01-01Completed
An 8 Weeks Open Label National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy [NCT01241487]Phase 4150 participants (Anticipated)Interventional2009-02-28Completed
Comparative Trial of Combination Therapy of ARB/Diuretic Versus ARB/CCB in Uncontrolled Hypertensive Patients With Monotherapy of ARB [NCT00492128]Phase 4196 participants (Actual)Interventional2007-09-30Completed
A Phase-3 Randomized, Double-Blind, Parallel-Group Efficacy and Safety Study Evaluating the Fixed-Dose Combination of Candesartan Plus Amlodipine (8/5 mg) in Chinese Subjects With Mild/Moderate Essential Hypertension, Who Do Not Achieve Target Blood Press [NCT02969265]Phase 30 participants (Actual)Interventional2017-05-09Withdrawn(stopped due to Business reasons unrelated to product safety)
Influence of Amlodipine on the Mortality of Patients With End-Stage Renal Failure (ADAM [Amlodipine and Dialysis Patients, Action on Mortality]) [NCT00124969]Phase 4356 participants (Actual)Interventional2002-01-31Completed
A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between a Fixed Dose Combination of Fimasartan/Amlodipine and Co-administration of Fimasartan and Amlodipine in Healthy [NCT02920047]Phase 160 participants (Actual)Interventional2016-10-31Completed
[NCT02933658]Phase 171 participants (Actual)Interventional2015-11-30Completed
"Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover, Comparative, Oral Bioequivalence Study of Test Product PERINDOPRES® TRIO, 8 mg Perindopril Tert-Butylamine / 2.5 mg Indapamide/ 10 mg Amlodipine Tablets (PrJSC Pharmaceutical Firm [NCT05470764]Phase 152 participants (Actual)Interventional2021-05-30Completed
Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of COZAAR XQ in Usual Practice [NCT01041807]669 participants (Actual)Observational2010-02-28Completed
African American Study of Kidney Disease and Hypertension [NCT04364139]Phase 31,094 participants (Actual)Interventional1995-02-01Completed
A Phase IV, Randomized, Open-Label, Active Controlled Study to Compare the Effects of Tarka® and Lotrel® on Albuminuria in Hypertensive, Type 2 Diabetic Subjects With Diabetic Nephropathy [NCT00234871]Phase 4357 participants (Actual)Interventional2004-01-31Completed
Effect of Atorvastatin in the Management of Hypertension [NCT05679102]120 participants (Actual)Interventional2022-12-20Completed
A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of Irbesartan/Amlodipine High Fixed Dose Combination in Comparison With Co-administration of Mono Compounds in Healthy Volunteers [NCT05688098]Phase 144 participants (Actual)Interventional2022-09-23Completed
A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of Irbesartan High/Amlodipine Fixed Dose Combination in Comparison With Co-administration of Mono Compounds in Healthy Volunteers [NCT05688085]Phase 144 participants (Actual)Interventional2022-10-18Completed
A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of Irbesartan/Amlodipine Fixed Dose Combination in Comparison With Co-administration of Mono Compounds in Healthy Volunteers [NCT05663073]Phase 146 participants (Actual)Interventional2022-09-13Completed
A Randomized, Double-blind, Multicenter, Placebo-control, Parallel Group Phase # Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients [NCT05475665]Phase 3157 participants (Actual)Interventional2022-07-14Completed
BLOCKade of Calcium Channels and Beta Adrenergic Receptors for the Treatment of Hypertension in Heart Failure With Preserved Ejection Fraction (BLOCK HFpEF) Trial [NCT04434664]Phase 450 participants (Anticipated)Interventional2021-05-01Recruiting
Effect of Renin-angiotensin-system Blockade on Urinary Free Light Chains in Patients With Type 2 Diabetes Mellitus [NCT02046395]Phase 428 participants (Actual)Interventional2012-01-31Completed
A Muticenter, Randomized, Double-blind, Parallel, Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension [NCT03897868]Phase 2248 participants (Actual)Interventional2019-03-21Completed
A Double-blind, Randomized, Multicenter Study to Evaluate the Effectiveness of the Combination of Valsartan & Amlodipine in Hypertensive Patients Not Controlled on Monotherapy [NCT00327145]Phase 3894 participants (Actual)Interventional2006-03-31Completed
The Comparison of the Antihypertensive Efficacy and Tolerability Between Valsartan Plus Hydrochlorothiazide 80mg/12.5mg and Amlodipine 5mg in the Essential Hypertensive Patients [NCT00426478]Phase 480 participants (Anticipated)Interventional2006-11-30Completed
The Study Comparing the Incidence of Cardiovascular Events Between High-dose ARB Monotherapy and Combination Therapy With ARB and Calcium Channel Blocker in Japanese Elderly Hypertensive Patients at High Cardiovascular Risk [NCT00134160]Phase 41,000 participants (Anticipated)Interventional2005-08-31Completed
Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus [NCT00136773]Phase 4332 participants (Actual)Interventional2003-04-30Completed
[NCT01738945]Phase 432 participants (Actual)Interventional2008-02-29Completed
An Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study of Amlodipine and Norvasc Under Fasting Condition Sand Under Non-fasting(FED) Conditions in Chinese Healthy Volunteers [NCT02974439]Phase 160 participants (Actual)Interventional2016-12-23Completed
An 8 Week Extension to a Randomized, Double-blind, Parallel Group, Active-controlled, Multi-center, 14 Week Study to Evaluate the Effectiveness of a Valsartan Versus and Amlodipine Treatment Strategy in Achieving Blood Pressure Control in Patients With St [NCT00351130]Phase 479 participants (Actual)Interventional2006-06-30Completed
A 54-week Extension to the Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled, Factorial Study to Evaluate the Efficacy and Safety of VAA489 (Valsartan and Amlodipine Combined) and Alone in Essential Hypertensive Patients - Long Te [NCT00446524]Phase 3403 participants (Actual)Interventional2007-02-28Completed
Korea University Guro Hospital [NCT00460915]Phase 4204 participants (Anticipated)Interventional2007-01-31Completed
Open Label Study Comparing Amlodipine vs Long-acting Nitrates in Patients With Chronic Stable Angina. [NCT00143195]Phase 4200 participants Interventional2001-04-30Completed
Clinical Utility of Amlodipine/Atorvastatin to Improve Concomitant Cardiovascular Risk Factors of Hypertension and Dyslipidemia [NCT00143234]Phase 31,825 participants Interventional2004-05-31Completed
Effect of Add-on of Amlodipine Versus Valsartan on Diastolic Dysfunction Associated With Hypertension [NCT02973035]Phase 4104 participants (Actual)Interventional2016-12-31Completed
Benefit of Amlodipine in HRT Cycle (Hormone Replacement Therapy) for Frozen Embryo Transfer in the Correction of Uterine Pulsatility Index: Randomized Controlled Double-blind Trial. [NCT04954196]Phase 20 participants (Actual)Interventional2021-10-08Withdrawn(stopped due to No participants enrolled)
Comparison of Anti-inflammatory Effects of Amlodipine and Levamlodipine in Patients With Hypertension [NCT04740840]Phase 2/Phase 3200 participants (Actual)Interventional2010-05-01Completed
A Randomized, Double-blind, Parallel Group, Active-controlled Study to Compare the Systolic Blood Pressure Lowering Efficacy of Aliskiren, Ramipril and a Combination of Aliskiren and Amlodipine, With an Initial 8-week Evaluation, Followed by a 2-3 Year Fo [NCT01922141]Phase 40 participants (Actual)Interventional2015-05-31Withdrawn
Comparative Effectiveness of Ambulatory Blood Pressure Monitoring vs Usual Care for Diagnosing and Managing Hypertension: A Pilot Study [NCT02121041]28 participants (Actual)Interventional2014-05-31Completed
Comparative Efficacy of Amlodipine Folic Acid vs. Amlodipine on the Risk of First Ischemic Stroke Among Patients With H-type Hypertension and MTHFR 677 CC/CT Genotype: A Multi-center, Randomized, Controlled Clinical Trial [NCT04974138]Phase 425,000 participants (Anticipated)Interventional2022-04-01Not yet recruiting
A 52 Week, Open Label Extension to the Randomized, Double-blind, Multicenter, Multifactorial, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients. [NCT00409851]Phase 31,293 participants (Actual)Interventional2003-04-30Completed
A Randomized, Double-blind, Multicenter, Multifactorial, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Valsartan (160 mg and 320 mg) and Amlodipine (10 mg) Combined and Alone in Hypertensive Patients [NCT00409643]Phase 31,259 participants (Actual)Interventional2004-01-31Completed
A Randomized, Double-blind, Multicenter, Multifactorial, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients. [NCT00409760]Phase 31,930 participants (Actual)Interventional2003-01-31Completed
A 12 Weeks, Multi-center, Open Label, Randomized, Active Drug Parallel Control Trial to Compare the Effectiveness of Valsartan/Amlodipine and Nifedipine in Treating Chinese Hypertensive Patients Not Respond to Mono Antihypertensive Treatment [NCT01167153]Phase 4564 participants (Actual)Interventional2010-05-31Completed
The Pleiotropic Effects of Atorvastatin When Combined With Common Antihypertenisve Medications: A Comparison of Amlodipine and Hydrochlorothiazide [NCT00656331]0 participants (Actual)Interventional2005-08-31Withdrawn
"A Prospective, Open-label TElmisartan/AMlodipine Single Pill STudy to Assess the Efficacy in Patients With Essential Hypertension..." [NCT01134393]Phase 3502 participants (Actual)Interventional2010-05-31Completed
Cognitive and Physical Impairment in Frail Older Adults [NCT04962841]485 participants (Anticipated)Observational2020-04-01Recruiting
A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People [NCT01259297]Phase 32,336 participants (Actual)Interventional2011-01-31Terminated(stopped due to Terminated early in agreement with Health Authorities for feasibility reasons)
An Open-label, Long-term Extension Study to Evaluate the Safety, Tolerability and Efficacy of 12 Months of LCZ696 Treatment in Patients With Essential Hypertension [NCT01256411]Phase 2341 participants (Actual)Interventional2010-11-30Completed
An International, Multicentre, Open Label Study To Assess The Effectiveness Of Amlodipine -Atorvastatin Combination In Subjects With Hypertension and Dyslipidaemia. (The JEWEL Study) [NCT00330785]Phase 31,250 participants Interventional2004-10-31Completed
A 12-week, Multicenter Study to Evaluate the Efficacy and Safety of Orally Administered Valsartan/Amlodipine Combo Based Therapy vs Amlodipine Monotherapy in Black Patients With Stage II Hypertension [NCT00353912]Phase 3571 participants (Actual)Interventional2006-06-30Completed
A Multi-center, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy vs. Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension [NCT02944734]Phase 2392 participants (Actual)Interventional2014-09-30Completed
Clinical Effect and Cost Effectiveness of Ca Antagonist in Combination With AII Receptor Antagonist in Patient With Essential Hypertension (PMS Study) [NCT01518855]Phase 4514 participants (Actual)Interventional2004-03-31Completed
[NCT01518998]Phase 2420 participants (Actual)Interventional2011-08-31Completed
A Drug Interaction Study Investigating the Effect of Boceprevir on the Pharmacokinetics of the Calcium Channel Blockers Amlodipine and Diltiazem and Vice Versa in Healthy Volunteers [NCT01549496]Phase 10 participants (Actual)Interventional2012-05-31Withdrawn(stopped due to Investigator left this hospital)
An Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy of the Combination of Valsartan and Hydrochlorothiazide and Amlodipine in Hypertensive Patients Not Controlled With Valsartan and Hydrochlorothiazide [NCT00400777]Phase 4460 participants (Anticipated)Interventional2006-08-31Completed
An Open-label Randomized, Single Dose, Two Way Crossover Oral Bioequivalence Study of Amlodipine Besylate/Benazepril HCl Capsules of Dr. Reddy's With Lotrel® Capsules of Novartis in Human Subjects Under Fasting Conditions. [NCT01506011]Phase 150 participants (Actual)Interventional2007-03-31Completed
Action to Control Cardiovascular Risk in Diabetes (ACCORD) [NCT00000620]Phase 310,251 participants (Actual)Interventional1999-09-30Completed
An Multicenter Study to Evaluate the Efficacy and Tolerability of a 4-week Therapy With the Combination of Valsartan 160mg + Amlodipine 5mg in Hypertensive Patients Not Adequately Responding to 4-week Treatment With Amlo 5mg or Felodipine 5mg in Monothera [NCT00392262]Phase 3224 participants (Actual)Interventional2006-08-31Completed
Randomized, Multicenter, Parallel, Open, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension Patient With Dyslipidemia [NCT03951207]Phase 4259 participants (Actual)Interventional2019-05-30Completed
Clinical Trial to Compare the Pharmacokinetics of TAH Tablet(80/10/12.5mg) in Comparison to the Co-administration of Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers [NCT03032315]Phase 144 participants (Actual)Interventional2016-10-01Completed
An Open-label, Multiple-dose, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of amlodipine10mg and candesartan32mg in Healthy Male Volunteers [NCT01806311]Phase 134 participants (Anticipated)Interventional2012-12-31Completed
Hypertension With Obesity Trial: Diabetes Mellitus Branch [NCT00847262]Phase 4120 participants (Actual)Interventional2008-06-30Completed
The Novel Antihypertensive Goal Of hYpertension With diAbetes - Hypertensive Events and ARb Treatment (NAGOYA-HEART) Study [NCT00129233]Phase 41,150 participants (Actual)Interventional2004-10-31Completed
Evaluation of Potential Pharmacokinetic Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers [NCT00039975]Phase 132 participants InterventionalCompleted
Hereditary Pancreatitis Amlodipine Trial(H-PAT): A Pilot Study [NCT00156403]Phase 1/Phase 28 participants Interventional2005-08-31Completed
A Study to Evaluate the Safety and Efficacy of Valsartan/Amlodipine Compared to Lisinopril/Hydrochlorothiazide Given Once Daily for 6 Weeks is Patients With Severe Hypertension [NCT00171535]Phase 3130 participants (Actual)Interventional2004-10-31Completed
An International, Multicentre, Open Label Study To Assess The Effectiveness Of Amlodipine/Atorvastatin Combination In Subjects With Hypertension And Dyslipidaemia. (The JEWEL II Study) [NCT00174304]Phase 41,120 participants Interventional2004-10-31Completed
Hypertension Control Based on Home Systolic Pressure Study (HOSP Study) [NCT00198562]Phase 42,600 participants (Anticipated)Interventional2000-04-30Active, not recruiting
An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of FDC of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tab 40+10+25 mg [Torrent,India] Vs Tribenzor 40+10+25 mg Tablets [ Daichi,USA] in Healthy Subjects-Fe [NCT02962258]Phase 134 participants (Actual)Interventional2011-05-31Completed
Filtered Trial for Telmisartan 40mg Non-responder [NCT00550953]Phase 3314 participants (Actual)Interventional2007-10-31Completed
Nephropathy in Type 2 Diabetes: Effects of an Intensive Multifactorial Intervention Trial on Cardio-renal Events. [NCT00535925]Phase 4850 participants (Actual)Interventional2005-10-31Completed
A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination Treatment of Fimasartan/Amlodipine/Rosuvastatin in Patients With Essential Hypertension and Dyslipidemia Who Fail to Respond Adequately to Fimasart [NCT03156842]Phase 3138 participants (Actual)Interventional2017-05-29Completed
Randomized, 2-Way, Crossover, Bioequivalence Study of Amlodipine-Benazepril 10mg-20mg Capsules and Lotrel® Administered as 1 x 10 mg-20 mg Capsule in Healthy Subjects Under Fasting Conditions. [NCT00834977]Phase 148 participants (Actual)Interventional2004-04-30Completed
Black Education and Treatment of Hypertension (BEAT HTN) [NCT00661895]Phase 499 participants (Actual)Interventional2005-08-31Completed
A Single-Dose, Comparative Bioavailability Study of Telmisartan/Amlodipine 80 mg/10 mg Tablets Versus Micardis 80 mg Tablets With Norvasc 10 mg Tablets Under Fasting Conditions [NCT01278797]Phase 128 participants (Actual)Interventional2011-01-31Completed
A Twenty-four Week, Open-label, Non-comparative, Multi-center Study to Assess the Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension. [NCT00765947]Phase 4256 participants (Actual)Interventional2008-09-30Completed
Comparison of the Effects of Amlodipine and Losartan on Blood Pressure and Diurnal Variation in Hypertensive Stroke Patients [NCT01830517]Phase 484 participants (Actual)Interventional2007-08-31Completed
Personalised Electronic Record Supported Optimisation When Alone for Patients With Hypertension- Pilot Study for Remote Medical Management of Hypertension During the COVID-19 Pandemic [NCT04559074]Phase 41,000 participants (Anticipated)Interventional2020-10-23Recruiting
Evaluation of Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial [NCT02213224]Phase 4180 participants (Anticipated)Interventional2014-08-31Recruiting
An Open-label, Randomized, Single Dose, Three-way Crossover Study to Determine the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Amlodipine (5mg) and Losartan (100mg) in Healthy Adult Male and Female Subjects Under Fasti [NCT01648231]Phase 123 participants (Actual)Interventional2012-08-06Completed
Azelnidipine and Amlodipine Anti-Coronary Atherosclerotic Trial in Hypertensive Patients Undergoing Coronary Intervention by Serial Volumetric Intravascular Ultrasound Analysis in Junten Medical University (ALPS-J) [NCT00294567]Phase 4199 participants (Actual)Interventional2005-12-31Completed
An 8 Weeks, Multi-Center, Randomized, Double Blinded, Comparative Phase 3 Clinical Trial to Assess the Efficacy and Safety of S-Amlodipine Gentisate Compared to Amlodipine Besylate in Patients With Mild-to-Moderate Hypertension [NCT00289406]Phase 3110 participants Interventional2006-01-31Completed
A 14 Week Study to Evaluate Effectiveness of a Valsartan Versus an Amlodipine Treatment Strategy in Achieving Blood Pressure Control in Patients With Stage 1 or Stage 2 Hypertension or Uncontrolled on Present Monotherapy [NCT00304226]Phase 41,288 participants (Actual)Interventional2006-02-28Completed
Impact of High-Dose Quinapril Versus Low-Dose Quinapril Plus Amlodipine on Autonomic Regulation and on Sympathetic Activation in Response to Cold Exposure in Hypertensive Patients With Impaired Glucose Tolerance, Diabetes or Coronary Artery Disease [NCT00313547]Phase 440 participants (Anticipated)Interventional2006-04-30Terminated(stopped due to Very difficult to recruit patients/slow recruitment(2 patients in nearly 2 years).)
Evaluate the Efficacy and Safety of a Fixed Dose Combination of S-Amlodipine and Telmisartan(CKD-828) vs. S-Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by S-Amlodipine Monotherapy. [NCT01501253]Phase 3187 participants (Actual)Interventional2011-08-31Completed
An Open-label Randomized, Single Dose, Two Way Crossover Oral Bioequivalence Study of Amlodipine Besylate/Benazepril HCl Capsules of Dr. Reddy's With Lotrel® Capsules of Novartis in Human Subjects Under Fed Conditions [NCT01505998]Phase 149 participants (Actual)Interventional2007-03-31Completed
A Prospective Open-label Multicentre Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan 150 mg or Amlodipine 5 mg Monotherapy [NCT01625494]Phase 3158 participants (Actual)Interventional2012-05-31Completed
Estimation of the Long Term Effectiveness of Routine Use of Cardiac Shock Wave Therapy in the General System of Noninvasive, Invasive, and Surgical Treatment of Ischemic Heart Disease in the Conditions of a Large General City Hospital [NCT01631409]0 participants (Actual)Observational2013-09-30Withdrawn(stopped due to The study has been withdrawn due to organizational problems)
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a Fixed Dose Combination of S-Amlodipine and Telmisartan(CKD-828) Versus S-Amlodipine Monotherapy in Patients With Stage 2 Hypertension [NCT01634295]Phase 3103 participants (Actual)Interventional2012-07-31Completed
[NCT01652339]Phase 140 participants (Actual)Interventional2012-07-31Completed
The Role of Aldosterone on Augmented Exercise Pressor Reflex in Hypertension [NCT01996449]Phase 214 participants (Actual)Interventional2013-07-31Completed
The Correlation Study Between Blood Pressure Variability and the Prognosis of Ischemic Stroke With Intracranial Artery Stenosis [NCT01665235]200 participants (Anticipated)Interventional2012-08-31Recruiting
Prevalence and Incidence of Dyskalemia in Hypertensive Patients Initiating a Fixed Dose Combination Pill of Telmisartan and Amlodipine [NCT05155436]Phase 41,090 participants (Actual)Interventional2022-01-15Completed
Efficacy and Tolerability of Combination Antihypertensive Drug in Non-Responders to Angiotensin Receptor Blocker(ARB) monoTHerapy Using 24h ABPM. [NCT01713920]Phase 468 participants (Actual)Interventional2010-04-30Completed
A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet After a Single Oral Administration in Healthy Male Volu [NCT01735890]Phase 148 participants (Actual)Interventional2012-09-30Completed
ARB and CCB Longest Combination Treatment on Ambulatory and Home BP in Hypertension With Atrial Fibrillation -Multicenter Study on Time of Dosing [NCT01748253]80 participants (Anticipated)Interventional2012-11-30Recruiting
Efficacy and Safety of GMRx2 (a Single Pill Combination Containing Telmisartan/Amlodipine/Indapamide) Compared to Placebo for the Treatment of Hypertension [NCT04518306]Phase 3295 participants (Actual)Interventional2021-06-06Completed
[NCT01819220]Phase 416 participants (Actual)Interventional2009-04-30Completed
Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects [NCT01819779]Phase 153 participants (Actual)Interventional2013-03-31Completed
Polipill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt in Primary Health Care [NCT05155137]Phase 312,268 participants (Anticipated)Interventional2021-12-20Recruiting
An Open-Label, Randomized, Single Dose, Two-Way Crossover Pilot Study to Evaluate the Relative Bioavailability of One Amlodipine 5 mg Tablet and One Enalapril Maleate 20mg Tablet to a Fixed Dose Combination Tablet Formulation of Amlodipine (5 mg) and Enal [NCT01822639]Phase 115 participants (Actual)Interventional2013-04-03Completed
An Eight-week, Randomized, Double-blind Multicenter Study to Compare the Efficacy and Safety of Amosartan® Tab 5/100mg Versus Cozaar® Plus Pro Tab in Patients With Essential Hypertension Uncontrolled With Losartan 100mg Monotherapy [NCT01828359]Phase 4199 participants (Actual)Interventional2010-08-31Completed
Bedtime Administration of Amlodipine Versus Lisinopril: a Randomized Trial [NCT01835418]100 participants (Anticipated)Interventional2013-04-30Not yet recruiting
A Randomized, Open-label, Single Dose, Two-treatment, Two-period, Two-sequence Crossover Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine After Oral Administration in Healthy Volunteers [NCT01842230]Phase 124 participants (Actual)Interventional2013-04-30Completed
A Randomized, Open-label, Single Dose, Two-treatment, Two-period, Two-sequence Crossover Study to Investigate the Effect of Telmisartan/S-amlodipine on the Pharmacokinetic Properties of Atorvastatin After Oral Administration in Healthy Volunteers [NCT01842256]Phase 124 participants (Actual)Interventional2013-04-30Completed
Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate in Healthy Male Volunteers. [NCT01845272]Phase 140 participants (Anticipated)Interventional2013-04-30Active, not recruiting
Azilsartan Circadian and Sleep Pressure - the 1st Study [NCT01762501]957 participants (Actual)Interventional2012-12-31Completed
An Eight-week Randomized, 4-arm, Double-blind Study to Compare the Efficacy and Safety of Combinations of Telmisartan 40mg + Amlodipine 5mg Versus Telmisartan 80mg + Amlodipine 5mg Versus Amlodipine 5mg Versus Amlodipine 10mg Monotherapy in Patients With [NCT00558428]Phase 31,098 participants (Actual)Interventional2007-10-31Completed
An Open-label, Randomized, Cross-over Study to Evaluate Pharmacokinetics and the Safety of HL068 16/10mg Compared to Candesartan 16mg and Amlodipine 10mg Co-administered in Healthy Male Volunteers. [NCT02988362]Phase 140 participants (Anticipated)Interventional2016-12-31Not yet recruiting
Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension [NCT04474899]Phase 4120 participants (Anticipated)Interventional2015-06-24Recruiting
Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study [NCT00421863]Phase 41,111 participants (Actual)Interventional2005-02-28Completed
Comparative Efficacy of Amlodipine Folic Acid vs. Amlodipine on the Risk of First Ischemic Stroke Among Patients With Hypertension and MTHFR 677 TT Genotype: A Multi-center, Randomized, Controlled Clinical Trial [NCT04974151]Phase 424,000 participants (Anticipated)Interventional2022-04-01Not yet recruiting
National, Multicenter, Open-Label and Prospective Study Assessment of Efficacy and Safety in Stage 1 and 2 Essential Hypertension With Olmesartan Medoxomil Based Treatment Algorithm From Monotherapy to Association With Hydrochlorothiazide and Amlodipine B [NCT00890591]Phase 4144 participants (Actual)Interventional2006-08-31Completed
Effects of Fimasartan on Insulin Secretion, and Interaction With DPP4 Inhibitors in Patients With Type 2 Diabetes [NCT02312375]46 participants (Actual)Interventional2015-03-31Completed
The CORONAvirus Disease 2019 Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker InvestigatiON (CORONACION) Randomized Clinical Trial [NCT04330300]Phase 42,414 participants (Anticipated)Interventional2020-04-30Suspended(stopped due to Challenges with funding and very low incidence of COVID-19 at Irish study site)
A Randomized, Comparative Trial of Concor AM, a Fixed Dose Combination of Bisoprolol and Amlodipine, on the Treatment of Essential Hypertensive Patients Whose Blood Pressure is Not Well Controlled by Monotherapy of Bisoprolol 5mg or Amlodipine 5mg [NCT01977794]Phase 3200 participants (Actual)Interventional2014-03-31Completed
A Multi-center, Randomized, Open-label, Active-controlled, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of OLOMAX Tab in Hypertension Patients With Low-Intermediate Risk for Cardiovascular Disease [NCT04120753]Phase 4106 participants (Actual)Interventional2019-08-26Completed
Amlodipine Plus/Minus Atorvastatin for Protection of Arteries [NCT01922687]Phase 4109 participants (Anticipated)Interventional2011-04-30Recruiting
Fixed Combination for Lipid and Blood Pressure Control. Randomized Cross-over Study [NCT03047538]Phase 40 participants (Actual)Interventional2017-09-01Withdrawn(stopped due to Insufficient funds)
An Open-label, Randomized, Two-sequence, Multiple-dose, Crossover Study to Evaluate Drug-drug Interaction Following Oral Administration of Telmisartan/Amlodipine and Atorvastatin in Healthy Adult Volunteers [NCT03461081]Phase 132 participants (Actual)Interventional2017-05-07Completed
The Effect of Antihypertensive Agents Over Sleep Apnea: a Randomized Controlled Trial [NCT01896661]Phase 353 participants (Actual)Interventional2014-12-31Completed
A Randomized, Open-label, 4-way Crossover Single Dose Clinical Trial to Investigate the Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405 When Administered Alone and in Combination in Healthy Male Volunteers [NCT02387554]Phase 133 participants (Actual)Interventional2014-08-31Completed
An Open-label, Multicenter Study to Evaluate the Efficacy and Tolerability of a 4 Week Therapy With the Fixed Dose Combination of Valsartan 160 mg Plus HCTZ 25 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With the Free Combina [NCT00360178]Phase 3198 participants (Actual)Interventional2006-07-31Completed
Effect of Renin-angiotensin-system (RAS) Blocker Drugs on Chronic Kidney Disease (CKD) Progression in Elderly Patients With Non Proteinuric Nephropathies (PROERCAN01) [NCT03195023]Phase 4106 participants (Anticipated)Interventional2015-06-30Recruiting
The Study Was Approved by the Ethics Committee of Our Institution, Which is Accredited by the Office of Human Research Protection as an Institutional Review Board [NCT02408172]Phase 2/Phase 320 participants (Anticipated)Interventional2013-10-31Recruiting
A Randomized, Multicenter, Study to Determine the Efficacy and Safety of Amlodipine/Benazepril Hydrochloride Versus Enalapril in the Treatment of Hypertension in an African-American Population With Type 2 Diabetes [NCT00367978]Phase 4275 participants (Actual)Interventional2001-12-31Completed
Blood Pressure and Lipids Reduction in High Risk Elderly Patients With Isolated Systolic Hypertension [NCT05165251]Phase 4480 participants (Anticipated)Interventional2022-01-04Recruiting
Vascular Augmentation of Late-life Unremitted Depression (VALUeD) [NCT01557153]Phase 380 participants (Anticipated)Interventional2012-04-30Not yet recruiting
Efficacy and Safety of a Sequential Therapy Change From Candesartan 32 mg to the Fixed Combination of Olmesartan 40 mg/Amlodipine 10 mg in Patients With Poorly Controlled Moderate Hypertension - an Open Phase IV Trial [NCT01611077]Phase 488 participants (Actual)Interventional2012-01-31Completed
A Phase II Study to Explore the Effect of Different Dose of DMTA07 Combine With Amlodipine Treatment in Patients With Hypertension [NCT01614366]Phase 2111 participants (Actual)Interventional2012-07-31Completed
A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients With Dyslipidemia and Hypertension [NCT03088254]Phase 3126 participants (Actual)Interventional2016-09-20Completed
A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension [NCT04488978]Phase 2440 participants (Actual)Interventional2020-05-21Completed
A 10-week Multicenter,Forced-titration Study Using 24-hr ABPM to Evaluate the Efficacy of Valsartan/Hydrochlorothiazide (HCTZ) Treatment Regimen vs Conventional Treatment Regimen With Amlodipine and Hydrochlorothiazide (HCTZ) in Patients With Stage 2 Hype [NCT00425997]Phase 4480 participants (Anticipated)Interventional2006-12-31Completed
An 8-week, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Valsartan/HCTZ/Amlodipine Compared to Valsartan/HCTZ, Valsartan/Amlodipine, and HCTZ/Amlodipine in Patients With Moderate to Severe Hypertension. [NCT00327587]Phase 32,279 participants (Actual)Interventional2006-05-31Completed
A Randomized, Double-blind, Active-controlled, Parallel Group, 52-week Study to Evaluate the Effect of LCZ696 Compared to Olmesartan on Regional Aortic Stiffness in Subjects With Essential Hypertension [NCT01870739]Phase 2115 participants (Actual)Interventional2013-10-31Completed
[NCT00000542]Phase 30 participants Interventional1993-08-31Completed
Interventional Clinical Trial to Assess Efficacy and Safety of the Extemporaneous Combination of Zofenopril Calcium and Amlodipine in Grade 1-2 Hypertensive Patients Versus Each Monotherapy - (MASOLINO Study) [NCT05279807]Phase 4290 participants (Actual)Interventional2021-10-15Completed
Swiss Interventional Study on Silent Ischemia (SWISSI 1) [NCT00382421]0 participants Interventional1992-02-29Completed
An Eight-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 40mg + Amlodipine 10mg Versus Telmisartan 80mg + Amlodipine 10mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequat [NCT00553267]Phase 3947 participants (Actual)Interventional2007-11-30Completed
Upstream-therapy by Telmisartan and Amlodipine Combination for Improvement of Left Atrial Mechanical Function After Pulmonary Vein Antrum Isolation [NCT02734355]Phase 464 participants (Actual)Interventional2015-11-30Completed
An Multicenter Study to Evaluate the Efficacy and Safety of a 5 Week Therapy With the Combination of Valsartan 160 mg Plus Amlodipine 10 mg in Hypertensive Patients Not Adequately Responding to a 5 Week Therapy With Ramipril 5 mg and Felodipine 5 mg [NCT00367939]Phase 3132 participants (Actual)Interventional2005-12-31Completed
"Azilsartan/Amlodipine (Zacras) Combination Tablets LD & HD Specified Drug-use Survey Long-term Use Survey" [NCT02181816]1,090 participants (Actual)Observational2014-06-26Completed
Intensive Management of Blood Pressure and Cholesterol in Elderly Chinese With Hypertension and Atrial Fibrillation (IMPRESSION) [NCT04111419]Phase 41,200 participants (Anticipated)Interventional2020-07-01Recruiting
Efficacy of a Combination of Amlodipine / Valsartan on Blood Pressure Control, With One Nocturnal or Diurnal Intake a Day, in Ambulatory Blood Pressure Monitoring Setting, in Essential Uncontrolled Hypertensive Patients With Amlodipine 5mg ; The ExPERT St [NCT00700271]Phase 4478 participants (Actual)Interventional2007-10-31Completed
Efficacy and Safety of S-amlodipine 2,5 mg and 5 mg in Hypertension Patients: Open-label, Local, Phase IV Study [NCT03038451]Phase 443 participants (Actual)Interventional2013-03-20Completed
Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects: A Single-dose and Two-period Crossover Study [NCT04411875]Phase 148 participants (Actual)Interventional2018-11-13Completed
Single-center, Randomized, Open-label, Parallel-group Study to Characterize Renin-angiotensin-system (RAS) Peptide Profiles Before and After Treatment Initiation With Different Antihypertensive Drug-classes in Patients With Treatment-naive Arterial Hypert [NCT02449811]107 participants (Actual)Observational2015-04-30Completed
A Prospective Randomized Placebo Controlled Study to Evaluate the Effect of Celecoxib on the Efficacy and Safety of Amlodipine in Subjects With Hypertension Requiring Antihypertensive Therapy [NCT02172040]Phase 3152 participants (Actual)Interventional2014-06-26Completed
Effects and Safety of Sacubitril/Valsartan Versus Valsartan on Refractory Hypertension: The EOSORH Trial [NCT05545059]Phase 3138 participants (Anticipated)Interventional2022-09-24Recruiting
A Randomized, 8-week, Double-blind, Parallel-group, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Patients With Essential Hypertension N [NCT01663233]Phase 3266 participants (Actual)Interventional2012-08-31Completed
Lowering Blood Pressure in Primary Care in Vienna [NCT02377661]Phase 4229 participants (Actual)Interventional2015-03-31Completed
Manidipine Versus Amlodipine in Patients With Hypertension: Effects on Peripheral Edema Evaluated by Bioimpedance Analysis [NCT03106597]Phase 446 participants (Actual)Interventional2015-08-20Terminated(stopped due to Difficulty in enrolling subjects)
An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80 mg and Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg vs. Telmisartan 80 mg and Amlodipine 5 mg in Patients With Hypertension Who Fail to Respond Adequately [NCT01975246]Phase 3309 participants (Actual)Interventional2013-11-30Completed
Characterization of Arterial Hypertension and Efficacy of Blood-pressure Lowering Therapy at Different Altitudes Above Sea Level [NCT02373163]Phase 4120 participants (Anticipated)Interventional2014-09-30Recruiting
Hypertension in Young Adults Trial [NCT05370599]Phase 2120 participants (Anticipated)Interventional2022-04-15Recruiting
A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension [NCT01658657]17 participants (Actual)Interventional2012-10-31Completed
Perindopril Amlodipine for the Treatment of Hypertension (PATH): A Multicenter, Randomized, Double-Blind, Parallel-Group Study Evaluating the Efficacy and Safety of a Fixed-Dose Combination of Perindopril Arginine Plus Amlodipine Besylate Versus Perindopr [NCT01556997]Phase 3837 participants (Actual)Interventional2012-02-29Completed
An Open-label, Multiple-dosing, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Amlodipine 10mg and Candesartan 32mg in Healthy Male Volunteers [NCT01926652]Phase 134 participants (Actual)Interventional2013-07-31Completed
Efficacy and Safety of a Single-pill Fixed Combination of Sufficient Losartan/Hydrochlorothiazide in Chinese Hypertensive Patients (FOCUS) [NCT03946514]Phase 4300 participants (Anticipated)Interventional2018-09-01Recruiting
A Two Way Cross Over Pharmacokinetic (PK) Interaction Study Between Raltegravir and Amlodipine in Healthy Volunteers [NCT01841593]Phase 119 participants (Actual)Interventional2013-04-30Completed
Blood Pressure Reduction by Fixed-dose Compared to Free Dose Combination Therapy of ACE Inhibitor and Calcium Antagonist in Hypertensive Patients [NCT02995954]Phase 4100 participants (Actual)Interventional2014-01-31Completed
An Open-label, Randomized, Single-dose, 2X3X3 Partial Replicate, Crossover Study to Compare the Pharmacokinetics and Safety Between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a Fixed Dose Combination of Fimasar [NCT02995720]Phase 160 participants (Actual)Interventional2016-08-26Completed
Changes in Central Aortic Pressure, Endothelial Function and Biomarkers in African Americans With Cardiometabolic Syndrome: Comparison of Amlodipine/Olmesartan Versus Hydrochlorothiazide/Losartan [NCT01271374]Phase 480 participants (Anticipated)Interventional2010-04-30Active, not recruiting
A Randomized, Double-blind 52-week Study to Evaluate the Safety and Efficacy of an LCZ696 Regimen Compared to an Olmesartan Regimen on Arterial Stiffness Through Assessment of Central Blood Pressure in Elderly Patients With Hypertension [NCT01692301]Phase 2454 participants (Actual)Interventional2012-12-31Completed
[NCT03210532]Phase 3129 participants (Actual)Interventional2016-10-07Completed
A Prospective, Multicentre, Randomized, Open Label, Evaluator-Blind, Phase IV Study to Evaluate the Effect on Improvement of Left Ventricular Hypertrophy by the Control of Blood Pressure in Hypertension Patients With Aortic Valve Disease [NCT03666351]Phase 4128 participants (Actual)Interventional2018-10-18Completed
"Unisia Combination Tablets LD, HD Special Drug Use Surveillance Hypertension: Long-Term Use" [NCT02068495]3,409 participants (Actual)Observational2010-06-15Completed
Randomized Controlled Blind End Point Study of Enalapril Folic Acid Tablets Combined With Calcium Antagonist or Diuretic to Prevent Stroke in Patients With Type H Hypertension [NCT04952051]Phase 31,000 participants (Actual)Interventional2014-07-01Completed
Mechanism of Masked Hypertension - Intervention [NCT04121299]Phase 30 participants (Actual)Interventional2021-07-31Withdrawn(stopped due to lack of funding)
Effect of Amlodipine Versus Amlodipine Combined With Atorvastatin on the Symptoms, Function, and Quality of Life in Patients With Coronary Vasospastic Angina [NCT03054467]Phase 4150 participants (Anticipated)Interventional2018-12-01Not yet recruiting
A Phase IV Study, Prospective, Randomised, Open Label, Blinded Endpoint, Parallel Group, 9 Weeks of Comparison Between Oral Administration of Telmisartan Tablet (80mg Once Daily) and Amlodipine Tablet (10 mg Once Daily) on Biological PPAR Gamma Activities [NCT00242814]Phase 4100 participants (Actual)Interventional2005-11-03Completed
An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80 mg and Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg vs. Telmisartan 80 mg and Hydrochlorothiazide 12.5 mg in Patients With Hypertension Who Fail to Respond [NCT01911780]Phase 3132 participants (Actual)Interventional2013-07-31Completed
Evaluation of the Clinical Efficacy and Safety of Amlodipine 5mg/ Bisoprolol Fumarate 5mg /Perindopril Arginine 5mg Fixed-dose Combination in Capsule and Free Monotherapy at the Same Dose in Patients With Uncontrolled Essential Hypertension. A Multicentre [NCT05288400]Phase 3150 participants (Actual)Interventional2018-05-14Completed
An Open-label, Randomised, Single Dose, Three-way Crossover, Parallel Groups Study to Determine the Bioequivalence of Two Fixed Dose Combination (FDC) Tablet Formulations of Amlodipine and Losartan FDC5/50 and FDC5/100 to Respective Reference Dosages in H [NCT01797926]Phase 1102 participants (Actual)Interventional2013-05-23Completed
The 8 Weeks, Multicenter, Randomized, Double-blind, Clinical Study To Evaluate Efficacy Of Treatment With Losartan/Amlodipine 100/5 mg Combination Compared To Amlodipine 10 mg Monotherapy In Hypertensive Patients Who Are Not Appropriately Respond To Amlod [NCT01277822]Phase 4334 participants (Actual)Interventional2011-05-30Completed
Relative Bioavailability Study of Amlodipine Powder for Oral Solution, 5 mg (Base) Under Fasting and Fed Conditions [NCT05808725]Phase 124 participants (Actual)Interventional2022-12-29Completed
Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Amlodipine / Valsartan From Amlodipine/Valsartan 10/160 Tablets (Pharmacare, Palestine) and Exforge Tablets (Novartis Pharma, USA) [NCT02519010]Phase 136 participants (Actual)Interventional2011-03-31Completed
Filtered Trial for Amlodipine Non-responder [NCT00558064]Phase 3531 participants (Actual)Interventional2007-10-31Completed
Randomized, 2-Way, Crossover, Bioequivalence Study of Amlodipine-Benazepril 10mg-20mg Capsules and Lotrel® Administered as 1 x 10 mg-20 mg Capsule in Healthy Subjects Under Fed Conditions. [NCT00835367]Phase 168 participants (Actual)Interventional2004-03-31Completed
An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment [NCT05398393]150 participants (Anticipated)Interventional2022-01-01Enrolling by invitation
Gut Microbiomes and Viromes in Patients With Metabolic Syndrome [NCT03489317]1,000 participants (Anticipated)Observational2017-11-27Recruiting
Efficacy and Safety of Single Pill Combination (Amlodipine/Valsartan) in Hypertensive Patients Not Controlled on Previous Monotherapy: An Observational Real Life Study [NCT03371797]800 participants (Actual)Observational2018-02-20Completed
Management of Hypertension Utilizing Trained Community Health Worker in Rural Municipalities of Nepal (MUTU) Study [NCT04521582]1,428 participants (Actual)Interventional2021-04-27Completed
Bioequivalence of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet Compared to Concomitant Administration of Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet and Amlodipine 5 mg Capsule [NCT02129192]Phase 172 participants (Actual)Interventional2014-05-31Completed
Pharmacokinetics of Multiple Oral Doses of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet, Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet and Telmisartan 80 mg/Amlodipine 5 mg Fixed [NCT02183675]Phase 136 participants (Actual)Interventional2014-07-31Completed
A Single-Arm Open-Label Multicenter Phase IV Clinical Trial to Explore the Blood Pressure Lowering Effect of Exforge® (Amlodipine/Valsartan: AMLO/VAL) in Hypertensive Patients [NCT02062645]Phase 4115 participants (Actual)Interventional2014-02-28Completed
An Open Label, Randomized, Single-dose, 4-period Cross-over Study to Compare the Pharmacokinetics and Safety Following Administration of JLP-1401 and Coadministration of Rosuvastatin and Telmisartan/Amlodipine in Healthy Adult Volunteers [NCT03247140]Phase 140 participants (Actual)Interventional2017-06-10Completed
A Multicenter, Prospective Observational Study to Evaluate the Safety and Efficacy for Levacalm Tab. Versus Valsartan/Amlodipine Combination Therapy in Patient With Essential Hypertension [NCT02415192]2,001 participants (Anticipated)Observational2014-07-31Recruiting
Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes-----renal Substudy [NCT04978649]Phase 40 participants (Actual)Interventional2021-09-01Withdrawn(stopped due to Cooperation plan has been changed)
The SCCS Polypill Pilot Trial [NCT02278471]Phase 2303 participants (Actual)Interventional2015-12-31Completed
Endogenous Renin-Angiotensin-Aldosterone System and Glucose Metabolism [NCT02034435]Phase 444 participants (Actual)Interventional2013-10-31Completed
Series of N-of-1 Crossover Trials of Antihypertensive Therapy in Adolescents With Essential Hypertension [NCT02412761]42 participants (Actual)Interventional2013-06-30Completed
Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension: A Randomized Controlled Noninferiority Trial [NCT04790279]Phase 4132 participants (Actual)Interventional2021-04-09Completed
A Randomized, Double-blind, Parallel Group Study to Evaluate Metabolic Effects of LCZ696 and Amlodipine in Obese Hypertensive Subjects [NCT01631864]Phase 298 participants (Actual)Interventional2012-10-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00000620 (6) [back to overview]Death From Any Cause in the Glycemia Trial.
NCT00000620 (6) [back to overview]First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial.
NCT00000620 (6) [back to overview]First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial.
NCT00000620 (6) [back to overview]First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial.
NCT00000620 (6) [back to overview]First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial.
NCT00000620 (6) [back to overview]Stroke in the Blood Pressure Trial.
NCT00015457 (2) [back to overview]Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo
NCT00015457 (2) [back to overview]Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score
NCT00170950 (3) [back to overview]Time-to-event Analysis of Percentage of Patients With a Cardiovascular (CV) Mortality Event, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke
NCT00170950 (3) [back to overview]Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event
NCT00170950 (3) [back to overview]Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event
NCT00171054 (13) [back to overview]Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Week 12
NCT00171054 (13) [back to overview]Change in Left Ventricular Mass Index (LVMI) and Diastolic Function Using Echocardiography From Baseline to Week 38
NCT00171054 (13) [back to overview]Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 12
NCT00171054 (13) [back to overview]Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Endpoint (Week 38)
NCT00171054 (13) [back to overview]Changes in Central Blood Pressure, Evaluated by Applanation Tonometry From Baseline at Weeks 12 and 38
NCT00171054 (13) [back to overview]Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at Week 12
NCT00171054 (13) [back to overview]Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 38
NCT00171054 (13) [back to overview]Changes in Mean Left Carotid Distensibility at Week 12
NCT00171054 (13) [back to overview]Changes in Mean Left Carotid Distensibility at Week 38
NCT00171054 (13) [back to overview]Changes in Mean Right Carotid Distensibility at Week 12
NCT00171054 (13) [back to overview]Changes in Mean Right Carotid Distensibility at Week 38
NCT00171054 (13) [back to overview]Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at End-point (Week 38)
NCT00171054 (13) [back to overview]Change From Baseline to Week 38 in the Carotid-femoral Pulse Wave Velocity (PWV)
NCT00281580 (46) [back to overview]Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects)
NCT00281580 (46) [back to overview]Change From Baseline in Seated Trough Cuff Mean SBP
NCT00281580 (46) [back to overview]Change From Baseline in Seated Trough Pulse Rate
NCT00281580 (46) [back to overview]Change From Baseline in Standing Trough Cuff Mean DBP
NCT00281580 (46) [back to overview]Change From Baseline in Standing Trough Cuff Mean SBP
NCT00281580 (46) [back to overview]Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)
NCT00281580 (46) [back to overview]BP Control
NCT00281580 (46) [back to overview]DBP Control
NCT00281580 (46) [back to overview]DBP Control
NCT00281580 (46) [back to overview]DBP Response
NCT00281580 (46) [back to overview]DBP Response
NCT00281580 (46) [back to overview]Orthostatic Change in Trough Cuff Mean DBP
NCT00281580 (46) [back to overview]Orthostatic Change in Trough Cuff Mean DBP
NCT00281580 (46) [back to overview]Orthostatic Change in Trough Cuff Mean SBP
NCT00281580 (46) [back to overview]Orthostatic Change in Trough Cuff Mean SBP
NCT00281580 (46) [back to overview]SBP Response
NCT00281580 (46) [back to overview]BP Normality
NCT00281580 (46) [back to overview]BP Normality
NCT00281580 (46) [back to overview]Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP
NCT00281580 (46) [back to overview]Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)
NCT00281580 (46) [back to overview]Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
NCT00281580 (46) [back to overview]Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
NCT00281580 (46) [back to overview]Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
NCT00281580 (46) [back to overview]Change From Baseline in Seated Trough Cuff DBP
NCT00281580 (46) [back to overview]Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)
NCT00281580 (46) [back to overview]Change From Baseline in Seated Trough Pulse Rate
NCT00281580 (46) [back to overview]Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)
NCT00281580 (46) [back to overview]Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)
NCT00281580 (46) [back to overview]Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)
NCT00281580 (46) [back to overview]BP Control
NCT00281580 (46) [back to overview]Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)
NCT00281580 (46) [back to overview]Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect)
NCT00281580 (46) [back to overview]Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP)
NCT00281580 (46) [back to overview]Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP
NCT00281580 (46) [back to overview]SBP Response
NCT00281580 (46) [back to overview]Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP
NCT00281580 (46) [back to overview]Change From Baseline in ABPM 24-hour Mean DBP
NCT00281580 (46) [back to overview]Change From Baseline in ABPM 24-hour Mean DBP
NCT00281580 (46) [back to overview]Change From Baseline in ABPM 24-hour Mean SBP
NCT00281580 (46) [back to overview]Change From Baseline in ABPM 24-hour Mean SBP
NCT00281580 (46) [back to overview]Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)
NCT00281580 (46) [back to overview]Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)
NCT00281580 (46) [back to overview]Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)
NCT00281580 (46) [back to overview]Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)
NCT00281580 (46) [back to overview]Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)
NCT00281580 (46) [back to overview]Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect)
NCT00311155 (6) [back to overview]The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.
NCT00311155 (6) [back to overview]Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved
NCT00311155 (6) [back to overview]Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.
NCT00311155 (6) [back to overview]Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved
NCT00311155 (6) [back to overview]Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
NCT00311155 (6) [back to overview]Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
NCT00368277 (4) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12
NCT00368277 (4) [back to overview]Change From Baseline in the Mean Sitting Diastolic Blood Pressure to Week 36
NCT00368277 (4) [back to overview]Percentage of Patients With Cough
NCT00368277 (4) [back to overview]Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints
NCT00402103 (4) [back to overview]Overall Percentage of Patients With Adverse Events
NCT00402103 (4) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points
NCT00402103 (4) [back to overview]Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg
NCT00402103 (4) [back to overview]Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT00407537 (22) [back to overview]Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12
NCT00407537 (22) [back to overview]Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD
NCT00407537 (22) [back to overview]Change From Baseline in Framingham 10-year Risk of Developing Total CHD
NCT00407537 (22) [back to overview]Change From Baseline in Lipid Parameters at Month 4
NCT00407537 (22) [back to overview]Mean Lipid Parameters at Month 12
NCT00407537 (22) [back to overview]Mean Lipid Parameters at Month 4
NCT00407537 (22) [back to overview]Mean Systolic and Diastolic Blood Pressure at Month 12
NCT00407537 (22) [back to overview]Mean Systolic and Diastolic Blood Pressure at Month 4
NCT00407537 (22) [back to overview]Number of Participants With Increase of Treatment Dosages After 4 Months.
NCT00407537 (22) [back to overview]Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months
NCT00407537 (22) [back to overview]Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months
NCT00407537 (22) [back to overview]Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months
NCT00407537 (22) [back to overview]Change From Baseline in DBP at Month 12
NCT00407537 (22) [back to overview]Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4
NCT00407537 (22) [back to overview]Change From Baseline in SBP at Month 12
NCT00407537 (22) [back to overview]Change From Baseline in Systolic Blood Pressure (SBP) at Month 4
NCT00407537 (22) [back to overview]European SCORE 10-year Risk of Fatal CVD at Month 4
NCT00407537 (22) [back to overview]European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12
NCT00407537 (22) [back to overview]Framingham 10-year Risk of Stroke at Month 12
NCT00407537 (22) [back to overview]Framingham 10-year Risk of Stroke at Month 4
NCT00407537 (22) [back to overview]Framingham 10-year Risk of Total CHD at Month 4
NCT00407537 (22) [back to overview]Change From Baseline in Lipid Parameters at Month 12
NCT00412113 (24) [back to overview]Change From Baseline in LDL at Week 4.
NCT00412113 (24) [back to overview]Change From Baseline in LDL at Week 6.
NCT00412113 (24) [back to overview]Change From Baseline in Total Cholesterol (TC) to Week 6.
NCT00412113 (24) [back to overview]Change From Baseline in Triglycerides (TG) at Week 6.
NCT00412113 (24) [back to overview]Change From Baseline in Triglycerides (TG) to Week 4.
NCT00412113 (24) [back to overview]Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)
NCT00412113 (24) [back to overview]Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.
NCT00412113 (24) [back to overview]Change From Baseline to Week 4 in Pulse Rate
NCT00412113 (24) [back to overview]Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).
NCT00412113 (24) [back to overview]Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk
NCT00412113 (24) [back to overview]Change From Baseline to Week 6 in Pulse Rate
NCT00412113 (24) [back to overview]Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)
NCT00412113 (24) [back to overview]Change in Total Cholesterol (TC) From Baseline to Week 4.
NCT00412113 (24) [back to overview]Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6
NCT00412113 (24) [back to overview]Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4
NCT00412113 (24) [back to overview]Subjects With BP < 140/90 mmHg at Week 4
NCT00412113 (24) [back to overview]Subjects With BP < 140/90 mmHg at Week 6
NCT00412113 (24) [back to overview]Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.
NCT00412113 (24) [back to overview]Subjects With LDL-C < 100 mg/dL at Week 4
NCT00412113 (24) [back to overview]Subjects With LDL-C < 100 mg/dL at Week 6
NCT00412113 (24) [back to overview]Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)
NCT00412113 (24) [back to overview]Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.
NCT00412113 (24) [back to overview]Change From Baseline in HDL at Week 6.
NCT00412113 (24) [back to overview]Change From Baseline in High Density Lipoprotein (HDL) at Week 4.
NCT00413049 (6) [back to overview]Percentage of Patients Achieving a Diastolic Response at the End of the Study (Week 8)
NCT00413049 (6) [back to overview]Change in 24-hour Mean Ambulatory Diastolic and Systolic BP From Baseline at the End of the Study (Week 8)
NCT00413049 (6) [back to overview]Percentage of Patients Achieving Diastolic Control at the End of the Study (Week 8)
NCT00413049 (6) [back to overview]Percentage of Patients Achieving Overall Control at the End of the Study (Week 8)
NCT00413049 (6) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
NCT00413049 (6) [back to overview]Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
NCT00413413 (5) [back to overview]Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8)
NCT00413413 (5) [back to overview]Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
NCT00413413 (5) [back to overview]Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)
NCT00413413 (5) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
NCT00413413 (5) [back to overview]Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8)
NCT00415623 (10) [back to overview]Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8
NCT00415623 (10) [back to overview]Change in Systolic Blood Pressure (SBP) From Baseline to Week 8
NCT00415623 (10) [back to overview]Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient)
NCT00415623 (10) [back to overview]Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient)
NCT00415623 (10) [back to overview]Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Both Weeks 6 and 8
NCT00415623 (10) [back to overview]Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8
NCT00415623 (10) [back to overview]Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8
NCT00415623 (10) [back to overview]Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg
NCT00415623 (10) [back to overview]Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg
NCT00415623 (10) [back to overview]Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Week 8
NCT00417170 (5) [back to overview]Mean Change in Insulin Concentration as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment
NCT00417170 (5) [back to overview]Mean Change in Arterial Compliance as Measured by Pulse Wave Analysis From Baseline and After 12 Weeks of Treatment
NCT00417170 (5) [back to overview]Mean Change From Baseline in Inflammatory Marker ( C-peptide) as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment [Time Frame: At Baseline and After 12 Weeks of Treatment
NCT00417170 (5) [back to overview]Mean Change in Insulin Sensitivity as Measured by Glucose Infusion Rate (Last 30 Minutes) From Baseline and After 12 Weeks of Treatment.
NCT00417170 (5) [back to overview]Mean Change in Endothelial Function as Measured by Myocardial Blood Flow (MBF) From Baseline and After 12 Weeks of Treatment
NCT00425373 (5) [back to overview]Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8)
NCT00425373 (5) [back to overview]Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8)
NCT00425373 (5) [back to overview]Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Study (Week 8)
NCT00425373 (5) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8)
NCT00425373 (5) [back to overview]Percentage of Patients Achieving MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8)
NCT00437645 (5) [back to overview]Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8
NCT00437645 (5) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8
NCT00437645 (5) [back to overview]Percentage of Patients With Peripheral Edema From Baseline to Week 8
NCT00437645 (5) [back to overview]Percentage of Patients Achieving a Systolic Response at Weeks 4, 8, and 12
NCT00437645 (5) [back to overview]Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP, msDBP) From Baseline to Weeks 4, 8, and 12
NCT00439738 (7) [back to overview]Change in Mean Sitting Systolic Blood Pressure (MSSBP)
NCT00439738 (7) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (MSDBP)
NCT00439738 (7) [back to overview]Change From Baseline in Postprandial Glucose
NCT00439738 (7) [back to overview]Change From Baseline in Postprandial Non-esterified Fatty Acids
NCT00439738 (7) [back to overview]Change From Baseline in Postprandial Insulin
NCT00439738 (7) [back to overview]Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)
NCT00439738 (7) [back to overview]Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)
NCT00443456 (12) [back to overview]Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
NCT00443456 (12) [back to overview]Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study
NCT00443456 (12) [back to overview]Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent
NCT00443456 (12) [back to overview]Change in Systolic Blood Pressure From Baseline of This Long-term Study
NCT00443456 (12) [back to overview]Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value
NCT00443456 (12) [back to overview]Change in Diastolic Blood Pressure From Baseline of This Long-term Study
NCT00443456 (12) [back to overview]Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
NCT00443456 (12) [back to overview]Change in Diastolic Blood Pressure From Baseline of the Preceding Study
NCT00443456 (12) [back to overview]Change in Systolic Blood Pressure From Baseline of the Preceding Study
NCT00443456 (12) [back to overview]Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
NCT00443456 (12) [back to overview]Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
NCT00443456 (12) [back to overview]Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
NCT00446563 (15) [back to overview]Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI
NCT00446563 (15) [back to overview]Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI
NCT00446563 (15) [back to overview]Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI
NCT00446563 (15) [back to overview]Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI
NCT00446563 (15) [back to overview]Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI
NCT00446563 (15) [back to overview]Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI
NCT00446563 (15) [back to overview]Percentage of Participants Achieving Target Blood Pressure at Week 52
NCT00446563 (15) [back to overview]Percentage of Participants Who Experienced Adverse Events (AEs)
NCT00446563 (15) [back to overview]Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI
NCT00446563 (15) [back to overview]Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI
NCT00446563 (15) [back to overview]Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI
NCT00446563 (15) [back to overview]Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)
NCT00446563 (15) [back to overview]Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP)
NCT00446563 (15) [back to overview]Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP)
NCT00446563 (15) [back to overview]Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI
NCT00498433 (11) [back to overview]Part 2: Number of Participants With Reported Any Adverse Events, Serious Adverse Events and Death
NCT00498433 (11) [back to overview]Part 1: Aliskiren Concentrations From Tissue at the End of Aliskiren Treatment Period
NCT00498433 (11) [back to overview]Part 1: Amlodipine Concentrations From Plasma at the End of Amlodipine Treatment Period
NCT00498433 (11) [back to overview]Part 1: Renin Concentrations From Plasma During Aliskiren Treatment Period
NCT00498433 (11) [back to overview]Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period
NCT00498433 (11) [back to overview]Part 1: Angiotensin II Levels in Plasma During Aliskiren Treatment Period
NCT00498433 (11) [back to overview]Part 1: Angiotensin II Levels in Plasma During Amlodipine Treatment Period
NCT00498433 (11) [back to overview]Part 1: Renin Activity From Plasma During Aliskiren Treatment Period
NCT00498433 (11) [back to overview]Part 1: Renin Activity From Plasma During Amlodipine Treatment Period
NCT00498433 (11) [back to overview]Part 1: Aliskiren Concentrations From Plasma at the End of Aliskiren Treatment Period
NCT00498433 (11) [back to overview]Part 1: Renin Concentrations From Plasma During Amlodipine Treatment Period
NCT00523549 (7) [back to overview]Percent Change From Baseline in Vascular Stiffness
NCT00523549 (7) [back to overview]Change in Ratio of Peak E Wave Velocity/Lateral Mitral Annular Myocardial Relaxation Velocity
NCT00523549 (7) [back to overview]Change in Lateral Mitral Annular Myocardial Relaxation Velocity
NCT00523549 (7) [back to overview]Change in Left Atrial Size
NCT00523549 (7) [back to overview]Change in Estimated Central Aortic Pressure
NCT00523549 (7) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT00523549 (7) [back to overview]Change in Mean Sitting Systolic Blood Pressure (msSBP)
NCT00523744 (12) [back to overview]Change in Sitting Pulse Pressure During the Core Phase of the Study
NCT00523744 (12) [back to overview]Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study
NCT00523744 (12) [back to overview]Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study
NCT00523744 (12) [back to overview]Change in Sitting Pulse Rate During the Extension Phase of the Study
NCT00523744 (12) [back to overview]Change in Sitting Pulse Rate During the Core Phase of the Study
NCT00523744 (12) [back to overview]Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study
NCT00523744 (12) [back to overview]Change in Sitting Pulse Pressure During the Extension Phase of the Study
NCT00523744 (12) [back to overview]Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study
NCT00523744 (12) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study
NCT00523744 (12) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study
NCT00523744 (12) [back to overview]Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Extension Phase of the Study
NCT00523744 (12) [back to overview]Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study
NCT00527514 (6) [back to overview]Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring
NCT00527514 (6) [back to overview]Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group.
NCT00527514 (6) [back to overview]Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group
NCT00527514 (6) [back to overview]Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 10 mg + Olmesartan 40 mg Group
NCT00527514 (6) [back to overview]Change From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure
NCT00527514 (6) [back to overview]Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group.
NCT00530946 (11) [back to overview]Percent Change in Triglycerides From Baseline to Each Observation Point
NCT00530946 (11) [back to overview]Change in Systolic Blood Pressure
NCT00530946 (11) [back to overview]Change in Diastolic Blood Pressure From Baseline to Each Observation Point
NCT00530946 (11) [back to overview]Percent Change in Low Density Lipoprotein-Cholesterol
NCT00530946 (11) [back to overview]Change in Apolipoprotein B From Baseline to Each Observation Point
NCT00530946 (11) [back to overview]Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point
NCT00530946 (11) [back to overview]Change in Systolic Blood Pressure From Baseline to Each Observation Point
NCT00530946 (11) [back to overview]Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point
NCT00530946 (11) [back to overview]Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
NCT00530946 (11) [back to overview]Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
NCT00530946 (11) [back to overview]Percent Change in Total Cholesterol From Baseline to Each Observation Point
NCT00535925 (2) [back to overview]"Number of Participants Who Achieved of BP, HbA1c and Total, HDL and LDL Cholesterol Goals at the End of Intervention Phase"
NCT00535925 (2) [back to overview]"Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs)"
NCT00542269 (10) [back to overview]Change in HOMA-IR From Baseline to End of Study
NCT00542269 (10) [back to overview]Percentage of Patients Who Developed Diabetes at End of Study
NCT00542269 (10) [back to overview]Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine)
NCT00542269 (10) [back to overview]Percentage of Patients Who Achieved Normalized Blood Pressure at End of Study
NCT00542269 (10) [back to overview]Change in HbA1c (Glycated Hemoglobin) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine)
NCT00542269 (10) [back to overview]Change in HbA1c (Glycated Hemoglobin) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine
NCT00542269 (10) [back to overview]Change in HOMA-β From Baseline to End of Study
NCT00542269 (10) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine
NCT00542269 (10) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine
NCT00542269 (10) [back to overview]Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine
NCT00550953 (8) [back to overview]Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
NCT00550953 (8) [back to overview]Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)
NCT00550953 (8) [back to overview]Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline)
NCT00550953 (8) [back to overview]Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)
NCT00550953 (8) [back to overview]Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks
NCT00550953 (8) [back to overview]Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)
NCT00550953 (8) [back to overview]Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)
NCT00550953 (8) [back to overview]Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks
NCT00553267 (10) [back to overview]Change From Baseline in Trough Seated Diastolic Blood Pressure
NCT00553267 (10) [back to overview]Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg)
NCT00553267 (10) [back to overview]Trough Seated SBP Control
NCT00553267 (10) [back to overview]Trough Seated SBP Response
NCT00553267 (10) [back to overview]Trough Seated BP Normality Classes
NCT00553267 (10) [back to overview]Change From Baseline in Trough Seated Systolic Blood Pressure
NCT00553267 (10) [back to overview]Trough Seated Diastolic Blood Pressure <80 mmHg
NCT00553267 (10) [back to overview]Oedema Incidence Rate
NCT00553267 (10) [back to overview]Peripheral Oedema Incidence Rate
NCT00553267 (10) [back to overview]Trough Seated DBP Response
NCT00558064 (8) [back to overview]Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing)
NCT00558064 (8) [back to overview]Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)
NCT00558064 (8) [back to overview]Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
NCT00558064 (8) [back to overview]Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)
NCT00558064 (8) [back to overview]Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks
NCT00558064 (8) [back to overview]Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)
NCT00558064 (8) [back to overview]Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)
NCT00558064 (8) [back to overview]Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing)
NCT00558428 (8) [back to overview]Trough Seated SBP Control
NCT00558428 (8) [back to overview]Trough Seated Blood Pressure (BP) Normality Classes
NCT00558428 (8) [back to overview]Trough Seated DBP Response
NCT00558428 (8) [back to overview]Number of Patients With Oedema
NCT00558428 (8) [back to overview]Change From Baseline in Trough Seated Systolic Blood Pressure (SBP)
NCT00558428 (8) [back to overview]Trough Seated SBP Response
NCT00558428 (8) [back to overview]Trough Seated Diastolic Blood Pressure Control
NCT00558428 (8) [back to overview]Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP)
NCT00568178 (5) [back to overview]Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12
NCT00568178 (5) [back to overview]Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36
NCT00568178 (5) [back to overview]Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36
NCT00568178 (5) [back to overview]Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12
NCT00568178 (5) [back to overview]Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12
NCT00591266 (15) [back to overview]Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00591266 (15) [back to overview]Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00591266 (15) [back to overview]Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00591266 (15) [back to overview]Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00591266 (15) [back to overview]Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
NCT00591266 (15) [back to overview]Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
NCT00591266 (15) [back to overview]Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure
NCT00591266 (15) [back to overview]Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00591266 (15) [back to overview]Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00591266 (15) [back to overview]Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.
NCT00591266 (15) [back to overview]Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response
NCT00591266 (15) [back to overview]Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg
NCT00591266 (15) [back to overview]Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg
NCT00591266 (15) [back to overview]Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00591266 (15) [back to overview]Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00614380 (14) [back to overview]Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7
NCT00614380 (14) [back to overview]Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7
NCT00614380 (14) [back to overview]Change From Baseline in Trough Seated Diastolic Blood Pressure
NCT00614380 (14) [back to overview]Change From Baseline in Trough Seated Systolic Blood Pressure
NCT00614380 (14) [back to overview]Additional Reduction in SBP by Use of Additional Antihypertensive Therapy
NCT00614380 (14) [back to overview]Additional Reduction in DBP by Use of Additional Antihypertensive Therapy
NCT00614380 (14) [back to overview]Trough Seated Systolic Blood Pressure (SBP) Control
NCT00614380 (14) [back to overview]Trough Seated SBP Response
NCT00614380 (14) [back to overview]Trough Seated Diastolic Blood Pressure (DBP) Control
NCT00614380 (14) [back to overview]Trough Seated DBP Response
NCT00614380 (14) [back to overview]Trough DBP Control Pre- and Post- Uptitration
NCT00614380 (14) [back to overview]Trough Blood Pressure (BP) Normality Classes
NCT00614380 (14) [back to overview]Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control
NCT00614380 (14) [back to overview]Time to First Additional Antihypertensive
NCT00618774 (13) [back to overview]Seated DBP Control Rate at Trough After 6 and 12 Months
NCT00618774 (13) [back to overview]Change From Baseline in Seated Diastolic Blood Pressure at Week 8
NCT00618774 (13) [back to overview]Change From Baseline in Seated Systolic Blood Pressure at Week 8
NCT00618774 (13) [back to overview]Percentage of Participants Who Experienced Adverse Events
NCT00618774 (13) [back to overview]Seated DBP Control Rate at Trough After 8 Weeks
NCT00618774 (13) [back to overview]Seated SBP Control Rate at Trough After 8 Weeks
NCT00618774 (13) [back to overview]Change From Baseline in Seated Diastolic Blood Pressure
NCT00618774 (13) [back to overview]Change From Baseline in Seated Systolic Blood Pressure
NCT00618774 (13) [back to overview]Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
NCT00618774 (13) [back to overview]Seated Blood Pressure Normalisation at Trough
NCT00618774 (13) [back to overview]Seated DBP Response Rate at Trough
NCT00618774 (13) [back to overview]Seated SBP Control Rate at Trough After 6 and 12 Months
NCT00618774 (13) [back to overview]Seated SBP Response Rate at Trough
NCT00624052 (14) [back to overview]Additional Reduction in DBP by Use of Additional Antihypertensive Therapy
NCT00624052 (14) [back to overview]Additional Reduction in SBP by Use of Additional Antihypertensive Therapy
NCT00624052 (14) [back to overview]Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure
NCT00624052 (14) [back to overview]Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure
NCT00624052 (14) [back to overview]Trough Seated DBP Response
NCT00624052 (14) [back to overview]Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
NCT00624052 (14) [back to overview]Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
NCT00624052 (14) [back to overview]Time to First Additional Antihypertensive
NCT00624052 (14) [back to overview]Trough Seated Diastolic Blood Pressure (DBP) Control
NCT00624052 (14) [back to overview]Trough Seated Systolic Blood Pressure (SBP) Control
NCT00624052 (14) [back to overview]Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control
NCT00624052 (14) [back to overview]Trough BP Normality Classes
NCT00624052 (14) [back to overview]Trough DBP Control Pre- and Post- Uptitration
NCT00624052 (14) [back to overview]Trough Seated SBP Response
NCT00626743 (2) [back to overview]Maximal Change From Baseline in Standing DBP
NCT00626743 (2) [back to overview]Maximal Change From Baseline in Standing SBP
NCT00649389 (4) [back to overview]Change in Mean 24-hour Ambulatory Blood Pressure From Baseline to Week 12 or Early Termination
NCT00649389 (4) [back to overview]Percentage of Subjects Who Reached Blood Pressure Goal (<140/90 mmHg; <130/80 mmHg for Subjects With Diabetes, Chronic Renal Disease, or Chronic Cardiovascular Disease)by 12 Weeks
NCT00649389 (4) [back to overview]Change in Seated Systolic Blood Pressure From Baseline to Week 12
NCT00649389 (4) [back to overview]Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP).
NCT00654745 (29) [back to overview]Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12
NCT00654745 (29) [back to overview]Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9
NCT00654745 (29) [back to overview]Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6
NCT00654745 (29) [back to overview]Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6
NCT00654745 (29) [back to overview]Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment
NCT00654745 (29) [back to overview]Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3
NCT00654745 (29) [back to overview]Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18
NCT00654745 (29) [back to overview]Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12
NCT00654745 (29) [back to overview]Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12
NCT00654745 (29) [back to overview]Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9
NCT00654745 (29) [back to overview]Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
NCT00654745 (29) [back to overview]Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
NCT00654745 (29) [back to overview]Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12
NCT00654745 (29) [back to overview]Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
NCT00654745 (29) [back to overview]Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
NCT00654745 (29) [back to overview]Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
NCT00654745 (29) [back to overview]Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment
NCT00654745 (29) [back to overview]Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment
NCT00654745 (29) [back to overview]Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12
NCT00654745 (29) [back to overview]Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
NCT00654745 (29) [back to overview]Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15
NCT00654745 (29) [back to overview]Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions
NCT00654745 (29) [back to overview]Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12
NCT00654745 (29) [back to overview]Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
NCT00654745 (29) [back to overview]Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
NCT00654745 (29) [back to overview]Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12
NCT00654745 (29) [back to overview]Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15
NCT00654745 (29) [back to overview]Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18
NCT00654745 (29) [back to overview]Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3
NCT00661895 (1) [back to overview]Percentage of Subjects Achieving Blood Pressure Goals
NCT00666536 (6) [back to overview]Change From Baseline to Weeks 2, 8 and 12 in MSDBP
NCT00666536 (6) [back to overview]Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)
NCT00666536 (6) [back to overview]Change From Baseline to Weeks 2, 8 and 12 in MSSBP
NCT00666536 (6) [back to overview]Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)
NCT00666536 (6) [back to overview]Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12
NCT00666536 (6) [back to overview]Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12
NCT00667719 (6) [back to overview]Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Diastolic Blood Pressure
NCT00667719 (6) [back to overview]Percentage of Participants Achieving the Blood Pressure Control Target of <140/90 mmHg
NCT00667719 (6) [back to overview]Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Death
NCT00667719 (6) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
NCT00667719 (6) [back to overview]Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT00667719 (6) [back to overview]Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Systolic Blood Pressure
NCT00687973 (11) [back to overview]Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)
NCT00687973 (11) [back to overview]Change From Baseline of SBP/DBP at Week 24 (Office BP)
NCT00687973 (11) [back to overview]Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center)
NCT00687973 (11) [back to overview]Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement)
NCT00687973 (11) [back to overview]Change From Baseline of Pulse Pressure at Week 24 (Office BP)
NCT00687973 (11) [back to overview]Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement)
NCT00687973 (11) [back to overview]Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement)
NCT00687973 (11) [back to overview]Change From Baseline of Augmentation Index (Aix) at Week 8
NCT00687973 (11) [back to overview]Change From Baseline of Aix Corrected to Heart Rate at Week 24
NCT00687973 (11) [back to overview]Change From Baseline of Aix at Week 24
NCT00687973 (11) [back to overview]Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center)
NCT00699192 (5) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
NCT00699192 (5) [back to overview]Percentage of Patients Achieving a Systolic Blood Pressure Response at Week 8
NCT00699192 (5) [back to overview]Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)
NCT00699192 (5) [back to overview]Percentage of Patients Achieving Systolic Blood Pressure Control at the End of the Study (Week 8)
NCT00699192 (5) [back to overview]Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
NCT00700271 (11) [back to overview]Absolute Reduction From Baseline in Nocturnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring
NCT00700271 (11) [back to overview]Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) Variation Between Week 0 and Week 8 in Office Blood Pressure
NCT00700271 (11) [back to overview]Absolute Reduction From Baseline in 6-hour Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring
NCT00700271 (11) [back to overview]Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) Variation Between Week -4 to Week 8 in Office Blood Pressure
NCT00700271 (11) [back to overview]Percentage of Participants With Nocturnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 120/70 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring
NCT00700271 (11) [back to overview]Absolute Reduction From Baseline in Diurnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring
NCT00700271 (11) [back to overview]Absolute Reduction From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring
NCT00700271 (11) [back to overview]Absolute Reduction From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) on Ambulatory Blood Pressure Monitoring
NCT00700271 (11) [back to overview]Percentage of Participants With 24-hour Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 125/80 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring
NCT00700271 (11) [back to overview]Percentage of Participants With Diurnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 135/85 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring
NCT00700271 (11) [back to overview]Percentage of Participants With Controlled Office Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) at Endpoint
NCT00739596 (5) [back to overview]Percentage of Participants Achieving BP Control After 8 Weeks of Treatment
NCT00739596 (5) [back to overview]Percentage of Responders After 8 Weeks of Treatment.
NCT00739596 (5) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (MSDBP) After 8 Weeks of Treatment
NCT00739596 (5) [back to overview]Change in Mean Sitting Pulse Pressure (MSPP) After 8 Weeks of Treatment
NCT00739596 (5) [back to overview]Change in Mean Sitting Systolic Blood Pressure (MSSBP) After 8 Weeks of Treatment
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT00739973 (27) [back to overview]Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study
NCT00739973 (27) [back to overview]Percentage of Patients Achieving a Successful Systolic Blood Pressure Response
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT00739973 (27) [back to overview]Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (mssBP)
NCT00739973 (27) [back to overview]Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT00765674 (4) [back to overview]Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8)
NCT00765674 (4) [back to overview]Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
NCT00765674 (4) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
NCT00765674 (4) [back to overview]Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8)
NCT00765947 (4) [back to overview]Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP]
NCT00765947 (4) [back to overview]Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen
NCT00765947 (4) [back to overview]Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients.
NCT00765947 (4) [back to overview]Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP]
NCT00777946 (6) [back to overview]Number of Participants With Serious Adverse Events and Adverse Events
NCT00777946 (6) [back to overview]Percentage of Participants Achieving Blood Pressure Control
NCT00777946 (6) [back to overview]Percentage of Participants Achieving a Systolic Blood Pressure Response
NCT00777946 (6) [back to overview]Percentage of Participants Achieving a Diastolic Blood Pressure Response
NCT00777946 (6) [back to overview]Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP)
NCT00777946 (6) [back to overview]Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP)
NCT00778921 (3) [back to overview]Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study
NCT00778921 (3) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study
NCT00778921 (3) [back to overview]Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group
NCT00787605 (6) [back to overview]Evaluate the Safety and Tolerability
NCT00787605 (6) [back to overview]Percentage of Responders
NCT00787605 (6) [back to overview]Biomarker Measurements
NCT00787605 (6) [back to overview]Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT00787605 (6) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
NCT00787605 (6) [back to overview]Percentage of Patients Achieving Blood Pressure Control
NCT00789321 (2) [back to overview]Change From Baseline in Foot Volume by Water Displacement (Weight of Water Displaced) at Week 2
NCT00789321 (2) [back to overview]Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2
NCT00791258 (59) [back to overview]Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks
NCT00791258 (59) [back to overview]Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks
NCT00791258 (59) [back to overview]Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks
NCT00791258 (59) [back to overview]Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks
NCT00791258 (59) [back to overview]Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks
NCT00791258 (59) [back to overview]Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks
NCT00791258 (59) [back to overview]Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks
NCT00791258 (59) [back to overview]Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks
NCT00791258 (59) [back to overview]Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values
NCT00791258 (59) [back to overview]The Percentage of Subjects Achieving Seated Diastolic BP Goal (<90 mmHg for Non-diabetics or < 80 mmHg for Subjects With Diabetes) From Baseline to 12 Weeks
NCT00791258 (59) [back to overview]Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks
NCT00791258 (59) [back to overview]Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks
NCT00791258 (59) [back to overview]Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values
NCT00791258 (59) [back to overview]Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00791258 (59) [back to overview]Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
NCT00797862 (7) [back to overview]Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints
NCT00797862 (7) [back to overview]Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks
NCT00797862 (7) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24
NCT00797862 (7) [back to overview]Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32
NCT00797862 (7) [back to overview]Overall Mean Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Over 8, 16, and 24 Weeks
NCT00797862 (7) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 32
NCT00797862 (7) [back to overview]Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24
NCT00818779 (5) [back to overview]Plasminogen Activator Inhibitor 1
NCT00818779 (5) [back to overview]Serum Level of Nitric Oxide
NCT00818779 (5) [back to overview]Serum Level of Intracellular Cell Adhesion Molecule
NCT00818779 (5) [back to overview]Serum Level of Vascular Cell Adhesion Molecule
NCT00818779 (5) [back to overview]Serum Level of C-reactive Protein
NCT00834977 (9) [back to overview]AUC0-inf - Benazepril
NCT00834977 (9) [back to overview]AUC0-t - Amlodipine
NCT00834977 (9) [back to overview]AUC0-inf - Benazeprilat
NCT00834977 (9) [back to overview]AUC0-t - Benazaprilat
NCT00834977 (9) [back to overview]AUC0-inf - Amlodipine
NCT00834977 (9) [back to overview]AUC0-t - Benazepril
NCT00834977 (9) [back to overview]Cmax - Amlodipine
NCT00834977 (9) [back to overview]Cmax - Benazepril
NCT00834977 (9) [back to overview]Cmax - Benazeprilat
NCT00835367 (9) [back to overview]Cmax - Benazepril
NCT00835367 (9) [back to overview]Cmax - Benazeprilat
NCT00835367 (9) [back to overview]AUC0-t - Amlodipine
NCT00835367 (9) [back to overview]AUC0-inf - Amlodipine
NCT00835367 (9) [back to overview]AUC0-inf - Benazepril
NCT00835367 (9) [back to overview]AUC0-inf - Benazeprilat
NCT00835367 (9) [back to overview]AUC0-t - Benazepril
NCT00835367 (9) [back to overview]AUC0-t - Benazeprilat
NCT00835367 (9) [back to overview]Cmax - Amlodipine
NCT00841542 (3) [back to overview]AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
NCT00841542 (3) [back to overview]Cmax - Maximum Observed Concentration
NCT00841542 (3) [back to overview]AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
NCT00841672 (5) [back to overview]Mean Sitting Systolic Blood Pressure (msSBP)
NCT00841672 (5) [back to overview]Mean Sitting Diastolic Blood Pressure (msDBP)
NCT00841672 (5) [back to overview]Systolic Blood Pressure Response
NCT00841672 (5) [back to overview]Blood Pressure Control
NCT00841672 (5) [back to overview]Diastolic Blood Pressure Response
NCT00841815 (3) [back to overview]AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
NCT00841815 (3) [back to overview]Cmax - Maximum Observed Concentration
NCT00841815 (3) [back to overview]AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
NCT00853957 (6) [back to overview]Percentage of Patients With Peripheral Edema by Visit
NCT00853957 (6) [back to overview]Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT00853957 (6) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
NCT00853957 (6) [back to overview]Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)
NCT00853957 (6) [back to overview]Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)
NCT00853957 (6) [back to overview]Change From Baseline in MSSBP at Week 1 and 4
NCT00860262 (35) [back to overview]Patients Achieving Systolic Blood Pressure Response at Week 2
NCT00860262 (35) [back to overview]Patients Achieving Systolic Blood Pressure Response at Week 4
NCT00860262 (35) [back to overview]Patients Achieving Systolic Blood Pressure Response at Week 6
NCT00860262 (35) [back to overview]Patients Achieving Systolic Blood Pressure Response at Week 8
NCT00860262 (35) [back to overview]Patients Achieving Diastolic Blood Pressure Response at Week 2
NCT00860262 (35) [back to overview]Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8
NCT00860262 (35) [back to overview]Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1
NCT00860262 (35) [back to overview]Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2
NCT00860262 (35) [back to overview]Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4
NCT00860262 (35) [back to overview]Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6
NCT00860262 (35) [back to overview]Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8
NCT00860262 (35) [back to overview]Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1
NCT00860262 (35) [back to overview]Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2
NCT00860262 (35) [back to overview]Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4
NCT00860262 (35) [back to overview]Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6
NCT00860262 (35) [back to overview]Number of Patients Achieving Various Blood Pressure Response Levels at Week 1
NCT00860262 (35) [back to overview]Number of Patients Achieving Various Blood Pressure Response Levels at Week 2
NCT00860262 (35) [back to overview]Patients Achieving Blood Pressure Control at Week 1
NCT00860262 (35) [back to overview]Patients Achieving Blood Pressure Control at Week 2
NCT00860262 (35) [back to overview]Patients Achieving Blood Pressure Control at Week 4
NCT00860262 (35) [back to overview]Patients Achieving Blood Pressure Control at Week 6
NCT00860262 (35) [back to overview]Patients Achieving Blood Pressure Control at Week 8
NCT00860262 (35) [back to overview]Patients Achieving Diastolic Blood Pressure Control at Week 1
NCT00860262 (35) [back to overview]Patients Achieving Diastolic Blood Pressure Control at Week 2
NCT00860262 (35) [back to overview]Patients Achieving Diastolic Blood Pressure Control at Week 4
NCT00860262 (35) [back to overview]Patients Achieving Diastolic Blood Pressure Control at Week 6
NCT00860262 (35) [back to overview]Patients Achieving Diastolic Blood Pressure Control at Week 8
NCT00860262 (35) [back to overview]Patients Achieving Diastolic Blood Pressure Response at Week 1
NCT00860262 (35) [back to overview]Patients Achieving Diastolic Blood Pressure Response at Week 4
NCT00860262 (35) [back to overview]Patients Achieving Diastolic Blood Pressure Response at Week 6
NCT00860262 (35) [back to overview]Patients Achieving Diastolic Blood Pressure Response at Week 8
NCT00860262 (35) [back to overview]Patients Achieving Normal Blood Pressure Response at Week 4
NCT00860262 (35) [back to overview]Patients Achieving Normal Blood Pressure Response at Week 6
NCT00860262 (35) [back to overview]Patients Achieving Normal Blood Pressure Response at Week 8
NCT00860262 (35) [back to overview]Patients Achieving Systolic Blood Pressure Response at Week 1
NCT00867490 (12) [back to overview]Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study
NCT00867490 (12) [back to overview]Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study
NCT00867490 (12) [back to overview]Change in Sitting Pulse Pressure During the Extension Phase of the Study
NCT00867490 (12) [back to overview]Change in Sitting Pulse Rate During the Extension Phase of the Study
NCT00867490 (12) [back to overview]Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study
NCT00867490 (12) [back to overview]Change in Sitting Pulse Pressure During the Core Phase of the Study
NCT00867490 (12) [back to overview]Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study
NCT00867490 (12) [back to overview]Change in Sitting Pulse Rate During the Core Phase of the Study
NCT00867490 (12) [back to overview]Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study
NCT00867490 (12) [back to overview]Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study
NCT00867490 (12) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study
NCT00867490 (12) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study
NCT00877929 (41) [back to overview]Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1
NCT00877929 (41) [back to overview]BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks
NCT00877929 (41) [back to overview]Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8
NCT00877929 (41) [back to overview]SBP Control 130 at One Week
NCT00877929 (41) [back to overview]SBP Control 130 at Six Weeks
NCT00877929 (41) [back to overview]SBP Response 140 at One Week
NCT00877929 (41) [back to overview]SBP Response 140 at Two Weeks
NCT00877929 (41) [back to overview]BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks
NCT00877929 (41) [back to overview]BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week
NCT00877929 (41) [back to overview]BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks
NCT00877929 (41) [back to overview]BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks
NCT00877929 (41) [back to overview]BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks
NCT00877929 (41) [back to overview]BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week
NCT00877929 (41) [back to overview]BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks
NCT00877929 (41) [back to overview]Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks
NCT00877929 (41) [back to overview]BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks
NCT00877929 (41) [back to overview]SBP Control 140 at Two Weeks
NCT00877929 (41) [back to overview]SBP Response 130 at Eight Weeks
NCT00877929 (41) [back to overview]SBP Response 130 at Four Weeks
NCT00877929 (41) [back to overview]SBP Response 130 at One Week
NCT00877929 (41) [back to overview]SBP Response 130 at Six Weeks
NCT00877929 (41) [back to overview]SBP Response 130 at Two Weeks
NCT00877929 (41) [back to overview]SBP Response 140 at Eight Weeks
NCT00877929 (41) [back to overview]SBP Response 140 at Four Weeks
NCT00877929 (41) [back to overview]SBP Control 130 at Four Weeks
NCT00877929 (41) [back to overview]SBP Response 140 at Six Weeks
NCT00877929 (41) [back to overview]Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6
NCT00877929 (41) [back to overview]Systolic Blood Pressure (SBP) Control 140 at Eight Weeks
NCT00877929 (41) [back to overview]Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4
NCT00877929 (41) [back to overview]Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2
NCT00877929 (41) [back to overview]SBP Control 130 at Two Weeks
NCT00877929 (41) [back to overview]SBP Control 140 at Four Weeks
NCT00877929 (41) [back to overview]SBP Control 140 at Six Weeks
NCT00877929 (41) [back to overview]SBP Control 140 at One Week
NCT00877929 (41) [back to overview]Change From Baseline in Urine Albumin:Creatinine Ratio (UACR)
NCT00877929 (41) [back to overview]SBP Control 130 at Eight Weeks
NCT00877929 (41) [back to overview]DBP Response at Week Two
NCT00877929 (41) [back to overview]DBP Response at Week One
NCT00877929 (41) [back to overview]DBP Response at Week Four
NCT00877929 (41) [back to overview]DBP Response at Six Weeks
NCT00877929 (41) [back to overview]DBP Response at Eight Weeks
NCT00890591 (4) [back to overview]Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)
NCT00890591 (4) [back to overview]Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)
NCT00890591 (4) [back to overview]Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in First Titrated Group (Olmesartan 20 mg + 12.5 mg Hydrochlorothiazide)
NCT00890591 (4) [back to overview]Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)
NCT00902304 (12) [back to overview]Change in Self-care Behavior Score From Baseline to Week 26
NCT00902304 (12) [back to overview]Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments
NCT00902304 (12) [back to overview]Number of Patients With Depression
NCT00902304 (12) [back to overview]Number of Patients With Major Clinical Endpoints
NCT00902304 (12) [back to overview]Participants With End Organ Disease at Baseline and Week 26
NCT00902304 (12) [back to overview]Change in Mean Sitting Diastolic Blood Pressure
NCT00902304 (12) [back to overview]Change in Absolute Cardiovascular Risk Score
NCT00902304 (12) [back to overview]Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26
NCT00902304 (12) [back to overview]Change in Mean Sitting Systolic Blood Pressure
NCT00902304 (12) [back to overview]Change in the EQ-5D Score
NCT00902304 (12) [back to overview]Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy
NCT00902304 (12) [back to overview]Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target
NCT00902538 (10) [back to overview]Change in 24-hour Diastolic Blood Pressure (DBP) Assessed by 24-hour Ambulatory Blood Pressure Measurement (ABPM).
NCT00902538 (10) [back to overview]Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.
NCT00902538 (10) [back to overview]Change in Seated Diastolic Blood Pressure (SeDBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg
NCT00902538 (10) [back to overview]Change in Seated Systolic Blood Pressure (SeSBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg
NCT00902538 (10) [back to overview]In Non-responders, the Change in 24-hour Diastolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.
NCT00902538 (10) [back to overview]In Non-responders, the Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.
NCT00902538 (10) [back to overview]In Non-responders, the Change in Seated Systolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.
NCT00902538 (10) [back to overview]Number of Subjects Achieving Blood Pressure (BP) Goal at Week 16.
NCT00902538 (10) [back to overview]In Non-responders, the Change in Seated Diastolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.
NCT00902538 (10) [back to overview]In Non-responders, the Number of Subject Meeting Their Blood Pressure Goals Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.
NCT00923091 (10) [back to overview]Change in Seated Diastolic Blood Pressure (SeDBP).
NCT00923091 (10) [back to overview]Change in Seated Diastolic Blood Pressure From Week 22 to Week 26
NCT00923091 (10) [back to overview]Change in Seated Systolic Blood Pressure (SeDBP) During Open-Label Period VI (Titration Effect From OM/AML/HCTZ 40/5/25 to 40/10/25.
NCT00923091 (10) [back to overview]Change in Seated Systolic Blood Pressure (SeDBP).
NCT00923091 (10) [back to overview]Change in Seated Systolic Blood Pressure From Week 22 to Week 26
NCT00923091 (10) [back to overview]Number of Subjects Reaching Blood Pressure Goal at Week 10
NCT00923091 (10) [back to overview]Change in Seated Diastolic Blood Pressure From Week 18 to Week 22
NCT00923091 (10) [back to overview]Change in Seated Systolic Blood Pressure From Week 18 to Week 22
NCT00923091 (10) [back to overview]Number of Subjects Reaching Blood Pressure Goal at Week 26
NCT00923091 (10) [back to overview]Number of Subjects Reaching Blood Pressure Goal From Week 18 to Week 22
NCT00931710 (6) [back to overview]Change in Mean Sitting Diastolic Blood Pressure After 6 Weeks
NCT00931710 (6) [back to overview]Change in Mean Sitting Systolic and Diastolic Blood Pressure After 12 Weeks
NCT00931710 (6) [back to overview]Change in Mean Sitting Systolic Blood Pressure After 6 Weeks
NCT00931710 (6) [back to overview]Cumulative Percentage of Treatment Responders
NCT00931710 (6) [back to overview]Cumulative Percentage of Patients Achieving Blood Pressure Control
NCT00931710 (6) [back to overview]Cumulative Percentage of Patients With Incidence of Peripheral Edema Before or at the Corresponding Visit
NCT00942994 (6) [back to overview]Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 2 and Week 4
NCT00942994 (6) [back to overview]Percentage of Responders (Defined as Patients With MSSBP < 140 mmHg or a Reduction From Baseline in MSSBP of ≥20 mmHg) During 8 Weeks.
NCT00942994 (6) [back to overview]Percentage of Patients Achieving Blood Pressure Control (Defined as MSSBP < 140 mmHg and MSDBP < 90 mmHg) During 8 Weeks
NCT00942994 (6) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
NCT00942994 (6) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 and Week 4
NCT00942994 (6) [back to overview]Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8
NCT01001572 (5) [back to overview]Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint
NCT01001572 (5) [back to overview]Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint
NCT01001572 (5) [back to overview]Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint
NCT01001572 (5) [back to overview]Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint
NCT01001572 (5) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint
NCT01004614 (7) [back to overview]Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast), Area Under the Plasma Concentration-Time Curve to Infinity (AUCinf)
NCT01004614 (7) [back to overview]Time to Reach Maximum Observed Plasma Concentration (Tmax)
NCT01004614 (7) [back to overview]Mean Residence Time (MRT)
NCT01004614 (7) [back to overview]Maximum Observed Plasma Concentration (Cmax)
NCT01004614 (7) [back to overview]Apparent Terminal Elimination Half-Life (T-half)
NCT01004614 (7) [back to overview]Apparent Terminal Elimination Phase Rate Constant (Kel)
NCT01004614 (7) [back to overview]Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt)
NCT01030458 (4) [back to overview]Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up
NCT01030458 (4) [back to overview]Time to Blood Pressure Control
NCT01030458 (4) [back to overview]Sitting Systolic Blood Pressure on Automated Measurement
NCT01030458 (4) [back to overview]Side-effects to Study Medications
NCT01070043 (5) [back to overview]Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) From Office Blood Pressure Measurement
NCT01070043 (5) [back to overview]Number of Participants With Adverse Events During Double-blind Phase
NCT01070043 (5) [back to overview]Change From Baseline in Mean Systolic Blood Pressure (mSBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours
NCT01070043 (5) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) From Office Blood Pressure Measurement
NCT01070043 (5) [back to overview]Change From Baseline in Mean Diastolic Blood Pressure (mDBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours After 8 Weeks of Treatment During the Double-blind Phase
NCT01103960 (10) [back to overview]DBP and SBP Control and Response After 8 Weeks of Treatment
NCT01103960 (10) [back to overview]Number of Patients in Blood Pressure Categories Over Time
NCT01103960 (10) [back to overview]Number of Patients in Blood Pressure Categories at 4 Weeks
NCT01103960 (10) [back to overview]Change From Baseline in SBP After 4 Weeks of Treatment
NCT01103960 (10) [back to overview]DBP and SBP Control and Response After 4 Weeks of Treatment
NCT01103960 (10) [back to overview]Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG.
NCT01103960 (10) [back to overview]Change From Baseline in DBP After 4 Weeks of Treatment
NCT01103960 (10) [back to overview]Change From Baseline in DBP After 8 Weeks of Treatment
NCT01103960 (10) [back to overview]Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients
NCT01103960 (10) [back to overview]Change From Baseline in SBP After 8 Weeks of Treatment
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Complications.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypertension -Complications.
NCT01107743 (38) [back to overview]Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension.
NCT01107743 (38) [back to overview]Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia.
NCT01107743 (38) [back to overview]Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypertension -Gender.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypertension -Age.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs.
NCT01107743 (38) [back to overview]Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type.
NCT01107743 (38) [back to overview]Number of Treatment Related Adverse Events.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Angina Pectoris -Complications.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs.
NCT01107743 (38) [back to overview]Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Angina Pectoris -Gender.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Angina Pectoris -Age.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Renal Dysfunction.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hepatic Dysfunction.
NCT01118520 (2) [back to overview]Change in the Growth Rate of Abdominal Aortic Aneurysm
NCT01118520 (2) [back to overview]Number of Participants With Aneurysm Related Death
NCT01130168 (10) [back to overview]TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral SBP After A Single Dose of Treatment
NCT01130168 (10) [back to overview]Change From Baseline (0 Hours) to Week 4 in Central DBP After Multiple Doses of Treatment
NCT01130168 (10) [back to overview]Change From Baseline (0 Hours) to Week 4 in Central SBP After Multiple Doses of Treatment
NCT01130168 (10) [back to overview]Change From Baseline (0 Hours) to Week 4 in Heart-Rate-Corrected AIx After Multiple Doses of Treatment
NCT01130168 (10) [back to overview]Change From Baseline (0 Hours) to Week 4 in Peripheral DBP After Multiple Doses of Treatment
NCT01130168 (10) [back to overview]Change From Baseline (0 Hours) to Week 4 in Peripheral SBP After Multiple Doses of Treatment
NCT01130168 (10) [back to overview]Time-weighted Average (TWA) Change From Baseline (0 Hours) to 12 Hours in Heart-Rate-Corrected Augmentation Index (AIx) After A Single Dose of Treatment
NCT01130168 (10) [back to overview]TWA Change From Baseline (0 Hours) to 12 Hours in Central Diastolic Blood Pressure (DBP) After A Single Dose of Treatment
NCT01130168 (10) [back to overview]TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral DBP After A Single Dose of Treatment
NCT01130168 (10) [back to overview]TWA Change From Baseline (0 Hours) to 12 Hours in Central Systolic Blood Pressure (SBP) After A Single Dose of Treatment
NCT01134393 (9) [back to overview]Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements.
NCT01134393 (9) [back to overview]BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM).
NCT01134393 (9) [back to overview]BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements.
NCT01134393 (9) [back to overview]Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate
NCT01134393 (9) [back to overview]Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP
NCT01134393 (9) [back to overview]DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
NCT01134393 (9) [back to overview]Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time
NCT01134393 (9) [back to overview]Percentage of Patients in Blood Pressure Categories Over Time
NCT01134393 (9) [back to overview]DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements
NCT01138826 (5) [back to overview]Time to Reach Maximum Observed Plasma Concentration (Tmax)
NCT01138826 (5) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
NCT01138826 (5) [back to overview]AUC From Time Zero to Last Quantifiable Concentration (AUClast)
NCT01138826 (5) [back to overview]Maximum Observed Plasma Concentration (Cmax)
NCT01138826 (5) [back to overview]Plasma Decay Half-Life (t1/2)
NCT01167153 (7) [back to overview]Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks)
NCT01167153 (7) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks)
NCT01167153 (7) [back to overview]Change From Baseline in Sitting Pulse at 12 Weeks
NCT01167153 (7) [back to overview]Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks)
NCT01167153 (7) [back to overview]Change From Baseline in Orthostatic SBP and DBP at 12 Weeks
NCT01167153 (7) [back to overview]Change From Baseline in Orthostatic Pulse at 12 Weeks
NCT01167153 (7) [back to overview]Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks
NCT01176032 (20) [back to overview]Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson)
NCT01176032 (20) [back to overview]Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs
NCT01176032 (20) [back to overview]Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline
NCT01176032 (20) [back to overview]Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate
NCT01176032 (20) [back to overview]Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine
NCT01176032 (20) [back to overview]Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease
NCT01176032 (20) [back to overview]Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter
NCT01176032 (20) [back to overview]Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP)
NCT01176032 (20) [back to overview]Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine
NCT01176032 (20) [back to overview]Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine
NCT01176032 (20) [back to overview]Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method)
NCT01176032 (20) [back to overview]Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI)
NCT01176032 (20) [back to overview]Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP)
NCT01176032 (20) [back to overview]Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP)
NCT01176032 (20) [back to overview]Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule
NCT01176032 (20) [back to overview]Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine
NCT01176032 (20) [back to overview]Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine
NCT01176032 (20) [back to overview]Change From Baseline in Biomarkers in Heart Disease
NCT01176032 (20) [back to overview]Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease.
NCT01176032 (20) [back to overview]Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine
NCT01177293 (5) [back to overview]Plasma Decay Half-life (t1/2)
NCT01177293 (5) [back to overview]Time to Reach Maximum Observed Plasma Concentration (Tmax)
NCT01177293 (5) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
NCT01177293 (5) [back to overview]Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
NCT01177293 (5) [back to overview]Maximum Observed Plasma Concentration (Cmax)
NCT01181011 (20) [back to overview]AUC_0-∞ of Amlodipine
NCT01181011 (20) [back to overview]The Maximum Observed Plasma Concentration (Cmax) of Telmisartan
NCT01181011 (20) [back to overview]V_z/F of Amlodipine
NCT01181011 (20) [back to overview]Apparent Clearance of Telmisartan in Plasma Following Extravascular Administration (CL/F)
NCT01181011 (20) [back to overview]Apparent Volume of Distribution During the Terminal Phase λz Following an Extravascular Administration (V_z/F) of Telmisartan
NCT01181011 (20) [back to overview]Area Under the Concentration-time Curve of Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC_0-tz)
NCT01181011 (20) [back to overview]Time to Attain Cmax (Tmax) of Telmisartan
NCT01181011 (20) [back to overview]Tmax of Amlodipine
NCT01181011 (20) [back to overview]λz of Amlodipine
NCT01181011 (20) [back to overview]Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUC_0-∞) of Telmisartan
NCT01181011 (20) [back to overview]Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities
NCT01181011 (20) [back to overview]Terminal Rate Constant in Plasma (λz) of Telmisartan
NCT01181011 (20) [back to overview]t_½ of Amlodipine
NCT01181011 (20) [back to overview]Number of Participants With at Least One Treatment Emergent Adverse Event
NCT01181011 (20) [back to overview]MRT_po of Amlodipine
NCT01181011 (20) [back to overview]Mean Residence Time of Telmisartan in the Body After Oral Administration (MRT_po)
NCT01181011 (20) [back to overview]Elimination Half-life (t_½) of Telmisartan
NCT01181011 (20) [back to overview]Cmax of Amlodipine
NCT01181011 (20) [back to overview]CL/F of Amlodipine
NCT01181011 (20) [back to overview]AUC_0-tz of Amlodipine
NCT01200407 (4) [back to overview]Change From Baseline in SBP and DBP at Week 12 With Last Observation Carried Forward (LOCF)
NCT01200407 (4) [back to overview]Percentage of Participants Achieving JNC VII Recommended Blood Pressure Goal at Week 12 With LOCF
NCT01200407 (4) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01200407 (4) [back to overview]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 4, 8 and 12 Without (w/o) LOCF
NCT01204398 (7) [back to overview]Treatment Emergent Adverse Events
NCT01204398 (7) [back to overview]Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment
NCT01204398 (7) [back to overview]Change From Baseline to End of Study in In-clinic Pulse Rate
NCT01204398 (7) [back to overview]ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
NCT01204398 (7) [back to overview]Change From Baseline to End of Study in DBP and SBP
NCT01204398 (7) [back to overview]Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
NCT01204398 (7) [back to overview]DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean
NCT01222520 (7) [back to overview]Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough
NCT01222520 (7) [back to overview]Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough
NCT01222520 (7) [back to overview]Seated Blood Pressure (BP) Normalisation at Trough
NCT01222520 (7) [back to overview]Seated DBP Control Rate at Trough
NCT01222520 (7) [back to overview]Seated DBP Response Rate at Trough
NCT01222520 (7) [back to overview]Seated SBP Control Rate at Trough
NCT01222520 (7) [back to overview]Seated SBP Response Rate at Trough
NCT01237223 (5) [back to overview]Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8)
NCT01237223 (5) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8)
NCT01237223 (5) [back to overview]Percentage of Participants Achieving a Successful Response Rate
NCT01237223 (5) [back to overview]Percentage of Participants Achieving Blood Pressure Control at Endpoint
NCT01237223 (5) [back to overview]Number of Participants With Adverse Events, Serious Adverse Events and Death
NCT01252238 (3) [back to overview]Pulse Wave Velocity
NCT01252238 (3) [back to overview]Change in Insulin Sensitivity by HOMA at 12 Weeks
NCT01252238 (3) [back to overview]Aortic Compliance
NCT01252563 (20) [back to overview]Number of Participants With Adverse Events Listed in Japanese Package Insert
NCT01252563 (20) [back to overview]Number of Participants With Treatment Related Adverse Events
NCT01252563 (20) [back to overview]Number of Participants With Treatment-Related Adverse Events: Male vs. Female
NCT01252563 (20) [back to overview]Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Angina Pectoris)
NCT01252563 (20) [back to overview]Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Dyslipidaemia)
NCT01252563 (20) [back to overview]Number of Participants With Treatment-Related Adverse Events: With/Without Complication(s)
NCT01252563 (20) [back to overview]Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (Antihypertensive)
NCT01252563 (20) [back to overview]Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (ARB)
NCT01252563 (20) [back to overview]Number of Treatment Related Adverse Events Unlisted in Japanese Package Insert
NCT01252563 (20) [back to overview]Changes in Ambulatory Diastolic Blood Pressure From Baseline
NCT01252563 (20) [back to overview]Changes in Ambulatory Systolic Blood Pressure From Baseline
NCT01252563 (20) [back to overview]Changes in Home Diastolic Blood Pressure From Baseline
NCT01252563 (20) [back to overview]Changes in Home Systolic Blood Pressure From Baseline
NCT01252563 (20) [back to overview]The Achievement Rate to Ambulatory Blood Pressure Goal
NCT01252563 (20) [back to overview]The Achievement Rate to Home Blood Pressure Goal
NCT01252563 (20) [back to overview]Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Metabolic Syndrome)
NCT01252563 (20) [back to overview]Number of Participants Who Achieved the Target Blood Pressure: Ambulatory Systolic Blood Pressure
NCT01252563 (20) [back to overview]Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Chronic Kidney Disease)
NCT01252563 (20) [back to overview]Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Diabetes Mellitus)
NCT01252563 (20) [back to overview]Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Myocardial Infarction)
NCT01256411 (5) [back to overview]Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment)
NCT01256411 (5) [back to overview]Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment)
NCT01256411 (5) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy)
NCT01256411 (5) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment)
NCT01256411 (5) [back to overview]Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy)
NCT01259297 (8) [back to overview]Number of Participants With Renal Dysfunction in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen
NCT01259297 (8) [back to overview]Percentage of Participants With Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part II)
NCT01259297 (8) [back to overview]Number of Participants With Composite Cardiovascular Endpoints in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen
NCT01259297 (8) [back to overview]Number of Participants With Composite Cardiovascular Endpoints in Aliskiren+Amlodipine/HCTZ Group Versus All Placebo Group
NCT01259297 (8) [back to overview]Number of Participants With Total Mortality in Aliskiren Based Regimen Versus Non-aliskiren Based Regimen
NCT01259297 (8) [back to overview]Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT01259297 (8) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
NCT01259297 (8) [back to overview]Change From Baseline to End of Study in Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part I)
NCT01277822 (8) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8
NCT01277822 (8) [back to overview]Percentage of Participants Who Achieve Target Blood Pressure at Week 8
NCT01277822 (8) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4
NCT01277822 (8) [back to overview]Change From Baseline in Ankle Circumference at Week 8
NCT01277822 (8) [back to overview]Percentage of Participants Who Had Peripheral Edema During the Study
NCT01277822 (8) [back to overview]Percentage of Participants Who Achieve Target Blood Pressure at Week 4
NCT01277822 (8) [back to overview]Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
NCT01277822 (8) [back to overview]Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4
NCT01278797 (3) [back to overview]Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72)
NCT01278797 (3) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Amlodipine
NCT01278797 (3) [back to overview]Time of Maximum Concentration of Amlodipine (TMAX)
NCT01280266 (9) [back to overview]Change in Digital Ulcer Number
NCT01280266 (9) [back to overview]Change in Health Assessment Questionnaire (HAQ)
NCT01280266 (9) [back to overview]RP Attacks Per Day
NCT01280266 (9) [back to overview]Dorsal-digital-difference.
NCT01280266 (9) [back to overview]Change in the RP Duration
NCT01280266 (9) [back to overview]Change in Physician's Global Assessment on Visual Analogue Scale (VAS)
NCT01280266 (9) [back to overview]Change in Peak Systolic Flow (cm/Sec)
NCT01280266 (9) [back to overview]Time-averaged Peak Velocity (cm/Sec)
NCT01280266 (9) [back to overview]Change in Raynaud's Condition Score (RCS)
NCT01286558 (13) [back to overview]Changes From the Reference Baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP
NCT01286558 (13) [back to overview]Seated DBP Response Rate at Trough
NCT01286558 (13) [back to overview]Seated SBP Control Rate at Trough
NCT01286558 (13) [back to overview]Seated SBP Response Rate at Trough
NCT01286558 (13) [back to overview]Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM
NCT01286558 (13) [back to overview]Seated DBP Control Rate at Trough
NCT01286558 (13) [back to overview]Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP
NCT01286558 (13) [back to overview]Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for DBP
NCT01286558 (13) [back to overview]Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM
NCT01286558 (13) [back to overview]Seated Blood Pressure (BP) Normalisation at Trough
NCT01286558 (13) [back to overview]Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough
NCT01286558 (13) [back to overview]Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough
NCT01286558 (13) [back to overview]Changes From the Reference Baseline in the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (Relative to Dose Time) for DBP
NCT01302691 (7) [back to overview]Percentage of Participants Who Had Study Drug Stopped Due to an AE
NCT01302691 (7) [back to overview]Percentage of Participants Who Experience ≥1 Serious Adverse Event (SAE)
NCT01302691 (7) [back to overview]Percentage of Participants Who Experience ≥1 Drug-related SAE
NCT01302691 (7) [back to overview]Percentage of Participants Who Experience ≥1 Drug-related AE
NCT01302691 (7) [back to overview]Percentage of Participants Who Experience ≥1 Adverse Event (AE)
NCT01302691 (7) [back to overview]Change in Mean Trough Sitting Systolic Blood Pressure (SiSBP)
NCT01302691 (7) [back to overview]Change in Mean Trough Sitting Diastolic Blood Pressure (SiDBP)
NCT01316419 (20) [back to overview]Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Overall
NCT01316419 (20) [back to overview]Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg.
NCT01316419 (20) [back to overview]Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks
NCT01316419 (20) [back to overview]Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Environment Domain
NCT01316419 (20) [back to overview]Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Physical Health Domain
NCT01316419 (20) [back to overview]Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Psychological Domain
NCT01316419 (20) [back to overview]Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Social Relationships Domain
NCT01316419 (20) [back to overview]EuroQol (EQ) Visual Analogue Scale (VAS)
NCT01316419 (20) [back to overview]Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol
NCT01316419 (20) [back to overview]Mean Blood Lipid Change - Low Density Lipoprotein (LDL)-Cholesterol
NCT01316419 (20) [back to overview]Mean Blood Lipid Change - Total Cholesterol
NCT01316419 (20) [back to overview]Mean Blood Lipid Change - Triglyceride
NCT01316419 (20) [back to overview]Mean Blood Pressure Change Diastolic Blood Pressure (DBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal.
NCT01316419 (20) [back to overview]Mean Blood Pressure Change Systolic Blood Pressure (SBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal.
NCT01316419 (20) [back to overview]Percentage of Patients Achieving DBP Response
NCT01316419 (20) [back to overview]Percentage of Patients Achieving Normal Body Mass Index (BMI)
NCT01316419 (20) [back to overview]Percentage of Patients Achieving SBP Response
NCT01316419 (20) [back to overview]Incidence and Severity of Reported Adverse Events.
NCT01316419 (20) [back to overview]Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease
NCT01316419 (20) [back to overview]Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks
NCT01337674 (4) [back to overview]Steady-state Area Under the Plasma Concentration Versus Time Curve (AUC0-24hr) for MK-4618
NCT01337674 (4) [back to overview]Maximum Change From Baseline in Semi-recumbent and Standing Systolic Blood Pressure: Panel A
NCT01337674 (4) [back to overview]Maximum Change From Baseline in Semi-recumbent and Standing Systolic Blood Pressure: Panel B
NCT01337674 (4) [back to overview]Percentage of Participants With a Clinical or Laboratory Adverse Experience
NCT01365481 (5) [back to overview]Change From Baseline in Mean Sitting Diastolic Blood Pressure (MsDBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)
NCT01365481 (5) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)
NCT01365481 (5) [back to overview]Percentage of Chronic Kidney Disease (CKD) Patients Who Had >=50% Reduction in Urine Albumin/Creatinine Ratio (UACR) From Baseline to End Point
NCT01365481 (5) [back to overview]Percentage of Chronic Kidney Disease (CKD) Patients Who Had Estimated Glomerular Filtration Rate (eGFR) Decrease > 25 % From Baselinefrom Baseline to End Point
NCT01365481 (5) [back to overview]Number of Participants With MSSBP, MSDBP and (MSSBP and MSDBP Combined) < 95th Percentile for Gender, Age, and Height
NCT01368536 (1) [back to overview]Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone
NCT01556997 (2) [back to overview]Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).
NCT01556997 (2) [back to overview]Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).
NCT01631864 (4) [back to overview]Number of Participants With Adverse Events, Serious Adverse Events and Deaths
NCT01631864 (4) [back to overview]Change From Baseline in Insulin Sensitivity Index
NCT01631864 (4) [back to overview]Oxidative Metabolism
NCT01631864 (4) [back to overview]Local Adipose Tissue Lipolysis, Glycerol Concentrations
NCT01658657 (1) [back to overview]Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic
NCT01663233 (9) [back to overview]Number of Participants Achieving Successful Response in msDBP (< 90 mmHg or a Reduction ≥ 10 mmHg From Baseline)
NCT01663233 (9) [back to overview]Number of Participants Achieving Successful Response in msSBP (< 140 mmHg or a Reduction ≥ 20 mmHg From Baseline)
NCT01663233 (9) [back to overview]Number of Participants Achieving Systolic and Diastolic Blood Pressure Control (< 140/90 mmHg)
NCT01663233 (9) [back to overview]Number of Participants With Adverse Event
NCT01663233 (9) [back to overview]Change in Mean 24-hour ABPM Diastolic Blood Pressure (maDBP)
NCT01663233 (9) [back to overview]Change in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT01663233 (9) [back to overview]Change in Mean Sitting Systolic Blood Pressure (msSBP)
NCT01663233 (9) [back to overview]Change in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (maSBP)
NCT01663233 (9) [back to overview]Change in Sitting Pulse Pressure (PP)
NCT01692301 (11) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
NCT01692301 (11) [back to overview]Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 12 Weeks
NCT01692301 (11) [back to overview]Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 52 Weeks
NCT01692301 (11) [back to overview]Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (maPP)
NCT01692301 (11) [back to overview]Change From Baseline in Mean 24-hour Diastolic Blood Pressure (maDBP)
NCT01692301 (11) [back to overview]Change From Baseline in Mean Arterial Pressure (MAP)
NCT01692301 (11) [back to overview]Change From Baseline in Mean Central Pulse (CPP) Pressure
NCT01692301 (11) [back to overview]Change From Baseline in Mean Pulse Wave Velocity (PWV)
NCT01692301 (11) [back to overview]Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT01692301 (11) [back to overview]Change From Baseline in Mean Sitting Pulse Pressure (msPP)
NCT01692301 (11) [back to overview]Change From Baseline in Mean 24-hour Systolic Blood Pressure (maSBP)
NCT01762501 (5) [back to overview]Change in Nocturnal Diastolic Blood Pressure Level
NCT01762501 (5) [back to overview]Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall**
NCT01762501 (5) [back to overview]Change in Nocturnal Systolic Blood Pressure Level
NCT01762501 (5) [back to overview]Change in 24-hour Mean Systolic Blood Pressure Level
NCT01762501 (5) [back to overview]Change in 24-hour Mean Diastolic Blood Pressure Level
NCT01841593 (5) [back to overview]Maximum Observed Concentration (Cmax) of Raltegravir and Amlodipine Without and With Co-administration of the Other Studied Drug.
NCT01841593 (5) [back to overview]Raltegravir AUC(0-12h )
NCT01841593 (5) [back to overview]Raltegravir C12h
NCT01841593 (5) [back to overview]Amlodipine AUC(0-24h)
NCT01841593 (5) [back to overview]Amlodipine C24h
NCT01870739 (10) [back to overview]Change From Baseline in Local Aortic Strain at 52 Weeks
NCT01870739 (10) [back to overview]Change From Baseline in Augmentation Index at 52 Weeks
NCT01870739 (10) [back to overview]Change From Baseline in Augmentation Pressure at 52 Weeks
NCT01870739 (10) [back to overview]Change From Baseline in Carotid-femoral Pulse Wave Velocity at 52 Weeks
NCT01870739 (10) [back to overview]Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks
NCT01870739 (10) [back to overview]Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks
NCT01870739 (10) [back to overview]Change From Baseline in Regional Aortic Pulse Wave Velocity at 52 Weeks
NCT01870739 (10) [back to overview]Change From Baseline in Central Blood Pressure at 52 Weeks
NCT01870739 (10) [back to overview]Change From Baseline in Ascending Aorta Distensibility at 52 Week
NCT01870739 (10) [back to overview]Number of Patients With Reported Adverse Events, Serious Adverse Events and Death
NCT01911780 (6) [back to overview]The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks of Extension Period.
NCT01911780 (6) [back to overview]The Percentage of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 8 Weeks of Double-blind Period.
NCT01911780 (6) [back to overview]Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the Extension Period.
NCT01911780 (6) [back to overview]Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.
NCT01911780 (6) [back to overview]Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.
NCT01911780 (6) [back to overview]Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the Extension Period.
NCT01975246 (3) [back to overview]Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.
NCT01975246 (3) [back to overview]The Proportion of Patients With DBP<90 mmHg and SBP<140 mmHg as Seated Blood Pressure at Trough After 8 Weeks of the Double-blind Period
NCT01975246 (3) [back to overview]Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.
NCT01977794 (5) [back to overview]Mean Reduction In Systolic Blood Pressure (SBP) After 18 Weeks of Treatment From Baseline
NCT01977794 (5) [back to overview]Percentage of Subjects With Controlled Blood Pressure
NCT01977794 (5) [back to overview]Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Discontinuation and AEs Leading to Death
NCT01977794 (5) [back to overview]Change From Baseline in Heart Rate (HR) After 18 Weeks of Treatment
NCT01977794 (5) [back to overview]Change From Baseline in Diastolic Blood Pressure (DBP) After 18 Weeks of Treatment
NCT01996449 (2) [back to overview]Muscle Sympathetic Nerve Activity During Exercise
NCT01996449 (2) [back to overview]Muscle Sympathetic Nerve Activity at Rest
NCT02034435 (2) [back to overview]Insulin Secretion
NCT02034435 (2) [back to overview]Insulin Sensitivity
NCT02046395 (2) [back to overview]Change in Urine Microalbumin Creatinine Ratio
NCT02046395 (2) [back to overview]Change in the Level of Urinary Free Light Chains
NCT02062645 (5) [back to overview]Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8
NCT02062645 (5) [back to overview]SBP and DBP in Patients With High Sodium Intake at Week 4 and 8
NCT02062645 (5) [back to overview]Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
NCT02062645 (5) [back to overview]Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
NCT02062645 (5) [back to overview]Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8
NCT02068495 (6) [back to overview]Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
NCT02068495 (6) [back to overview]Changes From Baseline in Diastolic Blood Pressure (DBP) at Final Assessment
NCT02068495 (6) [back to overview]Changes From Baseline in Pulse Rate at Final Assessment
NCT02068495 (6) [back to overview]Changes From Baseline in Systolic Blood Pressure (SBP) at Final Assessment
NCT02068495 (6) [back to overview]Number of Participants Who Experience at Least One Adverse Events
NCT02068495 (6) [back to overview]Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment
NCT02121041 (1) [back to overview]24 Hour Blood Pressure Average at the End of 4 Month Participation.
NCT02129192 (6) [back to overview]Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration After Single Administration of T80/A5/H12.5 mg FDC Tablet
NCT02129192 (6) [back to overview]Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration
NCT02129192 (6) [back to overview]Maximum Measured Concentration (Cmax) of the Analytes in Plasma
NCT02129192 (6) [back to overview]Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity After Single Administration of T80/A5/H12.5 mg FDC Tablet
NCT02129192 (6) [back to overview]Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity
NCT02129192 (6) [back to overview]Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet
NCT02172040 (12) [back to overview]Mean Change in Average 24-hour Ambulatory Systolic Blood Pressure (SBP24h)
NCT02172040 (12) [back to overview]Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Diastolic Blood Pressure (DBPday)
NCT02172040 (12) [back to overview]Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday) - Primary Endpoint
NCT02172040 (12) [back to overview]Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday) - Secondary Endpoint
NCT02172040 (12) [back to overview]Mean Change in Average Night-time (01:00 to 06:00) Ambulatory Diastolic Blood Pressure (DBPnight)
NCT02172040 (12) [back to overview]Mean Change in Average Night-time (01:00 to 06:00) Ambulatory Systolic Blood Pressure (SBPnight)
NCT02172040 (12) [back to overview]Mean Log-transformed Amlodipine Plasma Concentration
NCT02172040 (12) [back to overview]Mean Log-transformed Celecoxib Plasma Concentration
NCT02172040 (12) [back to overview]Mean Non-transformed Amlodipine Plasma Concentration
NCT02172040 (12) [back to overview]Mean Non-transformed Celecoxib Plasma Concentration
NCT02172040 (12) [back to overview]Frequency of Adverse Events (Number of Participants Affected/Number of Participants at Risk)
NCT02172040 (12) [back to overview]Mean Change in Average 24-hour Ambulatory Diastolic Blood Pressure (DBP24h)
NCT02181816 (3) [back to overview]Percentage of Participants Who Had One or More Adverse Events
NCT02181816 (3) [back to overview]Diastolic Office Blood Pressure
NCT02181816 (3) [back to overview]Systolic Office Blood Pressure
NCT02183675 (7) [back to overview]Amount of HCTZ Excreted in Urine at Steady State From 0 to 24 Hours
NCT02183675 (7) [back to overview]Maximum Measured Concentration (Cmax) at Steady State for Telmisartan
NCT02183675 (7) [back to overview]Maximum Measured Concentration (Cmax) at Steady State for HCTZ
NCT02183675 (7) [back to overview]Maximum Measured Concentration (Cmax) at Steady State for Amlodipine
NCT02183675 (7) [back to overview]Area Under the Plasma Concentration Curve at Steady State for Telmisartan
NCT02183675 (7) [back to overview]Area Under the Plasma Concentration Curve at Steady State for HCTZ
NCT02183675 (7) [back to overview]Area Under the Plasma Concentration Curve at Steady State for Amlodipine
NCT02278471 (6) [back to overview]LDL Cholesterol
NCT02278471 (6) [back to overview]LDL Cholesterol
NCT02278471 (6) [back to overview]Medication Adherence-Percentage of Pills Taken
NCT02278471 (6) [back to overview]Systolic Blood Pressure
NCT02278471 (6) [back to overview]Systolic Blood Pressure
NCT02278471 (6) [back to overview]Medication Adherence
NCT02353806 (12) [back to overview]Drug Level/Concentration in Infant Blood (Amlodipine Level/Concentration)
NCT02353806 (12) [back to overview]Neonatal Birth Weight
NCT02353806 (12) [back to overview]Amlodipine Concentration in Breastmilk
NCT02353806 (12) [back to overview]Area Under the Curve for Amlodipine in the Maternal Serum
NCT02353806 (12) [back to overview]Clearance Rate of Plasma Amlodipine
NCT02353806 (12) [back to overview]Half-life of Amlodipine in Maternal Plasma
NCT02353806 (12) [back to overview]Infant Gestational Age at Delivery.
NCT02353806 (12) [back to overview]Infant Length of Stay.
NCT02353806 (12) [back to overview]Maximal Amlodipine Maternal Serum Concentration
NCT02353806 (12) [back to overview]Time to Maximal Concentration in the Maternal Serum.
NCT02353806 (12) [back to overview]Drug Levels/Concentration in Cord Blood (Amlodipine Levels/Concentrations)
NCT02353806 (12) [back to overview]Major Infant Complications
NCT02387554 (1) [back to overview]AUClast
NCT02412761 (1) [back to overview]The Number of Patients for Whom Each Drug is Selected as the Preferred Therapy
NCT02734355 (13) [back to overview]Passive Emptying of Left Atrium
NCT02734355 (13) [back to overview]Diastolic Function
NCT02734355 (13) [back to overview]Left Atrial Reservoir Function
NCT02734355 (13) [back to overview]Quality of Life
NCT02734355 (13) [back to overview]Active Emptying of Left Atrium
NCT02734355 (13) [back to overview]Pulmonary Vein Flow Emptying
NCT02734355 (13) [back to overview]Left Atrial Pressure Load
NCT02734355 (13) [back to overview]Left Atrial Dimensions
NCT02734355 (13) [back to overview]Left Atrial Contractility
NCT02734355 (13) [back to overview]Isovolumic Relaxation
NCT02734355 (13) [back to overview]Pulmonary Circulation Pressure Load
NCT02734355 (13) [back to overview]Exercise Tolerance
NCT02734355 (13) [back to overview]Retrograde Flow in Pulmonary Veins
NCT02834403 (7) [back to overview]Recommended Phase 2 Dose (RP2D) of the L-NMMA and Docetaxel Combination
NCT02834403 (7) [back to overview]Dose Limiting Toxicities (DLTs) and Other Adverse Events
NCT02834403 (7) [back to overview]Time to Maximum Plasma Concentration of L-NMMA and Docetaxel
NCT02834403 (7) [back to overview]Clinical Benefit Rate
NCT02834403 (7) [back to overview]Recommended Phase 2 Dose (RP2D) of the L-NMMA and Docetaxel Combination
NCT02834403 (7) [back to overview]Asses the Maximum Tolerated Dose (MTD) of L-NMMA When Combined With Docetaxel/Amlodipine in the Treatment of Refractory Locally Advanced or Metastatic TNBC Patients, Based on the Number of Dose Limiting Toxicities (DLTs) Per Dose Level.
NCT02834403 (7) [back to overview]Asses the Maximum Tolerated Dose (MTD) of Docetaxel When Combined With L-NMMA/Amlodipine in the Treatment of Refractory Locally Advanced or Metastatic TNBC Patients, Based on the Number of Dose Limiting Toxicities (DLTs) Per Dose Level.
NCT02979197 (9) [back to overview]Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday)
NCT02979197 (9) [back to overview]Occurrence of Treatment Emergent Adverse Events
NCT02979197 (9) [back to overview]Non-transformed Plasma Concentration of Amlodipine
NCT02979197 (9) [back to overview]Log-transformed Plasma Concentration of Amlodipine
NCT02979197 (9) [back to overview]Change in Serum Creatinine
NCT02979197 (9) [back to overview]Change in Creatinine Clearance
NCT02979197 (9) [back to overview]Change in Average 24-hour Ambulatory Diastolic Blood Pressure (DBP24h)
NCT02979197 (9) [back to overview]Change in Body Weight
NCT02979197 (9) [back to overview]Change in Average 24-hour Ambulatory Systolic Blood Pressure (SBP24h)
NCT03226275 (10) [back to overview]Extrapolated Part of Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUCextra%) of Bisoprolol and Amlodipine
NCT03226275 (10) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Bisoprolol and Amlodipine
NCT03226275 (10) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Death, and AEs Leading to Discontinuation
NCT03226275 (10) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) of Bisoprolol and Amlodipine
NCT03226275 (10) [back to overview]Apparent Total Body Clearance From Plasma (CL/f) of Bisoprolol and Amlodipine
NCT03226275 (10) [back to overview]Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/f) of Bisoprolol and Amlodipine
NCT03226275 (10) [back to overview]Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC 0-inf) of Bisoprolol and Amlodipine
NCT03226275 (10) [back to overview]Area Under the Plasma Concentration-Time Curve From Time Zero to Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Bisoprolol and Amlodipine
NCT03226275 (10) [back to overview]Apparent Terminal Half-life (t1/2) of Bisoprolol and Amlodipine
NCT03226275 (10) [back to overview]Apparent Terminal Elimination Rate Constant (λz) of Bisoprolol and Amlodipine
NCT03461003 (5) [back to overview]Change in Mean Wake Ambulatory Systolic Blood Pressure
NCT03461003 (5) [back to overview]Patient Satisfaction With Intervention as Assessed by a Survey
NCT03461003 (5) [back to overview]Change in Mean 24-hour Ambulatory Systolic Blood Pressure
NCT03461003 (5) [back to overview]Number of Participants Who Reported That Side Effects From Medication Led Them to Discontinue Medication
NCT03461003 (5) [back to overview]Number of Participants Who Self-reported Adherence to Intervention
NCT03722524 (5) [back to overview]The Mean Standardized Score of the Physical Component of the Quality of Life Questionnaire The Short Form (36) Health Survey at Visit 4 vs Baseline
NCT03722524 (5) [back to overview]The Mean Systolic BP Changes (mm Hg) at the Visit 4 vs. Baseline
NCT03722524 (5) [back to overview]The Mean Diastolic BP Changes (mm Hg) at the Visit 4 vs Baseline.
NCT03722524 (5) [back to overview]Percentage of Patients Who Achieved the Target Office BP Levels (SBP <140 mm Hg and DBP <90 mm Hg) at Visit 4 vs Baseline
NCT03722524 (5) [back to overview]The Mean Standardized Score of the Mental Component of the Quality of Life Questionnaire The Short Form (36) Health Survey at Visit 4 vs Baseline

Death From Any Cause in the Glycemia Trial.

"Time to death from any cause. Secondary measure for Glycemia Trial.~A finding of higher mortality in the intensive-therapy group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid)." (NCT00000620)
Timeframe: 4.9 years

Interventionparticipants (Number)
Glycemia Trial: Intensive Control391
Glycemia Trial: Standard Control327

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First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial.

"Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. This was the primary outcome measure in all three trials: Glycemia (all participants), Blood Pressure (subgroup of participants not in Lipid Trial), and Lipid (subgroup of participants not in Blood Pressure Trial).~In the Glycemia Trial, a finding of higher mortality in the intensive arm group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid) to their planned completion." (NCT00000620)
Timeframe: 4.9 years

Interventionparticipants (Number)
Glycemia Trial: Intensive Control503
Glycemia Trial: Standard Control543

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First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial.

Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Primary outcome for Blood Pressure Trial. (NCT00000620)
Timeframe: 4.7 years

Interventionparticipants (Number)
BP Trial: Intensive Control208
BP Trial: Standard Control237

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First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial.

Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death in Lipid Trial participants. (NCT00000620)
Timeframe: 4.7 years

Interventionparticipants (Number)
Lipid Trial: Fenofibrate291
Lipid Trial: Placebo310

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First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial.

Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, cardiovascular death, revascularization procedure or hospitalization for CHF in Lipid Trial participants. (NCT00000620)
Timeframe: 4.7 years

Interventionparticipants (Number)
Lipid Trial: Fenofibrate641
Lipid Trial: Placebo667

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Stroke in the Blood Pressure Trial.

Time to first occurrence of nonfatal or fatal stroke among participants in the BP Trial. (NCT00000620)
Timeframe: 4.7 years

Interventionparticipants (Number)
BP Trial: Intensive Control36
BP Trial: Standard Control62

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Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo

Self reported duration of effect in weeks. (NCT00015457)
Timeframe: 3 months

Interventionweeks (Median)
Amlodipine6
Placebo5.5

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Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score

Rating scale assessing sum of severity of dystonia, disability score and pain scale. Ordinal scale ranging from 0 (least severe) to 30 (maximally severe). Score is maximal response TWSTR rating minus baseline rating. (NCT00015457)
Timeframe: 1-2 month maximal rating

Interventionunits on a scale (Mean)
Amlodipine-6.00
Placebo-3.23

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Time-to-event Analysis of Percentage of Patients With a Cardiovascular (CV) Mortality Event, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke

CV mortality was defined as death due to sudden cardiac death, fatal MI, fatal stroke, coronary intervention, congestive heart failure (CHF), or other CV causes. (NCT00170950)
Timeframe: For each patient, baseline to time of first CV mortality event, MI (non-fatal), or stroke (non-fatal) (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])

InterventionPercentage of Patients with an Event (Number)
Benazepril/Amlodipine5.0
Benazepril/Hydrochlorothiazide6.3

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Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event

CV morbidity was defined as non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure. CV mortality was defined as death due to MI, stroke, coronary intervention, congestive heart failure (CHF), sudden cardiac death, or other CV causes. (NCT00170950)
Timeframe: For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])

InterventionPercentage of Patients with an event (Number)
Benazepril/Amlodipine9.6
Benazepril/Hydrochlorothiazide11.8

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Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event

Cardiovascular morbidity was defined as including any of the following events: non-fatal MI, non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure (PCI or CABG). (NCT00170950)
Timeframe: For each patient, baseline to time of first CV morbidity event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])]

InterventionPercentage of Patients with an Event (Number)
Benazepril/Amlodipine8.6
Benazepril/Hydrochlorothiazide10.3

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Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Week 12

Cutaneous blood flow was continuously recorded by a laser Doppler flowmeter. The laser Doppler flow probe was applied on the volar part of the right forearm with a plastic holder 10 cm proximal to the wrist. All measurements were made with a pressure cuff on the arm and inflated 20 mmHg above systolic BP and maintained for 2 min then rapidly deflated. All measurements were made in a quiet room with a patient in the supine position. The maximal reactive hyperemia was measured after cuff deflation, which allows measurement of the right forearm postischemic skin reactive hyperemia (SRH). (NCT00171054)
Timeframe: Baseline and Week 12

InterventionPerfusion units (Least Squares Mean)
Valsartan 320 mg25.4
Amlodipine 10 mg-105.6

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Change in Left Ventricular Mass Index (LVMI) and Diastolic Function Using Echocardiography From Baseline to Week 38

(NCT00171054)
Timeframe: Baseline and Week 38

Interventionpercent (Least Squares Mean)
Valsartan 320 mg-4.8
Amlodipine 10 mg-6.2

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Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 12

The calculation of spontaneous baroflex sensitivity was obtained by the sequence method. Baroflex sequences are defined by at least three consecutive beats in which the systolic blood pressure and the RR interval of the following beat either both increased or decreased. The slope of each individual sequence is computed and the mean slope is determined as the average of all slopes within a given period of time and taken as the gain of the cardiac baroflex (BRSs). (NCT00171054)
Timeframe: Baseline and Week 12

InterventionEP (Least Squares Mean)
Valsartan 320 mg1.5
Amlodipine 10 mg-1.5

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Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Endpoint (Week 38)

Cutaneous blood flow was continuously recorded by a laser Doppler flowmeter. The laser Doppler flow probe was applied on the volar part of the right forearm with a plastic holder 10 cm proximal to the wrist. All measurements were made with a pressure cuff on the arm and inflated 20 mmHg above systolic BP and maintained for 2 min then rapidly deflated. All measurements were made in a quiet room with a patient in the supine position. The maximal reactive hyperemia was measured after cuff deflation, which allows measurement of the right forearm postischemic skin reactive hyperemia (SRH). (NCT00171054)
Timeframe: Week 38

InterventionPerfusion units (Least Squares Mean)
Valsartan 320 mg-9.7
Amlodipine 10 mg-94.6

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Changes in Central Blood Pressure, Evaluated by Applanation Tonometry From Baseline at Weeks 12 and 38

Central Blood Pressure was measured via applanation tonometry recordings of the common carotid artery and from brachial oscillometric recordings. The Simultaneously obtained carotid artery pressure and standard brachial artery blood pressure are computed to obtain the central systolic pressure. (NCT00171054)
Timeframe: Baseline, Week 12 and Week 38

,
Interventionmm Hg (Least Squares Mean)
Week 12Week 36
Amlodipine 10 mg-14.2-13.9
Valsartan 320 mg-9.1-11.1

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Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at Week 12

Endothelial function will be assessed using high-resolution duplex ultrasound with wall tracking to measure FMD of the brachial artery during reactive hyperemia. FMD of the brachial artery in response to reactive hyperemia in the distal forearm (and glyceryl trinitrate as a non-endothelium dependent control) will be measured from B-mode ultrasound images using a standard 7 MHz linear array transducer and HDI 5000 system with edge detection. (NCT00171054)
Timeframe: Baseline and Week 12

Interventionpercent (Least Squares Mean)
Valsartan 320 mg-8.7
Amlodipine 10 mg-8.6

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Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 38

The calculation of spontaneous baroflex sensitivity was obtained by the sequence method. Baroflex sequences are defined by at least three consecutive beats in which the systolic blood pressure and the RR interval of the following beat either both increased or decreased. The slope of each individual sequence is computed and the mean slope is determined as the average of all slopes within a given period of time and taken as the gain of the cardiac baroflex (BRSs). (NCT00171054)
Timeframe: Baseline and Week 38

InterventionEP (Least Squares Mean)
Valsartan 320 mg-2.0
Amlodipine 10 mg0.1

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Changes in Mean Left Carotid Distensibility at Week 12

For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure. (NCT00171054)
Timeframe: Baseline and Week 12

Interventionpercent (Least Squares Mean)
Valsartan 320 mg0.0
Amlodipine 10 mg0.0

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Changes in Mean Left Carotid Distensibility at Week 38

For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure. (NCT00171054)
Timeframe: Baseline and Week 38

Interventionpercent (Least Squares Mean)
Valsartan 320 mg0.0
Amlodipine 10 mg0.1

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Changes in Mean Right Carotid Distensibility at Week 12

For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure. (NCT00171054)
Timeframe: Baseline and Week 12

Interventionpercent (Least Squares Mean)
Valsartan 320 mg-0.4
Amlodipine 10 mg0.1

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Changes in Mean Right Carotid Distensibility at Week 38

For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure. (NCT00171054)
Timeframe: Baseline and Week 38

Interventionpercent (Least Squares Mean)
Valsartan 320 mg-0.2
Amlodipine 10 mg0.0

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Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at End-point (Week 38)

Endothelial function will be assessed using high-resolution duplex ultrasound with wall tracking to measure FMD of the brachial artery during reactive hyperemia. FMD of the brachial artery in response to reactive hyperemia in the distal forearm (and glyceryl trinitrate as a non-endothelium dependent control) will be measured from B-mode ultrasound images using a standard 7 MHz linear array transducer and HDI 5000 system with edge detection. (NCT00171054)
Timeframe: Baseline and Week 38

Interventionpercent (Least Squares Mean)
Valsartan 320 mg-8.1
Amlodipine 10 mg-8.2

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Change From Baseline to Week 38 in the Carotid-femoral Pulse Wave Velocity (PWV)

PWV was determined from transcutaneous Doppler flow recordings and the foot-to-foot method triggered by the simultaneous ECG. Two simultaneous Doppler flow tracings were taken at the left common carotid and the right femoral artery in the groin with a linear array probe. The time delay (t) was measured between R wave of the ECG and the base of the flow waves recorded at these points, and averaged over 10 beats. The distance (D) traveled by the pulse wave was measured over body surface as the distance from the suprasternal notch to the carotid artery. PWV was calculated as PWV=D/t. (NCT00171054)
Timeframe: Baseline and Week 38

Interventionm/s (Least Squares Mean)
Valsartan 320 mg-1.9
Amlodipine 10 mg-1.7

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Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects)

Observed results (NCT00281580)
Timeframe: Up to 8 weeks (LOCF)

InterventionmmHg (Mean)
Placebo (Pl)-5.5
Telmisartan 20 mg (T20)-13.9
Telmisartan 40 mg (T40)-13.8
Telmisartan 80 mg (T80)-13.9
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)-18.4
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)-15.8
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)-19.5
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)-18.7
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-16.8
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-19.6
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)-16.3
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-18.8
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-20.4
Amlodipine 2.5 mg (A2.5)-11.4
Amlodipine 5 mg (A5)-13.1
Amlodipine 10 mg (A10)-17.1

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Change From Baseline in Seated Trough Cuff Mean SBP

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate. (NCT00281580)
Timeframe: Up to 8 weeks (LOCF)

InterventionmmHg (Least Squares Mean)
Placebo (Pl)-1.9
Telmisartan 20 mg (T20)-15.6
Telmisartan 40 mg (T40)-15.4
Telmisartan 80 mg (T80)-15.4
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)-19
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)-22.1
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)-25.2
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)-23.2
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-22.2
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-25.3
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)-17.4
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-22.5
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-26.5
Amlodipine 2.5 mg (A2.5)-12.4
Amlodipine 5 mg (A5)-14.8
Amlodipine 10 mg (A10)-21

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Change From Baseline in Seated Trough Pulse Rate

Observed results for all patients - key combination therapies (NCT00281580)
Timeframe: End-of-study visit (LOCF)

Interventionbpm (Mean)
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)0
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)0
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)2.4
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-1.5

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Change From Baseline in Standing Trough Cuff Mean DBP

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. (NCT00281580)
Timeframe: Up to 8 weeks (LOCF)

InterventionmmHg (Least Squares Mean)
Placebo (Pl)-4.2
Telmisartan 20 mg (T20)-11.7
Telmisartan 40 mg (T40)-10.9
Telmisartan 80 mg (T80)-11.3
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)-15.1
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)-13.3
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)-17.6
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)-17.5
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-14.2
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-18
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)-14.5
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-17.3
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-19.2
Amlodipine 2.5 mg (A2.5)-8
Amlodipine 5 mg (A5)-11
Amlodipine 10 mg (A10)-15.5

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Change From Baseline in Standing Trough Cuff Mean SBP

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate. (NCT00281580)
Timeframe: Up to 8 weeks (LOCF)

InterventionmmHg (Least Squares Mean)
Placebo (Pl)1
Telmisartan 20 mg (T20)-13.7
Telmisartan 40 mg (T40)-13.6
Telmisartan 80 mg (T80)-14
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)-16.2
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)-19.4
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)-23.2
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)-21.8
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-20.4
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-22.8
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)-16.3
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-21.9
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-24.3
Amlodipine 2.5 mg (A2.5)-10.1
Amlodipine 5 mg (A5)-13.2
Amlodipine 10 mg (A10)-19.3

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Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. (NCT00281580)
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

InterventionmmHg (Least Squares Mean)
Placebo (Pl)-12.2
Amlodipine 2.5 mg (A2.5)-15.3
Amlodipine 5 mg (A5)-16.2
Amlodipine 10 mg (A10)-19.3

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BP Control

Responders SBP<10 mmHg and DBP<90 mmHg) for mod-sev patients - key combination therapies (NCT00281580)
Timeframe: Up to 8 weeks (LOCF)

Interventionpercentage of participants (Number)
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)53.7
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)70.8
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)58.5
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)77

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DBP Control

DBP control is defined as DBP < 90 mmHg - key combination therapies (NCT00281580)
Timeframe: End-of-study (up to 8 weeks) visit (LOCF)

Interventionpercentage of participants (Number)
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)71.6
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)82.1
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)74.8
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)85.3

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DBP Control

DBP control is defined as DBP < 90 mmHg - key combination therapies (NCT00281580)
Timeframe: Up to 8 weeks (LOCF)

Interventionpercentage of participants (Number)
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)69.4
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)77.1
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)68.9
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)85

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DBP Response

DBP response is defined as DBP < 90 mmHg or a reduction of DBP of >= 10 mmHg - key combination therapies (NCT00281580)
Timeframe: End-of-study (up to 8 weeks) visit (LOCF)

Interventionpercentage of participants (Number)
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)80.9
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)91.9
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)88.8
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)91.2

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DBP Response

DBP response is defined as DBP < 90 mmHg or a reduction of DBP of >= 10 mmHg - key combination therapies (NCT00281580)
Timeframe: Up to 8 weeks (LOCF)

Interventionpercentage of participants (Number)
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)81.5
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)89.6
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)87.7
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)93

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Orthostatic Change in Trough Cuff Mean DBP

Calculated as seated minus standing for all patients - key combination therapies (NCT00281580)
Timeframe: Week 8

InterventionmmHg (Mean)
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)2.2
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)1.7
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)2
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)1.1

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Orthostatic Change in Trough Cuff Mean DBP

Calculated as seated minus standing for mod-sev patients - key combination therapies (NCT00281580)
Timeframe: Week 8

InterventionmmHg (Mean)
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)2.5
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)2
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)1.4
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)1.6

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Orthostatic Change in Trough Cuff Mean SBP

Calculated as seated minus standing for all patients - key combination therapies (NCT00281580)
Timeframe: Week 8

InterventionmmHg (Mean)
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)0
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)0.6
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)0.9
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)0.8

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Orthostatic Change in Trough Cuff Mean SBP

Calculated as seated minus standing for mod-sev patients - key combination therapies (NCT00281580)
Timeframe: Week 8

InterventionmmHg (Mean)
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)0
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)1.4
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)0.1
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)1.1

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SBP Response

SBP Response is defined as SBP < 140 mmHg or a reduction of SBP of >= 10 mmHg - key combination therapies (NCT00281580)
Timeframe: Up to 8 weeks (LOCF)

Interventionpercentage of participants (Number)
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)88.9
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)96.9
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)84.9
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)95

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BP Normality

"No: Mean seated SBP >=140 and/or mean seated DBP >=90 mmHg at trough High normal: mean seated SBP >=130 and <140 mmHg and mean seated DBP >=85 and <90 mmHg at trough Normal: mean seated SBP >=120 and <130 mmHg and mean seated DBP >=80 and <85 mmHg at trough Optimal: mean seated SBP < 120 mmHg and mean seated DBP <80 mmHg at trough~- key combination therapies" (NCT00281580)
Timeframe: End-of-study (up to 8 weeks) visit (LOCF)

,,,
Interventionpercentage of participants (Number)
No (SBP>=140 and/or DBP>=90)High Normal (140>SBP>=130 and 90>DBP>=85)Normal (130>SBP>=120 and 85>DBP>=80)Optimal (SBP<120 and DBP<80)
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)24.430.132.513
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)41.128.421.39.2
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)23.522.139.714.7
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)34.330.125.99.8

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BP Normality

"No: Mean seated SBP >=140 and/or mean seated DBP >=90 mmHg at trough High normal: mean seated SBP >=130 and <140 mmHg and mean seated DBP >=85 and <90 mmHg at trough Normal: mean seated SBP >=120 and <130 mmHg and mean seated DBP >=80 and <85 mmHg at trough Optimal: mean seated SBP < 120 mmHg and mean seated DBP <80 mmHg at trough~- key combination therapies" (NCT00281580)
Timeframe: Up to 8 weeks (LOCF)

,,,
Interventionpercentage of participants (Number)
No (SBP>=140 and/or DBP>=90)High Normal (140>SBP>=130 and 90>DBP>=85)Normal (130>SBP>=120 and 85>DBP>=80)Optimal (SBP<120 and DBP<80)
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)29.229.230.211.5
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)46.325.918.59.3
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)2327419
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)41.526.421.710.4

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Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP

Observed results for key combination therapies (NCT00281580)
Timeframe: Baseline to nominal week over the trial

,,,
InterventionmmHg (Mean)
Week 2Week 4 (N=133, 115, 135, 129)Week 6 (N=134, 118, 131, 124)Week 8 (N=133, 112, 132, 121)
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-14.4-18.1-19.0-19.5
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-14.5-16.0-17.1-16.3
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-14.6-18.8-20.0-20.0
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-15.3-17.2-18.0-18.3

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Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. (NCT00281580)
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

InterventionmmHg (Least Squares Mean)
Telmisartan 0 mg (T0)-12.5
Telmisartan 20 mg (T20)-16.8
Telmisartan 40 mg (T40)-16.6
Telmisartan 80 mg (T80)-17.2

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Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP

Observed results - key combination therapies (NCT00281580)
Timeframe: End-of-study (up to 8 weeks) visit (LOCF)

,,,
InterventionmmHg (Mean)
Hour 1Hour 2Hour 3Hour 4Hour 5Hour 6Hour 7Hour 8Hour 9Hour 10Hour 11Hour 12Hour 13Hour 14Hour 15Hour 16Hour 17Hour 18Hour 19Hour 20Hour 21Hour 22Hour 23Hour 24
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-15.4-15-14.1-16.5-14.1-14.5-15.6-17.4-15.7-13.8-14.4-13.3-14.7-14.8-11.5-10.3-10.4-9.9-10.5-9.9-8.9-9.8-13.3-12.6
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-10.7-9.8-11.2-11.3-13.1-10.9-12.8-12.1-13.1-11.8-11.2-12-10.3-8.9-10.3-10.1-9.8-11.9-9.1-11-10.4-11.1-9.8-11.1
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-13.4-14.6-15.4-15.8-15.7-16.4-15.7-17.1-17.2-18.5-16.1-15.7-15.1-11-10-12.2-11.5-12.2-13.2-15.9-14.8-15.4-14.6-13.1
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-12.7-13.4-14.8-15.6-16.3-14.6-12.9-12.7-14.3-14.7-15.1-12.5-14.1-13.4-11.9-11.3-11.2-10.3-11.9-12.6-8.5-9.7-9.9-12

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Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP

Observed results for mod-sev patients - key combination therapies (NCT00281580)
Timeframe: Up to 8 weeks (LOCF)

,,,
InterventionmmHg (Mean)
Hour 1Hour 2Hour 3Hour 4Hour 5Hour 6Hour 7Hour 8Hour 9Hour 10Hour 11Hour 12Hour 13Hour 14Hour 15Hour 16Hour 17Hour 18Hour 19Hour 20Hour 21Hour 22Hour 23Hour 24
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-16.9-16.3-13.8-16.3-15.3-15.3-15.3-19.4-16.6-14.6-14.8-13.9-14.9-14.5-10.5-10.3-9.8-9.9-11.6-10.9-8.6-10-14-13.6
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-11-8.8-11.2-10.7-12.8-10.5-13.8-13.3-14-10.7-11.4-12.4-9.7-8.5-10.5-10.9-10.1-11.8-9-10-10.5-10.9-10-9.7
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-13.7-15.9-16.1-16.8-16.6-16.3-17.5-17.8-18.1-20.8-17.9-16.6-15.9-12-10-13.7-12.3-12.8-12.5-15.7-15.1-15.2-14.3-14.4
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-13.8-13.9-16.4-15.9-17.2-15.2-12.9-13.5-15.8-17-16.8-14.3-14.1-15.1-13.8-12.8-11.5-10.6-12.2-13.3-8.4-10.2-10-13.2

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Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP

Observed results - key combination therapies (NCT00281580)
Timeframe: End-of-study (up to 8 weeks) visit (LOCF)

,,,
InterventionmmHg (Mean)
Hour 1Hour 2Hour 3Hour 4Hour 5Hour 6Hour 7Hour 8Hour 9Hour 10Hour 11Hour 12Hour 13Hour 14Hour 15Hour 16Hour 17Hour 18Hour 19Hour 20Hour 21Hour 22Hour 23Hour 24
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-20.2-22.0-17.9-24.4-21.1-22.6-24.3-24.1-24.9-22.9-20.9-20.3-21.7-21.6-19.4-17.7-17.9-17.4-19.7-18.0-17.8-15.7-18.9-20.7
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-18.7-13.1-15.3-18.0-19.3-14.1-17.8-18.8-20.3-20.0-18.7-18.4-18.5-16.7-15.7-17.0-17.3-17.5-16.5-17.8-17.5-16.2-14.4-15.8
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-17.5-21.9-22.4-23.8-24.0-24.6-22.4-21.8-25.6-26.8-24.9-25.0-24.7-20.2-18.9-19.8-19.1-19.6-20.9-24.4-22.7-23.8-22.4-19.9
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-19.1-20.5-21.1-22.5-25.3-21.6-19.9-20.3-22.0-22.5-23.2-19.7-22.7-21.7-19.0-18.0-14.7-15.1-16.9-16.5-15.7-15.5-16.5-18.5

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Change From Baseline in Seated Trough Cuff DBP

Observed results for mod-sev patients - key combination therapies (NCT00281580)
Timeframe: Nominal week over the trial

,,,
InterventionmmHg (Mean)
Week 2Week 4 (N=102, 90, 102, 96)Week 6 (N=102, 92, 98, 96)Week 8 (N=102, 87, 99, 88)
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-14.7-18.2-19.7-19.4
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-14.7-16.5-17.9-17.1
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-14.9-19.2-19.5-21.1
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-16.1-17.8-18.9-19.3

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Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)

Clinical relevant abnormalities for laboratory parameters and Electrocardiogram (ECG). New abnormal findings or worsening of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations). (NCT00281580)
Timeframe: 8 weeks

,,,
Interventionpercentage of participants (Number)
Alanine aminotransferase increasedAspartate aminotransferase increasedBlood potassium increasedElectrocardiogram QT shortenedElectrocardiogram T wave abnormalElectrocardiogram repolarisation abnormalityHeart rate irregularQRS axis abnormalAtrioventricular block first degreeLeft atrial dilatationMyocardial ischaemiaPalpitationSinus bradycardia
Amlodipine Monotherapy0.00.00.00.30.30.00.30.30.00.00.00.60.0
Combination Therapy0.10.10.00.00.10.10.00.00.30.10.00.10.1
Placebo (Pl)0.00.00.00.00.00.00.00.00.00.00.00.00.0
Telmisartan Monotherapy0.30.30.30.00.00.00.00.00.00.00.10.00.0

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Change From Baseline in Seated Trough Pulse Rate

Observed results for mod-sev patients - key combination therapies (NCT00281580)
Timeframe: Up to 8 weeks (LOCF)

Interventionbpm (Mean)
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)0.5
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)0
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)2.5
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-1.9

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Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. (NCT00281580)
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

InterventionmmHg (Least Squares Mean)
Telmisartan 20 mg (T20)-13.8
Telmisartan 40 mg (T40)-13.4
Telmisartan 80 mg (T80)-14
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)-18.3
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)-15.9
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)-19.3
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)-16.9
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-16.5
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-20.2
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)-15.7
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-18.2
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-20.1
Amlodipine 2.5 mg (A2.5)-10.6
Amlodipine 5 mg (A5)-13.4
Amlodipine 10 mg (A10)-17.1

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Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. (NCT00281580)
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

InterventionmmHg (Least Squares Mean)
Placebo (Pl)-6.2
Telmisartan 20 mg (T20)-13.8
Telmisartan 40 mg (T40)-13.4
Telmisartan 80 mg (T80)-14
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)-18.3
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)-15.9
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)-19.3
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)-16.9
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-16.5
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-20.2
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)-15.7
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-18.2
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-20.1
Amlodipine 2.5 mg (A2.5)-10.6
Amlodipine 5 mg (A5)-13.4
Amlodipine 10 mg (A10)-17.11

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Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)

Observed results (NCT00281580)
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

InterventionmmHg (Mean)
Placebo (Pl)-12.3
Amlodipine 2.5 mg (A2.5)-14.9
Amlodipine 5 mg (A5)-15.6
Amlodipine 10 mg (A10)-18.6

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BP Control

Percentage of responders (SBP<140 mmHg and DBP<90 mmHg) for all patients - key combination therapies (NCT00281580)
Timeframe: End-of-study (up to 8 weeks) visit (LOCF)

Interventionpercentage of participants (Number)
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)58.9
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)75.6
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)65.7
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)76.5

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Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)

Observed results (NCT00281580)
Timeframe: End-of-study visit (LOCF)

InterventionmmHg (Mean)
Placebo (Pl)-5.9
Telmisartan 20 mg (T20)-13.2
Telmisartan 40 mg (T40)-13.1
Telmisartan 80 mg (T80)-13.6
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)-18
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)-15.7
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)-18.7
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)-16.2
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-16
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-19.6
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)-15.3
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-17.8
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-19.6
Amlodipine 2.5 mg (A2.5)-10.4
Amlodipine 5 mg (A5)-13
Amlodipine 10 mg (A10)-16.5

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Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect)

Observed results (NCT00281580)
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF))

InterventionmmHg (Mean)
Telmisartan 0 mg (T0)-13
Telmisartan 20 mg (T20)-16.4
Telmisartan 40 mg (T40)-16.2
Telmisartan 80 mg (T80)-16.9

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Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP)

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate. (NCT00281580)
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

InterventionmmHg (Least Squares Mean)
Placebo (Pl)-2.5
Telmisartan 20 mg (T20)-15.1
Telmisartan 40 mg (T40)-14.6
Telmisartan 80 mg (T80)-14.3
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)-18.8
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)-21
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)-24.4
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)-21.9
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-21.8
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-24.7
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)-17.4
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-22.1
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-26.4
Amlodipine 2.5 mg (A2.5)-11.4
Amlodipine 5 mg (A5)-15.4
Amlodipine 10 mg (A10)-20.7

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Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. (NCT00281580)
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

InterventionmmHg (Least Squares Mean)
Placebo (Pl)-4.9
Telmisartan 20 mg (T20)-10.4
Telmisartan 40 mg (T40)-10
Telmisartan 80 mg (T80)-11.1
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)-14.9
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)-13.1
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)-16.9
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)-15.8
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-13.6
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-18.4
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)-13.4
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-16.2
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-19
Amlodipine 2.5 mg (A2.5)-8.1
Amlodipine 5 mg (A5)-11.3
Amlodipine 10 mg (A10)-14.6

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SBP Response

SBP Response is defined as SBP < 140 mmHg or a reduction of SBP of >= 10 mmHg - key combination therapies (NCT00281580)
Timeframe: End-of-study (up to 8 weeks) visit (LOCF)

Interventionpercentage of participants (Number)
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)91.5
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)96.7
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)87.4
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)94.9

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Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate. (NCT00281580)
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

InterventionmmHg (Least Squares Mean)
Placebo (Pl)-0.5
Telmisartan 20 mg (T20)-13.2
Telmisartan 40 mg (T40)-13.2
Telmisartan 80 mg (T80)-12.9
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)-17.4
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)-18.9
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)-22.3
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)-20.3
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-20
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-22.8
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)-17.4
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-21.2
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-24.9
Amlodipine 2.5 mg (A2.5)-9.1
Amlodipine 5 mg (A5)-14.7
Amlodipine 10 mg (A10)-19.1

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Change From Baseline in ABPM 24-hour Mean DBP

Observed results - key combination therapies (NCT00281580)
Timeframe: End-of-study (up to 8 weeks) visit (LOCF)

InterventionmmHg (Mean)
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-11
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-13.2
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-12.8
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-14.6

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Change From Baseline in ABPM 24-hour Mean DBP

Observed results for mod-sev patients - key combination therapies (NCT00281580)
Timeframe: Up to 8 weeks (LOCF)

InterventionmmHg (Mean)
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-11
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-13.6
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-13.6
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-15.3

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Change From Baseline in ABPM 24-hour Mean SBP

Observed results - key combination therapies (NCT00281580)
Timeframe: End-of-study (up to 8 weeks) visit (LOCF)

InterventionmmHg (Mean)
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-17.3
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-20.5
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-19.5
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-22.4

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Change From Baseline in ABPM 24-hour Mean SBP

Observed results for mod-sev patients - key combination therapies (NCT00281580)
Timeframe: Up to 8 weeks (LOCF)

InterventionmmHg (Mean)
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-16.7
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-20.8
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-20.9
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-22.7

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Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. (NCT00281580)
Timeframe: Up to 8 weeks (LOCF)

InterventionmmHg (Least Squares Mean)
Amlodipine 0 mg (A0) - Overall-12.5
Amlodipine 2.5 mg (A2.5) - Overall-16.4
Amlodipine 5 mg (A5) - Overall-16.7
Amlodipine 10 mg (A10) - Overall-19.7

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Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. (NCT00281580)
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

InterventionmmHg (Least Squares Mean)
Placebo (Pl)-12.7
Amlodipine 2.5 mg (A2.5)-17.3
Amlodipine 5 mg (A5)-17.3
Amlodipine 10 mg (A10)-18

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Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. (NCT00281580)
Timeframe: Up to 8 weeks (LOCF)

InterventionmmHg (Least Squares Mean)
Telmisartan 20 mg (T20)-14.5
Telmisartan 40 mg (T40)-14.2
Telmisartan 80 mg (T80)-14.1
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)-18.9
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)-15.9
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)-19.7
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)-18.8
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-17.2
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-20.1
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)-16.6
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-19.1
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-21
Amlodipine 2.5 mg (A2.5)-11.7
Amlodipine 5 mg (A5)-13.3
Amlodipine 10 mg (A10)-17.6

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Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)

Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. (NCT00281580)
Timeframe: Up to 8 weeks (LOCF)

InterventionmmHg (Least Squares Mean)
Placebo (Pl)-5.8
Telmisartan 20 mg (T20)-14.4
Telmisartan 40 mg (T40)-14.2
Telmisartan 80 mg (T80)-14.1
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)-18.9
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)-15.9
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)-19.7
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)-18.8
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)-17.2
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)-20.1
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)-16.6
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)-19.1
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)-21
Amlodipine 2.5 mg (A2.5)-11.7
Amlodipine 5 mg (A5)-13.3
Amlodipine 10 mg (A10)-17.6

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Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)

Observed results (NCT00281580)
Timeframe: Up to 8 weeks (LOCF)

InterventionmmHg (Mean)
Amlodipine 0 mg (A0) - Overall-12.7
Amlodipine 2.5 mg (A2.5) - Overall-16
Amlodipine 5 mg (A5) - Overall-16.3
Amlodipine 10 mg (A10) - Overall-19.2

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Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect)

Observed results (NCT00281580)
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)

InterventionmmHg (Mean)
Telmisartan 0 mg (T0)-13.1
Telmisartan 20 mg (T20)-16.8
Telmisartan 40 mg (T40)-16.9
Telmisartan 80 mg (T80)-17.7

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The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.

For non-diabetic participants the target seated blood pressure goals were: Systolic - ≤130 mm Hg; Diastolic - ≤85 mm Hg. For diabetic participants the target seated blood pressure goals were: Systolic - <130 mm Hg; Diastolic - <80 mm Hg. (NCT00311155)
Timeframe: Baseline to ≤20 weeks

InterventionPercentage of participants (Number)
Overall N=691OLM 20 mg N=688OLM 20 mg+HCTZ 12.5 mg N=580OLM 20 mg+HCTZ 25 mg N=446OLM 20 mg+HCTZ 25 mg+AML 5 mg N=296OLM 20 mg+HCTZ 25 mg+AML 10 mg N=176
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed71.812.316.419.214.98.5

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Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved

Systolic responders defined as a participant who is a normaliser or has a lowering of the mean sitting systolic blood pressure of ≥20 mmHg at trough (NCT00311155)
Timeframe: Baseline to ≤20 weeks

InterventionPercentage of Participants (Number)
Overall N=691OLM 20 mg N=688OLM 20 mg + HCTZ 12.5 mg N=580OLM 20 mg + HCTZ 25 mg N=446OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed92.634.249.646.633.320.5

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Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.

Diastolic responders were defined as a participant who is a normaliser or has a lowering of the mean sitting diastolic blood pressure of ≥10 mmHg at trough. (NCT00311155)
Timeframe: Baseline to ≤20 weeks

InterventionPercentage of participants (Number)
Overall N=691OLM 20 mg N=688OLM 20 mg + HCTZ 12.5 mg N=580OLM 20 mg + HCTZ 25 mg N=446OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed93.336.652.448.633.420.4

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Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved

Normalized blood pressure is defined as a mean sitting systolic blood (sBP) pressure at trough of <140 mmHg and mean sitting diastolic blood pressure (dBP)of <90 mmHg for non-diabetic patients or a mean sitting sBP at trough of <130 mmHg and mean sitting dBP <80 mmHg for diabetic patients. (NCT00311155)
Timeframe: Baseline to ≤20 weeks

InterventionPercentage of participants (Number)
Overall N=691OLM 20 mg N=688OLM 20 mg + HCTZ 12.5 mg N=580OLM 20 mg + HCTZ 25 mg N=446OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed84.522.731.132.723.914.8

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Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment

(NCT00311155)
Timeframe: Baseline to ≤20 weeks

Interventionmm Hg (Mean)
Overall N=691OLM 20 mg N=688OLM 20 mg + HCTZ 12.5 mg N=580OLM 20 mg + HCTZ 25 mg N=446OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed-29.58-11.97-19.55-24.51-27.06-28.02

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Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment

(NCT00311155)
Timeframe: Baseline to ≤20 weeks

Interventionmm Hg (Mean)
Overall N=691OLM 20 mg N=688OLM 20 mg + HCTZ 12.5 mg N=580OLM 20 mg + HCTZ 25 mg N=446OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed-15.73-6.44-10.15-13.04-14.03-14.47

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Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12

(NCT00368277)
Timeframe: Baseline and Week 12

Interventionmm Hg (Least Squares Mean)
Aliskiren Based Treatment Regimen-13.96
Ramipril Based Treatment Regimen-11.64

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Change From Baseline in the Mean Sitting Diastolic Blood Pressure to Week 36

(NCT00368277)
Timeframe: Baseline and week 36

Interventionmm Hg (Least Squares Mean)
Aliskiren Based Treatment Regimen-8.24
Ramipril Based Treatment Regimen-7.02

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Percentage of Patients With Cough

(NCT00368277)
Timeframe: Weeks 12 and 36

,
InterventionPercentage of Participants (Number)
Week 12Week 36
Aliskiren Based Treatment Regimen3.14.4
Ramipril Based Treatment Regimen9.914.2

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Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints

Blood pressure control is defined as a mean sitting blood pressure < 140/90 mm Hg (NCT00368277)
Timeframe: Weeks 12 and 36

,
InterventionPercentage of participants (Number)
week 12 endpointweek 36 endpoint
Aliskiren Based Treatment Regimen46.365.6
Ramipril Based Treatment Regimen39.357.5

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Overall Percentage of Patients With Adverse Events

(NCT00402103)
Timeframe: 52 weeks

InterventionPercentage of Participants (Number)
Aliskiren 150mg/ Amlodipine 5mg Alone23.6
Aliskiren 300mg/ Amlodipine 10mg Alone71.2
Aliskiren 300mg/ Amlodipine 10mg/ HCTZ57.0

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Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points

(NCT00402103)
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54

,
Interventionmm Hg (Mean)
Week 2 (Visit 5)Week 4 (Visit 6)Week 6 (Visit 7)Week 10 (Visit 8)Week 14 (Visit 9)Week 28 (Visit 10)Week 41 (Visit 11)Week 54 (Visit 12)Week 54 (Visit 12) (LOCF)
Aliskiren/Amlodipine-8.7-14.0-15.7-16.3-17.1-16.7-17.0-16.3-15.7
Aliskiren/Amlodipine/HCTZ-5.9-11.9-11.5-9.3-13.1-14.7-15.4-15.3-14.2

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Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg

(NCT00402103)
Timeframe: Baseline, Week 2, Week 10, Week 28 and Week 54

,
InterventionPercentage of patients (Number)
Week 2 (Visit 5)Week 10 (Visit 8)Week 28 (Visit 10)Week 54 (Visit 12)Week 54 (Visit 12) (LOCF)
Aliskiren/Amlodipine35.388.088.282.077.3
Aliskiren/Amlodipine/HCTZ8.116.356.862.258.1

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Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)

(NCT00402103)
Timeframe: Baseline, Week 2, Week 10, Week 28 and Week 54

,
InterventionPercentage of patients (Number)
Week 2 (Visit 5)Week 10 (Visit 8)Week 28 (Visit 10)Week 54 (Visit 12)Week 54 (Visit 12) (LOCF)
Aliskiren/Amlodipine61.296.895.993.290.6
Aliskiren/Amlodipine/HCTZ38.461.685.289.284.9

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Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12

Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated at the end of study treatment (Month 12). (NCT00407537)
Timeframe: Baseline, Month 12

Interventionpercent risk (Mean)
Caduet12.5
Usual Care16.3

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Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD

European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. Change from baseline calculated as mean at observation minus mean at Baseline. (NCT00407537)
Timeframe: Baseline, Month 4, Month 12

,
Interventionpercent risk (Least Squares Mean)
Month 4Month 12
Caduet-1.8438-1.9693
Usual Care-0.9678-0.9963

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Change From Baseline in Framingham 10-year Risk of Developing Total CHD

Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. Change from baseline calculated as mean at observation minus mean at Baseline. (NCT00407537)
Timeframe: Baseline, Month 4, Month 12

,
Interventionpercent risk (Least Squares Mean)
Month 4Month 12
Caduet-7.2705-7.2374
Usual Care-2.5155-2.5167

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Change From Baseline in Lipid Parameters at Month 4

Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. Change from baseline measured as mean at Month 4 minus mean at Baseline. (NCT00407537)
Timeframe: Baseline, Month 4

,
Interventionmg/dL (Least Squares Mean)
TCLDLHDLTriglycerides
Caduet-42.7542-38.2765-0.2060-20.5645
Usual Care-3.8144-2.9628-1.19783.0828

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Mean Lipid Parameters at Month 12

Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. (NCT00407537)
Timeframe: Month 12

,
Interventionmg/dL (Mean)
TCLDLHDLTriglycerides
Caduet163.387.147.3151.5
Usual Care196.6117.347.1166.4

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Mean Lipid Parameters at Month 4

Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. (NCT00407537)
Timeframe: Month 4

,
Interventionmg/dL (Mean)
TCLDLHDLTriglycerides
Caduet156.080.947.6143.5
Usual Care195.2116.446.8164.8

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Mean Systolic and Diastolic Blood Pressure at Month 12

(NCT00407537)
Timeframe: Month 12

,
InterventionmmHg (Mean)
SystolicDiastolic
Caduet130.679.2
Usual Care134.381.1

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Mean Systolic and Diastolic Blood Pressure at Month 4

(NCT00407537)
Timeframe: Month 4

,
InterventionmmHg (Mean)
SystolicDiastolic
Caduet133.580.7
Usual Care134.581.1

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Number of Participants With Increase of Treatment Dosages After 4 Months.

Treatments indicative of prescribed medications other than study provided Caduet. (NCT00407537)
Timeframe: Month 4

,
InterventionParticipants (Number)
Increased doseincreased dose of anti-hypertensive medicationsincreased dose of lipid lowering medicationsincrease in either medicationincrease in both medications
Caduet3030040
Usual Care90882450

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Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months

Treatments indicative of prescribed medications other than study provided Caduet. (NCT00407537)
Timeframe: Month 4, Month 12

,
Interventionparticipants (Number)
Month 4: anti-hypertensive and/or lipid loweringMonth 4: anti-hypertensiveMonth 4: lipid loweringMonth 4: anti-hypertensive and lipid loweringMonth 12: anti-hypertensive and/or lipid loweringMonth 12: anti-hypertensiveMonth 12: lipid loweringMonth 12: anti-hypertensive and lipid lowering
Caduet64864745446556544645
Usual Care642637202197642638208204

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Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months

Goals set at <140/90 mmHg according to the seventh Joint National Committee (JNC) on prevention, detection, evaluation, and treatment of high blood pressure and <140/90 mm Hg or <130/80 mm Hg for diabetics ccording to the European Society of Cardiology (ESC) guidelines. (NCT00407537)
Timeframe: Month 4, Month 12

,
Interventionpercentage of participants (Number)
JNC Month 4JNC Month 12ESC Month 4ESC Month 12
Caduet65.276.148.658.2
Usual Care62.660.646.047.5

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Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months

Goal set at <100 mg/dL according to the United States (US) National Cholesterol Education Program Adult Treatment Panel 3 and at <80 mg/dL according to the European (EU) Society of Cardiology guidelines. (NCT00407537)
Timeframe: Month 4, Month 12

,
InterventionPercentage of participants (Number)
US Month 4US Month 12EU Month 4EU Month 12
Caduet77.371.952.446.7
Usual Care28.228.813.311.5

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Change From Baseline in DBP at Month 12

(NCT00407537)
Timeframe: Baseline, Month 12

InterventionmmHg (Least Squares Mean)
Caduet-10.0128
Usual Care-6.8429

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Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4

(NCT00407537)
Timeframe: Baseline, Month 4

InterventionmmHG (Least Squares Mean)
Caduet-8.3024
Usual Care-6.6908

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Change From Baseline in SBP at Month 12

(NCT00407537)
Timeframe: Baseline, Month 12

InterventionmmHg (Least Squares Mean)
Caduet-18.2409
Usual Care-12.4903

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Change From Baseline in Systolic Blood Pressure (SBP) at Month 4

(NCT00407537)
Timeframe: Baseline, Month 4

InterventionmmHG (Least Squares Mean)
Caduet-15.3088
Usual Care-12.1619

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European SCORE 10-year Risk of Fatal CVD at Month 4

European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 4 months of study treatment (Month 4). (NCT00407537)
Timeframe: Baseline, Month 4

Interventionpercent risk (Mean)
Caduet3.1
Usual Care3.7

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European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12

European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 12 months of study treatment (Month 12). (NCT00407537)
Timeframe: Baseline, Month 12

Interventionpercent risk (Mean)
Caduet3.0
Usual Care3.7

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Framingham 10-year Risk of Stroke at Month 12

"Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific calibration factor for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12)." (NCT00407537)
Timeframe: Baseline, Month 12

Interventionpercent risk (Mean)
Caduet3.7
Usual Care4.9

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Framingham 10-year Risk of Stroke at Month 4

"Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific calibration factor for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12)." (NCT00407537)
Timeframe: Baseline, Month 4

Interventionpercent risk (Mean)
Caduet3.7
Usual Care4.9

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Framingham 10-year Risk of Total CHD at Month 4

Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated after 4 months of treatment (Month 4). (NCT00407537)
Timeframe: Baseline, Month 4

Interventionpercent risk (Mean)
Caduet12.5
Usual Care16.3

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Change From Baseline in Lipid Parameters at Month 12

Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. (NCT00407537)
Timeframe: Baseline, Month 12

,
Interventionmg/dL (Least Squares Mean)
TCLDLHDLTriglycerides
Caduet-37.1024-33.2420-0.4339-15.2270
Usual Care-4.0368-3.4168-1.01053.0398

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Change From Baseline in LDL at Week 4.

Change: mean of observation minus mean at baseline. (NCT00412113)
Timeframe: Week 4, baseline

Interventionmg/dL (Mean)
Norvasc + TLC-0.5
Caduet + TLC-47.8

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Change From Baseline in LDL at Week 6.

Mean change at observation minus baseline. (NCT00412113)
Timeframe: Week 6, baseline

Interventionmg/dL (Mean)
Norvasc + TLC0.3
Caduet + TLC-49.2

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Change From Baseline in Total Cholesterol (TC) to Week 6.

Mean change at observation minus baseline. (NCT00412113)
Timeframe: Week 6, baseline

Interventionmg/dL (Mean)
Norvasc + TLC3.7
Caduet + TLC-56.8

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Change From Baseline in Triglycerides (TG) at Week 6.

Mean change at observation minus mean baseline. (NCT00412113)
Timeframe: Week 6 , baseline

Interventionmg/dL (Mean)
Norvasc + TLC11.6
Caduet + TLC-42.6

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Change From Baseline in Triglycerides (TG) to Week 4.

Mean change at observation minus baseline (NCT00412113)
Timeframe: Week 4, baseline

Interventionmg/dL (Mean)
Norvasc + TLC2.4
Caduet + TLC-45.7

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Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)

Mean at observation minus mean at baseline (NCT00412113)
Timeframe: Week 4, baseline

InterventionmmHg (Mean)
Norvasc + TLC-1.5
Caduet + TLC-1.2

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Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.

Framingham prediction of absolute 10-year risk of CHD outcomes (MI or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol and systolic blood pressure calculated at Week 4. Mean at observation minus mean at baseline. (NCT00412113)
Timeframe: Week 4, baseline

Interventionscore on scale (Least Squares Mean)
Norvasc + TLC-0.3
Caduet + TLC-2.8

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Change From Baseline to Week 4 in Pulse Rate

Mean at observation minus mean at baseline measured in beats per minute (bpm). (NCT00412113)
Timeframe: Week 4, baseline

Interventionbpm (Mean)
Norvasc + TLC-0.1
Caduet + TLC-0.9

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Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).

Mean at observation minus mean at baseline (NCT00412113)
Timeframe: Week 4, baseline

InterventionmmHg (Mean)
Norvasc + TLC-2.6
Caduet + TLC-1.5

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Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk

Framingham prediction of absolute 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol, and systolic blood pressure calculated at Week 6. Mean at observation minus mean at baseline. (NCT00412113)
Timeframe: Week 6, baseline

Interventionscore on scale (Least Squares Mean)
Norvasc + TLC-0.1
Caduet + TLC-2.9

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Change From Baseline to Week 6 in Pulse Rate

Mean at observation minus mean at baseline (NCT00412113)
Timeframe: Week 6, baseline

Interventionbpm (Mean)
Norvasc + TLC0.9
Caduet + TLC1.1

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Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)

Mean change at observation minus mean baseline. (NCT00412113)
Timeframe: Week 6, baseline

InterventionmmHg (Mean)
Norvasc + TLC-1.0
Caduet + TLC-4.0

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Change in Total Cholesterol (TC) From Baseline to Week 4.

Mean change at observation minus baseline. (NCT00412113)
Timeframe: Week 4, baseline

Interventionmg/dL (Mean)
Norvasc + TLC0.5
Caduet + TLC-55.9

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Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6

Number of subjects reaching dual goal of systolic blood pressure <140 millimeters of mercury (mmHg) and diastolic blood pressue of <90 mmHg and low density lipoprotein-cholesterol(LDL-C) <100 milligrams per deciliter(mg/dL) (NCT00412113)
Timeframe: Week 6

Interventionparticipants (Number)
Norvasc + TLC11
Caduet + TLC80

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Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4

Subjects achieving both the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC)-7 blood pressure goal of <140/90 mmHg and the National Cholesterol Education Program Adult Treatment Panel (NCEP/ATP) III Update low density lipoprotein-cholesterol (LDL-C) goal <100 mg/dL at Week 4. (NCT00412113)
Timeframe: Week 4

Interventionparticipants (Number)
Norvasc + TLC6
Caduet + TLC73

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Subjects With BP < 140/90 mmHg at Week 4

Subjects achieving BP goal of <140/90 mmHg at week 4 (NCT00412113)
Timeframe: Week 4

Interventionparticipants (Number)
Norvasc + TLC84
Caduet + TLC87

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Subjects With BP < 140/90 mmHg at Week 6

Subjects achieving BP goal of <140/90 mmHg at week 6 (NCT00412113)
Timeframe: Week 6

Interventionparticipants (Number)
Norvasc + TLC83
Caduet + TLC94

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Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.

Subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III LDL-C goal <130 mg/dL at Week 6. (NCT00412113)
Timeframe: Week 6

Interventionparticipants (Number)
Norvasc + TLC45
Caduet + TLC90

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Subjects With LDL-C < 100 mg/dL at Week 4

Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 4. (NCT00412113)
Timeframe: Week 4

Interventionparticipants (Number)
Norvasc + TLC8
Caduet + TLC96

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Subjects With LDL-C < 100 mg/dL at Week 6

Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 6. (NCT00412113)
Timeframe: Week 6

Interventionparticipants (Number)
Norvasc + TLC13
Caduet + TLC99

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Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)

Change from mean at observation minus mean at baseline (NCT00412113)
Timeframe: Week 6, baseline

InterventionmmHg (Median)
Norvasc + TLC-1.1
Caduet + TLC-1.7

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Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.

Subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III LDL-C goal <130 mg/dL at Week 4. (NCT00412113)
Timeframe: Week 4

Interventionparticipants (Number)
Norvasc + TLC41
Caduet + TLC85

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Change From Baseline in HDL at Week 6.

Mean change at observation minus baseline. (NCT00412113)
Timeframe: Week 6, baseline

Interventionmg/dL (Mean)
Norvasc + TLC1.2
Caduet + TLC0.4

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Change From Baseline in High Density Lipoprotein (HDL) at Week 4.

Mean change at observation minus baseline. (NCT00412113)
Timeframe: Week 4, baseline

Interventionmg/dL (Mean)
Norvasc + TLC0.6
Caduet + TLC0.6

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Percentage of Patients Achieving a Diastolic Response at the End of the Study (Week 8)

A patient achieved a diastolic response if their msDBP < 90 mmHg at Week 8 or they had a ≥ 10 mmHg decrease in msDBP compared to baseline at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. (NCT00413049)
Timeframe: Baseline to end of study (Week 8)

InterventionPercentage of patients (Number)
Valsartan/Amlodipine 80/5 mg79.3
Amlodipine 5 mg66.8

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Change in 24-hour Mean Ambulatory Diastolic and Systolic BP From Baseline at the End of the Study (Week 8)

Two 24 hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline prior to randomization and one at Week 8 (end of study), in a subset of the intent-to-treat population of patients. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient. A correlation was made between the ABPM device readings and measurements taken with a mercury sphygmomanometer and stethoscope. Following the correlation procedure, BP was measured at study specified intervals. A negative change score indicates lowered BP. (NCT00413049)
Timeframe: Baseline to end of study (Week 8)

,
InterventionmmHg (Mean)
Diastolic BPSystolic BP
Amlodipine 5 mg0.3-0.2
Valsartan/Amlodipine 80/5 mg-6.3-7.3

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Percentage of Patients Achieving Diastolic Control at the End of the Study (Week 8)

A patient achieved diastolic control if their msDBP < 90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. (NCT00413049)
Timeframe: Baseline to end of study (Week 8)

InterventionPercentage of patients (Number)
Valsartan/Amlodipine 80/5 mg75.5
Amlodipine 5 mg64.5

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Percentage of Patients Achieving Overall Control at the End of the Study (Week 8)

A patient achieved overall control if the msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. (NCT00413049)
Timeframe: Baseline to end of study (Week 8)

InterventionPercentage of patients (Number)
Valsartan/Amlodipine 80/5 mg69.2
Amlodipine 5 mg57.6

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Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)

Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. A negative change score indicates lowered BP. (NCT00413049)
Timeframe: Baseline to end of study (Week 8)

InterventionmmHg (Least Squares Mean)
Valsartan/Amlodipine 80/5 mg-9.7
Amlodipine 5 mg-7.1

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Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)

Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. A negative change score indicates lowered BP. (NCT00413049)
Timeframe: Baseline to end of study (Week 8)

InterventionmmHg (Least Squares Mean)
Valsartan/Amlodipine 80/5 mg-11.4
Amlodipine 5 mg-7.4

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Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8)

Diastolic blood pressure control was defined as a msDBP < 90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. (NCT00413413)
Timeframe: End of study (Week 8)

InterventionPercentage of patients (Number)
Valsartan/Amlodipine 80/5 mg74.4
Valsartan 80 mg53.6
Valsartan 160 mg64.2

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Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)

Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. (NCT00413413)
Timeframe: Baseline to end of study (Week 8)

InterventionmmHg (Least Squares Mean)
Valsartan/Amlodipine 80/5 mg-12.5
Valsartan 80 mg-6.0
Valsartan 160 mg-7.7

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Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)

Overall blood pressure control rate was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. (NCT00413413)
Timeframe: End of study (Week 8)

InterventionPercentage of patients (Number)
Valsartan/Amlodipine 80/5 mg70.5
Valsartan 80 mg44.1
Valsartan 160 mg58.6

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Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)

Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. (NCT00413413)
Timeframe: Baseline to end of study (Week 8)

InterventionmmHg (Least Squares Mean)
Valsartan/Amlodipine 80/5 mg-10.8
Valsartan 80 mg-6.3
Valsartan 160 mg-7.2

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Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8)

A diastolic blood pressure response was defined as a msDBP < 90 mmHg or a ≥ 10 mmHg decrease compared to baseline at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. (NCT00413413)
Timeframe: Baseline to end of study (Week 8)

InterventionPercentage of patients (Number)
Valsartan/Amlodipine 80/5 mg77.9
Valsartan 80 mg57.8
Valsartan 160 mg66.6

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Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8

Mean change in the trough DBP (NCT00415623)
Timeframe: Baseline to Week 8

InterventionmmHg (Least Squares Mean)
Amlodipine 5 mg-2.7
Amlodipine 10 mg-6.8

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Change in Systolic Blood Pressure (SBP) From Baseline to Week 8

Mean change in the trough SBP (NCT00415623)
Timeframe: Baseline to Week 8

InterventionmmHg (Least Squares Mean)
Amlodipine 5 mg-7.0
Amlodipine 10 mg-13.7

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Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient)

"Arithmetic mean of Week 6 & Week 8 by patient for Change from baseline in DBP at Week 6 and Change from baseline in DBP at Week 8" (NCT00415623)
Timeframe: Baseline to Week 6 and Week 8

InterventionmmHg (Least Squares Mean)
Amlodipine 5 mg-2.5
Amlodipine 10 mg-6.5

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Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient)

"Arithmetic mean of Week 6 & Week 8 by patient for Change from baseline in SBP at Week 6 and Change from baseline in SBP at Week 8" (NCT00415623)
Timeframe: Baseline to Week 6 and Week 8

InterventionmmHg (Least Squares Mean)
Amlodipine 5 mg-6.8
Amlodipine 10 mg-13.9

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Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Both Weeks 6 and 8

Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old (NCT00415623)
Timeframe: Week 6 and Week 8

Interventionparticipants (Number)
Amlodipine 5 mg16
Amlodipine 10 mg44

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Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8

Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old (NCT00415623)
Timeframe: Week 6 and Week 8

Interventionparticipants (Number)
Amlodipine 5 mg22
Amlodipine 10 mg52

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Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8

Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old (NCT00415623)
Timeframe: Week 8

Interventionparticipants (Number)
Amlodipine 5 mg43
Amlodipine 10 mg66

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Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg

(NCT00415623)
Timeframe: Baseline, Week 4, and Week 8

Interventionng/mL (Geometric Mean)
Baseline7.18
Week 416.9
Week 816.9

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Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg

(NCT00415623)
Timeframe: Baseline, Week 4 and Week 8

Interventionng/mL (Geometric Mean)
Baseline7.02
Week 46.83
Week 87.03

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Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Week 8

Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old (NCT00415623)
Timeframe: Week 8

Interventionparticipants (Number)
Amlodipine 5 mg35
Amlodipine 10 mg61

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Mean Change in Insulin Concentration as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment

Insulin Concentration is determined by the Oral Glucose Tolerance Test (OGTT) which begins after a 10 hour overnight fast. Blood samples are taken at baseline and after an oral 75 gram dose of glucose. Additional samples of blood are taken to measure glucose and insulin levels at 30, 60, 120 and 180 minutes post glucose intake. Changes from pre-glucose intake values are analyzed by an analysis of variance (ANOVA) model including treatment, visit and post-dose time points ( 30, 60, 120 and 180 minutes) as fixed factors and subject (nested in treatment) as a random factor. (NCT00417170)
Timeframe: At baseline and after 12 weeks of treatment

,
InterventionmU/L (Least Squares Mean)
0 minutes (n=21, 23)30 minutes (n=17, 21)60 minutes (n=19, 22)120 minutes (n=17, 19)180 minutes (n=19, 22)
Aliskiren 300 mg3.5431.2616.7133.2722.96
Amlodipine 5 mg-3.08-15.46-27.87-52.67-43.58

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Mean Change in Arterial Compliance as Measured by Pulse Wave Analysis From Baseline and After 12 Weeks of Treatment

Arterial Compliance is determined by Pulse Wave Analysis measured by a detector placed at the carotid artery while taking ECG and tonometry at the same time. Procedure is repeated for the femoral artery. Pulse Wave data are calculated by dividing distance between 2 arteries by the difference between the rise delay of the distal pulse wave and the R wave of the QRS complex and the rise delay of the proximal pulse wave to the QRS complex. Data analysis used an analysis of variance (ANOVA) model including treatment and week as fixed factors and subject (nested in treatment) as a random factor. (NCT00417170)
Timeframe: At baseline and after 12 weeks of treatment

,
InterventionmmHg (Least Squares Mean)
Central Systolic Blood PressureCentral Mean PressureCentral Diastolic Blood PressureSystolic Blood Pressure (Peripheral)Diastolic Blood Pressure (Peripheral)
Aliskiren 300 mg-17.7-1.39-11.0-16.2-10.6
Amlodipine 5 mg-11.1-0.85-6.3-10.0-6.0

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Mean Change From Baseline in Inflammatory Marker ( C-peptide) as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment [Time Frame: At Baseline and After 12 Weeks of Treatment

C-peptide level is determined by the Oral Glucose Tolerance Test (OGTT) which begins after a 10 hour overnight fast. Blood samples are taken at baseline and after an oral 75 gram dose of glucose. Additional samples of blood are taken to measure glucose and insulin levels at 30, 60, 120 and 180 minutes post glucose intake. Changes from pre-glucose intake values are analyzed by an analysis of variance (ANOVA) model including treatment, visit and post-dose time points ( 30, 60, 120 and 180 minutes) as fixed factors and subject (nested in treatment) as a random factor. (NCT00417170)
Timeframe: Baseline and after 12 weeks of treatment

,
Interventionng/mL (Least Squares Mean)
0 minutes ( n = 21, 23)30 minutes ( n= 20, 22)
Aliskiren 300 mg0.3020.862
Amlodipine 5 mg-0.215-0.888

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Mean Change in Insulin Sensitivity as Measured by Glucose Infusion Rate (Last 30 Minutes) From Baseline and After 12 Weeks of Treatment.

Insulin sensitivity is measured by the hyperglycemic euglycemic clamp procedure where a supine patient has 2 IV lines inserted for sampling blood. Regular human insulin (60mU/m^2 surface area/min) is infused for 120 minutes. Dextrose (20% w/v) is infused to maintain glycemia at < 100 mg/dL and is adjusted based on plasma glucose levels obtained every 5 minutes. Blood for glucose and insulin is taken at specified time intervals. Change from baseline data is analyzed by analysis of variance model including treatment and week as fixed factors, and subject (nested in treatment) as a random factor. (NCT00417170)
Timeframe: At baseline and after 12 weeks of treatment

Interventionmg/kg/min (Least Squares Mean)
Aliskiren 300 mg0.23
Amlodipine 5 mg0.55

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Mean Change in Endothelial Function as Measured by Myocardial Blood Flow (MBF) From Baseline and After 12 Weeks of Treatment

MBF is measured by Positron Emission Tomography (PET) first at rest, then 45 minutes later, during cold pressor testing (CPT). The patient is placed in the PET scanner and injected with N-13 ammonia as a tracer. PET images are taken to assess myocardial blood flow at rest. After 40 minutes, the patient immerses one hand in ice water and PET images are taken to assess myocardial blood flow at sympathetic activation. Change from baseline data is analyzed by an analysis of variance (ANOVA) model including treatment and week as fixed factors and subject (nested in treatment) as a random factor. (NCT00417170)
Timeframe: At baseline and after 12 weeks of treatment

InterventionmL/g/min (Least Squares Mean)
Aliskiren 300 mg0.06
Amlodipine 5 mg0.12

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Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8)

At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure. (NCT00425373)
Timeframe: Baseline to end of study (Week 8)

InterventionPercentage of patients (Number)
Valsartan + Amlodipine 40/2.5 mg55.3
Valsartan + Amlodipine 40/5 mg75.4
Valsartan + Amlodipine 80/2.5 mg59.4
Valsartan + Amlodipine 80/5 mg72.2
Valsartan 40 mg33.1
Valsartan 80 mg30.1
Amlodipine 2.5 mg41.0
Amlodipine 5 mg57.1
Placebo18.7

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Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8)

At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure. (NCT00425373)
Timeframe: Baseline to end of study (Week 8)

InterventionPercentage of patients (Number)
Valsartan + Amlodipine 40/2.5 mg67.3
Valsartan + Amlodipine 40/5 mg82.6
Valsartan + Amlodipine 80/2.5 mg72.5
Valsartan + Amlodipine 80/5 mg80.9
Valsartan 40 mg46.2
Valsartan 80 mg41.1
Amlodipine 2.5 mg55.3
Amlodipine 5 mg67.1
Placebo31.9

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Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Study (Week 8)

At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure. (NCT00425373)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Valsartan + Amlodipine 40/2.5 mg-16.7
Valsartan + Amlodipine 40/5 mg-22.0
Valsartan + Amlodipine 80/2.5 mg-16.9
Valsartan + Amlodipine 80/5 mg-22.9
Valsartan 40 mg-9.3
Valsartan 80 mg-9.5
Amlodipine 2.5 mg-13.6
Amlodipine 5 mg-16.6
Placebo-4.4

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Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8)

At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure. (NCT00425373)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Valsartan + Amlodipine 40/2.5 mg-13.5
Valsartan + Amlodipine 40/5 mg-16.5
Valsartan + Amlodipine 80/2.5 mg-12.6
Valsartan + Amlodipine 80/5 mg-17.0
Valsartan 40 mg-8.5
Valsartan 80 mg-8.8
Amlodipine 2.5 mg-10.3
Amlodipine 5 mg-13.4
Placebo-4.8

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Percentage of Patients Achieving MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8)

At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure. (NCT00425373)
Timeframe: Baseline to end of study (Week 8)

InterventionPercentage of patients (Number)
Valsartan + Amlodipine 40/2.5 mg77.4
Valsartan + Amlodipine 40/5 mg88.0
Valsartan + Amlodipine 80/2.5 mg80.6
Valsartan + Amlodipine 80/5 mg86.4
Valsartan 40 mg52.1
Valsartan 80 mg47.9
Amlodipine 2.5 mg62.1
Amlodipine 5 mg74.5
Placebo36.1

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Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8

Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0. 5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP. (NCT00437645)
Timeframe: Baseline to Week 8

InterventionmmHg (Least Squares Mean)
Valsartan/Amlodipine 160/5 mg-8.01
Amlodipine 10 mg-6.30

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Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8

Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0. 5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP. (NCT00437645)
Timeframe: Baseline to Week 8

InterventionmmHg (Least Squares Mean)
Valsartan/Amlodipine 160/5 mg-4.65
Amlodipine 10 mg-4.13

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Percentage of Patients With Peripheral Edema From Baseline to Week 8

Only occurrences of peripheral edema quantified as a reported adverse event coded as peripheral edema were included in the analysis. If a patient experienced more than one occurrence of peripheral edema between Day 1 and Week 8, it was only counted once in the analysis. (NCT00437645)
Timeframe: Baseline to Week 8

InterventionPercentage of patients (Number)
Valsartan/Amlodipine 160/5 mg6.6
Amlodipine 10 mg31.1

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Percentage of Patients Achieving a Systolic Response at Weeks 4, 8, and 12

Systolic response was defined as msSBP < 130 mmHg or at least a 20 mmHg reduction from baseline in msSBP at Weeks 4, 8, and 12. Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. (NCT00437645)
Timeframe: Baseline to Weeks 4, 8, and 12

,
InterventionPercentage of patients (Number)
Week 4 (n=576, 535)Week 8 (n=567, 510)Week 12 (n=569, 531)
Amlodipine 10 mg25.4225.4931.26
Valsartan/Amlodipine 160/5 mg35.0734.2237.96

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Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP, msDBP) From Baseline to Weeks 4, 8, and 12

Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0. 5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP. (NCT00437645)
Timeframe: Baseline to Weeks 4, 8, and 12

,
InterventionmmHg (Least Squares Mean)
msSBP: Week 4 (n=576, 535)msSBP: Week 8 (n=567, 510)msSBP: Week 12 (n=569, 531)msDBP: Week 4 (n=576, 535)msDBP: Week 8 (n=576, 510)msDBP: Week 12 (n=569, 531)
Amlodipine 10 mg-6.48-6.11-7.82-4.23-3.97-4.90
Valsartan/Amlodipine 160/5 mg-8.40-8.15-9.08-5.05-4.68-5.50

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Change in Mean Sitting Systolic Blood Pressure (MSSBP)

(NCT00439738)
Timeframe: Baseline to Week 8

,
Interventionmm Hg (Mean)
BaselineWeek 8Change from baseline
HCTZ +Amlodipine159.0137.5-21.5
Valsartan/HCTZ (Hydrochlorothiazide)159.7131.2-28.6

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Change in Mean Sitting Diastolic Blood Pressure (MSDBP)

(NCT00439738)
Timeframe: Baseline to Weeks 4, 8, 12 and 16

,
Interventionmm Hg (Mean)
BaselineWeek 4Week 8Week 12Week 16Change from baseline to week 16
HCTZ +Amlodipine93.687.685.182.880.9-12.7
Valsartan/HCTZ (Hydrochlorothiazide)94.985.781.981.180.8-14.0

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Change From Baseline in Postprandial Glucose

After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test (NCT00439738)
Timeframe: Week 16

,
Interventionmg/dL (Mean)
Baseline visit (0 minutes)Week 16 (0 minutes)Change from baseline to week 16 (0 minutes)Baseline visit (120 minutes)Week 16 (120 minutes)Change from baseline to week 16 (120 minutes)
HCTZ +Amlodipine99.4102.83.4127.7146.518.9
Valsartan/HCTZ (Hydrochlorothiazide)98.098.1-0.5123.9126.32.1

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Change From Baseline in Postprandial Non-esterified Fatty Acids

After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test (NCT00439738)
Timeframe: Week 16

,
Interventionmg/dL (Mean)
Baseline visit (0 minutes)Week 16 (0 minutes)Change from baseline to week 16 (0 minutes)Baseline visit (120 minutes)Week 16 (120 minutes)Change from baseline to week 16 (120 minutes)
HCTZ +Amlodipine0.470.470.000.100.10-0.01
Valsartan/HCTZ (Hydrochlorothiazide)0.450.460.010.110.10-0.01

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Change From Baseline in Postprandial Insulin

After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test (NCT00439738)
Timeframe: Week 16

,
Interventionmg/dL (Mean)
Baseline visit (0 minutes)Week 16 (0 minutes)Change from baseline to week 16 (0 minutes)Baseline visit (120 minutes)Week 16 (120 minutes)Change from baseline to week 16 (120 minute)
HCTZ +Amlodipine20.3723.623.6795.95120.0128.07
Valsartan/HCTZ (Hydrochlorothiazide)19.6623.453.4192.04116.0424.68

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Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)

Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 130/80 mm Hg (NCT00439738)
Timeframe: Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16)

,
Interventionparticipants (Number)
Week 4Week 8Week 12Week 16End of Study
HCTZ +Amlodipine1823466568
Valsartan/HCTZ (Hydrochlorothiazide)3359576268

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Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)

Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 140/90 mm Hg (NCT00439738)
Timeframe: Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16)

,
Interventionparticipants (Number)
Week 4Week 8Week 12Week 16End of study
HCTZ +Amlodipine69102112140146
Valsartan/HCTZ (Hydrochlorothiazide)91123122124133

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Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent

Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg (NCT00443456)
Timeframe: 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

,
Interventionparticipants (Number)
Week 8 (n=13, 121)Week 10 (n=13, 118)Week 12 (n=12, 119)Week 16 (n=12, 117)Week 20 (n=12, 116)Week 24 (n=11, 113)Week 28 (n=12, 111)Week 32 (n=12, 111)Week 36 (n=11, 108)Week 40 (n=12, 108)Week 44 (n=11, 108)Week 48 (n=9, 107)Week 52 (n=9, 106)
Subjects With Concomitant Antihypertensive Agent1344322221111
Subjects Without Concomitant Antihypertensive Agent35505553565346434344484751

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Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study

Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg (NCT00443456)
Timeframe: 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

,,
Interventionparticipants (Number)
Week 8Week 10Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52
Amlodipine36556059626054505452575660
The Preceding Study 10 mg Sub-set of This Long-term Study23303131273024282225322632
The Preceding Study 5 mg Sub-set of This Long-term Study13252928353030223227253028

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Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent

Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg (NCT00443456)
Timeframe: 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

,
Interventionparticipants (Number)
Week 8 (n=13, 121)Week 10 (n=13, 118)Week 12 (n=12, 119)Week 16 (n=12, 117)Week 20 (n=12, 116)Week 24 (n=11, 113)Week 28 (n=12, 111)Week 32 (n=12, 111)Week 36 (n=11, 108)Week 40 (n=12, 108)Week 44 (n=11, 108)Week 48 (n=9, 107)Week 52 (n=9, 106)
Subjects With Concomitant Antihypertensive Agent2344322221111
Subjects Without Concomitant Antihypertensive Agent39545956595746464548494954

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Change in Systolic Blood Pressure From Baseline of This Long-term Study

Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.) (NCT00443456)
Timeframe: Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

,,
InterventionmmHg (Mean)
Week 8: Baseline (Actual Value)Week 10Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52
Amlodipine140.1-6.0-6.9-8.0-7.1-6.7-6.0-5.1-4.7-5.2-7.0-6.6-6.9
The Preceding Study 10 mg Sub-set of This Long-term Study136.8-3.0-3.7-4.4-2.1-2.6-1.6-1.2-0.2-1.0-3.8-2.5-4.3
The Preceding Study 5 mg Sub-set of This Long-term Study143.2-8.9-10.0-11.3-11.8-10.5-10.1-8.8-9.0-9.1-10.0-10.4-9.4

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Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value

Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg (NCT00443456)
Timeframe: 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

,,
Interventionparticipants (Number)
Week 8Week 10Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52
Amlodipine41596462656454535656585863
The Preceding Study 10 mg Sub-set of This Long-term Study26323433303224302427322734
The Preceding Study 5 mg Sub-set of This Long-term Study15273029353230233229263129

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Change in Diastolic Blood Pressure From Baseline of This Long-term Study

Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.) (NCT00443456)
Timeframe: Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

,,
InterventionmmHg (Mean)
Week 8: Baseline (Actual Value)Week 10Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52
Amlodipine83.1-3.3-3.7-4.2-4.1-3.7-3.7-3.6-3.3-3.6-4.1-4.1-4.8
The Preceding Study 10 mg Sub-set of This Long-term Study80.3-1.7-1.5-1.7-1.9-2.0-1.2-1.9-0.9-1.7-2.3-2.5-3.2
The Preceding Study 5 mg Sub-set of This Long-term Study85.8-4.8-5.8-6.5-6.1-5.3-6.0-5.2-5.6-5.4-5.8-5.5-6.3

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Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent

Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.) (NCT00443456)
Timeframe: Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

,
InterventionmmHg (Mean)
Week 0: Baseline (Actual Value)Week 8 (n=13, 121)Week 10 (n=13, 118)Week 12 (n=12, 119)Week 16 (n=12, 117)Week 20 (n=12, 116)Week 24 (n=11, 113)Week 28 (n=12, 111)Week 32 (n=12, 111)Week 36 (n=11, 108)Week 40 (n=12, 108)Week 44 (n=11, 108)Week 48 (n=9, 107)Week 52 (n=9, 106)
Subjects With Concomitant Antihypertensive Agent85.90.3-3.6-4.8-4.9-2.5-2.9-3.21.72.10.8-2.4-0.8-2.7
Subjects Without Concomitant Antihypertensive Agent86.3-3.5-6.6-7.0-7.6-7.7-6.9-6.9-7.4-7.0-7.3-7.5-7.5-8.4

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Change in Diastolic Blood Pressure From Baseline of the Preceding Study

Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.) (NCT00443456)
Timeframe: Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

,,
InterventionmmHg (Mean)
Week 0: Baseline (Actual Value)Week 8Week 10Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52
Amlodipine86.3-3.1-6.4-6.9-7.3-7.2-6.8-6.8-6.8-6.5-6.8-7.3-7.2-7.9
The Preceding Study 10 mg Sub-set of This Long-term Study84.8-4.5-6.3-6.0-6.2-6.4-6.5-5.7-6.5-5.5-6.3-6.9-7.0-7.7
The Preceding Study 5 mg Sub-set of This Long-term Study87.6-1.8-6.6-7.7-8.4-7.9-7.1-7.8-7.1-7.4-7.2-7.6-7.3-8.2

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Change in Systolic Blood Pressure From Baseline of the Preceding Study

Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.) (NCT00443456)
Timeframe: Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

,,
InterventionmmHg (Mean)
Week 0: Baseline (Actual Value)Week 8Week 10Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52
Amlodipine148.8-8.7-14.8-15.6-16.7-15.8-15.4-14.7-13.8-13.4-13.9-15.7-15.3-15.6
The Preceding Study 10 mg Sub-set of This Long-term Study148.8-12.0-15.0-15.7-16.4-14.1-14.6-13.6-13.2-12.2-13.0-15.8-14.5-16.3
The Preceding Study 5 mg Sub-set of This Long-term Study148.8-5.6-14.5-15.6-16.9-17.4-16.1-15.7-14.4-14.6-14.7-15.6-16.0-15.0

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Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent

Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.) (NCT00443456)
Timeframe: Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

,
InterventionmmHg (Mean)
Week 8: Baseline (Actual Value)Week 10 (n=13, 118)Week 12 (n=12, 119)Week 16 (n=12, 117)Week 20 (n=12, 116)Week 24 (n=11, 113)Week 28 (n=12, 111)Week 32 (n=12, 111)Week 36 (n=11, 108)Week 40 (n=12, 108)Week 44 (n=11, 108)Week 48 (n=9, 107)Week 52 (n=9, 106)
Subjects With Concomitant Antihypertensive Agent149.1-9.0-8.4-12.0-5.6-9.2-9.90.40.2-4.5-9.1-7.3-7.1
Subjects Without Concomitant Antihypertensive Agent139.2-5.9-6.9-7.6-7.3-6.2-5.0-5.3-4.5-5.2-7.1-7.0-7.5

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Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent

Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.) (NCT00443456)
Timeframe: Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

,
InterventionmmHg (Mean)
Week 0: Baseline (Actual Value)Week 8 (n=13, 121)Week 10 (n=13, 118)Week 12 (n=12, 119)Week 16 (n=12, 117)Week 20 (n=12, 116)Week 24 (n=11, 113)Week 28 (n=12, 111)Week 32 (n=12, 111)Week 36 (n=11, 108)Week 40 (n=12, 108)Week 44 (n=11, 108)Week 48 (n=9, 107)Week 52 (n=9, 106)
Subjects With Concomitant Antihypertensive Agent153.9-4.8-13.8-13.5-17.2-10.8-13.8-15.1-4.8-4.8-9.6-13.7-11.1-10.8
Subjects Without Concomitant Antihypertensive Agent148.3-9.1-14.8-15.8-16.4-16.1-14.8-13.6-14.0-13.1-13.6-15.4-15.3-15.9

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Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent

Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.) (NCT00443456)
Timeframe: Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

,
InterventionmmHg (Mean)
Week 8: Baseline (Actual Value)Week 10 (n=13, 118)Week 12 (n=12, 119)Week 16 (n=12, 117)Week 20 (n=12, 116)Week 24 (n=11, 113)Week 28 (n=12, 111)Week 32 (n=12, 111)Week 36 (n=11, 108)Week 40 (n=12, 108)Week 44 (n=11, 108)Week 48 (n=9, 107)Week 52 (n=9, 106)
Subjects With Concomitant Antihypertensive Agent86.2-3.9-5.0-5.1-2.8-4.0-3.51.52.30.6-3.4-1.9-3.8
Subjects Without Concomitant Antihypertensive Agent82.8-3.3-3.7-4.2-4.4-3.6-3.6-4.2-3.8-4.1-4.4-4.6-5.4

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Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI

(NCT00446563)
Timeframe: Baseline to week 52

Interventionml (Mean)
Valsartan and Amlodipine0.0
Losartan and HCTZ-3.0

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Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI

(NCT00446563)
Timeframe: Baseline to week 52

Interventionml (Mean)
Valsartan and Amlodipine0.4
Losartan and HCTZ-1.5

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Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI

(NCT00446563)
Timeframe: Baseline to week 52

Interventionml (Mean)
Valsartan and Amlodipine0.2
Losartan and HCTZ-0.8

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Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI

(NCT00446563)
Timeframe: Baseline to week 52

Interventiong/m˄2 (Mean)
Valsartan and Amlodipine-3.5
Losartan and HCTZ-4.4

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Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI

(NCT00446563)
Timeframe: Baseline to week 52

Interventionmm (Mean)
Valsartan and Amlodipine-0.4
Losartan and HCTZ-0.3

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Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI

(NCT00446563)
Timeframe: Baseline to week 52

Interventionmm (Mean)
Valsartan and Amlodipine0.1
Losartan and HCTZ-0.8

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Percentage of Participants Achieving Target Blood Pressure at Week 52

Target blood pressure defined as having a mean sitting systolic blood pressure (MSSBP) < 140 mm Hg and a mean sitting diastolic blood pressure (MSDBP) < 90 mm Hg. (NCT00446563)
Timeframe: Week 52

InterventionPercentage of participants (Number)
Valsartan and Amlodipine53.5
Losartan and HCTZ14.9

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Percentage of Participants Who Experienced Adverse Events (AEs)

An adverse event was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after obtaining informed consent even if the event was not considered to be related to study drug. Medical conditions/diseases present before obtaining informed consent were only considered adverse events if they worsened after study start. Abnormal laboratory values or test results constituted adverse events only if they induced clinical signs or symptoms, required study drug discontinuation or required therapy. (NCT00446563)
Timeframe: Baseline to week 52

InterventionPercentage of participants (Number)
Valsartan and Amlodipine69.8
Losartan and HCTZ68.1

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Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI

(NCT00446563)
Timeframe: Baseline to week 52

Interventioncm˄2 (Mean)
Valsartan and Amlodipine-0.6
Losartan and HCTZ-1.0

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Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI

Ejection fraction is a measurement of the percentage of blood that is pumped out of a filled ventricle with each heartbeat. (NCT00446563)
Timeframe: Baseline to week 52

InterventionPercentage (Mean)
Valsartan and Amlodipine-0.8
Losartan and HCTZ-0.4

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Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI

(NCT00446563)
Timeframe: Baseline to week 52

Interventionml (Mean)
Valsartan and Amlodipine0.1
Losartan and HCTZ-6.4

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Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)

(NCT00446563)
Timeframe: Baseline to week 52

Interventiong/m˄2 (Mean)
Valsartan and Amlodipine-7.1
Losartan and HCTZ-9.1

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Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP)

(NCT00446563)
Timeframe: Baseline to week 52

Interventionmg/l (Mean)
Valsartan and Amlodipine0.8
Losartan and HCTZ-2.1

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Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP)

(NCT00446563)
Timeframe: Baseline to week 52

Interventionpg/ml (Mean)
Valsartan and Amlodipine-4.5
Losartan and HCTZ-40.1

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Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI

(NCT00446563)
Timeframe: Baseline to week 52

Interventionmm (Mean)
Valsartan and Amlodipine-1.1
Losartan and HCTZ-0.6

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Part 2: Number of Participants With Reported Any Adverse Events, Serious Adverse Events and Death

(NCT00498433)
Timeframe: 98 days

,,
InterventionParticipants (Number)
Adverse eventSerious Adverse EventDeath
Aliskiren200
Amlodipine300
Placebo run-in910

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Part 1: Aliskiren Concentrations From Tissue at the End of Aliskiren Treatment Period

Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine aliskiren concentration. Tissue biopsy samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42). (NCT00498433)
Timeframe: Day 42

Interventionng/g (Mean)
Adipose tissue (n=6)Skeletal muscle (n=9)
Part 1: Placebo/Aliskiren/Amlodipine29.05107.32

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Part 1: Amlodipine Concentrations From Plasma at the End of Amlodipine Treatment Period

Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the amlodipine treatment periods (Day 98). (NCT00498433)
Timeframe: Day 98

Interventionng/mL (Mean)
Part 1: Placebo/Aliskiren/Amlodipine7.78

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Part 1: Renin Concentrations From Plasma During Aliskiren Treatment Period

Renin concentrations from plasma were measured as: plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration). (NCT00498433)
Timeframe: Day 42

Interventionpg/mL (Geometric Mean)
Plasma Renin ConcentrationTotal Renin ConcentrationProrenin Concentration
Part 1: Placebo/Aliskiren/Amlodipine22.2989.962.1

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Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period

Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentrations on the last day of the aliskiren treatment periods (Day 42). (NCT00498433)
Timeframe: Day 42

Interventionng/mL (Mean)
Adipose tissueSkeletal muscle
Part 1: Placebo/Aliskiren/Amlodipine2.387.05

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Part 1: Angiotensin II Levels in Plasma During Aliskiren Treatment Period

Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration. (NCT00498433)
Timeframe: Day 42

Interventionfmol/mL (Geometric Mean)
Part 1: Placebo/Aliskiren/Amlodipine0.534

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Part 1: Angiotensin II Levels in Plasma During Amlodipine Treatment Period

Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration. (NCT00498433)
Timeframe: Day 98

Interventionfmol/mL (Geometric Mean)
Part 1: Placebo/Aliskiren/Amlodipine2.20

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Part 1: Renin Activity From Plasma During Aliskiren Treatment Period

Plasma Renin activity (PRC) was measured by a trapping PRA (tPRA) assay. (NCT00498433)
Timeframe: Day 42

Interventionng/nl/h (Geometric Mean)
Part 1: Placebo/Aliskiren/Amlodipine0.145

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Part 1: Renin Activity From Plasma During Amlodipine Treatment Period

Plasma renin activity (PRC) was measured by a trapping PRA (tPRA) assay. (NCT00498433)
Timeframe: Day 98

Interventionng/nl/h (Geometric Mean)
Part 1: Placebo/Aliskiren/Amlodipine0.670

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Part 1: Aliskiren Concentrations From Plasma at the End of Aliskiren Treatment Period

Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42). (NCT00498433)
Timeframe: Day 42

Interventionng/mL (Mean)
Part 1: Placebo/Aliskiren/Amlodipine8.38

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Part 1: Renin Concentrations From Plasma During Amlodipine Treatment Period

Renin concentrations from plasma were measured as plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration). (NCT00498433)
Timeframe: Day 98

Interventionpg/mL (Geometric Mean)
Plasma Renin ConcentrationTotal Renin ConcentrationProrenin Concentration
Part 1: Placebo/Aliskiren/Amlodipine7.3666.357.9

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Percent Change From Baseline in Vascular Stiffness

Percent change from baseline in Vascular Stiffness (measured by radial augmentation index [AI]) at Weeks 8 and 24 (NCT00523549)
Timeframe: Baseline to 8 and 24 weeks after treatment

,
Interventionpercentage of change in mean AI (Mean)
Week 8Week 24
Intensive Treatment Regimen-7.89-6.07
Standard Treatment Regimen-7.32-5.63

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Change in Ratio of Peak E Wave Velocity/Lateral Mitral Annular Myocardial Relaxation Velocity

Change from baseline in peak E-wave velocity / lateral mitral annular myocardial relaxation velocity (E/E') at Week 24 (NCT00523549)
Timeframe: Baseline to 24 weeks after treatment

Interventionratio (Mean)
Intensive Treatment Regimen-0.951
Standard Treatment Regimen-0.680

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Change in Lateral Mitral Annular Myocardial Relaxation Velocity

Change from baseline in lateral mitral annular myocardial relaxation velocity (E') at Week 24 (NCT00523549)
Timeframe: Baseline to 24 weeks after treatment

Interventioncm/s (Mean)
Intensive Treatment Regimen1.544
Standard Treatment Regimen1.476

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Change in Left Atrial Size

Change from baseline in left atrial size at Week 24 (NCT00523549)
Timeframe: Baseline to 24 weeks after treatment

Interventioncm (Mean)
Intensive Treatment Regimen-0.127
Standard Treatment Regimen-0.104

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Change in Estimated Central Aortic Pressure

Change from baseline in estimated central aortic pressure at Weeks 8 and 24 (NCT00523549)
Timeframe: Baseline to 8 and 24 weeks after treatment

,
Interventionmm Hg (Mean)
Week 8Week 24
Intensive Treatment Regimen-16.30-17.71
Standard Treatment Regimen-14.68-14.76

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Change in Mean Sitting Diastolic Blood Pressure (msDBP)

Change from baseline in msDBP at Weeks 8 and 24 (NCT00523549)
Timeframe: Baseline to 8 and 24 weeks after treatment

,
Interventionmm Hg (Mean)
Week 8Week 24
Intensive Treatment Regimen-12.77-15.21
Standard Treatment Regimen-12.62-14.08

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Change in Mean Sitting Systolic Blood Pressure (msSBP)

Change from baseline in msSBP at Weeks 8 and 24 (NCT00523549)
Timeframe: Baseline to 8 and 24 weeks after treatment

,
Interventionmm Hg (Mean)
Week 8Week 24
Intensive Treatment Regimen-25.74-30.37
Standard Treatment Regimen-22.31-25.06

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Change in Sitting Pulse Pressure During the Core Phase of the Study

Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. (NCT00523744)
Timeframe: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)

InterventionmmHg (Mean)
Amlodipine+Valsartan - Phase 21.26

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Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. (NCT00523744)
Timeframe: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)

InterventionmmHg (Mean)
Amlodipine+Valsartan+HCTZ - Phase 3-10.84

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Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study

Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 (Week 8) compared to Baseline in Phase 2 (week 4) or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2. (NCT00523744)
Timeframe: Baseline of Phase 2 (Week 4) to end of Phase 2 (Week 8)

InterventionPercentage of participants (Number)
msSBP responsemsDBP response
Amlodipine+Valsartan - Phase 247.473.1

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Change in Sitting Pulse Rate During the Extension Phase of the Study

Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position. (NCT00523744)
Timeframe: Baseline Phase 3 (Week 8) to end of Phase 3 (week 12)

InterventionBPM (beats per minute) (Mean)
Amlodipine+Valsartan+HCTZ - Phase 30.09

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Change in Sitting Pulse Rate During the Core Phase of the Study

Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position. (NCT00523744)
Timeframe: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)

InterventionBPM (beats per minute) (Mean)
Amlodipine+Valsartan - Phase 2-1.93

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Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study

Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg. (NCT00523744)
Timeframe: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)

InterventionPercentage of participants (Number)
msSBP < 140 mmHgmsDBP < 90 mmHg
Amlodipine+Valsartan+HCTZ - Phase 359.383.5

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Change in Sitting Pulse Pressure During the Extension Phase of the Study

Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. (NCT00523744)
Timeframe: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)

InterventionmmHg (Mean)
Amlodipine+Valsartan+HCTZ - Phase 3-5.62

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Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. (NCT00523744)
Timeframe: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)

InterventionmmHg (Mean)
Amlodipine+Valsartan - Phase 2-7.87

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Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. (NCT00523744)
Timeframe: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)

InterventionmmHg (Mean)
Amlodipine+Valsartan+HCTZ - Phase 3-5.22

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Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. (NCT00523744)
Timeframe: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)

InterventionmmHg (Mean)
Amlodipine+Valsartan - Phase 2-9.13

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Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Extension Phase of the Study

Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 3 compared to Baseline in Phase 3 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 3 compared to Baseline in Phase 3. (NCT00523744)
Timeframe: Baseline of Phase 3 (Week 8) to end of Phase 3 (Week 12)

InterventionPercentage of participants (Number)
msSBP responsemsDBP response
Amlodipine+Valsartan+HCTZ - Phase 361.583.5

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Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study

Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg. (NCT00523744)
Timeframe: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)

InterventionPercentage of participants (Number)
msSBP < 140 mmHgmsDBP < 90 mmHg
Amlodipine+Valsartan - Phase 244.672.6

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Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring

(NCT00527514)
Timeframe: Baseline to 12 Weeks

Interventionmm Hg (Mean)
Overall Active Treatment Period-21.4

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Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group.

Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis. (NCT00527514)
Timeframe: Baseline to end of week 3

Interventionmm Hg (Mean)
Group 1 Amlodipine 5 mg-10.1

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Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group

Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis. (NCT00527514)
Timeframe: Baseline to end of week 9

Interventionmm Hg (Mean)
Group 3 - Aml 5 mg + Olm 40 mg-20.5

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Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 10 mg + Olmesartan 40 mg Group

Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis. (NCT00527514)
Timeframe: Baseline to end end of week 12

Interventionmm Hg (Mean)
Group 4 - Aml 10 mg + Olm 40 mg-24.6

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Change From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure

(NCT00527514)
Timeframe: Baseline to 12 weeks

Interventionmm Hg (Mean)
DaytimeNighttime
Overall Active Treatment Period-23.1-18.5

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Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group.

Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis. (NCT00527514)
Timeframe: Baseline to end of week 6

Interventionmm Hg (Mean)
Group 2 - Aml 5 mg + Olmesartan 20 mg-18.0

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Percent Change in Triglycerides From Baseline to Each Observation Point

"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline" (NCT00530946)
Timeframe: 2 weeks, 4 weeks , and 8 weeks

,,,
InterventionPercent Change (Mean)
Week 2Week 4Week 8
CI-1038 2.5 mg/10 mg-27.4-25.7-21.1
CI-1038 2.5 mg/5 mg-15.1-14.2-14.1
CI-1038 5 mg/10 mg-23.9-23.2-24.0
CI-1038 5 mg/5 mg-16.2-15.1-10.8

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Change in Systolic Blood Pressure

Value at Week 8 minus value at baseline (NCT00530946)
Timeframe: 8 weeks

Interventionmm Hg (Least Squares Mean)
CI-1038 2.5 mg/5 mg-16.6
CI-1038 2.5 mg/10 mg-15.9
CI-1038 5 mg/5 mg-21.8
CI-1038 5 mg/10 mg-18.9

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Change in Diastolic Blood Pressure From Baseline to Each Observation Point

Value at Week 2, Week 4, or Week 8 minus value at baseline (NCT00530946)
Timeframe: 2 weeks, 4 weeks , and 8 weeks

,,,
Interventionmm Hg (Mean)
Week 2Week 4Week 8
CI-1038 2.5 mg/10 mg-6.0-8.2-8.7
CI-1038 2.5 mg/5 mg-4.9-5.3-7.7
CI-1038 5 mg/10 mg-8.2-9.2-9.9
CI-1038 5 mg/5 mg-8.1-9.4-12.0

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Percent Change in Low Density Lipoprotein-Cholesterol

"Percent of value at Week 8 minus value at baseline over value at baseline" (NCT00530946)
Timeframe: 8 weeks

InterventionPercent Change (Least Squares Mean)
CI-1038 2.5 mg/5 mg-37.2
CI-1038 2.5 mg/10 mg-42.5
CI-1038 5 mg/5 mg-34.3
CI-1038 5 mg/10 mg-40.6

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Change in Apolipoprotein B From Baseline to Each Observation Point

Value at Week 2, Week 4, or Week 8 minus value at baseline (NCT00530946)
Timeframe: 2 weeks, 4 weeks, and 8 weeks

,,,
Interventionmg/dL (Mean)
Week 2Week 4Week 8
CI-1038 2.5 mg/10 mg-45.8-47.2-46.4
CI-1038 2.5 mg/5 mg-36.6-40.1-40.2
CI-1038 5 mg/10 mg-44.4-45.8-45.1
CI-1038 5 mg/5 mg-33.5-36.6-36.6

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Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point

Value at Week 2, Week 4, or Week 8 minus value at baseline (NCT00530946)
Timeframe: 2 weeks, 4 weeks, and 8 weeks

,,,
InterventionRatio (Mean)
Week 2Week 4Week 8
CI-1038 2.5 mg/10 mg-1.4-1.4-1.4
CI-1038 2.5 mg/5 mg-1.2-1.3-1.2
CI-1038 5 mg/10 mg-1.3-1.4-1.4
CI-1038 5 mg/5 mg-1.1-1.2-1.2

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Change in Systolic Blood Pressure From Baseline to Each Observation Point

Value at Week 2, Week 4, or Week 8 minus value at baseline (NCT00530946)
Timeframe: 2 weeks, 4 weeks, and 8 weeks

,,,
Interventionmm Hg (Mean)
Week 2Week 4Week 8
CI-1038 2.5 mg/10 mg-13.5-14.6-15.3
CI-1038 2.5 mg/5 mg-12.8-14.2-16.8
CI-1038 5 mg/10 mg-16.0-19.6-18.7
CI-1038 5 mg/5 mg-19.2-20.2-21.3

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Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point

Value at Week 2, Week 4, or Week 8 minus value at baseline (NCT00530946)
Timeframe: 2 weeks, 4 weeks , and 8 weeks

,,,
InterventionRatio (Mean)
Week 2Week 4Week 8
CI-1038 2.5 mg/10 mg-1.6-1.6-1.5
CI-1038 2.5 mg/5 mg-1.3-1.4-1.3
CI-1038 5 mg/10 mg-1.5-1.6-1.5
CI-1038 5 mg/5 mg-1.2-1.4-1.4

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Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point

"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline" (NCT00530946)
Timeframe: 2 weeks, 4 weeks , and 8 weeks

,,,
InterventionPercent Change (Mean)
Week 2Week 4Week 8
CI-1038 2.5 mg/10 mg8.37.97.5
CI-1038 2.5 mg/5 mg7.77.27.2
CI-1038 5 mg/10 mg9.911.910.8
CI-1038 5 mg/5 mg6.69.39.7

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Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point

"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline" (NCT00530946)
Timeframe: 2 weeks, 4 weeks , and 8 weeks

,,,
InterventionPercent Change (Mean)
Week 2Week 4Week 8
CI-1038 2.5 mg/10 mg-42.5-43.8-42.9
CI-1038 2.5 mg/5 mg-34.8-37.4-37.6
CI-1038 5 mg/10 mg-40.2-41.8-40.8
CI-1038 5 mg/5 mg-32.8-35.0-34.2

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Percent Change in Total Cholesterol From Baseline to Each Observation Point

"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline" (NCT00530946)
Timeframe: 2 weeks, 4 weeks , and 8 weeks

,,,
InterventionPercent Change (Mean)
Week 2Week 4Week 8
CI-1038 2.5 mg/10 mg-30.5-31.5-30.0
CI-1038 2.5 mg/5 mg-24.2-26.6-26.1
CI-1038 5 mg/10 mg-28.3-28.6-28.2
CI-1038 5 mg/5 mg-23.0-24.7-23.4

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"Number of Participants Who Achieved of BP, HbA1c and Total, HDL and LDL Cholesterol Goals at the End of Intervention Phase"

Achievement of targets at end of intervention was performed applying generalized estimating equation (GEE) models, further adjusting for baseline values as covariate. (NCT00535925)
Timeframe: 13 years

InterventionParticipants (Count of Participants)
Standard of Care (SoC) Therapy150
Multifactorial Intensified Therapy191

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"Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs)"

number of MACEs in the two groups are reported. In addition, The primary endpoint was analyzed with event curves for the time-to-first event based on Kaplan-Meier analysis. Cox regression model was used to calculate hazard ratio (HR) and 95% Confidence Interval (CI). Due to the cluster randomized study design, a Cox shared-frailty model was fitted. multivariable model was adjusted for selected potential confounders: age, sex, systolic blood pressure (SBP), hemoglobin, estimated glomerular filtration rate (eGFR), albuminuria, HbA1c, total cholesterol and triglycerides (log-scaled) to reduce risk of bias. (NCT00535925)
Timeframe: 4 years (in the case the number of events needed by sample size is not reached at the expected 4-year time frame, primary end point will be assessed after the follow-up phase)

InterventionParticipants (Count of Participants)
Conventional Therapy146
Intensified Therapy116

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Change in HOMA-IR From Baseline to End of Study

Homeostasis model assessment-insulin resistance (HOMA-IR) was defined as (fasting insulin [μU/mL] x fasting glucose [mmol/L]) / 22.5. (NCT00542269)
Timeframe: Baseline to Week 12

Interventionmmol/L (Mean)
Aliskiren / Ramipril / Amlodipine0.98
Aliskiren /Amlodipine0.87
Ramipril / Amlodipine0.60

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Percentage of Patients Who Developed Diabetes at End of Study

A patient had diabetes if fasting plasma glucose > 7 mmol/L. (NCT00542269)
Timeframe: Week 12

InterventionPercentage of patients (Number)
Aliskiren / Ramipril / Amlodipine1.9
Aliskiren /Amlodipine4.1
Ramipril / Amlodipine2.1

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Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine)

Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msSBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement. (NCT00542269)
Timeframe: Baseline to Week 12

InterventionmmHg (Least Squares Mean)
Aliskiren / Ramipril / Amlodipine-12.8
Ramipril / Amlodipine-10.9

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Percentage of Patients Who Achieved Normalized Blood Pressure at End of Study

Normalized was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg. (NCT00542269)
Timeframe: Week 12

InterventionPercentage of patients (Number)
Aliskiren / Ramipril / Amlodipine45.90
Aliskiren /Amlodipine43.33
Ramipril / Amlodipine42.11

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Change in HbA1c (Glycated Hemoglobin) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine)

(NCT00542269)
Timeframe: Baseline to Week 12

Interventionmmol/mol (Least Squares Mean)
Aliskiren / Amlodipine0.1
Ramipril / Amlodipine0.1

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Change in HbA1c (Glycated Hemoglobin) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine

(NCT00542269)
Timeframe: Baseline to Week 12

Interventionmmol/mol (Least Squares Mean)
Aliskiren / Ramipril / Amlodipine0.1
Ramipril / Amlodipine0.1

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Change in HOMA-β From Baseline to End of Study

Homeostasis model assessment-β (HOMA-β) was defined as fasting insulin (μU/mL) x 20 / (fasting glucose (mmol/L) - 3.5). (NCT00542269)
Timeframe: Baseline to Week 12

Interventionmmol/L (Mean)
Aliskiren / Ramipril / Amlodipine2.71
Aliskiren /Amlodipine0.87
Ramipril / Amlodipine0.60

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Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine

Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msDBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement. (NCT00542269)
Timeframe: Baseline to Week 12

InterventionmmHg (Least Squares Mean)
Aliskiren / Amlodipine-5.8
Ramipril / Amlodipine-4.5

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Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine

Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msDBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement. (NCT00542269)
Timeframe: Baseline to Week 12

InterventionmmHg (Least Squares Mean)
Aliskiren / Ramipril / Amlodipine-6.0
Ramipril / Amlodipine-4.1

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Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine

Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msSBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement. (NCT00542269)
Timeframe: Baseline to Week 12

InterventionmmHg (Least Squares Mean)
Aliskiren / Amlodipine-12.4
Ramipril / Amlodipine-10.0

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Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG

Clinical relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. (NCT00550953)
Timeframe: First administration of randomised treatment to 24 hours post last dose of randomised treatment

,
Interventionparticipants (Number)
ArrhythmiaBlood potassium increasedBlood pressure increasedEosinophil count increasedOrthostatic hypotension
Telmisartan 40 mg Monotherapy00200
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination11011

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Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)

Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake (NCT00550953)
Timeframe: 8 weeks

Interventionpercentage of participants (Number)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination81.2
Telmisartan 40 mg Monotherapy37.1

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Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline)

Adequate response defined that seated trough systolic blood pressure was <140 mmHg or decreased from reference baseline by >=20 mmHg at 8 weeks (0 percent at baseline) (NCT00550953)
Timeframe: 8 weeks

Interventionpercentage of participants (Number)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination89.5
Telmisartan 40 mg Monotherapy58.2

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Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)

Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake (NCT00550953)
Timeframe: 8 weeks

Interventionpercentage of participants (Number)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination78.4
Telmisartan 40 mg Monotherapy46.8

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Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks

The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline. (NCT00550953)
Timeframe: Baseline and 8 weeks

InterventionmmHg (Mean)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination17.86
Telmisartan 40 mg Monotherapy6.51

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Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)

"Optimal, normal, high normal blood pressure were defined as follows:~Optimal: Systolic blood pressure (SBP) < 120 mmHg and diastolic blood pressure (DBP) < 80 mmHg~Normal: SBP >= 120 mmHg or DBP >= 80 mmHg and SBP < 130 mmHg and DBP < 85 mmHg~High normal: SBP >= 130 mmHg or DBP >= 85 mmHg and SBP < 140 mmHg and DBP < 90 mmHg" (NCT00550953)
Timeframe: 8 weeks

,
Interventionpercentage of participants (Number)
OptimalNormalHigh Normal
Telmisartan 40 mg Monotherapy3.217.117.1
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination17.030.726.1

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Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)

Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks (NCT00550953)
Timeframe: 8 weeks

Interventionpercentage of participants (Number)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination85
Telmisartan 40 mg Monotherapy50

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Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks

The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline. (NCT00550953)
Timeframe: Baseline and 8 Weeks

InterventionmmHg (Mean)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination13.49
Telmisartan 40 mg Monotherapy5.47

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Change From Baseline in Trough Seated Diastolic Blood Pressure

Change from baseline to the end of study in trough DBP (NCT00553267)
Timeframe: Baseline and end of study (8 weeks or last value on treatment)

InterventionmmHg (Least Squares Mean)
Amlodipine 10mg-6.48
Telmisartan 40mg and Amlodipine 10mg-9.24
Telmisartan 80mg and Amlodipine 10mg-9.33

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Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg)

The number of patients who reach the target DBP of <90mmHg (NCT00553267)
Timeframe: End of study (8 weeks or last value on treatment)

,,
InterventionParticipants (Number)
Yes (DBP<90 mmHg)No (DBP>=90 mmHg)
Amlodipine 10mg156149
Telmisartan 40mg and Amlodipine 10mg195111
Telmisartan 80mg and Amlodipine 10mg206104

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Trough Seated SBP Control

The number of patients who reach the target SBP of <140mmHg (NCT00553267)
Timeframe: End of study (8 weeks or last value on treatment)

,,
InterventionParticipants (Number)
Yes (SBP<140 mmHg)No (SBP>=140 mmHg)
Amlodipine 10mg153152
Telmisartan 40mg and Amlodipine 10mg180126
Telmisartan 80mg and Amlodipine 10mg187123

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Trough Seated SBP Response

The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg (NCT00553267)
Timeframe: End of study (8 weeks or last value on treatment)

,,
InterventionParticipants (Number)
Yes (Responder)No (Non-responder)
Amlodipine 10mg165140
Telmisartan 40mg and Amlodipine 10mg198108
Telmisartan 80mg and Amlodipine 10mg204106

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Trough Seated BP Normality Classes

The number of patients who reach predefined BP categories (NCT00553267)
Timeframe: End of study (8 weeks or last value on treatment)

,,
InterventionParticipants (Number)
Optimal (SBP<120 and DBP<80 mmHg)Normal (SBP<130 and DBP<85 mmHg and not optimal)High-normal (SBP<140 DBP<90 mmHg and not normal)Stage 1 hypertension (SBP<160 and DBP<100 mmHg)Stage 2 hypertension (SBP>=160 and DBP>=100 mmHg)
Amlodipine 10mg0367715735
Telmisartan 40mg and Amlodipine 10mg12439113921
Telmisartan 80mg and Amlodipine 10mg65010613315

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Change From Baseline in Trough Seated Systolic Blood Pressure

Change from baseline to the end of study in trough SBP (NCT00553267)
Timeframe: Baseline and end of study (8 weeks or last value on treatment)

InterventionmmHg (Least Squares Mean)
Amlodipine 10mg-7.44
Telmisartan 40mg and Amlodipine 10mg-11.09
Telmisartan 80mg and Amlodipine 10mg-11.29

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Trough Seated Diastolic Blood Pressure <80 mmHg

The number of patients who reach the target DBP of <80mmHg (NCT00553267)
Timeframe: End of study (8 weeks or last value on treatment)

,,
InterventionParticipants (Number)
Yes (DBP<80 mmHg)No (DBP>=80 mmHg)
Amlodipine 10mg18287
Telmisartan 40mg and Amlodipine 10mg39267
Telmisartan 80mg and Amlodipine 10mg39271

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Oedema Incidence Rate

The number of patients who experienced at least one case of oedema or worsening of oedema for the first time (expressed as number of patients/100 patient-years) (NCT00553267)
Timeframe: During randomised treatment period

InterventionNumber of patients/100 patient-years (Number)
Amlodipine 10mg44.7
Telmisartan 40mg and Amlodipine 10mg42.8
Telmisartan 80mg and Amlodipine 10mg54.0

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Peripheral Oedema Incidence Rate

The number of cases of peripheral oedema (expressed as number of cases/100 patient-years) (NCT00553267)
Timeframe: During randomised treatment period

InterventionNumber of cases/100 patient-years (Number)
Amlodipine 10mg48.8
Telmisartan 40mg and Amlodipine 10mg44.8
Telmisartan 80mg and Amlodipine 10mg54.0

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Trough Seated DBP Response

The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg (NCT00553267)
Timeframe: End of study (8 weeks or last value on treatment)

,,
InterventionParticipants (Number)
Yes (Responder)No (Non-responder)
Amlodipine 10mg163142
Telmisartan 40mg and Amlodipine 10mg202104
Telmisartan 80mg and Amlodipine 10mg21397

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Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing)

The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline. (NCT00558064)
Timeframe: Baseline and 8 Weeks

InterventionmmHg (Mean)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination13.04
Amlodipine 5 mg Monotherapy5.77

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Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)

Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks (NCT00558064)
Timeframe: 8 weeks

Interventionpercentage of patients (Number)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination74.5
Amlodipine 5 mg Monotherapy50.2

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Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG

Clinical relevant abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. (NCT00558064)
Timeframe: First administration of randomised treatment to 24 hours post last dose of randomised treatment

,
Interventionparticipants (Number)
Alanine aminotransferase increasedAspartate aminotransferase increasedBlood creatine phosphokinase increasedBlood potassium increasedBlood urine presentLiver function test abnormalBradycardia
Amlodipine 5 mg Monotherapy0001000
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination1120111

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Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)

"Optimal, normal, high normal blood pressure were defined as follows:~Optimal: Systolic blood pressure (SBP) < 120 mmHg and diastolic blood pressure (DBP) < 80 mmHg~Normal: SBP >= 120 mmHg or DBP >= 80 mmHg and SBP < 130 mmHg and DBP < 85 mmHg~High normal: SBP >= 130 mmHg or DBP >= 85 mmHg and SBP < 140 mmHg and DBP < 90 mmHg~No: SBP >= 140 mmHg and DPB >= 90 mmHg" (NCT00558064)
Timeframe: 8 weeks

,
Interventionpercentage of patients (Number)
OptimalNormalHigh Normal
Amlodipine 5 mg Monotherapy1.69.723.0
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination11.024.326.6

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Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks

Adequate response defined that seated trough systolic blood pressure was <140 mmHg or decreased from reference baseline by >=20 mmHg at 8 weeks (0 percent at baseline) (NCT00558064)
Timeframe: 8 weeks

Interventionpercentage of patients (Number)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination79.5
Amlodipine 5 mg Monotherapy58.4

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Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)

Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake (NCT00558064)
Timeframe: 8 weeks

Interventionpercentage of patients (Number)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination68.1
Amlodipine 5 mg Monotherapy47.1

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Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)

Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake (NCT00558064)
Timeframe: 8 weeks

Interventionpercentage of patients (Number)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination67.1
Amlodipine 5 mg Monotherapy45.8

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Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing)

The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline. (NCT00558064)
Timeframe: Baseline and 8 Weeks

InterventionmmHg (Mean)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination9.56
Amlodipine 5 mg Monotherapy4.45

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Trough Seated SBP Control

The number of patients who reach the target SBP of <140mmHg (NCT00558428)
Timeframe: End of study (8 weeks or last value on treatment)

,,,
Interventionpatients (Number)
Yes (SBP<140 mmHg)No (SBP>=140 mmHg)
Amlodipine 10mg142119
Amlodipine 5mg100155
Telmisartan 40mg and Amlodipine 5mg162108
Telmisartan 80mg and Amlodipine 5mg17893

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Trough Seated Blood Pressure (BP) Normality Classes

"The number of patients who reach predefined BP categories:~Optimal - SBP<120 and DBP<80 mmHg~Normal - SBP<130 and DBP<85 mmHg~High-normal - SBP<140 DBP<90 mmHg~Stage 1 hypertension - SBP<160 and DBP<100~Stage 2 hypertension SBP>=160 and DBP>=100 mmHg" (NCT00558428)
Timeframe: End of study (8 weeks or last value on treatment)

,,,
Interventionpatients (Number)
OptimalNormalHigh-normalStage 1 hypertensionStage 2 hypertension
Amlodipine 10mg5306812632
Amlodipine 5mg2234211870
Telmisartan 40mg and Amlodipine 5mg19356312726
Telmisartan 80mg and Amlodipine 5mg21516711022

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Trough Seated DBP Response

The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg (NCT00558428)
Timeframe: End of study (8 weeks or last value on treatment)

,,,
Interventionpatients (Number)
Yes (Responder)No (Non-responder)
Amlodipine 10mg16398
Amlodipine 5mg116139
Telmisartan 40mg and Amlodipine 5mg17793
Telmisartan 80mg and Amlodipine 5mg18784

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Number of Patients With Oedema

Patients from the treated set who experienced at least one case of general oedema. (NCT00558428)
Timeframe: During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment)

,,,
Interventionpatients (Number)
Number of patients with any oedemaNumber of patients with general oedema
Amlodipine 10mg7675
Amlodipine 5mg2323
Telmisartan 40mg and Amlodipine 5mg1414
Telmisartan 80mg and Amlodipine 5mg1010

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Change From Baseline in Trough Seated Systolic Blood Pressure (SBP)

Change from baseline to the end of study in trough SBP (NCT00558428)
Timeframe: End of study (8 weeks or last value on treatment)

InterventionmmHg (Least Squares Mean)
Amlodipine 5mg-6.18
Amlodipine 10mg-11.11
Telmisartan 40mg and Amlodipine 5mg-13.56
Telmisartan 80mg and Amlodipine 5mg-14.99

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Trough Seated SBP Response

The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg (NCT00558428)
Timeframe: End of study (8 weeks or last value on treatment)

,,,
Interventionpatients (Number)
Yes (Responder)No (Non-responder)
Amlodipine 10mg16695
Amlodipine 5mg118137
Telmisartan 40mg and Amlodipine 5mg18783
Telmisartan 80mg and Amlodipine 5mg20071

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Trough Seated Diastolic Blood Pressure Control

The number of patients who reach the target DBP of <90mmHg (NCT00558428)
Timeframe: End of study (8 weeks or last value on treatment)

,,,
Interventionpatients (Number)
Yes (DBP<90 mmHg)No (DBP>=90 mmHg)
Amlodipine 10mg148113
Amlodipine 5mg107148
Telmisartan 40mg and Amlodipine 5mg153117
Telmisartan 80mg and Amlodipine 5mg17398

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Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP)

Change from baseline to the end of study in trough DBP (NCT00558428)
Timeframe: End of study (8 weeks or last value on treatment)

InterventionmmHg (Least Squares Mean)
Amlodipine 5mg-5.71
Amlodipine 10mg-7.95
Telmisartan 40mg and Amlodipine 5mg-9.35
Telmisartan 80mg and Amlodipine 5mg-10.63

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Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12

"Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately twelve weeks of treatment.~Baseline is defined as values obtained at Visit 3, Week (-1) during the Single Blind Run-in period." (NCT00568178)
Timeframe: Baseline and Week 12

InterventionPercent Change in Pr/Cr (Geometric Mean)
Losartan-35.80
Amlodipine/Placebo1.37

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Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36

"Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately three years of treatment.~*The baseline for efficacy data in the extension was defined as the last value obtained in the double-blind treatment phase." (NCT00568178)
Timeframe: Baseline and Month 36

InterventionPercent Change in Pr/Cr (Geometric Mean)
Losartan Open Label Extension-30.01
Enalapril Open Label Extension-40.45

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Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36

"The outcome measure of glomerular filtration rate was based on mL/min/1.73m^2, as determined by the Schwartz formula:~GFR = _____0.55 x height (cm)_______ divided by serum creatinine (mg/dL)~GFR values were compared to the baseline GFR measure.~[Note: For male participants, ages 13 to 17 years, 0.70 was used as~the multiplier in place of 0.55]~Baseline in regard to the extension is defined as the last value obtained in the double-blind treatment phase." (NCT00568178)
Timeframe: Baseline and Month 36

InterventionChange in GFR mL/min1.73m^2 (Least Squares Mean)
Losartan Open Label Extension3.3
Enalapril Open Label Extension7.0

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Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12

(NCT00568178)
Timeframe: Baseline and Week 12

Interventionmm Hg (Least Squares Mean)
Losartan-Hypertensive Participants-5.5
Amlodipine-Hypertensive Participants-0.1

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Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12

(NCT00568178)
Timeframe: Baseline and Week 12

Interventionmm Hg (Least Squares Mean)
Losartan-Hypertensive Participants-3.8
Amlodipine-Hypertensive Participants0.8

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Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am. (NCT00591266)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD-22.75
Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD-22.72
Amlodipine 5 mg QD-13.05

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Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am. (NCT00591266)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD-13.76
Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD-13.78
Amlodipine 5 mg QD-7.50

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Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing. (NCT00591266)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD-24.79
Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD-24.51
Amlodipine 5 mg QD-13.60

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Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing. (NCT00591266)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD-15.26
Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD-15.43
Amlodipine 5 mg QD-7.79

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Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring

The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing. (NCT00591266)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD-26.10
Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD-25.40
Amlodipine 5 mg QD-13.82

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Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring

The change in the 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing. (NCT00591266)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD-16.13
Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD-15.97
Amlodipine 5 mg QD-7.74

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Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure

The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements. (NCT00591266)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD-12.00
Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD-12.65
Amlodipine 5 mg QD-7.07

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Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm. (NCT00591266)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD-25.42
Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD-24.95
Amlodipine 5 mg QD-13.79

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Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm. (NCT00591266)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD-15.81
Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD-15.86
Amlodipine 5 mg QD-7.82

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Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.

The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements. (NCT00591266)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD-26.96
Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD-25.50
Amlodipine 5 mg QD-15.94

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Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response

Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6 relative to baseline, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements. (NCT00591266)
Timeframe: Baseline and Week 6.

Interventionpercentage of participants (Number)
Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD65.8
Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD69.4
Amlodipine 5 mg QD43.0

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Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg

Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6 relative to baseline, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements. (NCT00591266)
Timeframe: Baseline and Week 6.

Interventionpercentage of participants (Number)
Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD72.7
Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD71.6
Amlodipine 5 mg QD45.8

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Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg

Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6 relative to baseline, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of 3 trough sitting diastolic blood pressure measurements. (NCT00591266)
Timeframe: Baseline and Week 6.

Interventionpercentage of participants (Number)
Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD86.1
Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD87.4
Amlodipine 5 mg QD65.9

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Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing. (NCT00591266)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD-22.60
Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD-22.67
Amlodipine 5 mg QD-13.76

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Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing. (NCT00591266)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD-14.34
Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD-14.93
Amlodipine 5 mg QD-8.39

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Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7

The difference between the last available troughs represents the additional reduction in SBP in this study (NCT00614380)
Timeframe: End of study (34 weeks or last value on treatment)

InterventionmmHg (Least Squares Mean)
Telmisartan 40mg and Amlodipine 5mg-4.14
Telmisartan 80mg and Amlodipine 5mg-5.62
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive-3.6
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive-7.17

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Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7

The difference between the last available troughs represents the additional reduction in DBP in this study (NCT00614380)
Timeframe: End of study (34 weeks or last value on treatment)

InterventionmmHg (Least Squares Mean)
Telmisartan 40mg and Amlodipine 5mg-3.54
Telmisartan 80mg and Amlodipine 5mg-5.52
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive-5.51
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive-5.74

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Change From Baseline in Trough Seated Diastolic Blood Pressure

Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5. (NCT00614380)
Timeframe: End of study (34 weeks or last value on treatment)

InterventionmmHg (Least Squares Mean)
Telmisartan 40mg and Amlodipine 5mg-14.18
Telmisartan 80mg and Amlodipine 5mg-12.64
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive-9.47
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive-10.17

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Change From Baseline in Trough Seated Systolic Blood Pressure

Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5. (NCT00614380)
Timeframe: End of study (34 weeks or last value on treatment)

InterventionmmHg (Least Squares Mean)
Telmisartan 40mg and Amlodipine 5mg-17.79
Telmisartan 80mg and Amlodipine 5mg-15.91
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive-12.6
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive-14.04

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Additional Reduction in SBP by Use of Additional Antihypertensive Therapy

Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7 (NCT00614380)
Timeframe: At any point during open-label treatment

InterventionmmHg (Mean)
Total-7.53

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Additional Reduction in DBP by Use of Additional Antihypertensive Therapy

Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7 (NCT00614380)
Timeframe: At any point during open-label treatment

InterventionmmHg (Mean)
Total-5.73

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Trough Seated Systolic Blood Pressure (SBP) Control

The number of patients who reach the target SBP of <140mmHg (NCT00614380)
Timeframe: End of study (34 weeks or last value on treatment)

,,,
InterventionParticipants (Number)
Yes (SBP<140 mmHg)No (SBP>=140 mmHg)
Telmisartan 40mg and Amlodipine 5mg440113
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive169
Telmisartan 80mg and Amlodipine 5mg14264
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive8992

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Trough Seated SBP Response

The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg (NCT00614380)
Timeframe: End of study (34 weeks or last value on treatment)

,,,
InterventionParticipants (Number)
Yes (Responder)No (Non-responder)
Telmisartan 40mg and Amlodipine 5mg49059
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive186
Telmisartan 80mg and Amlodipine 5mg17924
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive12848

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Trough Seated Diastolic Blood Pressure (DBP) Control

The number of patients who reach the target DBP of <90mmHg (NCT00614380)
Timeframe: End of study (34 weeks or last value on treatment)

,,,
InterventionParticipants (Number)
Yes (DBP<90 mmHg)No (DBP>=90 mmHg)
Telmisartan 40mg and Amlodipine 5mg50449
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive196
Telmisartan 80mg and Amlodipine 5mg16046
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive8497

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Trough Seated DBP Response

The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg (NCT00614380)
Timeframe: End of study (34 weeks or last value on treatment)

,,,
InterventionParticipants (Number)
Yes (Responder)No (Non-responder)
Telmisartan 40mg and Amlodipine 5mg50445
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive195
Telmisartan 80mg and Amlodipine 5mg17132
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive10868

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Trough DBP Control Pre- and Post- Uptitration

The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration (NCT00614380)
Timeframe: At any point during open-label treatment

,,
InterventionParticipants (Number)
Post-titration: Yes (DBP<90 mmHg)Post-titration: No (DBP>=90 mmHg)Post-titration: Total
Pre-titration: No (DBP>=90 mmHg)190171361
Pre-titration: Total207171378
Pre-titration: Yes (DBP<90 mmHg)17017

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Trough Blood Pressure (BP) Normality Classes

The number of patients who reach predefined BP categories (NCT00614380)
Timeframe: End of study (34 weeks or last value on treatment)

,,,
InterventionParticipants (Number)
Optimal (SBP<120 and DBP<80 mmHg)Normal (SBP<130 and DBP<85 mmHg and not optimal)High-normal (SBP<140 DBP<90 mmHg and not normal)Stage 1 hypertension (SBP<160 and DBP<100 mmHgStage 2 hypertension (SBP>=160 and DBP>=100 mmHg)
Telmisartan 40mg and Amlodipine 5mg6718816312213
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive139120
Telmisartan 80mg and Amlodipine 5mg42992738
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive6123410524

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Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control

The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment (NCT00614380)
Timeframe: At any point during open-label treatment

,,
InterventionParticipants (Number)
Post-antihypertensive: Yes (DBP<90 mmHg)Post-antihypertensive: No (DBP>=90 mmHg)Post-antihypertensive: Total
Pre-antihypertensive: No (DBP>=90 mmHg)100106206
Pre-antihypertensive: Total110108218
Pre-antihypertensive: Yes (DBP<90 mmHg)10212

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Time to First Additional Antihypertensive

Time from first intake of medication to first intake of an antihypertensive other than the study drug (NCT00614380)
Timeframe: At any point during open-label treatment

InterventionDays (Mean)
Total85.8

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Seated DBP Control Rate at Trough After 6 and 12 Months

Percentage of patients whose DBP <90 mmHg. (NCT00618774)
Timeframe: 6 months and 12 months

,
Interventionpercentage of participants (Number)
Week 20Week 48
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination90.892.8
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination54.266.7

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Change From Baseline in Seated Diastolic Blood Pressure at Week 8

mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure (NCT00618774)
Timeframe: Baseline and week 8

InterventionmmHg (Mean)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination20.81
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination15.75

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Change From Baseline in Seated Systolic Blood Pressure at Week 8

mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure (NCT00618774)
Timeframe: Baseline and week 8

InterventionmmHg (Mean)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination33.89
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination26.44

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Percentage of Participants Who Experienced Adverse Events

An adverse event is defined as any untoward medical occurrence (NCT00618774)
Timeframe: 52 weeks

Interventionpercentage of participants (Number)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination77.3
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination77.1

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Seated DBP Control Rate at Trough After 8 Weeks

Percentage of patients whose DBP <90 mmHg after 8 weeks of treatment (NCT00618774)
Timeframe: week 8

Interventionpercentage of participants (Number)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination91.8
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination52.1

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Seated SBP Control Rate at Trough After 8 Weeks

Percentage of patients whose SBP <140 mmHg after 8 weeks of treatment (NCT00618774)
Timeframe: Week 8

Interventionpercentage of participants (Number)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination93.2
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination85.4

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Change From Baseline in Seated Diastolic Blood Pressure

Mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure (NCT00618774)
Timeframe: Baseline and week 20 / week 48

,
InterventionmmHg (Mean)
Week 20Week 48
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination20.6721.39
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination16.3617.78

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Change From Baseline in Seated Systolic Blood Pressure

mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure (NCT00618774)
Timeframe: Baseline and week 20 / week 48

,
InterventionmmHg (Mean)
Week 20Week 48
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination33.7333.97
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination27.1828.11

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Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG

Clinically relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events. (NCT00618774)
Timeframe: First administration of study treatment to 24 hours post last dosing of study treatment.

,
Interventionparticipants (Number)
Blood Pressure DecreasedProstatic specific antigen increasedAcute myocardial infarctionArrhythmiaAtrial fibrillationExtrasystolesVentricular extrasystolesOrthostatic hypotension
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination21012110
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination00100001

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Seated Blood Pressure Normalisation at Trough

"Percentage of patients when classifying their blood pressure measurements into the following classes at 6 and 12 months:~Optimal: SBP <120 mmHg and DBP <80 mmHg~Normal: SBP >=120 mmHg or DBP >=80 mmHg and SBP <130 mmHg or DBP <85 mmHg~High normal: SBP >=130 mmHg or DBP >=85 mmHg and SBP <140 mmHg or DBP <90 mmHg~No: SBP >=140 mmHg or DBP >=90 mmHg" (NCT00618774)
Timeframe: 6 months and 12 months

,
Interventionpercentage of participants (Number)
Week 20: OptimalWeek 20: NormalWeek 20: High NormalWeek 20: NoWeek 48: OptimalWeek 48: NormalWeek 48: High NormalWeek 48: No
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination29.535.324.211.132.436.218.413.0
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination4.218.831.345.86.318.839.635.4

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Seated DBP Response Rate at Trough

Percentage of patients whose DBP <90 mmHg or decreased from pseudo-baseline by >=10 mmHg at 6 months and 12 months (NCT00618774)
Timeframe: 6 months and 12 months

,
Interventionpercentage of participants (Number)
Week 20Week 48
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination97.198.6
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination85.487.5

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Seated SBP Control Rate at Trough After 6 and 12 Months

Percentage of patients whose SBP <140 mmHg (NCT00618774)
Timeframe: 6 months and 12 months

,
Interventionpercentage of participants (Number)
Week 20Week 48
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination95.793.2
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination89.689.6

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Seated SBP Response Rate at Trough

Percentage of patients whose SBP <140 mmHg or decreased deom pseudo-baseline by >=20 mmHg after 6 and 12 months (NCT00618774)
Timeframe: 6 months and 12 months

,
Interventionpercentage of participants (Number)
Week 20Week 48
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination97.697.6
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination93.893.8

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Additional Reduction in DBP by Use of Additional Antihypertensive Therapy

Difference in trough DBP from last visit before add-on therapy and last visit during NCT00624052 (NCT00624052)
Timeframe: up to 34 weeks

InterventionmmHg (Mean)
Telmisartan 40mg and Amlodipine 10mg-6.79

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Additional Reduction in SBP by Use of Additional Antihypertensive Therapy

Difference in trough SBP from last visit before add-on therapy and last visit during NCT00624052 (NCT00624052)
Timeframe: up to 34 weeks

InterventionmmHg (Mean)
Telmisartan 40mg and Amlodipine 10mg-7.79

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Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure

Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.6 (NCT00624052)
Timeframe: Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment

InterventionmmHg (Least Squares Mean)
Telmisartan 40mg and Amlodipine 10mg-13.41
Randomised Telmisartan 80mg and Amlodipine 10mg-13.36
Titrated Telmisartan 80mg and Amlodipine 10mg-11.52
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on-10.64

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Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure

Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.6 (NCT00624052)
Timeframe: Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment

InterventionmmHg (Least Squares Mean)
Telmisartan 40mg and Amlodipine 10mg-14.76
Randomised Telmisartan 80mg and Amlodipine 10mg-15.93
Titrated Telmisartan 80mg and Amlodipine 10mg-14.85
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on-12.44

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Trough Seated DBP Response

The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg (NCT00624052)
Timeframe: End of study (34 weeks or last value on treatment)

,,,
Interventionpatients (Number)
Yes (Responder)No (Non-responder)
Randomised Telmisartan 80mg and Amlodipine 10mg40529
Telmisartan 40mg and Amlodipine 10mg20113
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on7318
Titrated Telmisartan 80mg and Amlodipine 10mg7116

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Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052

The difference between the last available troughs represents the additional reduction in DBP in this study (NCT00624052)
Timeframe: Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment)

InterventionmmHg (Least Squares Mean)
Telmisartan 40mg and Amlodipine 10mg-4.36
Randomised Telmisartan 80mg and Amlodipine 10mg-4.97
Titrated Telmisartan 80mg and Amlodipine 10mg-5.51
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on-5.43

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Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052

The difference between the last available troughs represents the additional reduction in SBP in this study (NCT00624052)
Timeframe: Last available trough in NCT00624052 to end of study (34 weeks or last value on treatment)

InterventionmmHg (Least Squares Mean)
Telmisartan 40mg and Amlodipine 10mg-4.73
Randomised Telmisartan 80mg and Amlodipine 10mg-6.02
Titrated Telmisartan 80mg and Amlodipine 10mg-6.55
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on-5.61

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Time to First Additional Antihypertensive

Time from first intake of medication to first intake of an antihypertensive other than the study drug (NCT00624052)
Timeframe: up to 34 weeks

InterventionDays (Mean)
Telmisartan 40mg and Amlodipine 10mg91.9

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Trough Seated Diastolic Blood Pressure (DBP) Control

The number of patients who reached the target DBP of <90mmHg (NCT00624052)
Timeframe: End of study (34 weeks or last value on treatment)

,,,
Interventionpatients (Number)
Yes (DBP<90 mmHg)No (DBP>=90 mmHg)
Randomised Telmisartan 80mg and Amlodipine 10mg40234
Telmisartan 40mg and Amlodipine 10mg20115
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on7022
Titrated Telmisartan 80mg and Amlodipine 10mg7219

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Trough Seated Systolic Blood Pressure (SBP) Control

The number of patients who reached the target SBP of >=140mmHg (NCT00624052)
Timeframe: End of study (34 weeks or last value on treatment)

,,,
Interventionpatients (Number)
Yes (SBP<140 mmHg)No (SBP>=140 mmHg)
Randomised Telmisartan 80mg and Amlodipine 10mg36670
Telmisartan 40mg and Amlodipine 10mg17937
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on5141
Titrated Telmisartan 80mg and Amlodipine 10mg7021

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Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control

The number of patients with DBP control (DBP>=90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment (NCT00624052)
Timeframe: up to 34 weeks

,,
Interventionpatients (Number)
Post-antihypertensive: Yes (DBP<90 mmHg)Post-antihypertensive: No (DBP>=90 mmHg)Post-antihypertensive: Total
Pre-antihypertensive: No (DBP>=90 mmHg)672390
Pre-antihypertensive: Total9427121
Pre-antihypertensive: Yes (DBP<90 mmHg)27431

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Trough BP Normality Classes

The number of patients who reach predefined BP categories (NCT00624052)
Timeframe: End of study (34 weeks or last value on treatment)

,,,
Interventionpatients (Number)
Optimal (SBP<120 and DBP<80 mmHg)Normal (SBP<130 and DBP<85 mmHg and not optimal)High-normal (SBP<140 DBP<90 mmHg and not normal)Stage 1 hypertension (SBP<160 and DBP<100 mmHgStage 2 hypertension (SBP>=160 and DBP>=100 mmHg)
Randomised Telmisartan 80mg and Amlodipine 10mg20146189765
Telmisartan 40mg and Amlodipine 10mg127094328
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on31329434
Titrated Telmisartan 80mg and Amlodipine 10mg51446233

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Trough DBP Control Pre- and Post- Uptitration

The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to telmisartan 80mg and amlodipine 10mg compared to first trough DBP taken after uptitration. Uptitration could be based DBP>90 or investigator opinion. (NCT00624052)
Timeframe: up to 34 weeks

,,
Interventionpatients (Number)
Post-titration: Yes (DBP<90 mmHg)Post-titration: No (DBP>=90 mmHg)Post-titration: Total
Pre-titration: No (DBP>=90 mmHg)16890258
Pre-titration: Total474108582
Pre-titration: Yes (DBP<90 mmHg)30618324

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Trough Seated SBP Response

The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg (NCT00624052)
Timeframe: End of study (34 weeks or last value on treatment)

,,,
Interventionpatients (Number)
Yes (Responder)No (Non-responder)
Randomised Telmisartan 80mg and Amlodipine 10mg40133
Telmisartan 40mg and Amlodipine 10mg19024
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on6922
Titrated Telmisartan 80mg and Amlodipine 10mg7512

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Maximal Change From Baseline in Standing DBP

(NCT00626743)
Timeframe: within 8 hrs after SK3530 or placebo

InterventionmmHg (Mean)
Amlodipine + SK3530-7.17
Amlodipine + Placebo-3.50

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Maximal Change From Baseline in Standing SBP

(NCT00626743)
Timeframe: within 8 hrs after SK3530 or placebo

InterventionmmHg (Mean)
Amlodipine + SK3530-7.42
Amlodipine + Placebo-4.42

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Change in Mean 24-hour Ambulatory Blood Pressure From Baseline to Week 12 or Early Termination

(NCT00649389)
Timeframe: Baseline to 12 weeks or early termination

,,,
Interventionmm Hg (Mean)
Diastolic blood pressureSystolic blood pressure
AML10/HCTZ25-10.7-18.5
OM40/AML10-13.9-23.5
OM40/AML10/HCTZ25-18.0-30.3
OM40/HCTZ25-14.5-23.9

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Percentage of Subjects Who Reached Blood Pressure Goal (<140/90 mmHg; <130/80 mmHg for Subjects With Diabetes, Chronic Renal Disease, or Chronic Cardiovascular Disease)by 12 Weeks

(NCT00649389)
Timeframe: Baseline to 12 weeks

InterventionPercentage of subjects (Number)
OM40/AML1046.0
OM40/HCTZ2546.6
AML10/HCTZ2534.9
OM40/AML10/HCTZ2564.3

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Change in Seated Systolic Blood Pressure From Baseline to Week 12

(NCT00649389)
Timeframe: Baseline to week 12

Interventionmm Hg (Mean)
OM40/AML10-31.1
OM40/HCTZ25-31.2
AML10/HCTZ25-28.9
OM40/AML10/HCTZ25-38.1

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Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP).

(NCT00649389)
Timeframe: baseline to 12 weeks

Interventionmm Hg (Mean)
OM40/AML10-17.8
OM40/HCTZ25-16.5
AML10/HCTZ25-14.8
OM40/AML10/HCTZ25-21.5

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Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean last 4 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12 (NCT00654745)
Timeframe: week 0 - week 12

Interventionparticipants (Number)
mean last 4 hour BP < 135/85mean last 4 hour BP < 130/80mean last 4 hour BP < 125/75mean last 4 hour BP < 120/80mean last 4 hour SBP < 135mean last 4 hour SBP < 130mean last 4 hour SBP < 125mean last 4 hour SBP < 120mean last 4 hour DBP < 85mean last 4 hour DBP < 80mean last 4 hour DBP < 75
Aml + Olm + Hctz129107927213111410272150137120

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Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9

number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 9 (NCT00654745)
Timeframe: week 0 - week 9

Interventionparticipants (Number)
mean BP < 135/85mean BP < 130/80mean BP < 125/75mean BP < 120/80mean SBP < 135mean SBP < 130mean SBP < 125mean SBP < 120mean DBP < 85mean DBP < 80mean DBP < 75
Aml + Olm + Hctz76472519826141201329564

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Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6

number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 6 (NCT00654745)
Timeframe: week 0 - week 6

Interventionparticipants (Number)
mean BP < 135/85mean BP < 130/80mean BP < 125/75mean BP < 120/80mean SBP < 135mean SBP < 130mean SBP < 125mean SBP < 120mean DBP < 85mean DBP < 80mean DBP < 75
Aml + Olm + Hctz61361813734831141279148

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Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6

number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 6 (NCT00654745)
Timeframe: week 0 - week 6

Interventionparticipants (Number)
mean seated SBP reduction =<15 mm Hgmean seated SBP reduction >15 & =<30 mm Hgmean seated SBP reduction >30 & =<45 mm Hgmean seated SBP reduction >45 mm Hgmean seated DBP reduction =<10 mm Hgmean seated DBP reduction >10 & =<15 mm Hgmean seated DBP reduction >15 & =<20 mm Hgmean seated DBP reduction >20 mm Hg
Aml + Olm + Hctz6990312120332415

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Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment

Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0. (NCT00654745)
Timeframe: week 0 - week 12

Interventionmm Hg (Mean)
Aml + Olm + Hctz-19.9

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Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3

number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 3 (NCT00654745)
Timeframe: week 0 - week 3

Interventionparticipants (Number)
mean BP < 135/85mean BP < 130/80mean BP < 125/75mean BP < 120/80mean SBP < 135mean SBP < 130mean SBP < 125mean SBP < 120mean DBP < 85mean DBP < 80mean DBP < 75
Aml + Olm + Hctz311042411792995829

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Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18

number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 18 (NCT00654745)
Timeframe: week 0 - week 18

Interventionparticipants (Number)
mean BP < 135/85mean BP < 130/80mean BP < 125/75mean BP < 120/80mean SBP < 135mean SBP < 130mean SBP < 125mean SBP < 120mean DBP < 85mean DBP < 80mean DBP < 75
Aml + Olm + Hctz117875649123101745114712894

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Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean daytime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12 (NCT00654745)
Timeframe: week 0 - week 12

Interventionparticipants (Number)
mean daytime BP < 135/85mean daytime BP < 130/80mean daytime BP < 125/75mean daytime BP < 120/80mean daytime SBP < 135mean daytime SBP < 130mean daytime SBP < 125mean daytime SBP < 120mean daytime DBP < 85mean daytime DBP < 80mean daytime DBP < 75
Aml + Olm + Hctz11683484211894674215112491

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Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12

number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12 (NCT00654745)
Timeframe: week 0 - week 12

Interventionparticipants (Number)
mean BP < 135/85mean BP < 130/80mean BP < 125/75mean BP < 120/80mean SBP < 135mean SBP < 130mean SBP < 125mean SBP < 120mean DBP < 85mean DBP < 80mean DBP < 75
Aml + Olm + Hctz866133289370462813410574

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Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9

number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 9 (NCT00654745)
Timeframe: week 0 - week 9

Interventionparticipants (Number)
mean seated SBP reduction =<15 mm Hgmean seated SBP reduction >15 & =<30 mm Hgmean seated SBP reduction >30 & =<45 mm Hgmean seated SBP reduction >45 mm Hgmean seated DBP reduction =<10 mm Hgmean seated DBP reduction >10 & =<15 mm Hgmean seated DBP reduction >15 & =<20 mm Hgmean seated DBP reduction >20 mm Hg
Aml + Olm + Hctz7269349100431823

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Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean nighttime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, BP<120/70, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75, DBP<70 at week 12 (NCT00654745)
Timeframe: week 0 - week 12

Interventionparticipants (Number)
mean nighttime BP < 135/85mean nighttime BP < 130/80mean nighttime BP < 125/75mean nighttime BP < 120/80mean nighttime BP < 120/70mean nighttime SBP < 135mean nighttime SBP < 130mean nighttime SBP < 125mean nighttime SBP < 120mean nighttime DBP < 85mean nighttime DBP < 80mean nighttime DBP < 75mean nighttime DBP < 70
Aml + Olm + Hctz152137119112101154139123112160158147124

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Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean last 2 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 (NCT00654745)
Timeframe: week 0 - week 12

Interventionparticipants (Number)
mean last 2 hour SBP reduction =<15 mm Hgmean last 2 hour SBP reduction >15 & =<30 mm Hgmean last 2 hour SBP reduction >30 & =<45 mm Hgmean last 2 hour SBP reduction >45 mm Hgmean last 2 hour DBP reduction =<10 mm Hgmean last 2 hour DBP reduction >10 & =<15 mm Hgmean last 2 hour DBP reduction >15 & =<20 mm Hgmean last 2 hour DBP reduction >20 mm Hg
Aml + Olm + Hctz636235577282931

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Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean last 2 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12 (NCT00654745)
Timeframe: week 0 - week 12

Interventionparticipants (Number)
mean last 2 hour BP < 135/85mean last 2 hour BP < 130/80mean last 2 hour BP < 125/75mean last 2 hour BP < 120/80mean last 2 hour SBP < 135mean last 2 hour SBP < 130mean last 2 hour SBP < 125mean last 2 hour SBP < 120mean last 2 hour DBP < 85mean last 2 hour DBP < 80mean last 2 hour DBP < 75
Aml + Olm + Hctz11085634911592765114512594

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Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean daytime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 (NCT00654745)
Timeframe: week 0 - week 12

Interventionparticipants (Number)
mean daytime SBP reduction =<15 mm Hgmean daytime SBP reduction >15 & =<30 mm Hgmean daytime SBP reduction >30 & =<45 mm Hgmean daytime SBP reduction >45 mm Hgmean daytime DBP reduction =<10 mm Hgmean daytime DBP reduction >10 & =<15 mm Hgmean daytime DBP reduction >15 & =<20 mm Hgmean daytime DBP reduction >20 mm Hg
Aml + Olm + Hctz478431368413323

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Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks

change in mean SeSBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18. (NCT00654745)
Timeframe: week 0 - weeks 3, 6, 9, 12, 15, 18

Interventionmm Hg (Mean)
week 3 mean SBP change from baselineweek 6 mean SBP change from baselineweek 9 mean SBP change from baselineweek 12 mean SBP change from baselineweek 15 mean SBP change from baselineweek 18 mean SBP change from baseline
Aml + Olm + Hctz-10.3-17.9-20.0-23.7-28.5-31.1

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Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks

change in mean SeDBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18. (NCT00654745)
Timeframe: week 0 - weeks 3, 6, 9, 12, 15, 18

Interventionmm Hg (Mean)
week 3 mean seDBP change from baselineweek 6 mean seDBP change from baselineweek 9 mean seDBP change from baselineweek 12 mean seDBP change from baselineweek 15 mean seDBP change from baselineweek 18 mean seDBP change from baseline
Aml + Olm + Hctz-4.1-8.2-9.7-11.2-14.4-15.1

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Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment

Daytime mean SBP, Nighttime mean SBP, Last 6 hour mean SBP, Last 4 hour mean SBP, Last 2 hour mean SBP (NCT00654745)
Timeframe: week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)

Interventionmm Hg (Mean)
daytime mean SBP change from baselinenighttime mean SBP change from baselinelast 6 hours mean SBP change from baselinelast 4 hours mean SBP change from baselinelast 2 hours mean SBP change from baseline
Aml + Olm + Hctz-20.8-18.5-18.9-19.1-19.5

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Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment

24-hour mean DBP, Daytime mean DBP, Nighttime mean DBP, Last 6 hour mean DBP, Last 4 hour mean DBP, Last 2 hour mean DBP (NCT00654745)
Timeframe: week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)

Interventionmm Hg (Mean)
24-hour mean DBP change from baselinedaytime mean DBP change from baselinenighttime mean DBP change from baselinelast 6 hour mean DBP change from baselinelast 4 hour mean DBP change from baselinelast 2 hour mean DBP change from baseline
Aml + Olm + Hctz-11.2-11.7-10.4-10.9-11.1-11.5

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Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean 24-hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12 (NCT00654745)
Timeframe: week 0 - week 12

Interventionparticipants (Number)
mean 24-hour BP <135/85mean 24-hour BP <130/80mean 24-hour BP <125/75mean 24-hour BP <120/80mean 24-hour SBP <135mean 24-hour SBP <130mean 24-hour SBP <125mean 24-hour SBP <120mean 24-hour DBP <85mean 24-hour DBP <80mean 24-hour DBP <75
Aml + Olm + Hctz14011676591401209259158146121

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Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean 24 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 (NCT00654745)
Timeframe: week 0 - week 12

Interventionparticipants (Number)
mean 24-hour SBP reduction =<15 mm Hgmean 24-hour SBP reduction >15 & =<30 mm Hgmean 24-hour SBP reduction >30 & =<45 mm Hgmean 24-hour SBP reduction >45 mm Hgmean 24-hour DBP reduction =<10 mm Hgmean 24-hour DBP reduction >10 & =<15 mm Hgmean 24-hour DBP reduction >15 & =<20 mm Hgmean 24-hour DBP reduction >20 mm Hg
Aml + Olm + Hctz509122272473115

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Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15

number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 15 (NCT00654745)
Timeframe: week 0 - week 15

Interventionparticipants (Number)
mean BP < 135/85mean BP < 130/80mean BP < 125/75mean BP < 120/80mean SBP < 135mean SBP < 130mean SBP < 125mean SBP < 120mean DBP < 85mean DBP < 80mean DBP < 75
Aml + Olm + Hctz11483514511695694815312296

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Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions

number of participants achieving mean last 4 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 (NCT00654745)
Timeframe: week 0 - week 12

Interventionparticipants (Number)
mean last 4 hour SBP reduction =<15 mm Hgmean last 4 hour SBP reduction >15 & =<30 mm Hgmean last 4 hour SBP reduction >30 & =<45 mm Hgmean last 4 hour SBP reduction >45 mm Hgmean last 4 hour DBP reduction =<10 mm Hgmean last 4 hour DBP reduction >10 & =<15 mm Hgmean last 4 hour DBP reduction >15 & =<20 mm Hgmean last 4 hour DBP reduction >20 mm Hg
Aml + Olm + Hctz676528576362528

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Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12

number participants achieving mean last 6 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12 (NCT00654745)
Timeframe: week 0 - week 12

Interventionparticipants (Number)
mean last 6 hour BP < 135/85mean last 6 hour BP < 130/80mean last 6 hour BP < 125/75mean last 6 hour BP < 120/80mean last 6 hour SBP < 135mean last 6 hour SBP < 130mean last 6 hour SBP < 125mean last 6 hour SBP < 120mean last 6 hour DBP < 85mean last 6 hour DBP < 80mean last 6 hour DBP < 75
Aml + Olm + Hctz1351241018514312710885157146130

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Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean last 6 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 (NCT00654745)
Timeframe: week 0 - week 12

Interventionparticipants (Number)
mean last 6 hour SBP reduction =<15 mm Hgmean last 6 hour SBP reduction >15 & =<30 mm Hgmean last 6 hour SBP reduction >30 & =<45 mm Hgmean last 6 hour SBP reduction >45 mm Hgmean last 6 hour DBP reduction =<10 mm Hgmean last 6 hour DBP reduction >10 & =<15 mm Hgmean last 6 hour DBP reduction >15 & =<20 mm Hgmean last 6 hour DBP reduction >20 mm Hg
Aml + Olm + Hctz617623576412721

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Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean nighttime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 (NCT00654745)
Timeframe: week 0 - week 12

Interventionparticipants (Number)
mean nighttime SBP reduction =<15 mm Hgmean nighttime SBP reduction >15 & =<30 mm Hgmean nighttime SBP reduction >30 & =<45 mm Hgmean nighttime SBP reduction >45 mm Hgmean nighttime DBP reduction =<10 mm Hgmean nighttime SBP reduction >10 & =<15 mm Hgmean nighttime SBP reduction >15 & =<20 mm Hgmean nighttime DBP reduction >20 mm Hg
Aml + Olm + Hctz607921580412123

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Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 (NCT00654745)
Timeframe: week 0 - week 12

Interventionparticipants (Number)
mean seated SBP reduction =<15 mm Hgmean seated SBP reduction >15 & =<30 mm Hgmean seated SBP reduction >30 & =<45 mm Hgmean seated SBP reduction >45 mm Hgmean seated DBP reduction =<10 mm Hgmean seated DBP reduction >10 & =<15 mm Hgmean seated DBP reduction >15 & =<20 mm Hgmean seated DBP reduction >20 mm Hg
Aml + Olm + Hctz4873451185422723

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Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15

number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 15 (NCT00654745)
Timeframe: week 0 - week 15

Interventionparticipants (Number)
mean seated SBP reduction =<15 mm Hgmean seated SBP reduction >15 & =<30 mm Hgmean seated SBP reduction >30 & =<45 mm Hgmean seated SBP reduction >45 mm Hgmean seated DBP reduction =<10 mm Hgmean seated DBP reduction >10 & =<15 mm Hgmean seated DBP reduction >15 & =<20 mm Hgmean seated DBP reduction >20 mm Hg
Aml + Olm + Hctz3166552052453243

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Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18

number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 18 (NCT00654745)
Timeframe: week 0 - week 18

Interventionparticipants (Number)
mean seated SBP reduction =<15 mm Hgmean seated SBP reduction >15 & =<30 mm Hgmean seated SBP reduction >30 & =<45 mm Hgmean seated SBP reduction >45 mm Hgmean seated DBP reduction =<10 mm Hgmean seated DBP reduction >10 & =<15 mm Hgmean seated DBP reduction >15 & =<20 mm Hgmean seated DBP reduction >20 mm Hg
Aml + Olm + Hctz2253642550332952

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Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3

number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 3 (NCT00654745)
Timeframe: week 0 - week 3

Interventionparticipants (Number)
mean seated SBP reduction =<15 mm Hgmean seated SBP reduction >15 & =<30 mm Hgmean seated SBP reduction >30 & =<45 mm Hgmean seated SBP reduction >45 mm Hgmean seated DBP reduction =<10 mm Hgmean seated DBP reduction >10 & =<15 mm Hgmean seated DBP reduction >15 & =<20 mm Hgmean seated DBP reduction >20 mm Hg
Aml + Olm + Hctz131626216325103

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Percentage of Subjects Achieving Blood Pressure Goals

Percentage of subjects who achieved JNC-VII defined blood pressure goals. (NCT00661895)
Timeframe: 3 month intervals

Interventionpercentage of participants (Number)
Intervention81
Control57

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Change From Baseline to Weeks 2, 8 and 12 in MSDBP

(NCT00666536)
Timeframe: Baseline and Weeks 2, 8 and 12

,
InterventionmmHg (Mean)
Baseline MSDBPWeek 2 MSDBPChange From Baseline to Week 2 in MSDBPWeek 8 MSDBPChange From Baseline to Week 8 in MSDBPWeek 12 MSDBPChange From Baseline to Week 12 in MSDBP
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)95.588.2-7.381.6-13.981.5-14.0
Moderate Treatment Regimen (5/160 mg)95.087.1-7.984.0-11.083.8-11.2

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Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)

(NCT00666536)
Timeframe: Baseline and Week 4

,
InterventionmmHg (Mean)
Baseline MSDBPWeek 4 MSDBPChange From Baseline to Week 4 in MSDBP
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)95.584.8-10.7
Moderate Treatment Regimen (5/160 mg)95.086.2-8.8

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Change From Baseline to Weeks 2, 8 and 12 in MSSBP

(NCT00666536)
Timeframe: Baseline and Weeks 2, 8 and 12

,
InterventionmmHg (Mean)
Baseline MSSBPWeek 2 MSSBPChange From Baseline to Week 2 in MSSBPWeek 8 MSSBPChange From Baseline to Week 8 in MSSBPWeek 12 MSSBPChange From Baseline to Week 12 in MSSBP
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)163.9147.0-16.9136.0-27.9135.7-28.1
Moderate Treatment Regimen (5/160 mg)163.3146.0-17.3140.5-22.8139.2-24.1

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Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)

(NCT00666536)
Timeframe: Baseline and Week 4

,
InterventionmmHg (Mean)
Baseline MSSBPWeek 4 MSSBPChange From Baseline to Week 4 in MSSBP
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)163.9140.9-23.0
Moderate Treatment Regimen (5/160 mg)163.3144.4-18.9

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Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12

(NCT00666536)
Timeframe: Weeks 2, 4, 8 and 12

,
InterventionPercentage of Patients (Number)
Week 2Week 4Week 8Week 12
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)31.149.266.162.8
Moderate Treatment Regimen (5/160 mg)32.537.549.655.7

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Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12

(NCT00666536)
Timeframe: Weeks 2, 4, 8 and 12

,
InterventionPercentage of Patients (Number)
Week 2Week 4Week 8Week 12
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)25.143.761.759.8
Moderate Treatment Regimen (5/160 mg)25.831.146.250.7

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Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Diastolic Blood Pressure

Diastolic Blood pressure response was defined as a mean sitting diastolic blood pressure <90 mmHg or a >=10 mmHg reduction from baseline value. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28. (NCT00667719)
Timeframe: Weeks 28 and 54 endpoints

Interventionpercentage of participants (Number)
Week 28 EndpointWeek 54 Endpoint
Aliskiren/Amlodipine/Hydrochlorothiazide91.896.6

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Percentage of Participants Achieving the Blood Pressure Control Target of <140/90 mmHg

Blood pressure control was defined as having a mean sitting diastolic blood pressure <90 mmHg and a mean sitting systolic blood pressure <140 mmHg. Percentage of participants achieving the blood pressure control of < 140/90 mmHg were reported. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28 and Week 54 Endpoint was the last non-missing measurement value after Week 28. (NCT00667719)
Timeframe: Weeks 28 and 54 endpoints

Interventionpercentage of participants (Number)
Week 28 EndpointWeek 54 Endpoint
Aliskiren/Amlodipine/Hydrochlorothiazide69.177.1

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Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Death

An AE was defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug, even if the event is not considered to be related to study drug. An SAE was defined as an event which was fatal or life-threatening, resulted in persistent or significant disability/incapacity, constituted a congenital anomaly/birth defect, required inpatient hospitalization or prolongation of existing hospitalization, was medically significant, i.e. defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above. (NCT00667719)
Timeframe: 54 weeks

,,
InterventionParticipants (Count of Participants)
Any Adverse EventsSerious Adverse EventsDeath
Aliskiren/Amlodipine/Hydrochlorothiazide 300/10/25 mg255140
Aliskiren/Amlodipine/Hydrochlorothiazide 300/5/12.5 mg5410
Aliskiren/Hydrochlorothiazide 300/12.5 mg5700

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Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the participant in a sitting position for five minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28. (NCT00667719)
Timeframe: Baseline, Weeks 28 and 54 endpoints

Interventionmillimeters of mercury (Mean)
BaselineChange from baseline to Week 28 EndpointChange from Baseline to Week 54 Endpoint
Aliskiren/Amlodipine/Hydrochlorothiazide166.1-34.2-37.3

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Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the participant in a sitting position for five minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28. (NCT00667719)
Timeframe: Baseline, Weeks 28 and 54 endpoint

InterventionmmHg (Mean)
BaselineChange from Baseline to Week 28 EndpointChange from Baseline to Week 54 Endpoint
Aliskiren/Amlodipine/Hydrochlorothiazide101.8-20.3-21.8

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Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Systolic Blood Pressure

Systolic blood pressure response was defined as a mean sitting systolic blood pressure <140 mmHg or a >=20 mmHg reduction from baseline value. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28. (NCT00667719)
Timeframe: Weeks 28 and 54 endpoints

Interventionpercentage of participants (Number)
Week 28 EndpointWeek 54 Endpoint
Aliskiren/Amlodipine/Hydrochlorothiazide90.293.7

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Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)

(NCT00687973)
Timeframe: Baseline and Week 24

InterventionmmHg (Least Squares Mean)
Valsartan/Amlodipine 160/10 mg-13.65
Atenolol/Amlodipine 100/10 mg-9.7

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Change From Baseline of SBP/DBP at Week 24 (Office BP)

(NCT00687973)
Timeframe: Baseline and Week 24

,
InterventionmmHg (Least Squares Mean)
SBPDBP
Atenolol/Amlodipine 100/10 mg-16.94-10.45
Valsartan/Amlodipine 160/10 mg-14.49-8.17

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Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center)

Applanation tonometry is a measurement of aortic pressure and vascular stiffness. To assess the central aortic blood pressure, it is necessary to calibrate the applanation tonometry device using the brachial blood pressure. (NCT00687973)
Timeframe: Baseline and Week 24

,
InterventionmmHg (Least Squares Mean)
SBPDBP
Atenolol/Amlodipine 100/10 mg-11.78-7.94
Valsartan/Amlodipine 160/10 mg-12.93-7.85

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Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement)

(NCT00687973)
Timeframe: Baseline and Week 24

Interventionm/s (Least Squares Mean)
Valsartan/Amlodipine 160/10 mg-0.98
Atenolol/Amlodipine 100/10 mg-0.95

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Change From Baseline of Pulse Pressure at Week 24 (Office BP)

(NCT00687973)
Timeframe: Baseline and Week 24

InterventionmmHg (Least Squares Mean)
Valsartan/Amlodipine 160/10 mg-6.32
Atenolol/Amlodipine 100/10 mg-6.48

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Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement)

(NCT00687973)
Timeframe: Baseline and Week 8

InterventionmmHg (Least Squares Mean)
Valsartan/Amlodipine 160/10 mg-10.92
Atenolol/Amlodipine 100/10 mg-8.3

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Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement)

(NCT00687973)
Timeframe: Baseline and Week 24

InterventionmmHg (Least Squares Mean)
Valsartan/Amlodipine 160/10 mg-5.5
Atenolol/Amlodipine 100/10 mg-1.7

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Change From Baseline of Augmentation Index (Aix) at Week 8

To calculate the blood pressure augmentation index, the inflection point of the pressure curve corresponding to the return of the reflection wave was determined. The ratio between the pressure located above and below the inflection point was calculated. (NCT00687973)
Timeframe: Baseline and Week 8

InterventionRatio (Least Squares Mean)
Valsartan/Amlodipine 160/10 mg-2.21
Atenolol/Amlodipine 100/10 mg3.61

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Change From Baseline of Aix Corrected to Heart Rate at Week 24

The heart rate correction was computed by a multivariate model analysis (NCT00687973)
Timeframe: Baseline and Week 24

InterventionRatio (Least Squares Mean)
Valsartan/Amlodipine 160/10 mg-4.12
Atenolol/Amlodipine 100/10 mg-2.43

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Change From Baseline of Aix at Week 24

(NCT00687973)
Timeframe: Baseline and Week 24

InterventionRatio (Least Squares Mean)
Valsartan/Amlodipine 160/10 mg-4.10
Atenolol/Amlodipine 100/10 mg2.40

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Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center)

(NCT00687973)
Timeframe: Baseline and Week 24

InterventionmmHg (Least Squares Mean)
Valsartan/Amlodipine 160/10 mg-5.02
Atenolol/Amlodipine 100/10 mg-3.66

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Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)

At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP. (NCT00699192)
Timeframe: Baseline to end of study (Week 8)

InterventionmmHg (Mean)
Amlodipine/Valsartan 5/80 mg-4.2
Amlodipine/Valsartan 5/40 mg-5.3
Amlodipine 5 mg-1.7

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Percentage of Patients Achieving a Systolic Blood Pressure Response at Week 8

A systolic blood pressure response was defined as a msSBP < 140 mmHg or ≥ 15 mmHg reduction from baseline at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. (NCT00699192)
Timeframe: Baseline to end of study (Week 8)

InterventionPercentage of patients (Number)
Amlodipine/Valsartan 5/80 mg46.0
Amlodipine/Valsartan 5/40 mg48.3
Amlodipine 5 mg34.0

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Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)

Overall blood pressure control was defined as a msSBP < 140 mmHg and msDBP < 90 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. (NCT00699192)
Timeframe: End of study (Week 8)

InterventionPercentage of patients (Number)
Amlodipine/Valsartan 5/80 mg30.9
Amlodipine/Valsartan 5/40 mg36.4
Amlodipine 5 mg19.0

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Percentage of Patients Achieving Systolic Blood Pressure Control at the End of the Study (Week 8)

Systolic blood pressure control was defined as a msSBP < 140 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. (NCT00699192)
Timeframe: End of study (Week 8)

InterventionPercentage of patients (Number)
Amlodipine/Valsartan 5/80 mg31.3
Amlodipine/Valsartan 5/40 mg37.5
Amlodipine 5 mg20.5

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Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)

At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP. (NCT00699192)
Timeframe: Baseline to end of study (Week 8)

InterventionmmHg (Mean)
Amlodipine/Valsartan 5/80 mg-11.1
Amlodipine/Valsartan 5/40 mg-12.3
Amlodipine 5 mg-6.9

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Absolute Reduction From Baseline in Nocturnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring

Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level. (NCT00700271)
Timeframe: Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)

,
InterventionmmHg (Least Squares Mean)
Systolic Blood Pressure (SBP)Diastolic Blood Pressure (DBP)
Evening Intake-10.33-6.3
Morning Intake-9.68-5.01

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Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) Variation Between Week 0 and Week 8 in Office Blood Pressure

At each of the office visits, blood pressure was recorded in the morning between 08.00 and 11.00, before any antihypertensive treatment was taken. The patient remained in a sitting position for five minutes; the investigator then took three blood pressure and one pulse rate reading. The measurements were recorded at 1-2 minute intervals. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level. (NCT00700271)
Timeframe: Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)

,
InterventionmmHg (Least Squares Mean)
Systolic Blood Pressure (SBP)Diastolic Blood Pressure (DBP)
Evening Intake-17.3-8.6
Morning Intake-18.7-10.1

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Absolute Reduction From Baseline in 6-hour Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring

Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level. (NCT00700271)
Timeframe: Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)

,
InterventionmmHg (Least Squares Mean)
Systolic Blood Pressure (SBP)Diastolic Blood Pressure (DBP)
Evening Intake-11.37-7.01
Morning Intake-12.16-7.71

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Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) Variation Between Week -4 to Week 8 in Office Blood Pressure

At each of the office visits, blood pressure was recorded in the morning between 08.00 and 11.00, before any antihypertensive treatment was taken. The patient remained in a sitting position for five minutes; the investigator then took three blood pressure and one pulse rate reading. The measurements were recorded at 1-2 minute intervals. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level. (NCT00700271)
Timeframe: Screening visit (Week -4, prior to 4-week open-label screening phase) and Week 8 (after 8 weeks of combination therapy)

,
InterventionmmHg (Mean)
Systolic Blood Pressure (SBP)Diastolic Blood Pressure (DBP)
Evening Intake-29-14.3
Morning Intake-32.2-16.6

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Percentage of Participants With Nocturnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 120/70 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring

Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. (NCT00700271)
Timeframe: Visit 4 (week 8)

InterventionPercentage of participants (Number)
Morning Intake41.3
Evening Intake46.8

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Absolute Reduction From Baseline in Diurnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring

Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level. (NCT00700271)
Timeframe: Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)

,
InterventionmmHg (Least Squares Mean)
Systolic Blood Pressure (SBP)Diastolic Blood Pressure (DBP)
Evening Intake-11.99-7.11
Morning Intake-13.50-7.56

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Absolute Reduction From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring

Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level. (NCT00700271)
Timeframe: Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)

InterventionmmHg (Least Squares Mean)
Morning Intake-6.53
Evening Intake-6.79

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Absolute Reduction From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) on Ambulatory Blood Pressure Monitoring

Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level. (NCT00700271)
Timeframe: Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)

InterventionmmHg (Least Squares Mean)
Morning Intake-12.01
Evening Intake-11.3

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Percentage of Participants With 24-hour Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 125/80 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring

Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. (NCT00700271)
Timeframe: Visit 4 (week 8)

InterventionPercentage of Participants (Number)
Morning Intake47.6
Evening Intake46.9

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Percentage of Participants With Diurnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 135/85 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring

Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. (NCT00700271)
Timeframe: Visit 4 (week 8)

InterventionPercentage of Participants (Number)
Morning Intake65.3
Evening Intake58.2

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Percentage of Participants With Controlled Office Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) at Endpoint

At each of the office visits, blood pressure was recorded in the morning between 08.00 and 11.00, before any antihypertensive treatment was taken. The patient remained in a sitting position for 5 minutes; the investigator then took 3 blood pressure and 1 pulse rate reading. The measurements were recorded at 1-2 minute intervals. BP Control is defined as msSBP/msDBP <149/90 mmHg and/or <130/80 mmHg if diabetes or renal insufficiency (RI). (NCT00700271)
Timeframe: Visit 4 (week 8)

InterventionPercentage of participants (Number)
Morning Intake71.1
Evening Intake72.6

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Percentage of Participants Achieving BP Control After 8 Weeks of Treatment

To compare the percentage of patients achieving BP control (<140/90 mm Hg) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension. (NCT00739596)
Timeframe: 8 weeks

InterventionCumulative percentage of participants (Number)
Aliskiren HCTZ63.6
Amlodipine62.3

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Percentage of Responders After 8 Weeks of Treatment.

To compare the percentage of responders after 8 weeks of treatment with an aliskiren HCTZ based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension: [ Responders were defined as patients with MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg at 1st response. A response was counted when a patient first achieved MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg.] (NCT00739596)
Timeframe: 8 weeks

InterventionCumulative percentage of responders (Number)
Aliskiren HCTZ84.6
Amlodipine90.7

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Change in Mean Sitting Diastolic Blood Pressure (MSDBP) After 8 Weeks of Treatment

To assess the change from baseline in mean sitting diastolic blood pressure (MSDBP) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension. (NCT00739596)
Timeframe: Baseline and 8 weeks

,
Interventionmm Hg (Mean)
BaselineWeek 8Change from Baseline to Week 8
Aliskiren HCTZ96.086.0-10.0
Amlodipine95.084.0-11.0

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Change in Mean Sitting Pulse Pressure (MSPP) After 8 Weeks of Treatment

To compare the change from baseline in mean sitting pulse pressure (MSPP) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension. (NCT00739596)
Timeframe: Baseline and 8 weeks

,
Interventionmm Hg (Mean)
BaselineWeek 8Change from Baseline to Week 8
Aliskiren HCTZ72.252.7-19.4
Amlodipine73.155.1-18.0

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Change in Mean Sitting Systolic Blood Pressure (MSSBP) After 8 Weeks of Treatment

To assess the change from baseline in MSSBP after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension. (NCT00739596)
Timeframe: Baseline and 8 weeks

,
Interventionmm Hg (Mean)
BaselineWeek 8Change from baseline to Week 8
Aliskiren HCTZ168.2138.8-29.4
Amlodipine168.1139.1-29.0

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Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Aliskiren 300 mg-15.37
Aliskiren/Amlodipine 300/5 mg-21.82

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Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Amlodipine 10 mg-21.04
Aliskiren/Amlodipine 150/10 mg-23.87

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Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Placebo-5.35
Aliskiren/Amlodipine 150/10 mg-16.16

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Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Placebo-6.79
Aliskiren/Amlodipine 150/10 mg-23.87

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Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Aliskiren 150 mg-7.99
Aliskiren/Amlodipine 150/5 mg-13.98

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Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Aliskiren 150 mg-10.67
Aliskiren/Amlodipine 150/5 mg-20.64

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Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Amlodipine 5 mg-11.0
Aliskiren/Amlodipine 150/5 mg-13.98

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Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Amlodipine 5 mg-15.82
Aliskiren/Amlodipine 150/5 mg-20.64

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Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Amlodipine 5 mg-11.0
Aliskiren/Amlodipine 300/5 mg-14.99

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Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Placebo-5.35
Aliskiren/Amlodipine 150/5 mg-13.98

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Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study

Blood pressure control defined as msSBP < 140 mm Hg and msDBP < 90 mm Hg. The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: End of study (Week 8)

InterventionPercentage of Participants (Number)
Placebo19.2
Aliskiren 150 mg26.9
Aliskiren 300 mg36.3
Amlodipine 5 mg35.9
Amlodipine 10 mg50.3
Aliskiren/Amlodipine 150/5 mg49.2
Aliskiren/Amlodipine 150/10 mg65.4
Aliskiren/Amlodipine 300/5 mg56.5
Aliskiren/Amlodipine 300/10 mg Tablet68.3

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Percentage of Patients Achieving a Successful Systolic Blood Pressure Response

Blood pressure response in msSBP is defined as a mean sitting systolic blood pressure < 140 mmHg or a >= 20 mmHg reduction from baseline. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: End of study (Week 8)

InterventionPercentage of Participants (Number)
Placebo32.3
Aliskiren 150 mg41.5
Aliskiren 300 mg53.2
Amlodipine 5 mg54.9
Amlodipine 10 mg72.1
Aliskiren/Amlodipine 150/5 mg67.6
Aliskiren/Amlodipine 150/10 mg77.1
Aliskiren/Amlodipine 300/5 mg69.7
Aliskiren/Amlodipine 300/10 mg Tablet80.3

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Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Placebo-6.79
Aliskiren/Amlodipine 150/5 mg-20.64

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Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Amlodipine 10 mg-13.82
Aliskiren/Amlodipine 150/10 mg-16.16

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Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Aliskiren 300 mg-15.37
Aliskiren/Amlodipine 300/10 mg Tablet-23.19

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Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Amlodipine 10 mg-13.82
Aliskiren/Amlodipine 300/10 mg Tablet-16.45

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Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Amlodipine 10 mg-21.04
Aliskiren/Amlodipine 300/10 mg Tablet-23.19

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Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Placebo-5.35
Aliskiren/Amlodipine 300/10 mg Tablet-16.45

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Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Placebo-6.79
Aliskiren/Amlodipine 300/10 mg Tablet-23.19

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Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Aliskiren 300 mg-10.19
Aliskiren/Amlodipine 300/5 mg-14.99

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Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response

Blood pressure response in msDBP is defined as a mean sitting diastolic blood pressure < 90 mmHg or a >=10 mmHg reduction from baseline. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: End of study (Week 8)

InterventionPercentage of Participants (Number)
Placebo34.3
Aliskiren 150 mg50.3
Aliskiren 300 mg54.2
Amlodipine 5 mg62.0
Amlodipine 10 mg74.3
Aliskiren/Amlodipine 150/5 mg73.2
Aliskiren/Amlodipine 150/10 mg83.8
Aliskiren/Amlodipine 300/5 mg73.7
Aliskiren/Amlodipine 300/10 mg Tablet84.7

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Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Placebo-5.35
Aliskiren/Amlodipine 300/5 mg-14.99

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Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Placebo-6.79
Aliskiren/Amlodipine 300/5 mg-21.82

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Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Amlodipine 5 mg-15.82
Aliskiren/Amlodipine 300/5 mg-21.82

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Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Aliskiren 150 mg-7.99
Aliskiren/Amlodipine 150/10 mg-16.16

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Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (mssBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Aliskiren 150 mg-10.67
Aliskiren/Amlodipine 150/10 mg-23.87

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Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. (NCT00739973)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Aliskiren 300 mg-10.19
Aliskiren/Amlodipine 300/10 mg Tablet-16.45

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Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8)

Twenty-four hour ambulatory blood pressure monitoring (ABPM) was performed in a subset of patients twice during the study, once at baseline and again at Week 8. The ABPM device was placed on the non-dominant arm between 7:00 and 10:00 am and verification readings obtained. If they were successful, the investigator initiated the 24 hour reading and instructed the patient regarding ABPM procedures. On the next day, the ABPM device was removed if it had been worn for a minimum of 24 hours. The ABPM data were downloaded and evaluated on site. (NCT00765674)
Timeframe: Baseline to end of study (Week 8)

,,,
InterventionmmHg (Least Squares Mean)
Systolic BPDiastolic BP
Aliskiren / Amlodipine-20.30-13.29
Aliskiren / Amlodipine / Hydrochlorothiazide-25.29-15.90
Aliskiren / Hydrochlorothiazide-16.27-9.57
Amlodipine / Hydrochlorothiazide-18.67-11.20

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Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)

Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP. (NCT00765674)
Timeframe: Baseline to end of study (Week 8)

InterventionmmHg (Least Squares Mean)
Aliskiren / Amlodipine-31.37
Aliskiren / Hydrochlorothiazide-27.99
Amlodipine / Hydrochlorothiazide-30.77
Aliskiren / Amlodipine / Hydrochlorothiazide-37.92

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Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)

Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP. (NCT00765674)
Timeframe: Baseline to end of study (Week 8)

InterventionmmHg (Least Squares Mean)
Aliskiren / Amlodipine-18.03
Aliskiren / Hydrochlorothiazide-14.32
Amlodipine / Hydrochlorothiazide-17.03
Aliskiren / Amlodipine / Hydrochlorothiazide-20.63

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Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8)

Blood pressure control was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. (NCT00765674)
Timeframe: End of study (Week 8)

InterventionPercentage of patients (Number)
Aliskiren / Amlodipine41.3
Aliskiren / Hydrochlorothiazide33.1
Amlodipine / Hydrochlorothiazide39.0
Aliskiren / Amlodipine / Hydrochlorothiazide62.3

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Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP]

(NCT00765947)
Timeframe: Baseline and Week 24

Interventionmm Hg (Mean)
msSBPmsDBP
Aliskiren-based Regimen-25.33-12.40

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Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen

For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg. (NCT00765947)
Timeframe: 24 weeks

InterventionPercentage of participants (Number)
Aliskiren-based Regimen86.12

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Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients.

For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg. (NCT00765947)
Timeframe: 24 weeks

InterventionPercentage of Participants (Number)
Mild HypertensiveModerate HypertensiveNon-diabeticDiabetic
Aliskiren-based Regimen91.4879.2492.7472.58

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Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP]

Response for mean sitting Systolic Blood Pressure [msSBP] is defined as a reduction of ≥ 20 mmHg from baseline or mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg (non diabetics) or < 130 mmHg (diabetics). Response for mean sitting Diastolic Blood Pressure [msDBP] is defined as a reduction of ≥10 mmHg from baseline or mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg (non diabetic) or < 80 mmHg (diabetics). (NCT00765947)
Timeframe: 24 weeks

InterventionPercentage of Participants (Number)
msSBPmsDBP
Aliskiren-based Regimen96.8097.78

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Number of Participants With Serious Adverse Events and Adverse Events

"The number of participants with any Serious Adverse Event and the number of participants with Adverse Events in any system organ class.~Additional information about Adverse Events can be found in the Adverse Event Section." (NCT00777946)
Timeframe: 8 weeks

,,
Interventionparticipants (Number)
Serious Adverse EventsAdverse Events
Aliskiren 300 mg159
Aliskiren 300 mg/Amlodipine 10 mg385
Aliskiren 300 mg/Amlodipine 5 mg480

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Percentage of Participants Achieving Blood Pressure Control

"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.~Blood Pressure control was defined as having a mean sitting Diastolic Blood Pressure <90 and a mean sitting Systolic Blood Pressure <140." (NCT00777946)
Timeframe: 8 weeks

InterventionPercentage of participants (Number)
Aliskiren 300 mg/Amlodipine 10 mg65.5
Aliskiren 300 mg/Amlodipine 5 mg56.5
Aliskiren 300 mg31.5

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Percentage of Participants Achieving a Systolic Blood Pressure Response

"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.~A Systolic Blood Pressure Response was defined as a mean sitting Systolic Blood Pressure (msSBP) <140 mmHg or a ≥ 20 mmHg reduction in msSBP from baseline." (NCT00777946)
Timeframe: 8 weeks

InterventionPercentage of participants (Number)
Aliskiren 300 mg/Amlodipine 10 mg77.2
Aliskiren 300 mg/Amlodipine 5 mg69.7
Aliskiren 300 mg43.8

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Percentage of Participants Achieving a Diastolic Blood Pressure Response

"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.~A Diastolic Blood Pressure Response was defined as a mean sitting Diastolic Blood Pressure (msDBP) <90 mmHg or a ≥ 10 mmHg reduction in msDBP from baseline." (NCT00777946)
Timeframe: 8 weeks

InterventionPercentage of participants (Number)
Aliskiren 300 mg/Amlodipine 10 mg83.6
Aliskiren 300 mg/Amlodipine 5 mg77.7
Aliskiren 300 mg51.5

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Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP)

After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msSBP at baseline from the msSBP at 8 weeks was calculated using an ANCOVA model with baseline as a covariate and treatment and region as two factors. (NCT00777946)
Timeframe: Baseline, End of Study (Week 8)

Interventionmm Hg (Least Squares Mean)
Aliskiren 300 mg/Amlodipine 10 mg-18.04
Aliskiren 300 mg/Amlodipine 5 mg-14.43
Aliskiren 300 mg-6.42

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Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP)

After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msDBP at baseline from the msDBP at 8 weeks was calculated using an Analysis of Covariance (ANCOVA) model with baseline as a covariate and treatment and region as two factors. (NCT00777946)
Timeframe: Baseline, End of Study (Week 8)

Interventionmm Hg (Least Squares Mean)
Aliskiren 300 mg/Amlodipine 10 mg-13.07
Aliskiren 300 mg/Amlodipine 5 mg-10.54
Aliskiren 300 mg-5.84

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Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study

(NCT00778921)
Timeframe: Baseline and Week 8

Interventionmm Hg (Least Squares Mean)
Aliskiren/Amlodipine 300/10 mg-14.42
Aliskiren/Amlodipine 150/10 mg-11.01
Amlodipine 10 mg-8.20

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Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study

(NCT00778921)
Timeframe: Baseline and Week 8

Interventionmm Hg (Least Squares Mean)
Aliskiren/Amlodipine 300/10 mg-10.99
Aliskiren/Amlodipine 150/10 mg-8.95
Amlodipine 10 mg-7.23

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Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group

(NCT00778921)
Timeframe: 8 weeks

InterventionParticipants (Number)
Aliskiren/Amlodipine 300/10 mg87
Aliskiren/Amlodipine 150/10 mg99
Amlodipine 10 mg92

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Evaluate the Safety and Tolerability

Percentage of patients with Adverse Event and percentage of patients with edema (NCT00787605)
Timeframe: after 8 weeks of treatment

,
InterventionPercentage of participants (Number)
Any Adverse Eventedema
Aliskiren/HCTZ36.02.6
Amlodipine48.317.6

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Percentage of Responders

Response defined by mean sitting Systolic Blood Pressure < 130 mm Hg or a reduction of mean sitting Systolic Blood Pressure >= 20 mm Hg from baseline (NCT00787605)
Timeframe: Week 8

InterventionPercentage of Participants (Number)
Aliskiren/HCTZ74.2
Amlodipine68.5

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Biomarker Measurements

Geometric mean of the post to baseline ratio in biomarkers of plasma renin activity (ng/ml/h), plasma renin concentration (ng/L), and cystatin C (mg/L) (NCT00787605)
Timeframe: Baseline and Week 8

,
Interventionratio (Geometric Mean)
Plasma Renin activity (ng/ml/h) (N= 317, 300)Plasma Renin concentration (ng/L) (N=315, 299)Cystatin C (mg/L) (N = 327 , 310)
Aliskiren/HCTZ0.429.531.04
Amlodipine1.751.490.98

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Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

(NCT00787605)
Timeframe: Baseline and Week 8

InterventionmmHg (Least Squares Mean)
Aliskiren/HCTZ-9.92
Amlodipine-8.97

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Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

(NCT00787605)
Timeframe: Baseline and Week 8

InterventionmmHg (Least Squares Mean)
Aliskiren/HCTZ-28.82
Amlodipine-26.22

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Percentage of Patients Achieving Blood Pressure Control

Blood pressure control is defined as patient achieving a target Blood Pressure of mean sitting Systolic BloodPressure / mean sitting Diastolic Blood Pressure < 130/80 mmHg. (NCT00787605)
Timeframe: after 8 weeks of treatment

InterventionPercentage of Participants (Number)
Aliskiren/HCTZ23.2
Amlodipine13.8

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Change From Baseline in Foot Volume by Water Displacement (Weight of Water Displaced) at Week 2

Least Squares Mean Difference from Baseline (NCT00789321)
Timeframe: Baseline and 2 weeks

InterventionGrams (Least Squares Mean)
Amlodipine 10 Milligrams44.8
Placebo5.8

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Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2

Segmental biomimpedance was measured using a multifrequency analyzer (ImpediMed SFB7). The device was used to measure impedance (measured in Ohms) of a small current traveling between leads placed at the ankle and knee. Least Squares Mean Difference from Baseline in impedance is the primary endpoint. (NCT00789321)
Timeframe: Baseline and 2 weeks

InterventionOhms (Least Squares Mean)
Amlodipine 10 Milligrams-7.9
Placebo3.8

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Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: ≤ 10 mm Hg, N=2244 weeks: >10 and ≤ 15 mm Hg, N=2244 weeks: >15 and ≤ 20 mm Hg, N=2244 weeks: >20 mm Hg, N=2248 weeks: ≤ 10 mm Hg, N=2178 weeks: >10 and ≤ 15 mm Hg, N=2178 weeks: >15 and ≤ 20 mm Hg, N=2178 weeks: >20 mm Hg, N=21712 weeks: ≤ 10 mm Hg, N=19912 weeks: >10 and ≤15 mm Hg, N=19912 weeks: >15 and ≤ 20 mm Hg, N=19912 weeks: >20 mm Hg, N=19916 weeks: ≤ 10 mm Hg, N=17916 weeks: >10 and ≤ 15 mm Hg, N=17916 weeks: >15 and ≤ 20 mm Hg, N=17916 weeks: >20 mm Hg, N=17920 weeks: ≤ 10 mm Hg, N=16620 weeks: >10 and ≤ 15 mm Hg, N=16620 weeks: >15 and ≤ 20 mm Hg, N=16620 weeks: >20 mm Hg, N=166
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide63.820.59.46.357.119.814.38.845.225.115.614.127.425.122.924.634.920.524.120.5

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Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks

(NCT00791258)
Timeframe: Baseline to 20 weeks

InterventionPercentage of participants (Number)
Systolic blood pressure <140 mmHgSystolic blood pressure <135 mmHgSystolic blood pressure <130 mmHgSystolic blood pressure <120 mmHgDiastolic blood pressure <90 mmHgDiastolic blood pressure <85 mmHgDiastolic blood pressure <80 mmHgBlood pressure <140/90 mmHgBlood pressure <135/80 mmHgBlood pressure <130/80 mmHgBlood pressure <120/80 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide91.584.571.447.498.289.878.590.571.061.544.5

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Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks

(NCT00791258)
Timeframe: Baseline to 12 weeks

InterventionPercentage of participants (Number)
Systolic blood pressure <140 mmHgSystolic blood pressure <135 mmHgSystolic blood pressure <130 mmHgSystolic blood pressure <120 mmHgDiastolic blood pressure <90 mmHgDiastolic blood pressure <85 mmHgDiastolic blood pressure <80 mmHgBlood pressure <140/90 mmHgBlood pressure <135/80 mmHgBlood pressure <130/80 mmHgBlood pressure <120/80 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide81.369.353.031.594.480.664.378.552.743.527.9

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Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks

(NCT00791258)
Timeframe: Baseline to 20 weeks

InterventionPercentage of participants (Number)
Systolic blood pressure <140 mmHgSystolic blood pressure <135 mmHgSystolic blood pressure <130 mmHgSystolic blood pressure <120 mmHgDiastolic blood pressure <90 mmHgDiastolic blood pressure <85 mmHgDiastolic blood pressure <80 mmHgBlood pressure <140/90 mmHgBlood pressure <135/80 mmHgBlood pressure <130/80 mmHgBlood pressure <120/80 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide100.0100.095.045.0100.095.095.0100.095.095.040.0

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Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks

(NCT00791258)
Timeframe: Baseline to 12 weeks

InterventionPercentage of participants (Number)
Systolic blood pressure <140 mmHgSystolic blood pressure <135 mmHgSystolic blood pressure <130 mmHgSystolic blood pressure <120 mmHgDiastolic blood pressure <90 mmHgDiastolic blood pressure <85 mmHgDiastolic blood pressure <80 mmHgBlood pressure <140/90 mmHgBlood pressure <135/80 mmHgBlood pressure <130/80 mmHgBlood pressure <120/80 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide100.090.075.025.0100.095.075.0100.070.065.020.0

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Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks

(NCT00791258)
Timeframe: Baseline to 20 weeks

InterventionPercentage of participants (Number)
Systolic blood pressure <140 mmHgSystolic blood pressure <135 mmHgSystolic blood pressure <130 mmHgSystolic blood pressure <120 mmHgDiastolic blood pressure <90 mmHgDiastolic blood pressure <85 mmHgDiastolic blood pressure <80 mmHgBlood pressure <140/90 mmHgBlood pressure <135/80 mmHgBlood pressure <130/80 mmHgBlood pressure <120/80 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide92.882.578.351.294.686.871.788.667.565.148.2

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Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks

(NCT00791258)
Timeframe: Baseline to 12 weeks

InterventionPercentage of participants (Number)
Systolic blood pressure <140 mmHgSystolic blood pressure <135 mmHgSystolic blood pressure <130 mmHgSystolic blood pressure <120 mmHgDiastolic blood pressure <90 mmHgDiastolic blood pressure <85 mmHgDiastolic blood pressure <80 mmHgBlood pressure <140/90 mmHgBlood pressure <135/80 mmHgBlood pressure <130/80 mmHgBlood pressure <120/80 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide92.882.578.351.294.686.871.788.667.565.148.2

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Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks

(NCT00791258)
Timeframe: Baseline to 20 weeks

InterventionPercentage of participants (Number)
Systolic blood pressure <140 mmHgSystolic blood pressure <135 mmHgSystolic blood pressure <130 mmHgSystolic blood pressure <120 mmHgDiastolic blood pressure <90 mmHgDiastolic blood pressure <85 mmHgDiastolic blood pressure <80 mmHgBlood pressure <140/90 mmHgBlood pressure <135/80 mmHgBlood pressure <130/80 mmHgBlood pressure <120/80 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide89.783.869.241.091.585.569.285.564.159.836.8

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Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks

(NCT00791258)
Timeframe: Baseline to 12 weeks

InterventionPercentage of participants (Number)
Systolic blood pressure <140 mmHgSystolic blood pressure <135 mmHgSystolic blood pressure <130 mmHgSystolic blood pressure <120 mmHgDiastolic blood pressure <90 mmHgDiastolic blood pressure <85 mmHgDiastolic blood pressure <80 mmHgBlood pressure <140/90 mmHgBlood pressure <135/80 mmHgBlood pressure <130/80 mmHgBlood pressure <120/80 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide73.559.047.918.886.372.748.768.440.234.216.2

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Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks

(NCT00791258)
Timeframe: Baseline to 20 weeks

InterventionPercentage of participants (Number)
Systolic blood pressure <140 mmHgSystolic blood pressure <135 mmHgSystolic blood pressure <130 mmHgSystolic blood pressure <120 mmHgDiastolic blood pressure <90 mmHgDiastolic blood pressure <85 mmHgDiastolic blood pressure <80 mmHgBlood pressure <140/90 mmHgBlood pressure <135/80 mmHgBlood pressure <130/80 mmHgBlood pressure <120/80 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide93.887.679.747.898.289.477.092.974.369.943.4

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Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: <90 mm Hg, N=4544 weeks: <85 mm Hg, N=4544 weeks: <80 mm Hg, N=4548 weeks: <90 mm Hg, N=4578 weeks: <85 mm Hg, N=4578 weeks: <80 mm Hg, N=45712 weeks: <90 mm Hg, N=45712 weeks: <85 mm Hg, N=45712 weeks: <80 mm Hg, N=45716 weeks: <90 mm Hg, N=45716 weeks: <85 mm Hg, N=45716 weeks: <80 mm Hg, N=45720 weeks: <90 mm Hg, N=45720 weeks: <85 mm Hg, N=45720 weeks: <80 mm Hg, N=457
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide69.653.531.982.166.143.590.476.656.594.883.265.995.486.272.0

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Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: ≤ 15 mm Hg, N=9754 weeks: >15 and ≤ 30 mm Hg, N=9754 weeks: >30 and ≤ 45 mm Hg, N=9754 weeks: >45 mm Hg, N=9758 weeks: ≤ 15 mm Hg, N=9298 weeks: >15 and ≤ 30 mm Hg, N=9298 weeks: >30 and ≤ 45 mm Hg, N=9298 weeks: >45 mm Hg, N=92912 weeks: ≤ 15 mm Hg, N=86512 weeks: >15 and ≤ 30 mm Hg, N=86512 weeks: >30 and ≤ 45 mm Hg, N=86512 weeks: >45 mm Hg, N=86516 weeks: ≤ 15 mm Hg, N=79716 weeks: >15 and ≤ 30 mm Hg, N=79716 weeks: >30 and ≤ 45 mm Hg, N=79716 weeks: >45 mm Hg, N=79720 weeks: ≤ 15 mm Hg, N=74520 weeks: >15 and ≤ 30 mm Hg, N=74520 weeks: >30 and ≤ 45 mm Hg, N=74520 weeks: >45 mm Hg, N=745
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide51.436.610.51.545.837.714.32.330.543.122.43.923.235.932.08.920.436.234.09.4

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Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: <140 mm Hg, N=9754 weeks: <135 mm Hg, N=9754 weeks: <130 mm Hg, N=9754 weeks: <120 mm Hg, N=9758 weeks: <140 mm Hg, N=9298 weeks: <135 mm Hg, N=9298 weeks: <130 mm Hg, N=9298 weeks: <120 mm Hg, N=92912 weeks: <140 mm Hg, N=86512 weeks: <135 mm Hg, N=86512 weeks: <130 mm Hg, N=86512 weeks: <120 mm Hg, N=86516 weeks: <140 mm Hg, N=79716 weeks: <135 mm Hg, N=79716 weeks: <130 mm Hg, N=79716 weeks: <120 mm Hg, N=79720 weeks: <140 mm Hg, N=74520 weeks: <135 mm Hg, N=74520 weeks: <130 mm Hg, N=74520 weeks: <120 mm Hg, N=745
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide54.239.825.38.957.245.935.012.972.659.045.319.480.970.358.930.984.375.264.231.5

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Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: ≤ 10 mm Hg, N=9754 weeks: >10 and ≤ 15 mm Hg, N=9754 weeks: >15 and ≤ 20 mm Hg, N=9754 weeks: >20 mm Hg, N=9758 weeks: ≤ 10 mm Hg, N=9298 weeks: >10 and ≤ 15 mm Hg, N=9298 weeks: >15 and ≤ 20 mm Hg, N=9298 weeks: >20 mm Hg, N=92912 weeks: ≤ 10 mm Hg, N=86512 weeks: >10 and ≤ 15 mm Hg, N=86512 weeks: >15 and ≤ 20 mm Hg, N=86512 weeks: >20 mm Hg, N=86516 weeks: ≤ 10 mm Hg, N=79716 weeks: >10 and ≤ 15 mm Hg, N=79716 weeks: >15 and ≤ 20 mm Hg, N=79716 weeks: >20 mm Hg, N=79720 weeks: ≤ 10 mm Hg, N=74520 weeks: >10 and ≤ 15 mm Hg, N=74520 weeks: >15 and ≤ 20 mm Hg, N=74520 weeks: >20 mm Hg, N=745
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide61.321.010.57.254.720.714.110.643.824.115.816.330.422.821.525.431.419.922.626.2

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Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks

(NCT00791258)
Timeframe: Baseline to 12 weeks

InterventionPercentage of participants (Number)
Systolic blood pressure <140 mmHgSystolic blood pressure <135 mmHgSystolic blood pressure <130 mmHgSystolic blood pressure <120 mmHgDiastolic blood pressure <90 mmHgDiastolic blood pressure <85 mmHgDiastolic blood pressure <80 mmHgBlood pressure <140/90 mmHgBlood pressure <135/80 mmHgBlood pressure <130/80 mmHgBlood pressure <120/80 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide88.575.262.033.694.783.261.186.755.849.629.2

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Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10 p.m. - 6 a.m. (NCT00791258)
Timeframe: Baseline to 20 weeks

InterventionPercentage of participants (Number)
Nighttime mean systolic blood pressure <140 mmHgNighttime mean systolic blood pressure <135 mmHgNighttime mean systolic blood pressure <130 mmHgNighttime mean systolic blood pressure <120 mmHgNighttime mean diastolic blood pressure <90 mmHgNighttime mean diastolic blood pressure <85 mmHgNighttime mean diastolic blood pressure <80 mmHgNighttime mean blood pressure <140/90 mmHgNighttime mean blood pressure <135/95 mmHgNighttime mean blood pressure <135/80 mmHgNighttime mean blood pressure <130/80 mmHgNighttime mean blood pressure <125/75 mmHgNighttime mean blood pressure <120/80 mmHgNighttime mean blood pressure <120/70 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide99.599.597.586.499.598.596.099.098.596.095.088.985.978.9

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Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10p.m. - 6 a.m. (NCT00791258)
Timeframe: Baseline to 12 weeks

InterventionPercentage of participants (Number)
Nighttime mean systolic blood pressure <140 mmHgNighttime mean systolic blood pressure <135 mmHgNighttime mean systolic blood pressure <130 mmHgNighttime mean systolic blood pressure <120 mmHgNighttime mean diastolic blood pressure <90 mmHgNighttime mean diastolic blood pressure <85 mmHgNighttime mean diastolic blood pressure <80 mmHgNighttime mean blood pressure <140/90 mmHgNighttime mean blood pressure <135/95 mmHgNighttime mean blood pressure <135/80 mmHgNighttime mean blood pressure <130/80 mmHgNighttime mean blood pressure <125/75 mmHgNighttime mean blood pressure <120/80 mmHgNighttime mean blood pressure <120/70 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide97.894.392.674.799.698.394.897.493.490.889.177.774.262.0

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Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM. (NCT00791258)
Timeframe: Baseline to 20 weeks

InterventionPercentage of participants (Number)
Daytime mean systolic blood pressure <140 mmHgDaytime mean systolic blood pressure <135 mmHgDaytime mean systolic blood pressure <130 mmHgDaytime mean systolic blood pressure <120 mmHgDaytime mean diastolic blood pressure <90 mmHgDaytime mean diastolic blood pressure <85 mmHgDaytime mean diastolic blood pressure <80 mmHgDaytime mean blood pressure <140/90 mmHgDaytime mean blood pressure <135/95 mmHgDaytime mean blood pressure <135/80 mmHgDaytime mean blood pressure <130/80 mmHgDaytime mean blood pressure <125/75 mmHgDaytime mean blood pressure <120/80 mmHgDaytime mean blood pressure <120/70 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide96.593.583.951.898.592.583.995.088.481.977.456.851.333.2

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Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM. (NCT00791258)
Timeframe: Baseline to 12 weeks

InterventionPercentage of participants (Number)
Daytime mean systolic blood pressure <140 mmHgDaytime mean systolic blood pressure <135 mmHgDaytime mean systolic blood pressure <130 mmHgDaytime mean systolic blood pressure <120 mmHgDaytime mean diastolic blood pressure <90 mmHgDaytime mean diastolic blood pressure <85 mmHgDaytime mean diastolic blood pressure <80 mmHgDaytime mean blood pressure <140/90 mmHgDaytime mean blood pressure <135/95 mmHgDaytime mean blood pressure <135/80 mmHgDaytime mean blood pressure <130/80 mmHgDaytime mean blood pressure <125/75 mmHgDaytime mean blood pressure <120/80 mmHgDaytime mean blood pressure <120/70 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide88.279.966.428.895.683.065.586.972.961.153.331.927.913.1

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Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. (NCT00791258)
Timeframe: Baseline to 20 weeks

InterventionPercentage of participants (Number)
24-hour mean systolic blood pressure <140 mmHg24-hour mean systolic blood pressure <135 mmHg24-hour mean systolic blood pressure <130 mmHg24-hour mean systolic blood pressure <120 mmHg24-hour mean diastolic blood pressure <90 mmHg24-hour mean diastolic blood pressure <85 mmHg24-hour mean diastolic blood pressure <80 mmHg24-hour mean blood pressure <140/90 mmHg24-hour mean blood pressure <135/95 mmHg24-hour mean blood pressure <135/80 mmHg24-hour mean blood pressure <130/80 mmHg24-hour mean blood pressure <125/75 mmHg24-hour mean blood pressure <120/80 mmHg24-hour mean blood pressure <120/70 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide99.597.594.570.4100.097.593.099.596.092.590.575.470.455.3

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Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. (NCT00791258)
Timeframe: Baseline to 12 weeks

InterventionPercentage of participants (Number)
24-hour mean systolic blood pressure <140 mmHg24-hour mean systolic blood pressure <135 mmHg24-hour mean systolic blood pressure <130 mmHg24-hour mean systolic blood pressure <120 mmHg24-hour mean diastolic blood pressure <90 mmHg24-hour mean diastolic blood pressure <85 mmHg24-hour mean diastolic blood pressure <80 mmHg24-hour mean blood pressure <140/90 mmHg24-hour mean blood pressure <135/95 mmHg24-hour mean blood pressure <135/80 mmHg24-hour mean blood pressure <130/80 mmHg24-hour mean blood pressure <125/75 mmHg24-hour mean blood pressure <120/80 mmHg24-hour mean blood pressure <120/70 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide95.690.479.947.298.796.184.794.389.180.373.452.445.927.5

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Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: ≤ 15 mm Hg, N=4954 weeks: >15 and ≤ 30 mm Hg, N=4954 weeks: >30 and ≤ 45 mm Hg, N=4954 weeks: >45 mm Hg, N=4958 weeks: ≤ 15 mm Hg, N=4688 weeks: >15 and ≤ 30 mm Hg, N=4688 weeks: >30 and ≤ 45 mm Hg, N=4688 weeks: >45 mm Hg, N=46812 weeks: ≤ 15 mm Hg, N=43612 weeks: >15 and ≤ 30 mm Hg, N=43612 weeks: >30 and ≤ 45 mm Hg, N=43612 weeks: >45 mm Hg, N=43616 weeks: ≤ 15 mm Hg, N=40016 weeks: >15 and ≤ 30 mm Hg, N=40016 weeks: >30 and ≤ 45 mm Hg, N=40016 weeks: >45 mm Hg, N=40020 weeks: ≤ 15 mm Hg, N=37920 weeks: >15 and ≤ 30 mm Hg, N=37920 weeks: >30 and ≤ 45 mm Hg, N=37920 weeks: >45 mm Hg, N=379
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide56.035.28.50.452.435.910.31.537.842.417.42.527.836.027.58.820.637.533.38.7

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Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: <140 mm Hg, N=4974 weeks: <135 mm Hg, N=4974 weeks: <130 mm Hg, N=4974 weeks: <120 mm Hg, N=4978 weeks: <140 mm Hg, N=5008 weeks: <135 mm Hg, N=5008 weeks: <130 mm Hg, N=5008 weeks: <120 mm Hg, N=50012 weeks: <140 mm Hg, N=50012 weeks: <135 mm Hg, N=50012 weeks: <130 mm Hg, N=50012 weeks: <120 mm Hg, N=50016 weeks: <140 mm Hg, N=50016 weeks: <135 mm Hg, N=50016 weeks: <130 mm Hg, N=50016 weeks: <120 mm Hg, N=50020 weeks: <140 mm Hg, N=50020 weeks: <135 mm Hg, N=50020 weeks: <130 mm Hg, N=50020 weeks: <120 mm Hg, N=500
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide51.337.223.37.963.249.237.013.876.661.649.223.285.875.663.634.690.282.672.243.0

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Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of participants (Number)
4 weeks: <90 mm Hg, N=9754weeks: <85 mm Hg, N=9754 weeks: <80 mm Hg, N=9758 weeks: <90 mm Hg, N=9298 weeks: <85 mm Hg, N=9298 weeks: <80 mm Hg, N=92912 weeks: <90 mm Hg, N=86512 weeks: <85 mm Hg, N=86512 weeks: <80 mm Hg, N=86516 weeks: <90 mm Hg, N=79716 weeks: <85 mm Hg, N=79716 weeks: <80 mm Hg, N=79720 weeks: <90 mm Hg, N=74520 weeks: <85 mm Hg, N=74520 weeks: <80 mm Hg, N=745
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide71.355.234.275.157.140.284.368.749.590.276.959.689.779.562.0

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Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: <140/90 mm Hg, N=9754 weeks: <135/80 mm Hg, N=9754 weeks: <130/80 mm Hg, N=9754 weeks: <120/80 mm Hg, N=9758 weeks: <140/90 mm Hg, N=9298 weeks: <135/80 mm Hg, N=9298 weeks: <130/80 mm Hg, N=9298 weeks: <120/80 mm Hg, N=92912 weeks: <140/90 mm Hg, N=86512 weeks: <135/80 mm Hg, N=86512 weeks: <130/80 mm Hg, N=86512 weeks: <120/80 mm Hg, N=86516 weeks: <140/90mm Hg, N=79716 weeks: <135/80mm Hg, N=79716 weeks: <130/80mm Hg, N=79716 weeks: <120/80mm Hg, N=79720 weeks: <140/90 mm Hg, N=74520 weeks: <135/80 mm Hg, N=74520 weeks: <130/80 mm Hg, N=74520 weeks: <120/80 mm Hg, N=745
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide49.123.017.37.852.429.824.811.268.140.034.317.677.851.346.228.781.355.650.128.2

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Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: <140/90 mm Hg, N=2304 weeks: <135/80 mm Hg, N=2304 weeks: <130/80 mm Hg, N=2304 weeks: <120/80 mm Hg, N=2308 weeks: <140/90 mm Hg, N=2318 weeks: <135/80 mm Hg, N=2318 weeks: <130/80 mm Hg, N=2328 weeks: <120/80 mm Hg, N=23212 weeks: <140/90mm Hg, N=23212 weeks: <135/80 mm Hg, N=23212 weeks: <130/80 mm Hg, N=23212 weeks: <120/80 mm Hg, N=23216 weeks: <140/90 mm Hg, N=23216 weeks: <135/80 mm Hg, N=23216 weeks: <130/80 mm Hg, N=23216 weeks: <120/80 mm Hg, N=23220 weeks: <140/90 mm Hg, N=23220 weeks: <135/80 mm Hg, N=23220 weeks: <130/80 mm Hg, N=23220 weeks: <120/80 mm Hg, N=232
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide45.714.810.43.955.023.820.810.468.538.435.816.480.649.147.430.686.657.855.239.7

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Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: <90 mm Hg, N=2304 weeks: <85 mm Hg, N=2304 weeks: <80 mm Hg, N=2308 weeks: <90 mm Hg, N=2318 weeks: <85 mm Hg, N=2318 weeks: <80 mm Hg, N=23112 weeks: <90 mm Hg, N=23212 weeks: <85 mm Hg, N=23212 weeks: <80 mm Hg, N=23216 weeks: <90 mm Hg, N=23216 weeks: <85 mm Hg, N=23216 weeks: <80 mm Hg, N=23220 weeks: <90 mm Hg, N=23220 weeks: <85 mm Hg, N=23220 weeks: <80 mm Hg, N=232
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide60.942.219.671.953.730.382.366.045.392.276.355.294.880.661.2

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Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: ≤ 10 mm Hg, N=2304 weeks: >10 and ≤ 15 mm Hg, N=2304 weeks: >15 and ≤ 20 mm Hg, N=2304 weeks: >20 mm Hg, N=2308 weeks: ≤ 10 mm Hg, N=2208 weeks: >10 and ≤ 15 mm Hg, N=2208 weeks: >15 and ≤ 20 mm Hg, N=2208 weeks: >20 mm Hg, N=22012 weeks: ≤ 10 mm Hg, N=20812 weeks: >10 and ≤15 mm Hg, N=20812 weeks: >15 and ≤ 20 mm Hg, N=20812 weeks: >20 mm Hg, N=20816 weeks: ≤ 10 mm Hg, N=19916 weeks: >10 and ≤ 15 mm Hg, N=19916 weeks: >15 and ≤ 20 mm Hg, N=19916 weeks: >20 mm Hg, N=19920 weeks: ≤ 10 mm Hg, N=18920 weeks: >10 and ≤ 15 mm Hg, N=18920 weeks: >15 and ≤ 20 mm Hg, N=18920 weeks: >20 mm Hg, N=189
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide70.017.87.94.466.815.010.97.354.821.212.012.038.719.623.118.636.019.620.623.8

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Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: <140 mm Hg, N=2304 weeks: <135 mm Hg, N=2304 weeks: <130 mm Hg, N=2304 weeks: <120 mm Hg, N=2308 weeks: <140 mm Hg, N=2318 weeks: <135 mm Hg, N=2318 weeks: <130 mm Hg, N=2318 weeks: <120 mm Hg, N=23112 weeks: <140 mm Hg, N=23212 weeks: <135 mm Hg, N=23212 weeks: <130 mm Hg, N=23212 weeks: <120 mm Hg, N=23216 weeks: <140 mm Hg, N=23216 weeks: <135 mm Hg, N=23216 weeks: <130 mm Hg, N=23216 weeks: <120 mm Hg, N=23220 weeks: <140 mm Hg, N=23220 weeks: <135 mm Hg, N=23220 weeks: <130 mm Hg, N=23220 weeks: <120 mm Hg, N=232
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide51.734.419.65.762.344.633.813.076.359.147.019.884.971.161.234.191.080.671.144.4

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Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: ≤ 15 mm Hg, N=2304 weeks: >15 and ≤ 30 mm Hg, N=2304 weeks: >30 and ≤ 45 mm Hg, N=2304 weeks: >45 mm Hg, N=2308 weeks: ≤ 15 mm Hg, N=2208 weeks: >15 and ≤ 30 mm Hg, N=2208 weeks: >30 and ≤ 45 mm Hg, N=2208 weeks: >45 mm Hg, N=22012 weeks: ≤ 15 mm Hg, N=20812 weeks: >15 and ≤ 30 mm Hg, N=20812 weeks: >30 and ≤ 45 mm Hg, N=20812 weeks: >45 mm Hg, N=20816 weeks: ≤ 15 mm Hg, N=19916 weeks: >15 and ≤ 30 mm Hg, N=19916 weeks: >30 and ≤ 45 mm Hg, N=19916 weeks: >45 mm Hg, N=19920 weeks: ≤ 15 mm Hg, N=18920 weeks: >15 and ≤ 30 mm Hg, N=18920 weeks: >30 and ≤ 45 mm Hg, N=18920 weeks: >45 mm Hg, N=189
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide60.032.27.40.453.638.27.30.938.941.816.42.930.737.225.17.024.337.629.68.5

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Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: <90 mm Hg, N=1284 weeks: <85 mm Hg, N=1284 weeks: <80 mm Hg, N=1288 weeks: <90 mm Hg, N=1288 weeks: <85 mm Hg, N=1288 weeks: <80 mm Hg, N=12812 weeks: <90 mm Hg, N=12812 weeks: <85 mm Hg, N=12812 weeks: <80 mm Hg, N=12816 weeks: <90 mm Hg, N=12816 weeks: <85 mm Hg, N=12816 weeks: <80 mm Hg, N=12820 weeks: <90 mm Hg, N=12820 weeks: <85 mm Hg, N=12820 weeks: <80 mm Hg, N=128
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide83.669.545.389.179.760.295.387.571.196.993.082.096.993.085.2

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Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m. (NCT00791258)
Timeframe: Baseline to 12 weeks

Interventionmm Hg (Mean)
24-hour mean systolic blood pressureMean daytime systolic blood pressureMean nighttime systolic blood pressureSystolic blood pressure - last 2 hours of doseSystolic blood pressure - last 4 hours of doseSystolic blood pressure - last 6 hours of dose24-hour mean diastolic blood pressureMean daytime diastolic blood pressureMean nighttime diastolic blood pressureDiastolic blood pressure - last 2 hours of doseDiastolic blood pressure - last 4 hours of doseDiastolic blood pressure - last 6 hours of dose
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide-14.8-16.3-12.5-13.6-13.0-12.6-9.4-10.6-7.6-8.6-8.0-7.7

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The Percentage of Subjects Achieving Seated Diastolic BP Goal (<90 mmHg for Non-diabetics or < 80 mmHg for Subjects With Diabetes) From Baseline to 12 Weeks

(NCT00791258)
Timeframe: baseline to 12 weeks

InterventionPercentage of participants (Number)
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide84.3

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Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: ≤ 15 mm Hg, N=1894 weeks: >15 and ≤ 30 mm Hg, N=1894 weeks: >30 and ≤ 45 mm Hg, N=1894 weeks: >45 mm Hg, N=1898 weeks: ≤ 15 mm Hg, N=1818 weeks: >15 and ≤ 30 mm Hg, N=1818 weeks: >30 and ≤ 45 mm Hg, N=1818 weeks: >45 mm Hg, N=18112 weeks: ≤ 15 mm Hg, N=17012 weeks: >15 and ≤ 30 mm Hg, N=17012 weeks: >30 and ≤ 45 mm Hg, N=17012 weeks: >45 mm Hg, N=17016 weeks: ≤ 15 mm Hg, N=15616 weeks: >15 and ≤ 30 mm Hg, N=15616 weeks: >30 and ≤ 45 mm Hg, N=15616 weeks: >45 mm Hg, N=15620 weeks: ≤ 15 mm Hg, N=15020 weeks: >15 and ≤ 30 mm Hg, N=15020 weeks: >30 and ≤ 45 mm Hg, N=15020 weeks: >45 mm Hg, N=150
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide56.136.07.90.054.134.311.60.035.338.222.93.528.240.426.35.126.040.026.77.3

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The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks

(NCT00791258)
Timeframe: Baseline to 12 and 20 weeks

InterventionPercentage of participants (Number)
12 weeks20 weeks
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide71.384.8

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Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: ≤ 10 mm Hg, N=4954 weeks: >10 and ≤ 15 mm Hg, N=4954 weeks: >15 and ≤ 20 mm Hg, N=4954 weeks: >20 mm Hg, N=4958 weeks: ≤ 10 mm Hg, N=4688 weeks: >10 and ≤ 15 mm Hg, N=4688 weeks: >15 and ≤ 20 mm Hg, N=4688 weeks: >20 mm Hg, N=46812 weeks: ≤ 10 mm Hg, N=43612 weeks: >10 and ≤15 mm Hg, N=43612 weeks: >15 and ≤ 20 mm Hg, N=43612 weeks: >20 mm Hg, N=43616 weeks: ≤ 10 mm Hg, N=40016 weeks: >10 and ≤ 15 mm Hg, N=40016 weeks: >15 and ≤ 20 mm Hg, N=40016 weeks: >20 mm Hg, N=40020 weeks: ≤ 10 mm Hg, N=37920 weeks: >10 and ≤ 15 mm Hg, N=37920 weeks: >15 and ≤ 20 mm Hg, N=37920 weeks: >20 mm Hg, N=379
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide67.517.88.56.359.419.913.07.748.922.516.112.633.323.019.024.831.918.722.426.9

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Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: <90 mm Hg, N=4974 weeks: <85 mm Hg, N=4974 weeks: <80 mm Hg, N=4978 weeks: <90 mm Hg, N=4978 weeks: <85 mm Hg, N=5008 weeks: <80 mm Hg, N=50012 weeks: <90 mm Hg, N=50012 weeks: <85 mm Hg, N=50012 weeks: <80 mm Hg, N=50016 weeks: <90 mm Hg, N=50016 weeks: <85 mm Hg, N=50016 weeks: <80 mm Hg, N=50020 weeks: <90 mm Hg, N=50020 weeks: <85 mm Hg, N=50020 weeks: <80 mm Hg, N=500
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide63.246.326.077.259.438.886.669.848.493.280.460.494.683.867.6

[back to top]

Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: ≤ 15 mm Hg, N=984 weeks: >15 and ≤ 30 mm Hg, N=984 weeks: >30 and ≤ 45 mm Hg, N=984 weeks: >45 mm Hg, N=988 weeks: ≤ 15 mm Hg, N=918 weeks: >15 and ≤ 30 mm Hg, N=918 weeks: >30 and ≤ 45 mm Hg, N=918 weeks: >45 mm Hg, N=9112 weeks: ≤ 15 mm Hg, N=8312 weeks: >15 and ≤ 30 mm Hg, N=8312 weeks: >30 and ≤ 45 mm Hg, N=8312 weeks: >45 mm Hg, N=8316 weeks: ≤ 15 mm Hg, N=7516 weeks: >15 and ≤ 30 mm Hg, N=7516 weeks: >30 and ≤ 45 mm Hg, N=7516 weeks: >45 mm Hg, N=7520 weeks: ≤ 15 mm Hg, N=7120 weeks: >15 and ≤ 30 mm Hg, N=7120 weeks: >30 and ≤ 45 mm Hg, N=7120 weeks: >45 mm Hg, N=71
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide50.037.87.15.142.944.09.93.331.336.125.37.222.736.034.76.723.933.833.88.5

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Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: <140 mm Hg, N=984 weeks: <135 mm Hg, N=984 weeks: <130 mm Hg, N=984 weeks: <120 mm Hg, N=988 weeks: <140 mm Hg, N=1008 weeks: <135 mm Hg, N=1008 weeks: <130 mm Hg, N=1008 weeks: <120 mm Hg, N=10012 weeks: <140 mm Hg, N=10012 weeks: <135 mm Hg, N=10012 weeks: <130 mm Hg, N=10012 weeks: <120 mm Hg, N=10016 weeks: <140 mm Hg, N=10016 weeks: <135 mm Hg, N=10016 weeks: <130 mm Hg, N=10016 weeks: <120 mm Hg, N=10020 weeks: <140 mm Hg, N=10020 weeks: <135 mm Hg, N=10020 weeks: <130 mm Hg, N=10020 weeks: <120 mm Hg, N=100
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide55.139.831.610.264.051.041.015.077.067.054.030.084.077.066.037.088.083.072.041.0

[back to top]

Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: ≤ 10 mm Hg, N=984 weeks: >10 and ≤ 15 mm Hg, N=984 weeks: >15 and ≤ 20 mm Hg, N=984 weeks: >20 mm Hg, N=988 weeks: ≤ 10 mm Hg, N=918 weeks: >10 and ≤ 15 mm Hg, N=918 weeks: >15 and ≤ 20 mm Hg, N=918 weeks: >20 mm Hg, N=9112 weeks: ≤ 10 mm Hg, N=8312 weeks: >10 and ≤15 mm Hg, N=8312 weeks: >15 and ≤ 20 mm Hg, N=8312 weeks: >20 mm Hg, N=8316 weeks: ≤ 10 mm Hg, N=7516 weeks: >10 and ≤ 15 mm Hg, N=7516 weeks: >15 and ≤ 20 mm Hg, N=7516 weeks: >20 mm Hg, N=7520 weeks: ≤ 10 mm Hg, N=7120 weeks: >10 and ≤ 15 mm Hg, N=7120 weeks: >15 and ≤ 20 mm Hg, N=7120 weeks: >20 mm Hg, N=71
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide65.316.38.210.252.818.714.314.341.020.514.524.130.725.316.028.031.012.726.829.6

[back to top]

Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: <90 mm Hg, N=984 weeks: <85 mm Hg, N=984 weeks: <80 mm Hg, N=988 weeks: <90 mm Hg, N=1008 weeks: <85 mm Hg, N=1008 weeks: <80 mm Hg, N=10012 weeks: <90 mm Hg, N=10012 weeks: <85 mm Hg, N=10012 weeks: <80 mm Hg, N=10016 weeks: <90 mm Hg, N=10016 weeks: <85 mm Hg, N=10016 weeks: <80 mm Hg, N=10020 weeks: <90 mm Hg, N=10020 weeks: <85 mm Hg, N=10020 weeks: <80 mm Hg, N=100
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide66.353.134.785.070.048.092.078.062.096.090.075.096.090.075.0

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Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: ≤ 15 mm Hg, N=2244 weeks: >15 and ≤ 30 mm Hg, N=2244 weeks: >30 and ≤ 45 mm Hg, N=2244 weeks: >45 mm Hg, N=2248 weeks: ≤ 15 mm Hg, N=2178 weeks: >15 and ≤ 30 mm Hg, N=2178 weeks: >30 and ≤ 45 mm Hg, N=2178 weeks: >45 mm Hg, N=21712 weeks: ≤ 15 mm Hg, N=19912 weeks: >15 and ≤ 30 mm Hg, N=19912 weeks: >30 and ≤ 45 mm Hg, N=19912 weeks: >45 mm Hg, N=19916 weeks: ≤ 15 mm Hg, N=17916 weeks: >15 and ≤ 30 mm Hg, N=17916 weeks: >30 and ≤ 45 mm Hg, N=17916 weeks: >45 mm Hg, N=17920 weeks: ≤ 15 mm Hg, N=16620 weeks: >15 and ≤ 30 mm Hg, N=16620 weeks: >30 and ≤ 45 mm Hg, N=16620 weeks: >45 mm Hg, N=166
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide47.340.211.21.342.937.816.62.826.646.724.62.017.932.439.710.114.537.438.010.2

[back to top]

Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: <140 mm Hg, N=2274 weeks: <135 mm Hg, N=2274 weeks: <130 mm Hg, N=2274 weeks: <120 mm Hg, N=2278 weeks: <140 mm Hg, N=2278 weeks: <135 mm Hg, N=2278 weeks: <130 mm Hg, N=2278 weeks: <120 mm Hg, N=22712 weeks: <140 mm Hg, N=22712 weeks: <135 mm Hg, N=22712 weeks: <130 mm Hg, N=22712 weeks: <120 mm Hg, N=22716 weeks: <140 mm Hg, N=22716 weeks: <135 mm Hg, N=22716 weeks: <130 mm Hg, N=22716 weeks: <120 mm Hg, N=22720 weeks: <140 mm Hg, N=22720 weeks: <135 mm Hg, N=22720 weeks: <130 mm Hg, N=22720 weeks: <120 mm Hg, N=227
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide52.037.923.49.767.057.743.618.180.670.056.828.687.779.770.943.691.685.978.950.7

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Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: <90 mm Hg, N=2274 weeks: <85 mm Hg, N=2274 weeks: <80 mm Hg, N=2278 weeks: <90 mm Hg, N=2278 weeks: <85 mm Hg, N=2278 weeks: <80 mm Hg, N=22712 weeks: <90 mm Hg, N=22712 weeks: <85 mm Hg, N=22712 weeks: <80 mm Hg, N=22716 weeks: <90 mm Hg, N=22716 weeks: <85 mm Hg, N=22716 weeks: <80 mm Hg, N=22720 weeks: <90 mm Hg, N=22720 weeks: <85 mm Hg, N=22720 weeks: <80 mm Hg, N=227
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide88.176.758.292.183.771.897.492.180.298.794.388.698.795.290.3

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Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: ≤ 15 mm Hg, N=1264 weeks: >15 and ≤ 30 mm Hg, N=1264 weeks: >30 and ≤ 45 mm Hg, N=1264 weeks: >45 mm Hg, N=1268 weeks: ≤ 15 mm Hg, N=1238 weeks: >15 and ≤ 30 mm Hg, N=1238 weeks: >30 and ≤ 45 mm Hg, N=1238 weeks: >45 mm Hg, N=12312 weeks: ≤ 15 mm Hg, N=12012 weeks: >15 and ≤ 30 mm Hg, N=12012 weeks: >30 and ≤ 45 mm Hg, N=12012 weeks: >45 mm Hg, N=12016 weeks: ≤ 15 mm Hg, N=11216 weeks: >15 and ≤ 30 mm Hg, N=11216 weeks: >30 and ≤ 45 mm Hg, N=11216 weeks: >45 mm Hg, N=11220 weeks: ≤ 15 mm Hg, N=10520 weeks: >15 and ≤ 30 mm Hg, N=10520 weeks: >30 and ≤ 45 mm Hg, N=10520 weeks: >45 mm Hg, N=105
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide43.738.115.92.440.735.822.01.628.339.227.55.020.536.631.311.629.528.633.38.6

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Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: <140 mm Hg, N=1284 weeks: <135 mm Hg, N=1284 weeks: <130 mm Hg, N=1284 weeks: <120 mm Hg, N=1288 weeks: <140 mm Hg, N=1288 weeks: <135 mm Hg, N=1288 weeks: <130 mm Hg, N=1288 weeks: <120 mm Hg, N=12812 weeks: <140 mm Hg, N=12812 weeks: <135 mm Hg, N=12812 weeks: <130 mm Hg, N=12812 weeks: <120 mm Hg, N=12816 weeks: <140 mm Hg, N=12816 weeks: <135 mm Hg, N=12816 weeks: <130 mm Hg, N=12816 weeks: <120 mm Hg, N=12820 weeks: <140 mm Hg, N=12820 weeks: <135 mm Hg, N=12820 weeks: <130 mm Hg, N=12820 weeks: <120 mm Hg, N=128
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide64.851.635.211.776.667.251.625.089.178.966.438.395.389.881.347.797.793.085.951.6

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Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: ≤ 10 mm Hg, N=1264 weeks: >10 and ≤ 15 mm Hg, N=1264 weeks: >15 and ≤ 20 mm Hg, N=1264 weeks: >20 mm Hg, N=1268 weeks: ≤ 10 mm Hg, N=1238 weeks: >10 and ≤ 15 mm Hg, N=1238 weeks: >15 and ≤ 20 mm Hg, N=1238 weeks: >20 mm Hg, N=12312 weeks: ≤ 10 mm Hg, N=12012 weeks: >10 and ≤15 mm Hg, N=12012 weeks: >15 and ≤ 20 mm Hg, N=12012 weeks: >20 mm Hg, N=12016 weeks: ≤ 10 mm Hg, N=11216 weeks: >10 and ≤ 15 mm Hg, N=11216 weeks: >15 and ≤ 20 mm Hg, N=11216 weeks: >20 mm Hg, N=11220 weeks: ≤ 10 mm Hg, N=10520 weeks: >10 and ≤ 15 mm Hg, N=10520 weeks: >15 and ≤ 20 mm Hg, N=10520 weeks: >20 mm Hg, N=105
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide47.626.213.512.738.224.422.015.533.325.819.221.727.717.020.534.836.216.218.129.5

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The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks

(NCT00791258)
Timeframe: baseline to 12 weeks

InterventionPercentage of participants (Number)
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide75.8

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Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks

(NCT00791258)
Timeframe: Baseline to 12 weeks

InterventionPercentage of participants (Number)
Systolic blood pressure <140 mmHgSystolic blood pressure <135 mmHgSystolic blood pressure <130 mmHgSystolic blood pressure <120 mmHgDiastolic blood pressure <90 mmHgDiastolic blood pressure <85 mmHgDiastolic blood pressure <80 mmHgBlood pressure <140/90 mmHgBlood pressure <135/80 mmHgBlood pressure <130/80 mmHgBlood pressure <120/80 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide80.869.256.026.189.776.959.076.152.646.223.1

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Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m. (NCT00791258)
Timeframe: Baseline to 20 weeks

Interventionmm Hg (Mean)
24-hour mean systolic blood pressureMean daytime systolic blood pressureMean nighttime systolic blood pressureSystolic blood pressure - last 2 hours of doseSystolic blood pressure - last 4 hours of doseSystolic blood pressure - last 6 hours of dose24-hour mean diastolic blood pressureMean daytime diastolic blood pressureMean nighttime diastolic blood pressureDiastolic blood pressure - last 2 hours of doseDiastolic blood pressure - last 4 hours of doseDiastolic blood pressure - last 6 hours of dose
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide-21.0-23.2-17.5-19.6-18.2-17.9-13.3-15.0-11.1-12.3-11.6-11.3

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Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Interventionmm Hg (Mean)
4 weeks, N=9758 weeks, N=92912 weeks, N=86516 weeks, N=79720 weeks, N=745
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide-8.1-9.1-11.9-14.6-14.5

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Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Interventionmm Hg (Mean)
4 weeks, N=9758 weeks, N=92912 weeks, N=86516 weeks, N=79720 weeks, N=745
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide-14.6-16.6-21.8-26.0-26.8

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Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks

(NCT00791258)
Timeframe: Baseline to 20 weeks

InterventionPercentage of participants (Number)
Systolic blood pressure <140 mmHgSystolic blood pressure <135 mmHgSystolic blood pressure <130 mmHgSystolic blood pressure <120 mmHgDiastolic blood pressure <90 mmHgDiastolic blood pressure <85 mmHgDiastolic blood pressure <80 mmHgBlood pressure <140/90 mmHgBlood pressure <135/80 mmHgBlood pressure <130/80 mmHgBlood pressure <120/80 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide92.387.279.547.496.689.374.890.670.165.044.0

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Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: <140 mm Hg, N=1904 weeks: <135 mm Hg, N=1904 weeks: <130 mm Hg, N=1904 weeks: <120 mm Hg, N=1908 weeks: <140 mm Hg, N=1908 weeks: <135 mm Hg, N=1908 weeks: <130 mm Hg, N=1908 weeks: <120 mm Hg, N=19012 weeks: <140 mm Hg, N=19012 weeks: <135 mm Hg, N=19012 weeks: <130 mm Hg, N=19012 weeks: <120 mm Hg, N=19016 weeks: <140 mm Hg, N=19016 weeks: <135 mm Hg, N=19016 weeks: <130 mm Hg, N=19016 weeks: <120 mm Hg, N=19020 weeks: <140 mm Hg, N=19020 weeks: <135 mm Hg, N=19020 weeks: <130 mm Hg, N=19020 weeks: <120 mm Hg, N=190
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide54.741.126.310.069.056.342.615.881.669.557.930.087.979.069.039.591.184.275.348.4

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Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: ≤ 10 mm Hg, N=1894 weeks: >10 and ≤ 15 mm Hg, N=1894 weeks: >15 and ≤ 20 mm Hg, N=1894 weeks: >20 mm Hg, N=1898 weeks: ≤ 10 mm Hg, N=1818 weeks: >10 and ≤ 15 mm Hg, N=1818 weeks: >15 and ≤ 20 mm Hg, N=1818 weeks: >20 mm Hg, N=18112 weeks: ≤ 10 mm Hg, N=17012 weeks: >10 and ≤15 mm Hg, N=17012 weeks: >15 and ≤ 20 mm Hg, N=17012 weeks: >20 mm Hg, N=17016 weeks: ≤ 10 mm Hg, N=15616 weeks: >10 and ≤ 15 mm Hg, N=15616 weeks: >15 and ≤ 20 mm Hg, N=15616 weeks: >20 mm Hg, N=15620 weeks: ≤ 10 mm Hg, N=15020 weeks: >10 and ≤ 15 mm Hg, N=15020 weeks: >15 and ≤ 20 mm Hg, N=15020 weeks: >20 mm Hg, N=150
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide67.716.911.63.760.820.414.93.941.232.412.913.532.726.921.818.637.318.026.018.7

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Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: <90 mm Hg, N=1904 weeks: <85 mm Hg, N=1904 weeks: <80 mm Hg, N=1908 weeks: <90 mm Hg, N=1908 weeks: <85 mm Hg, N=1908 weeks: <80 mm Hg, N=19012 weeks: <90 mm Hg, N=19012 weeks: <85 mm Hg, N=19012 weeks: <80 mm Hg, N=19016 weeks: <90 mm Hg, N=19016 weeks: <85 mm Hg, N=19016 weeks: <80 mm Hg, N=19020 weeks: <90 mm Hg, N=19020 weeks: <85 mm Hg, N=19020 weeks: <80 mm Hg, N=190
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide75.864.239.085.872.651.194.283.263.797.989.070.599.090.576.8

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Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: ≤ 15 mm Hg, N=4534 weeks: >15 and ≤ 30 mm Hg, N=4534 weeks: >30 and ≤ 45 mm Hg, N=4534 weeks: >45 mm Hg, N=4538 weeks: ≤ 15 mm Hg, N=4318 weeks: >15 and ≤ 30 mm Hg, N=4318 weeks: >30 and ≤ 45 mm Hg, N=4318 weeks: >45 mm Hg, N=43112 weeks: ≤ 15 mm Hg, N=40212 weeks: >15 and ≤ 30 mm Hg, N=40212 weeks: >30 and ≤ 45 mm Hg, N=40212 weeks: >45 mm Hg, N=40216 weeks: ≤ 15 mm Hg, N=37116 weeks: >15 and ≤ 30 mm Hg, N=37116 weeks: >30 and ≤ 45 mm Hg, N=37116 weeks: >45 mm Hg, N=37120 weeks: ≤ 15 mm Hg, N=35620 weeks: >15 and ≤ 30 mm Hg, N=35620 weeks: >30 and ≤ 45 mm Hg, N=35620 weeks: >45 mm Hg, N=356
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide49.538.411.50.748.035.514.42.130.443.822.63.224.037.729.19.219.736.536.07.9

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Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: <140 mm Hg, N=4544 weeks: <135 mm Hg, N=4544 weeks: <130 mm Hg, N=4544 weeks: <120 mm Hg, N=4548 weeks: <140 mm Hg, N=4578 weeks: <135 mm Hg, N=4578 weeks: <130 mm Hg, N=4578 weeks: <120 mm Hg, N=45712 weeks: <140 mm Hg, N=45712 weeks: <135 mm Hg, N=45712 weeks: <130 mm Hg, N=45712 weeks: <120 mm Hg, N=45716 weeks: <140 mm Hg, N=45716 weeks: <135 mm Hg, N=45716 weeks: <130 mm Hg, N=45716 weeks: <120 mm Hg, N=45720 weeks: <140 mm Hg, N=45720 weeks: <135 mm Hg, N=45720 weeks: <130 mm Hg, N=45720 weeks: <120 mm Hg, N=457
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide56.441.427.17.967.654.340.916.281.467.254.127.688.880.367.039.091.585.674.847.1

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Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

(NCT00791258)
Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

InterventionPercentage of Participants (Number)
4 weeks: ≤ 10 mm Hg, N=4534 weeks: >10 and ≤ 15 mm Hg, N=4534 weeks: >15 and ≤ 20 mm Hg, N=4534 weeks: >20 mm Hg, N=4538 weeks: ≤ 10 mm Hg, N=4318 weeks: >10 and ≤ 15 mm Hg, N=4318 weeks: >15 and ≤ 20 mm Hg, N=4318 weeks: >20 mm Hg, N=43112 weeks: ≤ 10 mm Hg, N=40212 weeks: >10 and ≤15 mm Hg, N=40212 weeks: >15 and ≤ 20 mm Hg, N=40212 weeks: >20 mm Hg, N=40216 weeks: ≤ 10 mm Hg, N=37116 weeks: >10 and ≤ 15 mm Hg, N=37116 weeks: >15 and ≤ 20 mm Hg, N=37116 weeks: >20 mm Hg, N=37120 weeks: ≤ 10 mm Hg, N=35620 weeks: >10 and ≤ 15 mm Hg, N=35620 weeks: >15 and ≤ 20 mm Hg, N=35620 weeks: >20 mm Hg, N=356
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide62.722.38.66.456.619.715.38.444.322.117.416.232.424.021.022.633.219.422.525.0

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Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints

Systolic & Diastolic Blood Pressure were measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and after 8, 16 , 24 and 32 weeks. Outcome is reported as percentage of participants achieving overall blood pressure control (msSBP <140 mmHg and msDBP <90 mmHg) at weeks 8, 16, 24 & 32 endpoints. (NCT00797862)
Timeframe: Baseline to week 8, 16, 24 and 32 endpoints

,,
InterventionPercentage of Participants (Number)
Week 8 endpointWeek 16 endpointWeek 24 endpointWeek 32 endpoint
Aliskiren Start-Amlodipine Add On22.833.362.859.0
Aliskiren+Amlodipine46.565.963.461.6
Amlodipine Start-Aliskiren Add On25.240.957.853.4

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Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks

Systolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msSBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures Analysis of Covariance (ANCOVA) model with treatment, visit, and region as factors, treatment by visit interaction and baseline msSBP as a covariate. (NCT00797862)
Timeframe: Baseline, 8 weeks, 16 weeks, and 24 weeks

InterventionmmHg (Least Squares Mean)
Aliskiren+Amlodipine-25.34
Aliskiren Start-Amlodipine Add On-17.94
Amlodipine Start-Aliskiren Add On-19.81

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Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24

Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region as factors, treatment by visit interaction and baseline msSBP as a covariate. (NCT00797862)
Timeframe: Baseline to 24 weeks

InterventionmmHg (Least Squares Mean)
Aliskiren+Amlodipine-27.37
Aliskiren Start-Amlodipine Add On-26.34
Amlodipine Start-Aliskiren Add On-25.52

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Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32

Diastolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 32 weeks of study treatment. Change at Week 32 used a separate repeated measures ANCOVA model containing Week 8, 16, 24 and 32 data. Treatment, visit and region were factors in the model, treatment by visit interaction and baseline msDBP a covariate. (NCT00797862)
Timeframe: Baseline to 32 weeks

InterventionmmHg (Least Squares Mean)
Aliskiren+Amlodipine-12.96
Aliskiren Start-Amlodipine Add On-12.96
Amlodipine Start-Aliskiren Add On-11.62

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Overall Mean Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Over 8, 16, and 24 Weeks

Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msDBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures ANCOVA model with treatment, visit and regions as factors, treatment by visit interaction and baseline msDBP as a covariate. (NCT00797862)
Timeframe: Baseline, 8 weeks, 16 weeks and 24 weeks

InterventionmmHg (Least Squares Mean)
Aliskiren+Amlodipine-12.39
Aliskiren Start-Amlodipine Add On-8.37
Amlodipine Start-Aliskiren Add On-9.02

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Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 32

Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 32 weeks of study treatment. Change at week 32 used a separate repeated measures ANCOVA model containing Week 8, 16, 24 & 32 data. Treatment, visit and region were factors in the model, treatment by visit interaction and baseline msSBP was a covariate. (NCT00797862)
Timeframe: Baseline to 32 weeks

InterventionmmHg (Least Squares Mean)
Aliskiren+Amlodipine-26.42
Aliskiren Start-Amlodipine Add On-25.75
Amlodipine Start-Aliskiren Add On-24.32

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Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24

Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region, as factors, treatment by visit interaction and baseline msDBP as a covariate. (NCT00797862)
Timeframe: Baseline to 24 weeks

InterventionmmHg (Least Squares Mean)
Aliskiren+Amlodipine-13.64
Aliskiren Start-Amlodipine Add On-13.22
Amlodipine Start-Aliskiren Add On-12.25

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Plasminogen Activator Inhibitor 1

Plasminogen Activator Inhibitor 1 is a biomarker found in serum that indirectly assesses blood clotting activity. Lower PAI-1 levels are thought to be better than higher levels. The primary outcome is mean change from baseline and can include negative numbers as a result. (NCT00818779)
Timeframe: 6 weeks (change from baseline)

Interventionng/ml (Mean)
Aliskiren0.65
Amlodipine3.82

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Serum Level of Nitric Oxide

Surrogate biomarker of cardiovascular risk (NCT00818779)
Timeframe: 6 week (change from baseline)

Interventionmmmol/l (Mean)
Aliskiren2.66
Amlodipine7.49

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Serum Level of Intracellular Cell Adhesion Molecule

Surrogate biomarker of cardiovascular risk (NCT00818779)
Timeframe: 6 week (change from baseline)

Interventionng/ml (Mean)
Aliskiren-4.9
Amlodipine-10.3

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Serum Level of Vascular Cell Adhesion Molecule

Surrogate biomarker cardiovascular risk (NCT00818779)
Timeframe: 6 week (change from baseline)

Interventionng/ml (Mean)
Aliskiren-2.4
Amlodipine-45.9

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Serum Level of C-reactive Protein

Surrogate biomarker of cardiovascular risk (NCT00818779)
Timeframe: 6 week (change from baseline)

Interventionmg/l (Mean)
Aliskiren0.0397
Amlodipine0.1032

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AUC0-inf - Benazepril

Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated) (NCT00834977)
Timeframe: Blood samples collected over 36 hour period

Interventionng*h/mL (Mean)
Amlodipine Benazepril245.15
Lotrel®253.21

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AUC0-t - Amlodipine

Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant) (NCT00834977)
Timeframe: Blood samples collected over 168 hour period

Interventionpg*h/mL (Mean)
Amlodipine Benazepril328249.86
Lotrel®331782.17

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AUC0-inf - Benazeprilat

AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated) (NCT00834977)
Timeframe: Blood samples collected over 36 hour period

Interventionng*h/mL (Mean)
Amlodipine Benazepril2027.53
Lotrel®2033.12

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AUC0-t - Benazaprilat

AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant) (NCT00834977)
Timeframe: Blood samples collected over 36 hour period

Interventionng*h/mL (Mean)
Amlodipine Benazepril1981.29
Lotrel®1990.26

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AUC0-inf - Amlodipine

Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated) (NCT00834977)
Timeframe: Blood samples collected over 168 hour period

Interventionpg*h/mL (Mean)
Amlodipine Benazepril365612.90
Lotrel®366523.24

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AUC0-t - Benazepril

Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant) (NCT00834977)
Timeframe: Blood samples collected over 36 hour period

Interventionng*h/mL (Mean)
Amlodipine Benazepril241.65
Lotrel®250.13

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Cmax - Amlodipine

Bioequivalence based on Cmax - Maximum observed concentration (NCT00834977)
Timeframe: Blood samples collected over 168 hour period

Interventionpg/mL (Mean)
Amlodipine Benazepril6299.49
Lotrel®6185.06

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Cmax - Benazepril

Bioequvialence based on Cmax - Maximum observed concentration (NCT00834977)
Timeframe: Blood samples collected over 36 hour period

Interventionng/mL (Mean)
Amlodipine Benazepril330.93
Lotrel®340.57

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Cmax - Benazeprilat

Cmax - Maximum observed concentration (NCT00834977)
Timeframe: Blood samples collected over 36 hour period

Interventionng/mL (Mean)
Amlodipine Benazepril378.27
Lotrel®397.50

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Cmax - Benazepril

Bioequivalence based on Cmax - Maximum observed concentration (NCT00835367)
Timeframe: Blood samples collected over 36 hour period

Interventionng/mL (Mean)
Amlodipine Benazepril92.13
Lotrel®101.55

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Cmax - Benazeprilat

Cmax - Maximum observed concentration (NCT00835367)
Timeframe: Blood samples collected over 36 hour period

Interventionng/mL (Mean)
Amlodipine Benazepril226.79
Lotrel®235.85

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AUC0-t - Amlodipine

Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant) (NCT00835367)
Timeframe: Blood samples collected over 168 hour period

Interventionpg*h/mL (Mean)
Amlodipine Benazepril329314.07
Lotrel®322615.55

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AUC0-inf - Amlodipine

Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated) (NCT00835367)
Timeframe: Blood samples collected over 168 hour period

Interventionpg*h/mL (Mean)
Amlodipine Benazepril370735.08
Lotrel®363080.38

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AUC0-inf - Benazepril

Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated) (NCT00835367)
Timeframe: Blood samples collected over 36 hour period

Interventionng*h/mL (Mean)
Amlodipine Benazepril201.36
Lotrel®194.76

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AUC0-inf - Benazeprilat

AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated) (NCT00835367)
Timeframe: Blood samples collected over 36 hour period

Interventionng*h/mL (Mean)
Amlodipine Benazepril1645.73
Lotrel®1631.10

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AUC0-t - Benazepril

Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant) (NCT00835367)
Timeframe: Blood samples collected over 36 hour period

Interventionng*h/mL (Mean)
Amlodipine Benazepril197.23
Lotrel®190.74

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AUC0-t - Benazeprilat

AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant) (NCT00835367)
Timeframe: Blood samples collected over 36 hour period

Interventionng*h/mL (Mean)
Amlodipine Benazepril1611.85
Lotrel®1597.94

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Cmax - Amlodipine

Bioequivalence based on Cmax - Maximum observed concentration (NCT00835367)
Timeframe: Blood samples collected over 168 hour period

Interventionpg/mL (Mean)
Amlodipine Benazepril5621.36
Lotrel®5536.86

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AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

Bioequivalence based on AUC0-t (NCT00841542)
Timeframe: Blood samples collected over 168 hour period

Interventionng*h/mL (Mean)
Amlodipine299.84
Norvasc®302.52

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Cmax - Maximum Observed Concentration

Bioequivalence based on Cmax (NCT00841542)
Timeframe: Blood samples collected over 168 hour period

Interventionng/mL (Mean)
Amlodipine6.16
Norvasc®6.29

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AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Bioequivalence based on AUC0-inf (NCT00841542)
Timeframe: Blood samples collected over 168 hour period

Interventionng*h/mL (Mean)
Amlodipine323.27
Norvasc®326.49

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Mean Sitting Systolic Blood Pressure (msSBP)

Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8) (NCT00841672)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Aliskiren/Amlodipine 300/10 mg Tablet-37.72
Amlodipine 10 mg Capsule-30.63

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Mean Sitting Diastolic Blood Pressure (msDBP)

Change in mean sitting diastolic blood pressure (msDBP) from baseline to end of study (Week 8) (NCT00841672)
Timeframe: Baseline to end of study (Week 8)

Interventionmm Hg (Least Squares Mean)
Aliskiren/Amlodipine 300/10 mg Tablet-16.10
Amlodipine 10 mg Capsule-12.27

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Systolic Blood Pressure Response

Percentage of patients achieving a mean sitting systolic blood pressure response (msSBP < 140 mmHg or a reduction => 20 mmHg from the baseline) from baseline to end of study (Week 8) (NCT00841672)
Timeframe: Baseline to end of study (Week 8)

InterventionPercentage of participants (Number)
Aliskiren/Amlodipine 300/10 mg Tablet88.8
Amlodipine 10 mg Capsule79.1

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Blood Pressure Control

Percentage of patients achieving blood pressure control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at end of study (NCT00841672)
Timeframe: End of study (Week 8)

InterventionPercentage of participants (Number)
Aliskiren/Amlodipine 300/10 mg Tablet67.0
Amlodipine 10 mg Capsule49.1

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Diastolic Blood Pressure Response

Percentage of patients achieving a mean sitting diastolic blood pressure response (msDBP < 90 mmHg or a reduction ≥ 10 mmHg from the baseline) from baseline to end of study (Week 8) (NCT00841672)
Timeframe: Baseline to end of study (Week 8)

InterventionPercentage of participants (Number)
Aliskiren/Amlodipine 300/10 mg Tablet92.7
Amlodipine 10 mg Capsule86.5

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AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Bioequivalence based on AUC0-inf (NCT00841815)
Timeframe: Blood samples collected over 168 hour period

Interventionng*h/mL (Mean)
Amlodipine318.95
Norvasc®315.94

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Cmax - Maximum Observed Concentration

Bioequivalence based on Cmax (NCT00841815)
Timeframe: Blood samples collected over 168 hour period

Interventionng/mL (Mean)
Amlodipine Besylate5.99
Norvasc®6.17

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AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

Bioequivalence based on AUC0-t (NCT00841815)
Timeframe: Blood samples collected over 168 hour period

Interventionng*h/mL (Mean)
Amlodipine296.74
Norvasc®295.84

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Percentage of Patients With Peripheral Edema by Visit

Cumulative percentage of patients with peripheral edema was calculated. 'Cumulative' refers to patients with peripheral edema before or at the corresponding visit. If peripheral edema occurred more than once, only the first occurrence was counted. Peripheral edema is the swelling of tissues due to the accumulation of fluids. Peripheral edema was assessed by investigators during physical examination. (NCT00853957)
Timeframe: 8 weeks

,
InterventionPercentage of participants (Number)
Week 1Week 4Week 8
Aliskiren/Amlodipine1.44.16.8
Amlodipine1.35.88.5

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Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

To compare the change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg). (NCT00853957)
Timeframe: Baseline, 8 weeks

Interventionmm Hg (Mean)
Aliskiren/Amlodipine-13.7
Amlodipine-10.4

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Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension. (NCT00853957)
Timeframe: Baseline, 8 weeks

Interventionmm Hg (Mean)
Aliskiren/Amlodipine-33.1
Amlodipine-27.8

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Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)

Cumulative percentage of patients achieving BP control (<140/90 mmHg)for both treatment arms was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted. (NCT00853957)
Timeframe: 8 weeks

InterventionPercentage of participants (Number)
Aliskiren/Amlodipine71.4
Amlodipine57.4

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Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)

Cumulative percentage of responders (Responders are defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted. (NCT00853957)
Timeframe: 8 weeks

InterventionPercentage of participants (Number)
Aliskiren/Amlodipine92.3
Amlodipine86.5

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Change From Baseline in MSSBP at Week 1 and 4

Compare the change from baseline in MSSBP at week 1 and 4 (NCT00853957)
Timeframe: Baseline, 1 and 4 weeks

,
Interventionmm Hg (Mean)
Baseline to Week 1baseline to Week 4
Aliskiren/Amlodipine-20.5-30.9
Amlodipine-18.2-27.3

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Patients Achieving Systolic Blood Pressure Response at Week 2

SBP < 140 mmHg or reduction of >= 15 mmHg (NCT00860262)
Timeframe: baseline, week 2

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 5 mg18923
T80+A538718
Telmisartan 80 mg16943

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Patients Achieving Systolic Blood Pressure Response at Week 4

SBP < 140 mmHg or reduction of >= 15 mmHg (NCT00860262)
Timeframe: baseline, week 4

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 10 mg1949
T80+A103884
Telmisartan 80 mg18032

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Patients Achieving Systolic Blood Pressure Response at Week 6

SBP < 140 mmHg or reduction of >= 15 mmHg (NCT00860262)
Timeframe: baseline, week 6

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 10 mg2014
T80+A103886
Telmisartan 80 mg18428

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Patients Achieving Systolic Blood Pressure Response at Week 8

SBP < 140 mmHg or reduction of >= 15 mmHg (NCT00860262)
Timeframe: baseline, week 8

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 10 mg2023
T80+A103914
Telmisartan 80 mg18824

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Patients Achieving Diastolic Blood Pressure Response at Week 2

DBP < 90 mmHg or reduction of >= 10 mmHg (NCT00860262)
Timeframe: baseline, week 2

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 5 mg12884
T80+A5289116
Telmisartan 80 mg12389

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Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8

Overall mean reduction from a common mean baseline in DBP (NCT00860262)
Timeframe: baseline and week 8

InterventionmmHg (millimeters of mercury) (Least Squares Mean)
T80+A10-18.7
Telmisartan 80 mg-13.8
Amlodipine 10 mg-16.3

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Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1

Overall mean reduction from a common mean baseline in DBP (NCT00860262)
Timeframe: baseline and week 1

InterventionmmHg (millimeters of mercury) (Least Squares Mean)
T80+A5-10.9
Telmisartan 80 mg-8.2
Amlodipine 5 mg-9.6

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Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2

Overall mean reduction from a common mean baseline in DBP (NCT00860262)
Timeframe: baseline and week 2

InterventionmmHg (millimeters of mercury) (Least Squares Mean)
T80+A5-13.2
Telmisartan 80 mg-10.4
Amlodipine 5 mg-11.4

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Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4

Overall mean reduction from a common mean baseline in DBP (NCT00860262)
Timeframe: baseline and week 4

InterventionmmHg (millimeters of mercury) (Least Squares Mean)
T80+A10-17.0
Telmisartan 80 mg-12.1
Amlodipine 10 mg-14.2

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Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6

Overall mean reduction from a common mean baseline in DBP (NCT00860262)
Timeframe: baseline and week 6

InterventionmmHg (millimeters of mercury) (Least Squares Mean)
T80+A10-18.3
Telmisartan 80 mg-13.5
Amlodipine 10 mg-15.7

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Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8

Overall mean reduction from a common mean baseline in SBP (NCT00860262)
Timeframe: baseline and week 8

InterventionmmHg (millimeters of mercury) (Least Squares Mean)
T80+A10-47.5
Telmisartan 80 mg-36.9
Amlodipine 10 mg-43.2

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Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1

Overall mean reduction from a common mean baseline in SBP (NCT00860262)
Timeframe: baseline and week 1

InterventionmmHg (millimeters of mercury) (Least Squares Mean)
T80+A5-31.9
Telmisartan 80 mg-25.4
Amlodipine 5 mg-28.6

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Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2

Overall mean reduction from a common mean baseline in SBP (NCT00860262)
Timeframe: baseline and week 2

InterventionmmHg (millimeters of mercury) (Least Squares Mean)
T80+A5-37.9
Telmisartan 80 mg-30.1
Amlodipine 5 mg-33.3

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Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4

Overall mean reduction from a common mean baseline in SBP (NCT00860262)
Timeframe: baseline and week 4

InterventionmmHg (millimeters of mercury) (Least Squares Mean)
T80+A10-44.5
Telmisartan 80 mg-34.4
Amlodipine 10 mg-39.8

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Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6

Overall mean reduction from a common mean baseline in SBP (NCT00860262)
Timeframe: baseline and week 6

InterventionmmHg (millimeters of mercury) (Least Squares Mean)
T80+A10-46.9
Telmisartan 80 mg-36.3
Amlodipine 10 mg-42.1

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Number of Patients Achieving Various Blood Pressure Response Levels at Week 1

Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 (NCT00860262)
Timeframe: week 1

,,
Interventionparticipants (Number)
OptimalNormalHigh NormalHigh
Amlodipine 5 mg0312192
T80+A53942333
Telmisartan 80 mg0313191

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Number of Patients Achieving Various Blood Pressure Response Levels at Week 2

Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 (NCT00860262)
Timeframe: week 2

,,
Interventionparticipants (Number)
OptimalNormalHigh NormalHigh
Amlodipine 5 mg0523184
T80+A562161317
Telmisartan 80 mg0723182

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Patients Achieving Blood Pressure Control at Week 1

Blood Pressure Control is defined as achieving SBP< 140 mmHg and DBP < 90mmHg (NCT00860262)
Timeframe: week 1

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 5 mg15192
T80+A554333
Telmisartan 80 mg16191

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Patients Achieving Blood Pressure Control at Week 2

SBP < 140 mmHg and DBP < 90 mmHg (NCT00860262)
Timeframe: week 2

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 5 mg28184
T80+A588317
Telmisartan 80 mg30182

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Patients Achieving Blood Pressure Control at Week 4

SBP < 140 mmHg and DBP < 90 mmHg (NCT00860262)
Timeframe: week 4

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 10 mg53150
T80+A10161231
Telmisartan 80 mg49163

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Patients Achieving Blood Pressure Control at Week 6

SBP < 140 mmHg and DBP < 90 mmHg (NCT00860262)
Timeframe: week 6

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 10 mg77128
T80+A10196198
Telmisartan 80 mg54158

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Patients Achieving Blood Pressure Control at Week 8

SBP < 140 mmHg and DBP < 90 mmHg (NCT00860262)
Timeframe: week 8

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 10 mg73132
T80+A10199196
Telmisartan 80 mg51161

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Patients Achieving Diastolic Blood Pressure Control at Week 1

Diastolic Blood Pressure Control is defined as achieving DBP < 90mmHg (NCT00860262)
Timeframe: week 1

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 5 mg64143
T80+A5147240
Telmisartan 80 mg61146

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Patients Achieving Diastolic Blood Pressure Control at Week 2

DBP < 90 mmHg (NCT00860262)
Timeframe: week 2

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 5 mg91121
T80+A5205200
Telmisartan 80 mg87125

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Patients Achieving Diastolic Blood Pressure Control at Week 4

DBP < 90 mmHg (NCT00860262)
Timeframe: week 4

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 10 mg10994
T80+A10268124
Telmisartan 80 mg106106

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Patients Achieving Diastolic Blood Pressure Control at Week 6

DBP < 90 mmHg (NCT00860262)
Timeframe: week 6

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 10 mg12877
T80+A10290104
Telmisartan 80 mg110102

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Patients Achieving Diastolic Blood Pressure Control at Week 8

DBP < 90 mmHg (NCT00860262)
Timeframe: week 8

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 10 mg13174
T80+A10291103
Telmisartan 80 mg112100

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Patients Achieving Diastolic Blood Pressure Response at Week 1

Diastolic Blood Pressure Response is defined as achieving DBP < 90 mmHg or a reduction of >= 10 mmHg (NCT00860262)
Timeframe: baseline, week 1

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 5 mg100107
T80+A5232155
Telmisartan 80 mg95112

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Patients Achieving Diastolic Blood Pressure Response at Week 4

DBP < 90 mmHg or reduction of >= 10 mmHg (NCT00860262)
Timeframe: baseline, week 4

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 10 mg15161
T80+A1033953
Telmisartan 80 mg13280

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Patients Achieving Diastolic Blood Pressure Response at Week 6

DBP < 90 mmHg or reduction of >= 10 mmHg (NCT00860262)
Timeframe: baseline, week 6

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 10 mg16837
T80+A1035638
Telmisartan 80 mg14468

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Patients Achieving Diastolic Blood Pressure Response at Week 8

DBP < 90 mmHg or reduction of >= 10 mmHg (NCT00860262)
Timeframe: baseline, week 8

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 10 mg17233
T80+A1036134
Telmisartan 80 mg14765

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Patients Achieving Normal Blood Pressure Response at Week 4

Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 (NCT00860262)
Timeframe: week 4

,,
Interventionparticipants (Number)
OptimalNormalHigh NormalHigh
Amlodipine 10 mg21437150
T80+A10154799231
Telmisartan 80 mg41530163

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Patients Achieving Normal Blood Pressure Response at Week 6

Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 (NCT00860262)
Timeframe: week 6

,,
Interventionparticipants (Number)
OptimalNormalHigh NormalHigh
Amlodipine 10 mg31856128
T80+A101773106198
Telmisartan 80 mg51930158

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Patients Achieving Normal Blood Pressure Response at Week 8

Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 (NCT00860262)
Timeframe: week 8

,,
Interventionparticipants (Number)
OptimalNormalHigh NormalHigh
Amlodipine 10 mg22546132
T80+A101876105196
Telmisartan 80 mg32127161

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Patients Achieving Systolic Blood Pressure Response at Week 1

Systolic Blood Pressure Response Control is defined as achieving SBP < 140 mmHg or a reduction of >= 15 mmHg (NCT00860262)
Timeframe: baseline, week 1

,,
Interventionparticipants (Number)
ControlledNot Controlled
Amlodipine 5 mg17334
T80+A533849
Telmisartan 80 mg16443

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Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study

Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 compared to Baseline in Phase 2 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2. (NCT00867490)
Timeframe: Baseline Phase 3 to end of Phase 3

InterventionPercentage of patients (Number)
msSBP responsemsDBP response
Phase III - Aliskiren+HCTZ+Amlodipine54.147.5

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Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study

Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 compared to Baseline in Phase 2 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2. (NCT00867490)
Timeframe: Baseline Phase 2 to end of Phase 2

InterventionPercentage of patients (Number)
msSBP responsemsDBP response
Phase 2 - Aliskiren+HCTZ37.434.1

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Change in Sitting Pulse Pressure During the Extension Phase of the Study

Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. (NCT00867490)
Timeframe: Baseline Phase 3 to end of Phase 3

InterventionmmHg (Mean)
Phase III - Aliskiren+HCTZ+Amlodipine-3.33

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Change in Sitting Pulse Rate During the Extension Phase of the Study

Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position. (NCT00867490)
Timeframe: Baseline Phase 3 to end of Phase 3

InterventionBPM (beats per minute) (Mean)
Phase III - Aliskiren+HCTZ+Amlodipine0.03

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Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study

Normalized was defined as a msSBP < 140 mm Hg and/or a msDBP < 90 mm Hg. (NCT00867490)
Timeframe: Baseline Phase 3 to end of Phase 3

InterventionPercentage of patients (Number)
msSBP < 140 mmHgmsDBP < 90 mmHg
Phase III - Aliskiren+HCTZ+Amlodipine54.144.3

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Change in Sitting Pulse Pressure During the Core Phase of the Study

Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. (NCT00867490)
Timeframe: Baseline Phase 2 to end of Phase 2

InterventionmmHg (Mean)
Phase 2 - Aliskiren+HCTZ0.31

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Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study

Normalized blood pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg. (NCT00867490)
Timeframe: Baseline Phase 2 to end of Phase 2

InterventionPercentage of patients (Number)
msSBP < 140 mmHgmsDBP < 90 mmHg
Phase 2 - Aliskiren+HCTZ37.433.3

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Change in Sitting Pulse Rate During the Core Phase of the Study

Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position. (NCT00867490)
Timeframe: Baseline Phase 2 to end of Phase 2

InterventionBPM (beats per minute) (Mean)
Phase 2 - Aliskiren+HCTZ0.27

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Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. (NCT00867490)
Timeframe: Baseline Phase 3 to end of Phase 3

InterventionmmHg (Mean)
Phase III - Aliskiren+HCTZ+Amlodipine-9.20

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Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. (NCT00867490)
Timeframe: Baseline Phase 2 to end of Phase 2

InterventionmmHg (Mean)
Phase 2 - Aliskiren+HCTZ-2.81

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Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. (NCT00867490)
Timeframe: Baseline Phase 3 to end of Phase 3

InterventionmmHg (Mean)
Phase III - Aliskiren+HCTZ+Amlodipine-5.87

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Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study

The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. (NCT00867490)
Timeframe: Baseline Phase 2 to end of Phase 2

InterventionmmHg (Mean)
Phase 2 - Aliskiren+HCTZ-3.12

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Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1

Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication. (NCT00877929)
Timeframe: Baseline, week 1

InterventionmmHg (Least Squares Mean)
Telmisartan 80 mg + Amlodipine 5 mg-17.5
Amlodipine 5 mg-12.6

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BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks

Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg (NCT00877929)
Timeframe: Baseline, week 2

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 5 mg184
Amlodipine 5 mg103

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Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8

Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication. (NCT00877929)
Timeframe: Baseline, week 8

InterventionmmHg (Least Squares Mean)
Telmisartan 80 mg + Amlodipine 10 mg-29.0
Amlodipine 10 mg-22.9

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SBP Control 130 at One Week

Mean seated SBP < 130 mmHg (NCT00877929)
Timeframe: Baseline, week 1

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 5 mg50
Amlodipine 5 mg26

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SBP Control 130 at Six Weeks

Mean seated SBP < 130 mmHg (NCT00877929)
Timeframe: Baseline, week 6

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg164
Amlodipine 10 mg81

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SBP Response 140 at One Week

SBP <140 mmHg or a reduction >=10 mmHg (NCT00877929)
Timeframe: Baseline, week 1

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 5 mg253
Amlodipine 5 mg201

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SBP Response 140 at Two Weeks

SBP <140 mmHg or a reduction >=10 mmHg (NCT00877929)
Timeframe: Baseline, week 2

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 5 mg297
Amlodipine 5 mg246

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BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks

Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg (NCT00877929)
Timeframe: Baseline, week 6

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg245
Amlodipine 10 mg168

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BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week

Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg (NCT00877929)
Timeframe: Baseline, week 1

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 5 mg130
Amlodipine 5 mg72

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BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks

Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg (NCT00877929)
Timeframe: Baseline, week 4

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg235
Amlodipine 10 mg155

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BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks

Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg (NCT00877929)
Timeframe: Baseline, week 2

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 5 mg58
Amlodipine 5 mg23

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BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks

Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg (NCT00877929)
Timeframe: Baseline, week 6

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg134
Amlodipine 10 mg60

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BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week

Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg (NCT00877929)
Timeframe: Baseline, week 1

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 5 mg35
Amlodipine 5 mg12

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BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks

Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg (NCT00877929)
Timeframe: Baseline, week 8

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg121
Amlodipine 10 mg59

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Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks

Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg (NCT00877929)
Timeframe: Baseline, week 8

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg237
Amlodipine 10 mg177

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BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks

Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg (NCT00877929)
Timeframe: Baseline, week 4

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg94
Amlodipine 10 mg38

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SBP Control 140 at Two Weeks

Mean seated SBP < 140 mmHg (NCT00877929)
Timeframe: Baseline, week 2

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 5 mg193
Amlodipine 5 mg112

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SBP Response 130 at Eight Weeks

SBP <130 mmHg or a reduction >=10 mmHg (NCT00877929)
Timeframe: Baseline, week 8

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg309
Amlodipine 10 mg288

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SBP Response 130 at Four Weeks

SBP <130 mmHg or a reduction >=10 mmHg (NCT00877929)
Timeframe: Baseline, week 4

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg309
Amlodipine 10 mg274

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SBP Response 130 at One Week

SBP <130 mmHg or a reduction >=10 mmHg (NCT00877929)
Timeframe: Baseline, week 1

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 5 mg253
Amlodipine 5 mg199

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SBP Response 130 at Six Weeks

SBP <130 mmHg or a reduction >=10 mmHg (NCT00877929)
Timeframe: Baseline, week 6

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg318
Amlodipine 10 mg286

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SBP Response 130 at Two Weeks

SBP <130 mmHg or a reduction >=10 mmHg (NCT00877929)
Timeframe: Baseline, week 2

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 5 mg297
Amlodipine 5 mg246

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SBP Response 140 at Eight Weeks

SBP < 140 mmHg or a reduction >=10 mmHg (NCT00877929)
Timeframe: Baseline, week 8

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg309
Amlodipine 10 mg288

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SBP Response 140 at Four Weeks

SBP <140 mmHg or a reduction >=10 mmHg (NCT00877929)
Timeframe: Baseline, week 4

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg309
Amlodipine 10 mg274

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SBP Control 130 at Four Weeks

Mean seated SBP < 130 mmHg (NCT00877929)
Timeframe: Baseline, week 4

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg137
Amlodipine 10 mg70

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SBP Response 140 at Six Weeks

SBP <140 mmHg or a reduction >=10 mmHg (NCT00877929)
Timeframe: Baseline, week 6

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg318
Amlodipine 10 mg286

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Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6

Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication. (NCT00877929)
Timeframe: Baseline, week 6

InterventionmmHg (Least Squares Mean)
Telmisartan 80 mg + Amlodipine 10 mg-29.7
Amlodipine 10 mg-22.6

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Systolic Blood Pressure (SBP) Control 140 at Eight Weeks

Mean seated SBP < 140 mmHg (NCT00877929)
Timeframe: Baseline, week 8

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg243
Amlodipine 10 mg187

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Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4

Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication. (NCT00877929)
Timeframe: Baseline, week 4

InterventionmmHg (Least Squares Mean)
Telmisartan 80 mg + Amlodipine 10 mg-27.7
Amlodipine 10 mg-21.1

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Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2

Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication. (NCT00877929)
Timeframe: Baseline, week 2

InterventionmmHg (Least Squares Mean)
Telmisartan 80 mg + Amlodipine 5 mg-22.4
Amlodipine 5 mg-16.4

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SBP Control 130 at Two Weeks

Mean seated SBP < 130 mmHg (NCT00877929)
Timeframe: Baseline, week 2

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 5 mg92
Amlodipine 5 mg42

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SBP Control 140 at Four Weeks

Mean seated SBP < 140 mmHg (NCT00877929)
Timeframe: Baseline, week 4

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg243
Amlodipine 10 mg163

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SBP Control 140 at Six Weeks

Mean seated SBP < 140 mmHg (NCT00877929)
Timeframe: Baseline, week 6

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg251
Amlodipine 10 mg177

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SBP Control 140 at One Week

Mean seated SBP < 140 mmHg (NCT00877929)
Timeframe: Baseline, week 1

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 5 mg141
Amlodipine 5 mg81

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Change From Baseline in Urine Albumin:Creatinine Ratio (UACR)

Change from baseline in UACR (measured in spot urine) after eight weeks of treatment (NCT00877929)
Timeframe: 8 weeks

Interventionratio (Mean)
Telmisartan 80 mg + Amlodipine 10 mg-0.36
Amlodipine 10 mg0.04

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SBP Control 130 at Eight Weeks

Mean seated SBP < 130 mmHg (NCT00877929)
Timeframe: Baseline, week 8

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg157
Amlodipine 10 mg89

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DBP Response at Week Two

Mean seated DBP <80 mmHg or a reduction of >=10 mmHg (NCT00877929)
Timeframe: Week 2

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 5 mg206
Amlodipine 5 mg166

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DBP Response at Week One

Mean seated DBP <80 mmHg or a reduction of >=10 mmHg (NCT00877929)
Timeframe: Week 1

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 5 mg165
Amlodipine 5 mg113

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DBP Response at Week Four

Mean seated DBP <80 mmHg or a reduction of >=10 mmHg (NCT00877929)
Timeframe: Week 4

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg250
Amlodipine 10 mg190

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DBP Response at Six Weeks

Mean seated DBP<80 mmHg or a reduction of <=10 mmHg (NCT00877929)
Timeframe: week 6

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg275
Amlodipine 10 mg214

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DBP Response at Eight Weeks

Mean seated DBP<80 mmHg or a reduction of <=10 mmHg (NCT00877929)
Timeframe: Week 8

Interventionparticipants (Number)
Telmisartan 80 mg + Amlodipine 10 mg253
Amlodipine 10 mg214

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Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)

Number of patients that achieved a blood pressure (BP) goal of less than 130/85 in the first group (olmesartan monotherapy 20 mg). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level for an additional 4-9 weeks at the next medication level (NCT00890591)
Timeframe: 4 - 9 wks of olmesartan monotherapy

InterventionParticipants (Number)
Olmesartan Monotherapy38

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Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)

Number of patients that achieved a blood pressure goal of less than 130/85 in third titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide + amlodipine 5 mg). This combination was maintained as long as the participant's blood pressure remained within predefined parameters. If not, participant discontinued for lack of efficacy. (NCT00890591)
Timeframe: 4 - 9 weeks

InterventionParticipants (Number)
Olmesartan + Hydrochlorothiazide + Amlodipine12

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Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in First Titrated Group (Olmesartan 20 mg + 12.5 mg Hydrochlorothiazide)

Number of patients that achieved a blood pressure goal of less than 130/85 in first titrated group (olmesartan 20 mg + 12.5 mg hydrochlorothiazide)If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks (NCT00890591)
Timeframe: 4 to 9 weeks on combination therapy

InterventionParticipants (Number)
Olmesartan + Hydrochlorothiazide33

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Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)

Number of patients that achieved a blood pressure goal of less than 130/85 in second titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks. (NCT00890591)
Timeframe: 4 to 9 weeks

InterventionParticipants (Number)
Olmesartan + Hydrochlorothiazide41

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Change in Self-care Behavior Score From Baseline to Week 26

A modified self-care behavior tool (questionnaire) was used to calculate 2 domain scales: maintenance and confidence. Each domain has a standardized score between 0 and 100. Self-care is best represented by maintenance. Confidence is an important process that moderates the relationship between self-care and outcomes. Higher index score suggests better self-care. A score of 70 or greater can be used as the cut-point to judge self-care adequacy. (NCT00902304)
Timeframe: Baseline and week 26

,,
InterventionChange in score (Mean)
Maintenance scoreConfidence score (N = 422, 269, 520)
Combination (Initial Combination Therapy Arm)3.17-0.71
Monotherapy (Initial Monotherapy Arm)2.27-0.72
Usual Care2.590.93

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Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments

A comparison of the early responders was made based on the blood pressure measurements taken at the week 6 visit window according to gender and guideline targets. The guideline targets were: patients with renal impairment: 125/75 mmHg; patients with end-organ damage/cardiovascular disease: 130/80 mmHg; others: 140/90 mmHg. (NCT00902304)
Timeframe: 26 weeks

,,
InterventionParticipants (Number)
Male patients with a target of <125/75 mmHgMale patients with a target of <130/80 mmHgMale patients with a target of <140/90 mmHgFemale patients with a target of <125/75 mmHgFemale patients with a target of <130/80 mmHgFemale patients with a target of <140/90 mmHg
Combination (Initial Combination Therapy Arm)6344823442
Monotherapy (Initial Monotherapy Arm)314222511
Usual Care3273121618

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Number of Patients With Depression

Patients with depression refers to potential depressive symptoms, not clinically diagnosed depression. The 2 question Arrol screening tool was used to determine if the patient had potential depressive symptoms. The 2 questions are: During the last month have you often been bothered by feeling down, depressed or hopeless? During the past month have you often been bothered by little interest or pleasure in doing things? The presence of potential depressive symptoms was determined by a 'yes' answer to either of these questions. (NCT00902304)
Timeframe: Baseline and week 26

,,
Interventionparticipants (Number)
BaselineWeek 26
Combination (Initial Combination Therapy Arm)185151
Monotherapy (Initial Monotherapy Arm)9678
Usual Care154129

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Number of Patients With Major Clinical Endpoints

Major clinical endpoints measured were all-cause mortality and fatal and non-fatal cardiovascular events (e.g. acute myocardial infarction, stroke and heart failure). (NCT00902304)
Timeframe: 26 weeks

,,
Interventionparticipants (Number)
All-cause mortalityNon-fatal cardiovascular events
Combination (Initial Combination Therapy Arm)013
Monotherapy (Initial Monotherapy Arm)16
Usual Care015

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Participants With End Organ Disease at Baseline and Week 26

"A patient was considered to have end organ damage with either of the following: 1) proteinuria (dipstick = 1+ or more or protein/creatinine ratio > 30mg/mol or 24h urine protein > 0.3g); 2) no proteinuria, but presence of microalbuminuria (urine albumin/creatinine ratio 3.6 to 25mg/mol(male) or 3.6 to 35mg/mol (female) detected; 3) no proteinuria or microalbuminuria, but presence of macroalbuminuria (urine albumin/creatinine ratio > 25mg/mol(male) or >35mg/mol (female) detected OR 4) ECG evidence of LVH (Sokolow-Lyon voltage criteria values >= 38mm).~Baseline potential for end organ damage was calculated in all 1562 randomised patients based on the criteria outlined above. If no investigation/data available, assumed no end-organ damage.~It is important to note that given the limited number of ECGs at 26 weeks, between group comparisons should be limited to the two time points (baseline and 26 weeks)." (NCT00902304)
Timeframe: Baseline and week 26

,,
Interventionparticipants (Number)
BaselineWeek 26 (N = 433, 277, 536)
Combination (Initial Combination Therapy Arm)315177
Monotherapy (Initial Monotherapy Arm)14688
Usual Care226157

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Change in Mean Sitting Diastolic Blood Pressure

The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization. (NCT00902304)
Timeframe: Baseline and 26 weeks

InterventionmmHg (Least Squares Mean)
Usual Care-5.45
Monotherapy (Initial Monotherapy Arm)-6.9
Combination (Initial Combination Therapy Arm)-8.29

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Change in Absolute Cardiovascular Risk Score

"The absolute cardiovascular risk assessment uses the Framingham Risk Equation to predict risk of a cardiovascular event over the next 5 years. A score of <10% is a low risk, 10 to 15% is a moderate risk, and >15% is a high risk.~A decrease indicates improvement." (NCT00902304)
Timeframe: Baseline and 26 weeks

Interventionpercentage risk score change (Mean)
Usual Care-2.6
Monotherapy (Initial Monotherapy Arm)-3.3
Combination (Initial Combination Therapy Arm)-3.9

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Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26

"The CES-D score was from 0 to 30, with a higher score indicating a higher level of depression.~The categories for the score are: 0 to 9 suggests no depression; 10 to 15 suggests mild depression; 16 to 24 suggests moderate depression; 24 or above suggests severe depression." (NCT00902304)
Timeframe: Baseline and week 26

Interventionchange in CES-D score (Mean)
Usual Care1.03
Monotherapy (Initial Monotherapy Arm)-1.12
Combination (Initial Combination Therapy Arm)1.19

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Change in Mean Sitting Systolic Blood Pressure

The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization. (NCT00902304)
Timeframe: Baseline and 26 weeks

InterventionmmHg (Least Squares Mean)
Usual Care-10
Monotherapy (Initial Monotherapy Arm)-11.6
Combination (Initial Combination Therapy Arm)-14.4

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Change in the EQ-5D Score

The EQ-5D total indexed score (AUS) measures self-reported quality of life with the following 5 dimensions: mobility (range 1,2,3), self-care (range 1,2,3), usual activity (range 1,2,3), pain/discomfort (range 1,2,3) and anxiety/depression (range 1,2,3), where a 1 indicates no problems, a 2 indicates moderate problems, and a 3 indicates severe problems. The range of possible utility scores are between -0.217 (derived from worse responses from all 5 dimensions with severe problems ie 3,3,3,3,3) and 1.000 (no problems for all 5 dimensions) for each dimension. An increase in EQ-5D indexed score (AUS) indicates improvement. (NCT00902304)
Timeframe: Baseline and 26 weeks

Interventionchange in EQ-5D score (Mean)
Usual Care-0.007
Monotherapy (Initial Monotherapy Arm)0.017
Combination (Initial Combination Therapy Arm)0.011

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Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy

The rate of all adverse events by preferred terms as determined by the General Practice investigators to be related to study intervention therapy was reported. Percentage of adverse events was calculated based on the number of participants analyzed. 41 adverse events were not reported as inadequate information was supplied to allow determination of drug treatment at onset. (NCT00902304)
Timeframe: 26 weeks

Interventionparticipants (Number)
Usual Care70
Monotherapy (Initial Monotherapy Arm)70
Combination (Initial Combination Therapy Arm)169

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Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target

BP target groups were: <= 125/75mmHg, <= 130/80mmHg and <= 140/90mmHg. The BP target was based on the patient's clinical risk profile as specified by National Heart Foundation of Australia guidelines. (NCT00902304)
Timeframe: 26 weeks

Interventionpercentage of participants (Number)
Usual Care27.4
Monotherapy (Initial Monotherapy Arm)33.0
Combination (Initial Combination Therapy Arm)37.9

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Change in 24-hour Diastolic Blood Pressure (DBP) Assessed by 24-hour Ambulatory Blood Pressure Measurement (ABPM).

Three cuff blood pressure measurements were taken at each visit. (NCT00902538)
Timeframe: Baseline (8 weeks) to 16 weeks

Interventionmm Hg (Least Squares Mean)
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg-2.1
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5-4.0
OLM 40-AML 10-HCTZ 25-5.3

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Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.

Three cuff blood pressure measurements were taken at each visit. (NCT00902538)
Timeframe: Baseline (8 weeks) to 16 weeks

Interventionmm Hg (Least Squares Mean)
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg-1.9
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5-5.1
OLM 40-AML 10-HCTZ 25-6.6

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Change in Seated Diastolic Blood Pressure (SeDBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg

Three cuff blood pressure measurements were taken at each visit. (NCT00902538)
Timeframe: baseline (8 weeks) to 16 weeks

Interventionmm Hg (Least Squares Mean)
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg-6.1
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5-7.1
OLM 40-AML 10-HCTZ 25-8.9

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Change in Seated Systolic Blood Pressure (SeSBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg

Three cuff blood pressure measurements were taken at each visit. (NCT00902538)
Timeframe: baseline (8 weeks) to week 16

Interventionmm Hg (Least Squares Mean)
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg-6.9
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5-8.6
OLM 40-AML 10-HCTZ 25-10.5

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In Non-responders, the Change in 24-hour Diastolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.

In non-responders, the change in 24-hour diastolic blood pressure assessed by 24-hour ambulatory blood pressure measurement from the beginning to the end of Period 4. (NCT00902538)
Timeframe: Week 16 to week 32

Interventionmm Hg (Least Squares Mean)
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5-2.2
OLM 40-AML 10-HCTZ 25-4.4

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In Non-responders, the Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.

In non-responders, the change in 24-hour systolic blood pressure assessed by 24-hour ambulatory blood pressure measurement from the beginning to the end of Period 4. (NCT00902538)
Timeframe: Week 16 to week 32

Interventionmm Hg (Least Squares Mean)
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5-0.4
OLM 40-AML 10-HCTZ 25-4.3

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In Non-responders, the Change in Seated Systolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.

Change in seated systolic blood pressure from the beginning to the end of Period 4. Three cuff blood pressure measurements were taken at each visit. (NCT00902538)
Timeframe: week 24 to week 32

Interventionmm Hg (Least Squares Mean)
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)-5.5
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)-7.8

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Number of Subjects Achieving Blood Pressure (BP) Goal at Week 16.

Achieving blood pressure goal is defined as seated blood pressure <140/90 mm Hg; 130/80 mm Hg for participants with diabetes and/or other chronic renal and/or chronic cardiovascular disease. Three cuff blood pressure measurements were taken at each visit. (NCT00902538)
Timeframe: baseline (week 8) to week 16

InterventionParticipants (Number)
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg65
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.579
OLM 40-AML 10-HCTZ 25111

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In Non-responders, the Change in Seated Diastolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.

Change in seated diastolic blood pressure from the beginning to the end of Period 4. Three cuff blood pressure measurements were taken at each visit. (NCT00902538)
Timeframe: week 24 to week 32

Interventionmm Hg (Least Squares Mean)
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)-6.7
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)-7.9

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In Non-responders, the Number of Subject Meeting Their Blood Pressure Goals Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.

The number of non-responding participants who achieved their blood pressure goals at the end of Period 4. Achieving blood pressure goal is defined as seated blood pressure <140/90 mm Hg; 130/80 mm Hg for participants with diabetes and/or other chronic renal and/or chronic cardiovascular disease. Three cuff blood pressure measurements were taken at each visit. (NCT00902538)
Timeframe: week 24 to week 32

InterventionParticipants (Number)
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)31
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)89

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Change in Seated Diastolic Blood Pressure (SeDBP).

Baseline blood pressure was defined as the average values obtained at the randomization visit and at the visit prior to randomization (NCT00923091)
Timeframe: Baseline to week 10

Interventionmm HG (Least Squares Mean)
Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg-22.5
Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg-22.5
Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg-23.0
Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg-23.9
Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg-23.8
Olmesartan/Amlodipine 20mg/5mg-20.5
Olmesartan/Amlodipine 40mg/5mg-21.2
Olmesartan/Amlodipine 40mg/10mg-22.1

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Change in Seated Diastolic Blood Pressure From Week 22 to Week 26

(NCT00923091)
Timeframe: Week 22 to week 26

Interventionmm Hg (Least Squares Mean)
OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5-2.7
OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/25-3.8

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Change in Seated Systolic Blood Pressure (SeDBP) During Open-Label Period VI (Titration Effect From OM/AML/HCTZ 40/5/25 to 40/10/25.

(NCT00923091)
Timeframe: Week 26 to week 54

Interventionmm Hg (Mean)
OLM/AML/HCTZ 40/5/25 Titrated to 40/10/25-11.9

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Change in Seated Systolic Blood Pressure (SeDBP).

(NCT00923091)
Timeframe: Baseline to week 10

Interventionmm Hg (Least Squares Mean)
Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg-33.2
Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg-33.7
Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg-35.3
Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg-35.5
Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg-36.2
Olmesartan/Amlodipine 20mg/5mg-29.9
Olmesartan/Amlodipine 40mg/5mg-30.4
Olmesartan/Amlodipine 40mg/10mg-32.8

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Change in Seated Systolic Blood Pressure From Week 22 to Week 26

(NCT00923091)
Timeframe: Week 22 to week 26

Interventionmm Hg (Least Squares Mean)
OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5-4.5
OLM/AML/HCTZ40/5/12.5mg Nonresponders Randomized to 40/5/25-6.7

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Number of Subjects Reaching Blood Pressure Goal at Week 10

Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease. (NCT00923091)
Timeframe: baseline to week 10

InterventionParticipants (Number)
Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg177
Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg176
Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg197
Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg190
Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg179
Olmesartan/Amlodipine 20mg/5mg144
Olmesartan/Amlodipine 40mg/5mg155
Olmesartan/Amlodipine 40mg/10mg166

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Change in Seated Diastolic Blood Pressure From Week 18 to Week 22

(NCT00923091)
Timeframe: Week 18 to week 22

Interventionmm Hg (Least Squares Mean)
Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg-3.3
Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg-4.1

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Change in Seated Systolic Blood Pressure From Week 18 to Week 22

(NCT00923091)
Timeframe: Week 18 to week 22

Interventionmm Hg (Least Squares Mean)
Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg-5.7
Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg-6.5

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Number of Subjects Reaching Blood Pressure Goal at Week 26

Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease. (NCT00923091)
Timeframe: Week 22 to week 26

InterventionParticipants (Number)
OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.529
OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/2547

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Number of Subjects Reaching Blood Pressure Goal From Week 18 to Week 22

Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease. (NCT00923091)
Timeframe: Week 18 to week 22

InterventionParticipants (Number)
Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg63
Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg137

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Change in Mean Sitting Diastolic Blood Pressure After 6 Weeks

To compare the change from baseline in mean sitting diastolic blood pressure (MSDBP) after 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension. (NCT00931710)
Timeframe: Baseline to Week 6

,
InterventionmmHg (Mean)
BaselineWeek 6Change from Baseline to Week 6
Losartan/HCTZ97.688.5-9.1
Valsartan/Amlodipine/HCTZ98.685.1-13.6

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Change in Mean Sitting Systolic and Diastolic Blood Pressure After 12 Weeks

To compare the change from baseline in MSSBP and MSDBP after 12 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension. (NCT00931710)
Timeframe: Baseline to week 12

,
InterventionmmHg (Mean)
Baseline MSSBPWeek 12 MSSBPChange in MSSBP from baseline to Week 12Baseline MSDBPWeek 12 MSDBPChange in MSDBP from baseline to Week 12
Losartan/HCTZ168.5134.3-34.297.682.5-15.1
Valsartan/Amlodipine/HCTZ166.8130.8-36.098.682.5-16.1

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Change in Mean Sitting Systolic Blood Pressure After 6 Weeks

To compare the change from baseline in mean sitting systolic blood pressure (MSSBP) after 6 weeks of valsartan/amlodipine-based regimen with a losartan-based regimen in patients with Stage 2 systolic hypertension. (NCT00931710)
Timeframe: Baseline to Week 6

,
InterventionmmHg (Mean)
BaselineWeek 6Change from Baseline to Week 6
Losartan/HCTZ168.5142.5-26.0
Valsartan/Amlodipine/HCTZ166.8135.5-31.3

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Cumulative Percentage of Treatment Responders

To compare the percentage of treatment responders (defined as patients with MSSBP < 140 mmHg or demonstrating a decrease from baseline of ≥ 20 mmHg) after 3 and 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension. (NCT00931710)
Timeframe: 3 and 6 weeks

,
InterventionCumulative percentage of responders (Number)
Week 3Week 6
Losartan/HCTZ34.371.5
Valsartan/Amlodipine/HCTZ65.387.0

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Cumulative Percentage of Patients Achieving Blood Pressure Control

To compare the percentage of patients achieving blood pressure control (defined as patients achieving MSSBP < 140 mmHg and MSDBP < 90 mmHg) after 3 and 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension. (NCT00931710)
Timeframe: 3 and 6 weeks

,
Interventioncumulative percentage of patients (Number)
Week 3Week 6
Losartan/HCTZ15.347.1
Valsartan/Amlodipine/HCTZ30.561.5

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Cumulative Percentage of Patients With Incidence of Peripheral Edema Before or at the Corresponding Visit

To assess the incidence of peripheral edema occurring with valsartan/amlodipine-based regimen versus losartan-based regimen in patients with Stage 2 systolic hypertension. (NCT00931710)
Timeframe: 3, 6, 9 and 12 weeks

,
Interventioncumulative percentage of patients (Number)
Week 3Week 6Week 9Week 12
Losartan/HCTZ0.80.80.84.5
Valsartan/Amlodipine/HCTZ0.80.81.32.9

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Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 2 and Week 4

Secondary objective at additional timepoint. (NCT00942994)
Timeframe: Baseline, Week 2 and Week 4

,
InterventionmmHg (Mean)
Baseline [N=202, 209]Week 2 [N=197, 209]Change from baseline to week 2 [N=197, 209]Week 4 [N=197, 209]Change from baseline to week 4 [N=197, 209]
Aliskiren / Amlodipine95.2586.24-9.0185.35-9.91
Aliskiren / Amlodipine / HCTZ95.2584.26-10.9581.29-13.92

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Percentage of Responders (Defined as Patients With MSSBP < 140 mmHg or a Reduction From Baseline in MSSBP of ≥20 mmHg) During 8 Weeks.

To compare the cumulative percentage of responders (defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension. Cumulative refers to achieving a response before or at the corresponding visit. (NCT00942994)
Timeframe: 8 weeks

,
InterventionPercentage of Responders (Number)
Week 2Week 4Week 8
Aliskiren / Amlodipine72.284.791.9
Aliskiren / Amlodipine / HCTZ79.291.192.6

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Percentage of Patients Achieving Blood Pressure Control (Defined as MSSBP < 140 mmHg and MSDBP < 90 mmHg) During 8 Weeks

To evaluate the cumulative percentage of patients achieving Blood Pressure control (defined as patients achieving an MSSBP <140 mmHg and MSDBP <90 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension. Cumulative refers to achieving BP control before or at the corresponding visit. (NCT00942994)
Timeframe: 8 weeks

,
InterventionPercentage of Participants (Number)
Week 2Week 4Week 8
Aliskiren / Amlodipine40.257.467.9
Aliskiren / Amlodipine / HCTZ50.574.881.7

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Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8

To evaluate change from baseline in MSSBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension. (NCT00942994)
Timeframe: Baseline and week 8

,
InterventionmmHg (Mean)
Baseline [N=202, 209]Week 8 [N=197, 209]Change from baseline to week 8 [N=197, 209]
Aliskiren / Amlodipine167.41137.87-29.54
Aliskiren / Amlodipine / HCTZ167.08130.73-36.43

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Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 and Week 4

Primary objective at additional timepoint. (NCT00942994)
Timeframe: Baseline, Week 2 and Week 4

,
InterventionmmHg (Mean)
Baseline [N=202, 209]Week 2 [N=197, 209]Change from baseline to week 2 [N=197, 209]Week 4 [N=197, 209]Change from baseline to week 4 [N=197, 209]
Aliskiren / Amlodipine167.41143.77-23.64140.43-26.98
Aliskiren / Amlodipine / HCTZ167.08138.35-28.81132.42-34.74

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Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8

To evaluate change from baseline in MSDBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension. (NCT00942994)
Timeframe: Baseline and week 8

,
InterventionmmHg (Mean)
Baseline [N=202, 209]Week 8 [N=197, 209]Change from baseline to week 8 [N=197, 209]
Aliskiren / Amlodipine95.2583.17-12.08
Aliskiren / Amlodipine / HCTZ95.2580.10-15.10

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Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint

Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSSBP as a covariate (NCT01001572)
Timeframe: Baseline and Week 8

InterventionmmHg (Least Squares Mean)
Valsartan/Amlodipine 160/5 mg-14.9
Valsartan 160 mg-7.0

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Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint

The percentage of participants with a Diastolic Blood Pressure Response defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) < 90 mmHg or a >= 10 mmHg reduction from baseline. (NCT01001572)
Timeframe: Baseline and Week 8

InterventionPercentage of Participants (Number)
Valsartan/Amlodipine 160/5 mg70.1
Valsartan 160 mg52.6

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Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint

The percentage of participants with Overall Blood Pressure Control defined as the percentage of participants with a Mean Sitting Systolic Blood Pressure (MSSBP)/Mean Sitting Diastolic Blood Pressure (MSDBP) < 140/90 mmHg. (NCT01001572)
Timeframe: Week 8

InterventionPercentage of Participants (Number)
Valsartan/Amlodipine 160/5 mg61.3
Valsartan 160 mg39.3

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Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint

The percentage of participants with Diastolic Blood Pressure Control defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) < 90 mmHg. (NCT01001572)
Timeframe: Week 8

InterventionPercentage of Participants (Number)
Valsartan/Amlodipine 160/5 mg65.9
Valsartan 160 mg50.8

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Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint

Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSDBP as a covariate. (NCT01001572)
Timeframe: Baseline and Week 8

InterventionmmHg (Least Squares Mean)
Valsartan/Amlodipine 160/5 mg-10.3
Valsartan 160 mg-6.6

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Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast), Area Under the Plasma Concentration-Time Curve to Infinity (AUCinf)

"AUC last = Area under the concentration versus time curve from zero time until the last measurable concentration is calculated using the trapezoidal rule.~AUCinf = AUClast + (Ct / kel), where Ct is the estimated concentration at the last measurable concentration." (NCT01004614)
Timeframe: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

,,,
Interventionng*h/mL (Mean)
AUClastAUCinf
Cohort I: 2nd OD Tablet (Reference) With Water127.36145.22
Cohort I: 3rd OD Tablet (Test) With Water124.14142.87
Cohort II: 2nd OD Tablet (Reference) Without Water118.27138.14
Cohort II: 3rd OD Tablet (Test) Without Water121.05140.41

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Time to Reach Maximum Observed Plasma Concentration (Tmax)

(NCT01004614)
Timeframe: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

Interventionhour (Median)
Cohort I: 3rd OD Tablet (Test) With Water8
Cohort I: 2nd OD Tablet (Reference) With Water8
Cohort II: 3rd OD Tablet (Test) Without Water8
Cohort II: 2nd OD Tablet (Reference) Without Water8

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Mean Residence Time (MRT)

MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from zero time to infinity calculated as AUMCinf = AUMCt + ((t x Ct) / kel) + (Ct / kel^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method. (NCT01004614)
Timeframe: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

Interventionhour (Mean)
Cohort I: 3rd OD Tablet (Test) With Water61.29
Cohort I: 2nd OD Tablet (Reference) With Water59.77
Cohort II: 3rd OD Tablet (Test) Without Water66.18
Cohort II: 2nd OD Tablet (Reference) Without Water67.33

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Maximum Observed Plasma Concentration (Cmax)

(NCT01004614)
Timeframe: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

Interventionng/mL (Mean)
Cohort I: 3rd OD Tablet (Test) With Water2.70
Cohort I: 2nd OD Tablet (Reference) With Water2.74
Cohort II: 3rd OD Tablet (Test) Without Water2.48
Cohort II: 2nd OD Tablet (Reference) Without Water2.45

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Apparent Terminal Elimination Half-Life (T-half)

Terminal phase half-life calculated as ln(2) / kel (NCT01004614)
Timeframe: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

Interventionhour (Mean)
Cohort I: 3rd OD Tablet (Test) With Water41.45
Cohort I: 2nd OD Tablet (Reference) With Water40.27
Cohort II: 3rd OD Tablet (Test) Without Water45.04
Cohort II: 2nd OD Tablet (Reference) Without Water46.20

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Apparent Terminal Elimination Phase Rate Constant (Kel)

Estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile. (NCT01004614)
Timeframe: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

InterventionL/h (Mean)
Cohort I: 3rd OD Tablet (Test) With Water0.0174
Cohort I: 2nd OD Tablet (Reference) With Water0.0179
Cohort II: 3rd OD Tablet (Test) Without Water0.0162
Cohort II: 2nd OD Tablet (Reference) Without Water0.0156

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Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt)

Area under the concentration-time curve from zero time until the last sampling time (NCT01004614)
Timeframe: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

Interventionng*h/mL (Mean)
Cohort I: 3rd OD Tablet (Test) With Water126.36
Cohort I: 2nd OD Tablet (Reference) With Water129.48
Cohort II: 3rd OD Tablet (Test) Without Water122.33
Cohort II: 2nd OD Tablet (Reference) Without Water119.75

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Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up

This variable gives the proportion of patients reaching blood pressure control over time (< 140 mmHg systolic and < 90 mmHg diastolic) (NCT01030458)
Timeframe: 6 months follow-up after randomization

Interventionparticipants (Number)
Amlodipine Plus Valsartan58
Hydrochlorothiazide Plus Bisoprolol40

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Time to Blood Pressure Control

The time (in weeks) after randomisation that will be required to reach and maintain the target, defined as a blood pressure below 140 mmHg systolic and 90 mmHg diastolic. (NCT01030458)
Timeframe: 6 months follow-up after randomization

Interventionweeks (Median)
Amlodipine Plus Valsartan12
Hydrochlorothiazide Plus Bisoprolol18

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Sitting Systolic Blood Pressure on Automated Measurement

Blood pressure is measured by means of validated oscillometric OMRON 705IT recorders (OMRON Healthcare Europe BV, Nieuwegein, Netherlands), after the patient has been seated for 5 minutes in a quiet room, according to the ESC/ESH guidelines. Three consecutive blood pressure readings are obtained and the average of these 3 measurements is used as the primary outcome. (NCT01030458)
Timeframe: 6 months follow-up after randomization

InterventionmmHg (Mean)
Amlodipine Plus Valsartan127.2
Hydrochlorothiazide Plus Bisoprolol134.1

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Side-effects to Study Medications

(NCT01030458)
Timeframe: 6 months follow-up after randomization

Interventionparticipants (Number)
Amlodipine Plus Valsartan1
Hydrochlorothiazide Plus Bisoprolol1

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Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) From Office Blood Pressure Measurement

Two arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in mean sitting diastolic blood pressure (msDBP) was calculated comparing the Week 8 readings to the readings taken at Baseline. (NCT01070043)
Timeframe: Baseline and 8 weeks

,
InterventionmmHg (Mean)
Baseline8 weeksChange from baseline to 8 weeks
Amlodipine 5 mg/Valsartan 80 mg92.1282.29-9.83
Valsartan 160 mg89.9886.73-2.65

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Number of Participants With Adverse Events During Double-blind Phase

(NCT01070043)
Timeframe: 8 weeks

,
InterventionParticipants (Number)
Total AEAt least one AEAE Not related to drug
Amlodipine 5 mg/Valsartan 80 mg979
Valsartan 160 mg151115

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Change From Baseline in Mean Systolic Blood Pressure (mSBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours

Validated automated ambulatory blood pressure monitors were dispensed to participants with instructions on correct use. Automated blood pressure readings were obtained every 15-30 minutes during waking hours and every 30-60 minutes during sleep for a total of 24 hours. The change in mean systolic blood pressure (mSBP) over 24 hours was measured from baseline to 8 weeks of treatment during the double-blind phase. (NCT01070043)
Timeframe: Baseline and 8 weeks

,
InterventionmmHg (Mean)
Baseline8 weeksChange from baseline to 8 weeks
Amlodipine 5 mg/Valsartan 80 mg144.38129.67-14.71
Valsartan 160 mg139.76131.11-6.39

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Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) From Office Blood Pressure Measurement

Two arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in mean sitting systolic blood pressure (msSBP) was calculated comparing the Week 8 readings to the readings taken at baseline. (NCT01070043)
Timeframe: Baseline and 8 weeks

,
InterventionmmHg (Mean)
Baseline8 weeksChange from baseline to 8 weeks
Amlodipine 5 mg/Valsartan 80 mg150.26133.79-16.48
Valsartan 160 mg141.14133.68-7.23

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Change From Baseline in Mean Diastolic Blood Pressure (mDBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours After 8 Weeks of Treatment During the Double-blind Phase

Validated automated ambulatory blood pressure monitors were dispensed to participants with instructions on correct use. Automated blood pressure readings were obtained every 15-30 minutes during waking hours and every 30-60 minutes during sleep for a total of 24 hours. The change in mean diastolic blood pressure (mDBP) over 24 hours was measured from baseline to 8 weeks of treatment during the double-blind. (NCT01070043)
Timeframe: Baseline and 8 weeks

,
InterventionmmHg (Mean)
Baseline8 weeksChange from baseline to 8 weeks
Amlodipine 5 mg/Valsartan 80 mg86.9579.29-7.67
Valsartan 160 mg87.9082.94-3.56

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DBP and SBP Control and Response After 8 Weeks of Treatment

DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg. (NCT01103960)
Timeframe: Baseline and 8 weeks

,
InterventionNumber of participants (Number)
DBP controlSBP controlDBP responseSBP response
A5 Alone85100101120
T80/A5112119124131

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Number of Patients in Blood Pressure Categories Over Time

BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg. (NCT01103960)
Timeframe: 8 weeks

,
InterventionNumber of participants (Number)
BP optimalBP normalBP high-normalGrade 1 hypertensionGrade 2 hypertensionGrade 3 hypertension
A5 Alone7333269153
T80/A51136534852

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Number of Patients in Blood Pressure Categories at 4 Weeks

BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg. (NCT01103960)
Timeframe: 4 weeks

,
InterventionNumber of participants (Number)
BP optimalBP normalBP high-normalGrade 1 hypertensionGrade 2 hypertensionGrade 3 hypertension
A5 Alone1203581175
T80/A57264462151

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Change From Baseline in SBP After 4 Weeks of Treatment

Seated trough SBP after 4 weeks. (NCT01103960)
Timeframe: Baseline and 4 weeks

InterventionmmHg (Mean)
A5 Alone-8.19
T80/A5-12.10

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DBP and SBP Control and Response After 4 Weeks of Treatment

DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg. (NCT01103960)
Timeframe: Baseline and 4 weeks

,
InterventionNumber of participants (Number)
DBP controlSBP controlDBP responseSBP response
A5 Alone719187108
T80/A595103108124

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Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG.

Clinically relevant abnormalities for Physical examination, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. (NCT01103960)
Timeframe: From drug administration until end of treatment plus one day

,
Interventionparticipants (Number)
Atrial fibrilationMyocardial ischaemiaBlood glucose increasedProtein urine presentAlanine aminotransferase increasedBlood creatinine phosphokinase increasedBlood creatinine increasedBlood glucose abnormalHeart rate increased
A5 Alone011201010
T80/A5104110111

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Change From Baseline in DBP After 4 Weeks of Treatment

Seated trough DBP after 4 weeks. (NCT01103960)
Timeframe: Baseline and 4 weeks

InterventionmmHg (Mean)
A5 Alone-7.51
T80/A5-9.41

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Change From Baseline in DBP After 8 Weeks of Treatment

Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint. (NCT01103960)
Timeframe: Baseline and 8 weeks

InterventionmmHg (Least Squares Mean)
A5 Alone-10.19
T80/A5-12.38

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Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients

Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint. (NCT01103960)
Timeframe: Baseline and 8 weeks

InterventionmmHg (Least Squares Mean)
A5 Alone-8.85
T80/A5-10.77

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Change From Baseline in SBP After 8 Weeks of Treatment

Seated trough SBP after 8 weeks or LOCF. Analysis will be adjusted for treatment, country, and baseline measurement of endpoint. (NCT01103960)
Timeframe: Baseline and 8 weeks

InterventionmmHg (Least Squares Mean)
A5 Alone-11.66
T80/A5-16.15

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Risk Factors for the Proportion of Responders for Hypertension -Complications.

Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypertension. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Without Complications527
With Complications624

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Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension.

The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results for Hypertension. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Amlodipine and Atorvastatin Combination Tablet1151

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Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia.

The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results for Hypercholesterolemia or Familial Hypercholesterolemia. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Amlodipine and Atorvastatin Combination Tablet1034

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Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris.

The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and enteterd the results for Angina Pectoris. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Amlodipine and Atorvastatin Combination Tablet163

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Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity.

"Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypertension severity, ClassⅠ, ClassⅡ, or ClassⅢ is significant risk factor for Hypertension. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension)." (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
ClassⅠ615
ClassⅡ325
ClassⅢ85

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Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction.

Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypertension. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Without Renal Dysfunction1036
With Renal Dysfunction102

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Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction.

Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypertension. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Without Hepatic Dysfunction1008
With Hepatic Dysfunction131

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Risk Factors for the Proportion of Responders for Hypertension -Gender.

Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypertension. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Male415
Female736

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Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs.

Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypertension. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Without Concomitant Drugs339
With Concomitant Drugs812

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Risk Factors for the Proportion of Responders for Hypertension -Age.

Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Hypertension. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
<65 Years347
>=65 Years804

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Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction.

Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Without Renal Dysfunction937
With Renal Dysfunction88

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Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction.

Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Without Hepatic Dysfunction904
With Hepatic Dysfunction122

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Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender.

Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Male380
Female654

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Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications.

Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Without Complications482
With Complications552

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Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age.

Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
<65 Years305
>=65 Years729

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Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction.

Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Angina Pectoris. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Without Renal Dysfunction137
With Renal Dysfunction25

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Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction.

Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Angina Pectoris. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Without Hepatic Dysfunction145
With Hepatic Dysfunction18

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Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs.

Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Angina Pectoris. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Without Concomitant Drugs22
With Concomitant Drugs141

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Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type.

"Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypercholesterolemia expression type, Ⅰ, Ⅱa, Ⅱb, Ⅲ, Ⅳ, or Ⅴ is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. Hypercholesterolemia expression types are defined by Japan Atherosclerosis Society Guideline for Prevention of Atherosclerosis Cardiovascular Diseases." (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Type Ⅰ13
Type Ⅱa533
Type Ⅱb180
Type Ⅲ10
Type Ⅳ5

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Risk Factors for the Proportion of Responders for Angina Pectoris -Complications.

Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Angina Pectoris is significant risk factor for Angina Pectoris. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Without Complications57
With Complications106

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Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs.

Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Without Concomitant Drugs306
With Concomitant Drugs728

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Risk Factors for the Proportion of Responders for Angina Pectoris -Gender.

Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Angina Pectoris. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Male75
Female88

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Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity.

"Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Angina Pectoris functional classification Severity, Class1, Class2, Class3, or Class4 is significant risk factor for Angina Pectoris. Angina Pectoris functional classification Severity is defined by Canadian Cardiovascular Society functional Classification of Angina." (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
Class1122
Class211
Class32
Class41

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Risk Factors for the Proportion of Responders for Angina Pectoris -Age.

Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Angina Pectoris. (NCT01107743)
Timeframe: 8 weeks

Interventionparticipants (Number)
<65 Years45
>=65 Years118

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Change in the Growth Rate of Abdominal Aortic Aneurysm

Aneurysm growth rate over 2 years, estimated from the sequential AAA diameter measurements (external diameter measured in the longitudinal plane). (NCT01118520)
Timeframe: Annual rate over the entire period of 24 month

Interventionmm (Least Squares Mean)
Perindopril1.77
Amlodipine1.81
Placebo1.66

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TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral SBP After A Single Dose of Treatment

Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Single dose effects on peripheral SBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period. (NCT01130168)
Timeframe: Baseline (0 hrs), 12 hours post-dose (Day 1)

Interventionmm mercury (Hg) (Least Squares Mean)
ISMN ER-12.1
Amlodipine-3.1
Placebo1.7

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Change From Baseline (0 Hours) to Week 4 in Central DBP After Multiple Doses of Treatment

Central DBP was measured by the SphygmoCor® device. Central DBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline. (NCT01130168)
Timeframe: Baseline (0 hrs), 24 hours after the Day 28 dose

Interventionmm mercury (Hg) (Least Squares Mean)
ISMN ER-0.7
Amlodipine-7.7
Placebo1.1

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Change From Baseline (0 Hours) to Week 4 in Central SBP After Multiple Doses of Treatment

Central SBP was measured by the SphygmoCor® device. Central SBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline. (NCT01130168)
Timeframe: Baseline (0 hrs), 24 hours after the Day 28 dose

Interventionmm mercury (Hg) (Least Squares Mean)
ISMN ER-0.7
Amlodipine-12.9
Placebo3.2

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Change From Baseline (0 Hours) to Week 4 in Heart-Rate-Corrected AIx After Multiple Doses of Treatment

"The augmentation index (AIx) is a measure of systemic arterial stiffness, and is the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows:~HR-corrected AIx = -0.39 x (75 - HR) + AIx. This value was used for all AIx analyses." (NCT01130168)
Timeframe: Baseline (0 hrs), 24 hours after the Day 28 dose

Interventionpercent (Least Squares Mean)
ISMN ER2.5
Amlodipine-4.7
Placebo1.2

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Change From Baseline (0 Hours) to Week 4 in Peripheral DBP After Multiple Doses of Treatment

Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Peripheral DBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline. (NCT01130168)
Timeframe: Baseline (0 hrs), 24 hours after the Day 28 dose

Interventionmm mercury (Hg) (Least Squares Mean)
ISMN ER-1.4
Amlodipine-7.5
Placebo1.0

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Change From Baseline (0 Hours) to Week 4 in Peripheral SBP After Multiple Doses of Treatment

Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Peripheral SBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline. (NCT01130168)
Timeframe: Baseline (0 hrs), 24 hours after the Day 28 dose

Interventionmm mercury (Hg) (Least Squares Mean)
ISMN ER-0.6
Amlodipine-11.4
Placebo3.9

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Time-weighted Average (TWA) Change From Baseline (0 Hours) to 12 Hours in Heart-Rate-Corrected Augmentation Index (AIx) After A Single Dose of Treatment

"The augmentation index (AIx) is a measure of systemic arterial stiffness, and is the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Single dose effects on AIx were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows:~HR-corrected AIx = -0.39 x (75 - HR) + AIx. This value was used for all AIx analyses." (NCT01130168)
Timeframe: Baseline (0 hrs), 12 hours post-dose (Day 1)

Interventionpercent (Least Squares Mean)
ISMN ER-11.1
Amlodipine-0.7
Placebo2.1

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TWA Change From Baseline (0 Hours) to 12 Hours in Central Diastolic Blood Pressure (DBP) After A Single Dose of Treatment

Central DBP was measured by the SphygmoCor® device. Single dose effects on central DBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period. (NCT01130168)
Timeframe: Baseline (0 hrs), 12 hours post-dose (Day 1)

Interventionmm mercury (Hg) (Least Squares Mean)
ISMN ER-8.2
Amlodipine-2.1
Placebo1.1

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TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral DBP After A Single Dose of Treatment

Peripheral DBP was measured by Brachial Sphygmomanometer (standard cuff). Single dose effects on peripheral DBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period. (NCT01130168)
Timeframe: Baseline (0 hrs), 12 hours post-dose (Day 1)

Interventionmm mercury (Hg) (Least Squares Mean)
ISMN ER-8.0
Amlodipine-2.0
Placebo1.0

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TWA Change From Baseline (0 Hours) to 12 Hours in Central Systolic Blood Pressure (SBP) After A Single Dose of Treatment

Central SBP was measured by the SphygmoCor® device. Single dose effects on central SBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period. (NCT01130168)
Timeframe: Baseline (0 hrs), 12 hours post-dose (Day 1)

Interventionmm mercury (Hg) (Least Squares Mean)
ISMN ER-14.7
Amlodipine-3.6
Placebo2.7

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Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements.

Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg. (NCT01134393)
Timeframe: 12 weeks

InterventionPercentage of participants (Number)
T80/A567.6

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BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM).

Achieving BP control with HBPM is defined as SBP<135 mmHg and DBP<85 mmHg. (NCT01134393)
Timeframe: Week 12

InterventionNumber of participants (Number)
MorningEvening
T80/A5179172

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BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements.

Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg. (NCT01134393)
Timeframe: 4 and 8 weeks

InterventionNumber of participants (Number)
Week 4Week 8
T80/A5262330

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Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate

Pulse pressure was not analysed for this study instead pulse rate was analysed at weeks 4, 8 and 12. (NCT01134393)
Timeframe: weeks 4, 8 and 12

Interventionbpm (Mean)
Change at week 4 (N=482)Change at week 8 (N=463)Change at week 12 (N=344)
T80/A51.430.320.51

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Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP

(NCT01134393)
Timeframe: weeks 4, 8 and 12

InterventionmmHg (Mean)
Change at week 4 SBP (N=485)Change at week 8 SBP (N=487)Change at week 12 SBP (N=487)Change at week 4 DBP (N=485)Change at week 8 DBP (N=487)Change at week 12 DBP (N=487)
T80/A5-13.58-16.37-16.92-8.24-10.33-10.43

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DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements

DBP control: DBP <85 mmHg, SBP control: SBP <135 mmHg, DBP response: DBP <85 mmHg or a reduction from baseline >=10 mmHg, SBP response: SBP <135 mmHg or a reduction from baseline >= 15 mmHg (NCT01134393)
Timeframe: weeks 4, 8 and 12

InterventionNumber of participants (Number)
DBP control morning at week 4DBP control morning at week 8DBP control morning at week 12DBP control evening at week 4DBP control evening at week 8DBP control evening at week 12SBP control morning at week 4SBP control morning at week 8SBP control morning at week 12SBP control evening at week 4SBP control evening at week 8SBP control evening at week 12DBP response morning at week 4 (N=354)DBP response morning at week 8 (N=354)DBP response morning at week 12 (N=354)DBP response evening at week 4 (N=354)DBP response evening at week 8 (N=354)DBP response evening at week 12 (N=354)SBP response morning at week 4 (N=299)SBP response morning at week 8 (N=299)SBP response morning at week 12 (N=299)SBP response evening at week 4 (N=299)SBP response evening at week 8 (N=299)SBP response evening at week 12 (N=299)
T80/A5256242252272247263204198206204183190256242252272247263204198206204183190

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Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time

(NCT01134393)
Timeframe: weeks 4 and 8

InterventionNumber of participants (Number)
Week 4 (n=482)Week 8 (n=284)
T80/A518646

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Percentage of Patients in Blood Pressure Categories Over Time

BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg. (NCT01134393)
Timeframe: weeks 4, 8 and 12

InterventionPercentage of participants (Number)
BP optimal at week 4 (N=482)BP normal at week 4 (N=482)BP high-normal at week 4 (N=482)Grade 1 hypertension at week 4 (N=482)Grade 2 hypertension at week 4 (N=482)Grade 3 hypertension at week 4 (N=482)BP optimal at week 8 (N=487)BP normal at week 8 (N=487)BP high-normal at week 8 (N=487)Grade 1 hypertension at week 8 (N=487)Grade 2 hypertension at week 8 (N=487)Grade 3 hypertension at week 8 (N=487)BP optimal at week 12 (N=487)BP normal at week 12 (N=487)BP high-normal at week 12 (N=487)Grade 1 hypertension at week 12 (N=487)Grade 2 hypertension at week 12 (N=487)Grade 3 hypertension at week 12 (N=487)
T80/A54.119.730.539.06.20.45.522.240.027.74.30.24.528.535.527.14.10.2

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DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements

DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg. (NCT01134393)
Timeframe: weeks 4, 8 and 12

InterventionNumber of participants (Number)
Week 4 DBP controlWeek 8 DBP controlWeek 12 DBP controlWeek 4 SBP controlWeek 8 SBP controlWeek 12 SBP controlWeek 4 DBP responseWeek 8 DBP responseWeek 12 DBP responseWeek 4 SBP responseWeek 8 SBP responseWeek 12 SBP response
T80/A5313368373247305311329393399337388393

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Time to Reach Maximum Observed Plasma Concentration (Tmax)

(NCT01138826)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose

Interventionhr (Median)
Amlodipine 10mg Tablet With Water (Reference Product A)8.00
Amlodipine 10 mg ODT With Water (Test Product B)10.00
Amlodipine 10 mg ODT Without Water (Test Product C)13.00

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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]

AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). (NCT01138826)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose

Interventionhr*ng/mL (Geometric Mean)
Amlodipine 10mg Tablet With Water (Reference Product A)307.225
Amlodipine 10 mg ODT With Water (Test Product B)324.324
Amlodipine 10 mg ODT Without Water (Test Product C)330.411

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AUC From Time Zero to Last Quantifiable Concentration (AUClast)

Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast). (NCT01138826)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose

Interventionhr*ng/mL (Geometric Mean)
Amlodipine 10mg Tablet With Water (Reference Product A)275.302
Amlodipine 10 mg ODT With Water (Test Product B)285.974
Amlodipine 10 mg ODT Without Water (Test Product C)287.035

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Maximum Observed Plasma Concentration (Cmax)

(NCT01138826)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose

Interventionng/mL (Geometric Mean)
Amlodipine 10mg Tablet With Water (Reference Product A)5.201
Amlodipine 10 mg ODT With Water (Test Product B)5.117
Amlodipine 10 mg ODT Without Water (Test Product C)4.952

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Plasma Decay Half-Life (t1/2)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. (NCT01138826)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose

Interventionhr (Mean)
Amlodipine 10mg Tablet With Water (Reference Product A)44.004
Amlodipine 10 mg ODT With Water (Test Product B)46.698
Amlodipine 10 mg ODT Without Water (Test Product C)49.869

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Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks)

The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher msDBP was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis. (NCT01167153)
Timeframe: Baseline, 12 weeks

Interventionmm Hg (Mean)
Valsartan/Amlodipine-8.5
Nifedipine-4.8

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Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks)

The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher mean sitting diastolic blood pressure (MSDBP) was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis. (NCT01167153)
Timeframe: Baseline, 12 weeks

Interventionmm Hg (Mean)
Valsartan/Amlodipine-16.8
Nifedipine-10.6

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Change From Baseline in Sitting Pulse at 12 Weeks

Sitting pulse was measured by sphygmomanometer after subject sat for 5 minutes at clinic during each visit. (NCT01167153)
Timeframe: Baseline, 12 weeks

Interventionbeats/min (Mean)
Valsartan/Amlodipine-1.1
Nifedipine0.0

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Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks)

"Effective SBP control rate was defined as proportion of subjects in whom MSSBP < 140 mmHg or MSSBP reduction ≥ 20 mmHg from baseline.~Effective DBP control rate was defined as proportion of subjects in whom MSDBP < 90 mmHg or MSDBP reduction ≥10 mmHg from baseline." (NCT01167153)
Timeframe: Baseline, 12 weeks

,
InterventionPercentage of participants (Number)
Achieving Effective SBP ControlAchieving Effective DBP Control
Nifedipine63.4076.98
Valsartan/Amlodipine82.4092.88

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Change From Baseline in Orthostatic SBP and DBP at 12 Weeks

The arm with higher sitting blood pressure was selected for all examinations throughout the study. Orthostatic blood pressure was measured when subject stood for 1 minute. Orthostatic blood pressures were measured at screening and each visit. (NCT01167153)
Timeframe: Baseline, 12 weeks

,
Interventionmm Hg (Mean)
Orthostatic diastolic blood pressureOrthostatic systolic blood pressure
Nifedipine-3.3-8.6
Valsartan/Amlodipine-7.2-13.3

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Change From Baseline in Orthostatic Pulse at 12 Weeks

Orthostatic pulse was measured by sphygmomanometer when subject stood for 1 minute at clinic during each visit. (NCT01167153)
Timeframe: Baseline, 12 weeks

Interventionbeats/min (Mean)
Valsartan/Amlodipine-0.6
Nifedipine0.4

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Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks

Blood Pressure (BP) target was defined as mean sitting BP<140/90 mm Hg in non-diabetic patients and<130/80 mm Hg in diabetic patients at 12 weeks. (NCT01167153)
Timeframe: 12 weeks

InterventionPercentage of participants (Number)
Valsartan/Amlodipine79.03
Nifedipine57.36

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Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson)

Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson) (NCT01176032)
Timeframe: Baseline, Week 36

,
InterventionPercent (Mean)
LV ejection fraction Teicholz(n=29,36)LV ejection fraction Simpson(n=22,34)
Aliskiren0.000.02
Lostaran0.010.00

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Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs

The rate of use of first and second antihypertensive rescue drugs added was also assessed at all visits after week 2. The rescue drug at week 10 and 18 for those patients not achieving the required BP was amlodipine, Patients who did not achieve the required BP at week 26 were treated with hydrochlorothiazide (NCT01176032)
Timeframe: Baseline, Week 10,18,26

,
InterventionPatients (Number)
Baseline, Week 10 (amlodipine)Baseline, Week 18 (amlodipine)Baseline, Week 26 (hydrochlorothiazide)
Aliskiren1122
Lostaran1594

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Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline

The control rate was defined as the proportion of patients with SBP < 140 mmHg and DBP < 90 mmHg compared to baseline (NCT01176032)
Timeframe: Week10,18,26,36

,
InterventionPatients (Number)
Control rate at Week 10Control rate at Week 18Control rate at Week 26Control rate at Week 36
Aliskiren15202221
Lostaran13192320

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Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate

Response rate was defined as the proportion of patients with a satisfactory systolic BP response (SBP < 140 mmHg or reduction of ≥ 10 mmHg compared to baseline) and a satisfactory diastolic BP response (DBP < 90 mmHg or reduction of ≥ 5 mmHg compared to baseline) (NCT01176032)
Timeframe: Baseline, Week10,18,26,36

,
InterventionPatients (Number)
Baseline, Week 10Baseline, Week 18Baseline, Week 26Baseline, Week 36
Aliskiren16242422
Lostaran15212725

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Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine

Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule (NCT01176032)
Timeframe: Baseline, Week 36

,,,
Interventionml (Mean)
LV end-diastolic volume (n=11,11,15,19)LV end-systolic volume (n=11,11, 15,19)
Aliskiren6.60-2.93
Aliskiren + Amlodipinet-2.001.09
Losartan5.016.11
Losartan + Amlodipine-2.98-3.69

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Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease

The plasma level of biomarker parameter (aldosterone (Aldo)) used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI) (NCT01176032)
Timeframe: Baseline, Week 36

Interventionng/dl (Mean)
Aliskiren-1.81
Lostaran-7.90

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Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter

Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter (NCT01176032)
Timeframe: Baseline, Week 36

Interventionmm/m^2 (Mean)
Aliskiren-0.13
Lostaran-0.22

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Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP)

PICP is a measure of blood concentration of procollagen I carboxy-terminal propeptide (PICP), a peptide released from the myocardium when procollagen is converted to type I collagen. This biomarker exhibits good specificity and sensitivity for identifying myocardial fibrosis in hypertension. (NCT01176032)
Timeframe: Baseline, Week 36

Interventionug/l (Mean)
Aliskiren-5.22
Lostaran-4.25

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Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine

Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson) (NCT01176032)
Timeframe: Baseline, Week 36

,,,
InterventionPercent (Mean)
LV ejection fraction Teicholz (n=14,15,16,20)LV ejection fraction Simpson(n=11,11,15,19)
Aliskiren0.000.05
Aliskiren + Amlodipinet-0.00-0.01
Losartan-0.00-0.02
Losartan + Amlodipine0.010.02

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Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine

Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter (NCT01176032)
Timeframe: Baseline, Week 36

Interventionmm/m^2 (Mean)
Aliskiren-0.18
Aliskiren + Amlodipinet-0.07
Losartan-0.19
Losartan + Amlodipine-0.24

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Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method)

Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method) (NCT01176032)
Timeframe: Baseline, Week 36

Interventioncm3/m^2 (Mean)
Aliskiren-0.55
Lostaran-2.27

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Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI)

Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI (NCT01176032)
Timeframe: Baseline, Week 36

Interventiong/m^2 (Mean)
Aliskiren-8.05
Lostaran-7.96

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Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP)

The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values (NCT01176032)
Timeframe: Baseline, Week 10,18,26,36

,
InterventionmmHg (Mean)
Baseline, Week 10 (n=30,37)Baseline, Week 18 (n=29,36)Baseline, Week 26 (n=29,36)Baseline, Week 36 (n=32,37)
Aliskiren-1.77-5.34-5.34-4.19
Lostaran-3.15-7.07-6.94-6.68

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Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP)

The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values (NCT01176032)
Timeframe: Baseline, Week 10,18,26,36

,
InterventionmmHg (Mean)
Baseline, Week 10 (n=30,37)Baseline, Week 18 (n=29,36)Baseline, Week 26 (n=29,36)Baseline, Week 36 (n=32,37)
Aliskiren-5.56-9.77-12.69-8.87
Lostaran-4.03-8.44-10.40-8.88

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Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule

Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule (NCT01176032)
Timeframe: Baseline, Week 36

,
Interventionml (Mean)
LV end-diastolic volume (n=22,34)LV end-systolic volume (n=22,34)
Aliskiren2.30-0.92
Lostaran0.540.64

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Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine

Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI (NCT01176032)
Timeframe: Baseline, Week 36

Interventiong/m2 (Mean)
Aliskiren-5.68
Aliskiren + Amlodipinet-10.26
Losartan-3.59
Losartan + Amlodipine-11.46

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Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine

Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method) (NCT01176032)
Timeframe: Baseline, Week 36

Interventioncm3/m^2 (Mean)
Aliskiren-8.88
Aliskiren + Amlodipinet7.78
Losartan-7.42
Losartan + Amlodipine1.30

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Change From Baseline in Biomarkers in Heart Disease

The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) (NCT01176032)
Timeframe: Baseline, Week 36

,
Interventionng/ml (Mean)
cardiotrophin-1 (CT-1) (n=32,37)matrix metalloproteinase-1 (MMP-1) (n=32,37)tissue inhibitor of MMPs (TIMP-1) (n=32,37)annexin A5 (AnxA5) (n=31,37)NT-proBNP (n=31,34)
Aliskiren-169.155.93-0.70-0.9818.66
Lostaran-128.235.519.15-1.21-7.55

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Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease.

The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) (NCT01176032)
Timeframe: Baseline, Week 36

,,,
Interventionng/ml (Mean)
CT-1(n=15,17,16,21)ANXA5 (n=15,16,16,21)MMP-1(n=15,17,16,21)TIMP-1 (n=15,17,16,21)NT-proBNP (n=15,16,15,19)
Aliskiren-289.18-1.247.00-10.0121.00
Aliskiren + Amlodipine-63.23-0.744.997.5116.46
Losartan156.89-1.735.4721.38-3.68
Losartan + Amlodipine-345.47-0.815.54-0.16-10.60

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Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine

The plasma level of biomarker parameter plasma aldosterone used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). (NCT01176032)
Timeframe: Baseline, Week 36

Interventionng/dl (Mean)
Aliskiren2.81
Aliskiren + Amlodipine-5.89
Losartan-3.12
Losartan + Amlodipine-11.55

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Plasma Decay Half-life (t1/2)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. (NCT01177293)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose

Interventionhr (Mean)
Amlodipine 10 mg Capsule51.374
Amlodipine 10 mg ODT45.120

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Time to Reach Maximum Observed Plasma Concentration (Tmax)

(NCT01177293)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose

Interventionhr (Median)
Amlodipine 10 mg Capsule8.00
Amlodipine 10 mg ODT10.00

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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]

AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). (NCT01177293)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose

Interventionhr*ng/mL (Geometric Mean)
Amlodipine 10 mg Capsule401.655
Amlodipine 10 mg ODT360.619

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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast). (NCT01177293)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose

Interventionhr*ng/mL (Geometric Mean)
Amlodipine 10 mg Capsule331.300
Amlodipine 10 mg ODT330.394

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Maximum Observed Plasma Concentration (Cmax)

(NCT01177293)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose

Interventionng/mL (Geometric Mean)
Amlodipine 10 mg Capsule6.427
Amlodipine 10 mg ODT5.571

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AUC_0-∞ of Amlodipine

(NCT01181011)
Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Interventionng·h/mL (Geometric Mean)
Telmisartan 80mg, Amlodipine 5mg225
Amlodipine 5mg210

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The Maximum Observed Plasma Concentration (Cmax) of Telmisartan

(NCT01181011)
Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Interventionng/mL (Geometric Mean)
Telmisartan 80mg, Amlodipine 5mg461
Telmisartan 80mg480

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V_z/F of Amlodipine

(NCT01181011)
Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

InterventionL (Mean)
Telmisartan 80mg, Amlodipine 5mg1241
Amlodipine 5mg1353

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Apparent Clearance of Telmisartan in Plasma Following Extravascular Administration (CL/F)

(NCT01181011)
Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

InterventionL/h (Mean)
Telmisartan 80mg, Amlodipine 5mg31.0
Telmisartan 80mg37.3

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Apparent Volume of Distribution During the Terminal Phase λz Following an Extravascular Administration (V_z/F) of Telmisartan

(NCT01181011)
Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

InterventionL (Mean)
Telmisartan 80mg, Amlodipine 5mg1021
Telmisartan 80mg1135

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Area Under the Concentration-time Curve of Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC_0-tz)

(NCT01181011)
Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Interventionng·h/mL (Geometric Mean)
Telmisartan 80mg, Amlodipine 5mg3200
Telmisartan 80mg2940

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Time to Attain Cmax (Tmax) of Telmisartan

(NCT01181011)
Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Interventionh (Mean)
Telmisartan 80mg, Amlodipine 5mg1.22
Telmisartan 80mg1.16

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Tmax of Amlodipine

(NCT01181011)
Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Interventionh (Mean)
Telmisartan 80mg, Amlodipine 5mg6.88
Amlodipine 5mg7.20

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λz of Amlodipine

(NCT01181011)
Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Intervention1/h (Mean)
Telmisartan 80mg, Amlodipine 5mg0.0305
Amlodipine 5mg0.0323

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Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUC_0-∞) of Telmisartan

(NCT01181011)
Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Interventionng·h/mL (Geometric Mean)
Telmisartan 80mg, Amlodipine 5mg3420
Telmisartan 80mg3140

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Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities

(NCT01181011)
Timeframe: 4 weeks

,,
InterventionParticipants (Number)
ECG abnormalitiesVital signs abnormalitiesPhysical finding abnormalitiesLaboratory finding abnormalities
Amlodipine 5mg0000
Telmisartan 80mg0001
Telmisartan 80mg, Amlodipine 5mg0001

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Terminal Rate Constant in Plasma (λz) of Telmisartan

reflect the speed of drug elimination in vivo (NCT01181011)
Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Intervention1/h (Mean)
Telmisartan 80mg, Amlodipine 5mg0.0305
Telmisartan 80mg0.0323

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t_½ of Amlodipine

(NCT01181011)
Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Interventionh (Mean)
Telmisartan 80mg, Amlodipine 5mg38.8
Amlodipine 5mg38.6

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Number of Participants With at Least One Treatment Emergent Adverse Event

(NCT01181011)
Timeframe: 4 weeks

InterventionParticipants (Number)
Telmisartan 80mg, Amlodipine 5mg4
Telmisartan 80mg2
Amlodipine 5mg4

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MRT_po of Amlodipine

(NCT01181011)
Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Interventionh (Mean)
Telmisartan 80mg, Amlodipine 5mg44.3
Amlodipine 5mg43.7

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Mean Residence Time of Telmisartan in the Body After Oral Administration (MRT_po)

(NCT01181011)
Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Interventionh (Mean)
Telmisartan 80mg, Amlodipine 5mg20.0
Telmisartan 80mg18.4

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Elimination Half-life (t_½) of Telmisartan

(NCT01181011)
Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Interventionh (Mean)
Telmisartan 80mg, Amlodipine 5mg27.0
Telmisartan 80mg25.0

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Cmax of Amlodipine

(NCT01181011)
Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days of wash-outs

Interventionng/mL (Geometric Mean)
Telmisartan 80mg, Amlodipine 5mg4.72
Amlodipine 5mg4.43

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CL/F of Amlodipine

(NCT01181011)
Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

InterventionL/h (Mean)
Telmisartan 80mg, Amlodipine 5mg22.7
Amlodipine 5mg25.1

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AUC_0-tz of Amlodipine

(NCT01181011)
Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Interventionng·h/mL (Geometric Mean)
Telmisartan 80mg, Amlodipine 5mg206
Amlodipine 5mg192

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Change From Baseline in SBP and DBP at Week 12 With Last Observation Carried Forward (LOCF)

(NCT01200407)
Timeframe: Baseline, Week 12

Interventionmillimeters of mercury (mmHg) (Mean)
Baseline: SBPBaseline: DBPChange at Week 12: SBP LOCFChange at Week12: DBP LOCF
Normetec161.698.9-35.8-19.4

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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last study drug administration (Week 12) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. (NCT01200407)
Timeframe: Baseline up to 28 days after last study drug administration (Week 12)

Interventionparticipants (Number)
Number of Participants with AEsNumber of Participants with SAEs
Normetec60

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Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 4, 8 and 12 Without (w/o) LOCF

(NCT01200407)
Timeframe: Baseline, Week 4, Week 8, Week 12

InterventionmmHg (Mean)
Change at Week 4: SBP w/o LOCFChange at Week 4: DBP w/o LOCFChange and Week 8: SBP w/o LOCFChange and Week 8: DBP w/o LOCFChange and Week 12: SBP w/o LOCFChange and Week 12: DBP w/o LOCF
Normetec-24.7-13.2-33.0-17.6-36.3-19.9

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Treatment Emergent Adverse Events

Electrocardiogram, laboratory parameters and physical examinations were performed and any abnormal findings were recorded within the adverse events (NCT01204398)
Timeframe: 8 weeks

InterventionParticipants (Number)
Patients with any AEsPatients with severe AEsPatients with drug-related AEsPatients with AEs related to laboratory changes
T80/A54010

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Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment

Calculated on the basis of changes in hourly means from baseline. Trough is defined as the mean of the last three hours of the 24-hour dosing interval. Peak is the greatest reduction in hourly means in hours 2 to 8 after dosing. All measurements are using ABPM. (NCT01204398)
Timeframe: 8 weeks

InterventionRatio (Median)
DBP T/P ratio (N=23)SBP T/P ratio (N=25)
T80/A51.130.98

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Change From Baseline to End of Study in In-clinic Pulse Rate

(NCT01204398)
Timeframe: 8 weeks

Interventionbeats per minute (bpm) (Mean)
T80/A52.37

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ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing

DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM at baseline and after 8 weeks of treatment (NCT01204398)
Timeframe: 0 and 8 weeks

InterventionmmHg (Mean)
DBP after 1 hour at baselineDBP after 2 hours at baselineDBP after 3 hours at baselineDBP after 4 hours at baselineDBP after 5 hours at baselineDBP after 6 hours at baselineDBP after 7 hours at baselineDBP after 8 hours at baselineDBP after 9 hours at baselineDBP after 10 hours at baselineDBP after 11 hours at baselineDBP after 12 hours at baselineDBP after 13 hours at baselineDBP after 14 hours at baselineDBP after 15 hours at baselineDBP after 16 hours at baselineDBP after 17 hours at baselineDBP after 18 hours at baselineDBP after 19 hours at baselineDBP after 20 hours at baselineDBP after 21 hours at baselineDBP after 22 hours at baselineDBP after 23 hours at baselineDBP after 24 hours at baselineDBP after 1 hour at the end of the studyDBP after 2 hours at the end of the studyDBP after 3 hours at the end of the studyDBP after 4 hours at the end of the studyDBP after 5 hours at the end of the studyDBP after 6 hours at the end of the studyDBP after 7 hours at the end of the studyDBP after 8 hours at the end of the studyDBP after 9 hours at the end of the studyDBP after 10 hours at the end of the studyDBP after 11 hours at the end of the studyDBP after 12 hours at the end of the studyDBP after 13 hours at the end of the studyDBP after 14 hours at the end of the studyDBP after 15 hours at the end of the studyDBP after 16 hours at the end of the studyDBP after 17 hours at the end of the studyDBP after 18 hours at the end of the studyDBP after 19 hours at the end of the studyDBP after 20 hours at the end of the studyDBP after 21 hours at the end of the studyDBP after 22 hours at the end of the studyDBP after 23 hours at the end of the studyDBP after 24 hours at the end of the studySBP after 1 hour at baselineSBP after 2 hours at baselineSBP after 3 hours at baselineSBP after 4 hours at baselineSBP after 5 hours at baselineSBP after 6 hours at baselineSBP after 7 hours at baselineSBP after 8 hours at baselineSBP after 9 hours at baselineSBP after 10 hours at baselineSBP after 11 hours at baselineSBP after 12 hours at baselineSBP after 13 hours at baselineSBP after 14 hours at baselineSBP after 15 hours at baselineSBP after 16 hours at baselineSBP after 17 hours at baselineSBP after 18 hours at baselineSBP after 19 hours at baselineSBP after 20 hours at baselineSBP after 21 hours at baselineSBP after 22 hours at baselineSBP after 23 hours at baselineSBP after 24 hours at baselineSBP after 1 hour at the end of the studySBP after 2 hours at the end of the studySBP after 3 hours at the end of the studySBP after 4 hours at the end of the studySBP after 5 hours at the end of the studySBP after 6 hours at the end of the studySBP after 7 hours at the end of the studySBP after 8 hours at the end of the studySBP after 9 hours at the end of the studySBP after 10 hours at the end of the studySBP after 11 hours at the end of the studySBP after 12 hours at the end of the studySBP after 13 hours at the end of the studySBP after 14 hours at the end of the studySBP after 15 hours at the end of the studySBP after 16 hours at the end of the studySBP after 17 hours at the end of the studySBP after 18 hours at the end of the studySBP after 19 hours at the end of the studySBP after 20 hours at the end of the studySBP after 21 hours at the end of the studySBP after 22 hours at the end of the studySBP after 23 hours at the end of the studySBP after 24 hours at the end of the study
T80/A5101.6101.7100.097.995.396.597.0100.6102.7100.497.995.993.692.089.489.188.088.888.490.391.497.6101.0101.889.187.186.386.285.384.881.185.888.987.584.382.880.480.177.977.375.575.776.679.682.483.887.287.0157.9156.5158.4152.6152.1152.6154.6157.3161.0157.6153.3150.0145.8146.3141.9142.2139.6137.8139.2142.2143.6148.5156.6158.2132.8130.2128.3130.6128.2128.8125.5129.7133.2131.7130.5126.6123.5124.2119.1117.8116.4116.1118.0121.7126.6129.3132.0133.1

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Change From Baseline to End of Study in DBP and SBP

Manually measured in-clinic DBP and SBP (NCT01204398)
Timeframe: 8 weeks

InterventionmmHg (Mean)
DBP: Change from baseline to 2 weeksDBP: Change from baseline to 4 weeksDBP: Change from baseline to 8 weeksSBP: Change from baseline to 2 weeksSBP: Change from baseline to 4 weeksSBP: Change from baseline to 8 weeks
T80/A5-9.67-13.49-13.73-11.04-17.95-19.80

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Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing

Changes from baseline in DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM after 8 weeks of treatment with T80/A5 (NCT01204398)
Timeframe: 8 weeks

InterventionmmHg (Mean)
DBP Change from baseline after 1 hourDBP Change from baseline after 2 hoursDBP Change from baseline after 3 hoursDBP Change from baseline after 4 hoursDBP Change from baseline after 5 hoursDBP Change from baseline after 6 hoursDBP Change from baseline after 7 hoursDBP Change from baseline after 8 hoursDBP Change from baseline after 9 hoursDBP Change from baseline after 10 hoursDBP Change from baseline after 11 hoursDBP Change from baseline after 12 hoursDBP Change from baseline after 13 hoursDBP Change from baseline after 14 hoursDBP Change from baseline after 15 hoursDBP Change from baseline after 16 hoursDBP Change from baseline after 17 hoursDBP Change from baseline after 18 hoursDBP Change from baseline after 19 hoursDBP Change from baseline after 20 hoursDBP Change from baseline after 21 hoursDBP Change from baseline after 22 hoursDBP Change from baseline after 23 hoursDBP Change from baseline after 24 hourSBP Change from baseline after 1 hourSBP Change from baseline after 2 hoursSBP Change from baseline after 3 hoursSBP Change from baseline after 4 hoursSBP Change from baseline after 5 hoursSBP Change from baseline after 6 hoursSBP Change from baseline after 7 hoursSBP Change from baseline after 8 hoursSBP Change from baseline after 9 hoursSBP Change from baseline after 10 hoursSBP Change from baseline after 11 hoursSBP Change from baseline after 12 hoursSBP Change from baseline after 13 hoursSBP Change from baseline after 14 hoursSBP Change from baseline after 15 hoursSBP Change from baseline after 16 hoursSBP Change from baseline after 17 hoursSBP Change from baseline after 18 hoursSBP Change from baseline after 19 hoursSBP Change from baseline after 20 hoursSBP Change from baseline after 21 hoursSBP Change from baseline after 22 hoursSBP Change from baseline after 23 hoursSBP Change from baseline after 24 hour
T80/A5-12.5-14.7-13.7-11.7-9.9-11.7-15.9-14.8-13.7-12.9-13.6-13.1-13.2-11.9-11.5-11.8-12.6-13.1-11.8-10.7-9.0-13.8-13.9-14.8-25.0-26.2-30.1-21.9-23.9-23.9-29.2-27.6-27.7-25.8-22.8-23.4-22.4-22.1-22.9-24.4-23.3-21.7-21.2-20.5-17.0-19.2-24.6-25.1

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DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean

ABPM measurements were taken every 20 minutes throughout the day and night by the validated SpaceLabs Model 90217 monitor. (NCT01204398)
Timeframe: 8 weeks

InterventionmmHg (Mean)
DBP change from baselineSBP change from baseline
T80/A5-12.76-23.82

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Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough

Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing (NCT01222520)
Timeframe: Baseline, 8 weeks

InterventionmmHg (Least Squares Mean)
Telmisartan and Amlodipine FDC12.28
Telmisartan3.14

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Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough

Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing (NCT01222520)
Timeframe: Baseline, 8 weeks

InterventionmmHg (Least Squares Mean)
Telmisartan and Amlodipine FDC18.37
Telmisartan3.49

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Seated Blood Pressure (BP) Normalisation at Trough

Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing (NCT01222520)
Timeframe: 8 weeks

,
InterventionParticipants (Number)
NoOptimalNormalHigh-normal
Telmisartan662711
Telmisartan and Amlodipine FDC28212216

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Seated DBP Control Rate at Trough

DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing (NCT01222520)
Timeframe: 8 weeks

,
InterventionPercentage of participants (Number)
NoYes
Telmisartan73.326.7
Telmisartan and Amlodipine FDC29.970.1

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Seated DBP Response Rate at Trough

DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (<90 mmHg and/or reduction from reference baseline ≥10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing (NCT01222520)
Timeframe: 8 weeks

,
InterventionPercentage of participants (Number)
NoYes
Telmisartan69.830.2
Telmisartan and Amlodipine FDC19.580.5

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Seated SBP Control Rate at Trough

SBP control rate: The rate of patients with controlled seated SBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing (NCT01222520)
Timeframe: 8 weeks

,
InterventionPercentage of participants (Number)
NoYes
Telmisartan71.228.8
Telmisartan and Amlodipine FDC26.074.0

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Seated SBP Response Rate at Trough

SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (<140 mmHg and/or reduction from reference baseline ≥20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing (NCT01222520)
Timeframe: 8 weeks

,
InterventionPercentage of participants (Number)
NoYes
Telmisartan48.851.2
Telmisartan and Amlodipine FDC11.588.5

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Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8)

Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate. (NCT01237223)
Timeframe: Baseline, Week 8

Interventionmm Hg (Least Squares Mean)
Placebo-5.21
Aliskiren 150 mg-7.49
Amlodipine 2.5 mg-9.46
Amlodipine 5 mg-11.90
Aliskiren/Amlodipine 150/2.5 mg-12.40
Aliskiren/Amlodipine 150/5 mg-16.43

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Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8)

Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate. (NCT01237223)
Timeframe: Baseline, Week 8

Interventionmm Hg (Least Squares Mean)
Placebo-4.57
Aliskiren 150 mg-10.63
Amlodipine 2.5 mg-13.16
Amlodipine 5 mg-17.98
Aliskiren/Amlodipine 150/2.5 mg-18.15
Aliskiren/Amlodipine 150/5 mg-25.49

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Percentage of Participants Achieving a Successful Response Rate

The response rate was defined as percentage of participants who achieved msDBP < 90 mmHg or its reduction ≥ 10 mmHg from baseline to endpoint. (NCT01237223)
Timeframe: 8 weeks

Interventionpercentage of participants (Number)
Placebo34.6
Aliskiren 150 mg46.5
Amlodipine 2.5 mg50.6
Amlodipine 5 mg70.3
Aliskiren/Amlodipine 150/2.5 mg65.4
Aliskiren/Amlodipine 150/5 mg86.2

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Percentage of Participants Achieving Blood Pressure Control at Endpoint

Blood pressure control is defined as having as a msDBP < 90 mmHg and a msSBP < 140 mmHg. (NCT01237223)
Timeframe: 8 weeks

Interventionpercentage of participants (Number)
Placebo16.3
Aliskiren 150 mg25.5
Amlodipine 2.5 mg32.9
Amlodipine 5 mg50.0
Aliskiren/Amlodipine 150/2.5 mg45.9
Aliskiren/Amlodipine 150/5 mg69.2

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Number of Participants With Adverse Events, Serious Adverse Events and Death

Number of patients with adverse events regardless of study drug relationship during the double-blind treatment period were reported. Serious adverse events of double blind period were reported. (NCT01237223)
Timeframe: 8 weeks

,,,,,
InterventionParticipants (Number)
Adverse EventsSerious Adverse EventsDeath
Aliskiren 150 mg5700
Aliskiren/Amlodipine 150/2.5 mg5700
Aliskiren/Amlodipine 150/5 mg5910
Amlodipine 2.5 mg5020
Amlodipine 5 mg4910
Placebo6200

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Pulse Wave Velocity

Measure of pulsewave velocity cm/s (NCT01252238)
Timeframe: 12 weeks

,,
Interventioncm/s (Mean)
baseline12 weeks
Aliskiren824696
Placebo Group1021574
Valsartan and Aliskiren991824

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Change in Insulin Sensitivity by HOMA at 12 Weeks

The difference (change) in HOMA calculated as Baseline HOMA minus 12-week HOMA value (NCT01252238)
Timeframe: 12 weeks

InterventionHOMA Scale (Mean)
Aliskiren-0.7
Placebo Group-0.4
Valsartan and Aliskiren-0.5

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Aortic Compliance

Characteristic aortic imedeance, dynes x s/cm5 (NCT01252238)
Timeframe: 12 weeks

,,
Interventiondyne x sec/cm5 (Mean)
baseline12 weeks
Aliskiren241127
Placebo Group111519
Valsartan and Aliskiren212174

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Number of Participants With Adverse Events Listed in Japanese Package Insert

Adverse events refer to all events undesirable for participants that occur after the start of treatment with Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day, regardless of presence/absence of causal relationship with Amlodipine Tablets or Amlodipine OD Tablets (including clinically significant abnormal changes in laboratory test values). (NCT01252563)
Timeframe: Last day of observation period (average of 14.76 weeks)

Interventionparticipants (Number)
Amlodipine 10 mg Tablet566

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Changes in Ambulatory Diastolic Blood Pressure From Baseline

Changes in ambulatory diastolic blood pressure (DBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. (NCT01252563)
Timeframe: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)

InterventionmmHg (Mean)
Week 4Week 8Week 12Last Day
Changes in Ambulatory DBP From Baseline-8.2-9.1-9.9-10.0

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Changes in Ambulatory Systolic Blood Pressure From Baseline

Changes in ambulatory systolic blood pressure (SBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. (NCT01252563)
Timeframe: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)

InterventionmmHg (Mean)
Week 4Week 8Week 12Last Day
Changes in Ambulatory SBP From Baseline-16.8-18.4-19.9-20.1

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Changes in Home Diastolic Blood Pressure From Baseline

Changes in home diastolic blood pressure (DBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. (NCT01252563)
Timeframe: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)

InterventionmmHg (Mean)
Week 4Week 8Week 12Last Day
Changes in Home Diastolic Blood Pressure From Baseline-8.3-9.5-10.4-10.4

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Changes in Home Systolic Blood Pressure From Baseline

Changes in home systolic blood pressure (SBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. (NCT01252563)
Timeframe: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)

InterventionmmHg (Mean)
Week 4Week 8Week 12Last Day
Changes in Home SBP From Baseline-15.7-18.0-19.9-19.6

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The Achievement Rate to Ambulatory Blood Pressure Goal

The achievement rates to ambulatory blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. (NCT01252563)
Timeframe: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)

InterventionPercentage of participants (Number)
Week 4Week 8Week 12Last Day
The Achievement Rate to Ambulatory Blood Pressure Goal35.140.143.943.9

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The Achievement Rate to Home Blood Pressure Goal

The achievement rates to home blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. (NCT01252563)
Timeframe: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)

InterventionPercentage of participants (Number)
Week 4Week 8Week 12Last Day
The Achievement Rate to Home Blood Pressure Goal21.227.932.231.3

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Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Metabolic Syndrome)

To determine whether having metabolic syndrome as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. (NCT01252563)
Timeframe: Last day of observation period (average of 14.76 weeks)

InterventionParticipants (Number)
With Metabolic Syndrome92
Without Metabolic Syndrome852

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Number of Participants Who Achieved the Target Blood Pressure: Ambulatory Systolic Blood Pressure

To determine whether ambulatory systolic blood pressure at baseline was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. (NCT01252563)
Timeframe: Last day of observation period (average of 14.76 weeks)

InterventionParticipants (Number)
<120 mmHg at Baseline19
120 to 140 mmHg at Baseline171
140 to 160 mmHg at Baseline543
160 to 180 mmHg at Baseline182
>= 180 mmHg at Baseline26

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Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Chronic Kidney Disease)

To determine whether having chronic kidney disease as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. (NCT01252563)
Timeframe: Last day of observation period (average of 14.76 weeks)

InterventionParticipants (Number)
With Chronic Kidney Disease24
Without Chronic Kidney Disease920

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Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Diabetes Mellitus)

To determine whether having diabetes mellitus as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. (NCT01252563)
Timeframe: Last day of observation period (average of 14.76 weeks)

InterventionParticipants (Number)
With Diabetes Mellitus52
Without Diabetes Mellitus892

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Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Myocardial Infarction)

To determine whether having myocardial infarction as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. (NCT01252563)
Timeframe: Last day of observation period (average of 14.76 weeks)

InterventionParticipants (Number)
With Myocardial Infarction1
Without Myocardial Infarction943

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Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment)

Blood pressure (BP) control is defined as BP <140/90 mmHg. (NCT01256411)
Timeframe: Baseline to 12 months

InterventionParticipants (Number)
LCZ696 200 mg114
LCZ696 400 mg62
LCZ606 400 mg/Amlodipine77
LCZ696 400 mg/Amlodipine/HCTZ3

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Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment)

Participants were monitored throughout the study for adverse events, serious adverse events and deaths. (NCT01256411)
Timeframe: Baseline to 12 months

,,,,
InterventionParticipants (Number)
Adverse events (serious and non-serious)Seroius adverse eventsDeaths
LCZ606 400 mg/Amlodipine5300
LCZ696 100 mg610
LCZ696 200 mg147100
LCZ696 400 mg7820
LCZ696 400 mg/Amlodipine/HCTZ000

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Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy)

Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement. (NCT01256411)
Timeframe: Baseline, 12 months

,
InterventionmmHg (Mean)
msDBPmsSBP
LCZ696 Combination Therapy-17.3-28.2
LCZ696 Monotherapy-15.7-23.0

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Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment)

Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement. (NCT01256411)
Timeframe: Baseline, 12 months

,,,
InterventionmmHg (Mean)
msDBPmsSBP
LCZ606 400 mg/Amlodipine-17.4-28.1
LCZ696 200 mg-16.6-24.1
LCZ696 400 mg-14.2-21.3
LCZ696 400 mg/Amlodipine/HCTZ-16.8-29.0

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Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy)

Blood pressure (BP) control is defined as BP <140/90 mmHg. (NCT01256411)
Timeframe: Baseline to 12 months

InterventionParticipants (Number)
LCZ696 Monotherapy176
LCZ696 Combination Therapy80

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Number of Participants With Renal Dysfunction in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen

"The renal dysfunction (composite endpoint) was defined as the first occurrence of either of the following:~End-stage renal disease [ESRD] requiring dialysis or transplantation~Doubling of serum creatinine and reaching an eGFR < 45 ml/min/1.73 m^2." (NCT01259297)
Timeframe: End of study (209 days (median))

,
Interventionparticipants (Number)
ESRD requiring dialysis or transplantationDoubling of creatinine & eGFR<45 ml/min/1.73 m^2
Aliskiren Based Regimen07
Non-Aliskiren Based Regimen01

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Percentage of Participants With Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part II)

"Decline in ability to perform everyday activities independently was measured primarily by using the Standard Assessment of Global Activities in the Elderly (SAGE) scale. The SAGE was comprised of 15 questions, each describing an activity. Patient had to indicate how much difficulty he/she had encountered in performing the activity in the last month. Each question's score ranges from 0 (No difficulty) to 3 (difficulty levels were mild (score = 1), moderate (score =2) and severe (score=3)).~Part II of SAGE included 2 dimensions:~Normal if the scores of all SAGE questions is 0 (i.e., No difficulty)~Mobility Only if scores of both SAGE questions 11 and 12 are 0" (NCT01259297)
Timeframe: End of study (209 days [median])

,
Interventionpercentage of participants (Number)
NormalMobility Only
Aliskiren Based Regimen44.266.8
Non-Aliskiren Based Regimen46.568.6

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Number of Participants With Composite Cardiovascular Endpoints in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen

The composite CV endpoint is based on the following first adjudicated events: CV death, non-fatal MI,non-fatal stroke, significant heart failure (NCT01259297)
Timeframe: End of study (209 days (median))

Interventionparticipants (Number)
Aliskiren Based Regimen11
Non-Aliskiren Based Regimen14

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Number of Participants With Composite Cardiovascular Endpoints in Aliskiren+Amlodipine/HCTZ Group Versus All Placebo Group

The composite CV endpoint is based on the following first adjudicated events: CV death, non-fatal MI,non-fatal stroke, significant heart failure (NCT01259297)
Timeframe: End of study (209 days (median))

Interventionparticipants (Number)
Aliskiren+Amlodipine/HCTZ Group2
Placebo8

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Number of Participants With Total Mortality in Aliskiren Based Regimen Versus Non-aliskiren Based Regimen

The total mortality endpoint was defined as time to death from any cause. Total mortality analysis used the date of last follow-up including the washout period as the censoring date. (NCT01259297)
Timeframe: End of study (209 days (median))

InterventionParticipants (Number)
Aliskiren Based Regimen5
Non-Aliskiren Based Regimen9

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Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

Mean sitting diastolic blood pressure (msDBP) is the average of 2 sitting DBP measurements (2 minutes apart). Since each patient had their final follow-up visit at a different time in the trial, these measurements were classified as falling into the 6 week, 6 month, or 12 month measurement period. All available blood pressures were sorted within these periods and the last value within each time range used for analysis. At each timepoint, a patient must have both baseline and postbaseline values to be included in the analysis. (NCT01259297)
Timeframe: Baseline (BL), 6 week, 6 month and 12 month

,
InterventionmmHg (Least Squares Mean)
change from Baseline to 6 week (n=821,867)change from baseline to 6 month (n=730,775)change from baseline to 12 month (n=397,399)
Aliskiren Based Regimen-5.6-4.9-4.3
Non-Aliskiren Based Regimen-3.6-3.5-3.9

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Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

Mean sitting systolic blood pressure (msSBP) is the average of 2 sitting SBP measurements (2 minutes apart). Since each patient had their final follow-up visit at a different time in the trial, these measurements were classified as falling into the 6 week, 6 month, or 12 month measurement period. All available blood pressures were sorted within these periods and the last value within each time range used for analysis. At each timepoint, a patient must have both baseline and postbaseline values to be included in the analysis. (NCT01259297)
Timeframe: Baseline (BL), 6 week, 6 month and 12 month

,
InterventionmmHg (Least Squares Mean)
change from Baseline to 6 week (n=821,867)change from baseline to 6 month (n=730,775)change from baseline to 12 month (n=397,399)
Aliskiren Based Regimen-11.9-10.1-7.7
Non-Aliskiren Based Regimen-8.02-6.8-5.8

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Change From Baseline to End of Study in Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part I)

"Decline in ability to perform everyday activities independently was measured primarily by using the Standard Assessment of Global Activities in the Elderly (SAGE) scale. The SAGE comprised of 15 questions, each describing an activity. Patient had to indicate how much difficulty he/she had encountered in performing the activity in last month. Each question's score ranges from 0 (No difficulty) to 3 (difficulty levels were mild (score = 1), moderate (score =2) and severe (score=3)). Part I of SAGE included 4 dimensions:~Community Cognition (maximum of scores of questions 1 to 6);~Instrumental Activities of daily Living (IADL) (maximum of scores of questions 7 to 10);~Mobility (maximum of scores of questions 11 and 12);.~Basic Activities of daily Living (ADL) (maximum of scores of questions 13 to 15) Each dimension's total score ranged from 0 to 3. 0=best, 3=worst A negative change in value from baseline means improvement in the ability to perform everyday activities." (NCT01259297)
Timeframe: Baseline, End of study (209 days [median])

,
Interventionunits on a scale (Mean)
Community CognitionInstrumental Activities of daily Living (IADL)MobilityADL
Aliskiren Based Regimen-0.04-0.060.01-0.09
Non-Aliskiren Based Regimen-0.05-0.040.00-0.08

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Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8

Diastolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded. (NCT01277822)
Timeframe: Baseline and Week 8

InterventionmmHg (Mean)
Losartan/Amlodipine-10.1
Amlodipine-8.8

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Percentage of Participants Who Achieve Target Blood Pressure at Week 8

Participants were evaluated at Week 8 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) <90mmHg or sitting systolic BP (sitSBP) <140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline. (NCT01277822)
Timeframe: Week 8

InterventionPercentage of Participants (Number)
Losartan/Amlodipine63.0
Amlodipine58.8

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Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4

Diastolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded. (NCT01277822)
Timeframe: Baseline and Week 4

InterventionmmHg (Mean)
Losartan/Amlodipine-9.3
Amlodipine-10.0

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Change From Baseline in Ankle Circumference at Week 8

Each ankle was marked with a semi-permanent marker at approximately 3 cm proximal to the midpoint of the medial malleolus to aid consistency in the performance of the measurements. Ankle circumference was measured in both ankles at baseline and Week 8 using a tension controlled tape to minimize error. (NCT01277822)
Timeframe: Baseline and Week 8

,
Interventionmm (Mean)
Left AnkleRight Ankle
Amlodipine-0.7-0.2
Losartan/Amlodipine-0.6-0.5

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Percentage of Participants Who Had Peripheral Edema During the Study

A pitting assessment of edema on both legs was performed at baseline and throughout the study. Participants were assessed in a seated position with both feet extended and the right ankle in a neutral dorsiflexion position. The index finger was pressed firmly over the bony prominence approximately 3cm proximal to the midpoint of the medial malleolus of the right ankle and will be held for three seconds. Presence of a residual indentation in the area after releasing pressure on the index finger was considered positive for pitting edema. (NCT01277822)
Timeframe: up to 8 weeks

InterventionPercentage of Participants (Number)
Losartan/Amlodipine6.5
Amlodipine5.4

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Percentage of Participants Who Achieve Target Blood Pressure at Week 4

Participants were evaluated at Week 4 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) <90mmHg or sitting systolic BP (sitSBP) <140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline. (NCT01277822)
Timeframe: Week 4

InterventionPercentage of Participants (Number)
Losartan/Amlodipine55.1
Amlodipine61.5

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Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8

Systolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded. (NCT01277822)
Timeframe: Baseline and Week 8

InterventionmmHg (Mean)
Losartan/Amlodipine-15.0
Amlodipine-12.7

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Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4

Systolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded. (NCT01277822)
Timeframe: Baseline and Week 4

InterventionmmHg (Mean)
Losartan/Amlodipine-12.5
Amlodipine-12.3

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Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72)

Area under the analyte concentration versus time curve from time zero to 72 hours as calculated by the linear trapezoidal method (NCT01278797)
Timeframe: Day 1, Day 22

Interventionnanograms*hour/milliliter (Mean)
Telm/Amlo 80 mg/10 mg260.7971
Telm 80 mg + Amlo 10 mg276.6315

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Maximum Observed Plasma Concentration (Cmax) of Amlodipine

(NCT01278797)
Timeframe: Day 1, Day 22

Interventionnanograms/milliliter (Mean)
Telm/Amlo 80 mg/10 mg6.7465
Telm 80 mg + Amlo 10 mg7.2258

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Time of Maximum Concentration of Amlodipine (TMAX)

Time of maximum measured amlodipine concentration over the zero to 72 hour sampling period (NCT01278797)
Timeframe: Day 1, Day 22

Interventionhours (Mean)
Telm/Amlo 80 mg/10 mg6.69
Telm 80 mg + Amlo 10 mg6.12

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Change in Digital Ulcer Number

0 - unlimited. Number of digital ulcers in all fingers are counted by the investigators and recorded at each visit. The number of ulcers in all fingers indirectly reflect the extent of critical ischemia. As such. the decrease in digital ulcer number reflects positive response to treatment (=better blood flow), whereas the increase ulcer numbers indicates worsening finger ischemia from baseline. (NCT01280266)
Timeframe: baseline and 4 weeks

InterventionDigital ulcers (Mean)
Amlodipine0.1
Udenafil0.1

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Change in Health Assessment Questionnaire (HAQ)

Ordinal scale 0-10 0 good 10 bad (NCT01280266)
Timeframe: 0 and 4 weeks

Interventionunits on a scale (Mean)
Amlodipine0.1
Udenafil-0.1

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RP Attacks Per Day

Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited. (NCT01280266)
Timeframe: baselin and 4 weeks

Interventionattacks per day (Mean)
Amlodipine-0.5
Udenafil-0.5

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Dorsal-digital-difference.

The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius. (NCT01280266)
Timeframe: baseline and 4 weeks

Interventiondegree celcius. (Mean)
Amlodipine-0.7
Udenafil-1.4

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Change in the RP Duration

Change in the average RP duration in minutes (min) per attack. 0 -- unlimited (NCT01280266)
Timeframe: baseline and 4 weeks

Interventionmin per attack (Mean)
Amlodipine-1.1
Udenafil-1.4

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Change in Physician's Global Assessment on Visual Analogue Scale (VAS)

"Physician's global assessment (PGA) on VAS assesses the overall condition of the patient. The scale ranges from 0 - 10, with 0 being good and 10 bad. As such, change in the GPA measures the change in the patient's condition from the baseline.~negative value (decrease in value) means improvement." (NCT01280266)
Timeframe: at 0 (baseline) and 4 weeks (after treatment)

Interventionunits on a scale (Mean)
Amlodipine-0.9
Udenafil-1.5

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Change in Peak Systolic Flow (cm/Sec)

"Change in digital artery flow velocity in proper palmar digital artery in cm/sec.~0-unlimited" (NCT01280266)
Timeframe: baseline and 4 weeks

Interventioncm/sec (Mean)
Amlodipine-19.9
Udenafil63.2

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Time-averaged Peak Velocity (cm/Sec)

changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited. (NCT01280266)
Timeframe: baseline and 4 weeks

Interventioncm/sec (Mean)
Amlodipine-17.3
Udenafil33.4

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Change in Raynaud's Condition Score (RCS)

"change in the RCS. RCS combines daily activty, frequency, duration and severity as well as impact of RP attack (Measuring disease activity and functional status in patients with scleroderma and Raynaud's phenomenon, Merkel et al,Arthritis Rheum. 2002 Sep;46(9):2410-20).~Range 0-10 ordinal scale 0..good 10.. bad" (NCT01280266)
Timeframe: baseline and 4 weeks

Interventionunits on a scale (Mean)
Amlodipine-0.5
Udenafil-0.3

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Changes From the Reference Baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP

Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined (NCT01286558)
Timeframe: Reference baseline, 8 weeks

Interventionmm Hg (Least Squares Mean)
80 mg Telmisartan and 5 mg Amlodipine FDC-2.81
40 mg Telmisartan and 5 mg Amlodipine FDC-0.91

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Seated DBP Response Rate at Trough

DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (<90 mmHg and/or reduction from reference baseline >=10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing (NCT01286558)
Timeframe: 8 weeks

,
Interventionpercentage of participants (Number)
NoYes
40 mg Telmisartan and 5 mg Amlodipine FDC32.167.9
80 mg Telmisartan and 5 mg Amlodipine FDC29.570.5

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Seated SBP Control Rate at Trough

SBP control rate: The rate of patients with controlled seated DBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing (NCT01286558)
Timeframe: 8 weeks

,
Interventionpercentage of participants (Number)
NoYes
40 mg Telmisartan and 5 mg Amlodipine FDC55.344.7
80 mg Telmisartan and 5 mg Amlodipine FDC55.244.8

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Seated SBP Response Rate at Trough

SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (<140 mmHg and/or reduction from reference baseline >=20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing (NCT01286558)
Timeframe: 8 weeks

,
Interventionpercentage of participants (Number)
NoYes
40 mg Telmisartan and 5 mg Amlodipine FDC17.982.1
80 mg Telmisartan and 5 mg Amlodipine FDC19.680.4

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Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM

Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined (NCT01286558)
Timeframe: Reference baseline, 8 weeks

,
Interventionmm Hg (Mean)
Hour 1Hour 2Hour 3Hour 4Hour 5Hour 6Hour 7Hour 8Hour 9Hour 10Hour 11Hour 12Hour 13Hour 14Hour 15Hour 16Hour 17Hour 18Hour 19Hour 20Hour 21Hour 22Hour 23Hour 24
40 mg Telmisartan and 5 mg Amlodipine FDC-0.220.322.87-0.02-0.75-0.86-1.250.55-0.73-0.14-1.16-1.43-1.05-0.081.860.85-0.801.020.10-1.27-0.90-1.67-0.530.42
80 mg Telmisartan and 5 mg Amlodipine FDC-1.04-1.95-2.25-3.69-1.39-1.58-0.40-1.58-2.77-2.80-1.47-0.74-2.33-0.53-0.36-0.010.70-1.89-3.120.23-3.25-2.00-2.07-0.82

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Seated DBP Control Rate at Trough

DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing (NCT01286558)
Timeframe: 8 weeks

,
Interventionpercentage of participants (Number)
NoYes
40 mg Telmisartan and 5 mg Amlodipine FDC60.040.0
80 mg Telmisartan and 5 mg Amlodipine FDC53.146.9

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Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP

Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined (NCT01286558)
Timeframe: Pseudo-baseline, 14 weeks

Interventionmm Hg (Least Squares Mean)
80 mg Telmisartan and 5 mg Amlodipine FDC-20.96
40 mg Telmisartan and 5 mg Amlodipine FDC-19.32

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Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for DBP

Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined (NCT01286558)
Timeframe: Pseudo-baseline, 14 weeks

Interventionmm Hg (Least Squares Mean)
80 mg Telmisartan and 5 mg Amlodipine FDC-12.16
40 mg Telmisartan and 5 mg Amlodipine FDC-11.28

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Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM

Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined (NCT01286558)
Timeframe: Reference baseline, 8 weeks

,
Interventionmm Hg (Mean)
Hour 1Hour 2Hour 3Hour 4Hour 5Hour 6Hour 7Hour 8Hour 9Hour 10Hour 11Hour 12Hour 13Hour 14Hour 15Hour 16Hour 17Hour 18Hour 19Hour 20Hour 21Hour 22Hour 23Hour 24
40 mg Telmisartan and 5 mg Amlodipine FDC-1.78-0.282.72-1.88-2.54-2.48-2.45-0.27-1.17-0.700.690.610.26-1.091.410.68-1.161.01-1.24-3.56-1.20-4.12-2.710.29
80 mg Telmisartan and 5 mg Amlodipine FDC-6.54-2.78-3.41-4.72-1.14-1.68-0.60-2.05-3.09-5.78-2.04-4.57-2.27-1.46-1.21-0.78-0.71-2.66-4.580.57-4.02-3.88-4.65-2.24

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Seated Blood Pressure (BP) Normalisation at Trough

Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing (NCT01286558)
Timeframe: 8 weeks

,
Interventionparticipants (Number)
NoOptimalNormalHigh-normal
40 mg Telmisartan and 5 mg Amlodipine FDC44132629
80 mg Telmisartan and 5 mg Amlodipine FDC41212327

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Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough

Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing (NCT01286558)
Timeframe: Reference baseline, 8 weeks

Interventionmm Hg (Least Squares Mean)
80 mg Telmisartan and 5 mg Amlodipine FDC5.55
40 mg Telmisartan and 5 mg Amlodipine FDC3.41

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Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough

Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing (NCT01286558)
Timeframe: Reference baseline, 8 weeks

Interventionmm Hg (Least Squares Mean)
80 mg Telmisartan and 5 mg Amlodipine FDC4.93
40 mg Telmisartan and 5 mg Amlodipine FDC3.47

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Changes From the Reference Baseline in the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (Relative to Dose Time) for DBP

Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined (NCT01286558)
Timeframe: Reference baseline, 8 weeks

Interventionmm Hg (Least Squares Mean)
80 mg Telmisartan and 5 mg Amlodipine FDC-1.54
40 mg Telmisartan and 5 mg Amlodipine FDC-0.33

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Percentage of Participants Who Had Study Drug Stopped Due to an AE

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug stopped during the 8-week treatment period due to an AE regardless of whether or not they completed the study was summarized by treatment arm (NCT01302691)
Timeframe: up to 8 weeks

InterventionPercentage of Participants (Number)
L50/H12.5/A51.2
L50 + A50.0

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Percentage of Participants Who Experience ≥1 Serious Adverse Event (SAE)

An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. The percentage of participants who experienced at least 1 SAE during the 10-week treatment and follow-up period were summarized by study drug received. (NCT01302691)
Timeframe: up to 14 days after last dose of study drug (up to 10 weeks)

InterventionPercentage of Participants (Number)
L50/H12.5/A50.6
L50 + A50.6

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Percentage of Participants Who Experience ≥1 Adverse Event (AE)

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced at least 1 AE during the 10-week treatment and follow-up period were summarized by study drug received. (NCT01302691)
Timeframe: up to 14 days after last dose of study drug (up to 10 weeks)

InterventionPercentage of Participants (Number)
L50/H12.5/A530.5
L50 + A528.8

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Change in Mean Trough Sitting Systolic Blood Pressure (SiSBP)

Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm. (NCT01302691)
Timeframe: Baseline and Week 8

InterventionmmHg (Least Squares Mean)
L50/H12.5/A5-13.4
L50 + A5-10.2

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Change in Mean Trough Sitting Diastolic Blood Pressure (SiDBP)

Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm. (NCT01302691)
Timeframe: Baseline and Week 8

InterventionmmHg (Least Squares Mean)
L50/H12.5/A5-9.1
L50 + A5-8.0

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Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Overall

"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health." (NCT01316419)
Timeframe: baseline and 24±2 weeks

Interventionscores on a scale (Mean)
Twynsta (Telmisartan and Amlodipine FDC) Tablets0.03

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Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg.

Percentage of patients achieving target blood pressure SBP/DBP <140/90 mmHg is a key secondary endpoint. (NCT01316419)
Timeframe: 24±2 weeks

Interventionpercentage of participants (Number)
Twynsta (Telmisartan and Amlodipine FDC) Tablets74.07

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Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks

Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks (NCT01316419)
Timeframe: 24±2 weeks

Interventionpercentage of participants (Number)
Physical activityWell balanced dietDietary sodium reductionModeration of alcohol consumption
Twynsta (Telmisartan and Amlodipine FDC) Tablets77.2187.3876.0983.49

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Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Environment Domain

"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health." (NCT01316419)
Timeframe: baseline and 24±2 weeks

Interventionscores on a scale (Mean)
Twynsta (Telmisartan and Amlodipine FDC) Tablets0.12

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Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Physical Health Domain

"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health." (NCT01316419)
Timeframe: baseline and 24±2 weeks

Interventionscores on a scale (Mean)
Twynsta (Telmisartan and Amlodipine FDC) Tablets0.07

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Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Psychological Domain

"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health." (NCT01316419)
Timeframe: baseline and 24±2 weeks

Interventionscores on a scale (Mean)
Twynsta (Telmisartan and Amlodipine FDC) Tablets0.11

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Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Social Relationships Domain

"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health." (NCT01316419)
Timeframe: baseline and 24±2 weeks

Interventionscores on a scale (Mean)
Twynsta (Telmisartan and Amlodipine FDC) Tablets-0.04

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EuroQol (EQ) Visual Analogue Scale (VAS)

The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'best imaginable health state' and 'worst imaginable health state. The scale goes from 0 to 100, a low value shows better physical health. (NCT01316419)
Timeframe: baseline and 24±2 weeks

Interventionscores on a scale (Mean)
Twynsta (Telmisartan and Amlodipine FDC) Tablets4.64

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Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol

Mean blood lipid change from baseline - high density lipoprotein (HDL)-Cholesterol (NCT01316419)
Timeframe: baseline and 24±2 weeks

Interventionmg/dl (Mean)
Twynsta (Telmisartan and Amlodipine FDC) Tablets0.44

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Mean Blood Lipid Change - Low Density Lipoprotein (LDL)-Cholesterol

Mean blood lipid change from baseline - low density lipoprotein (LDL)-Cholesterol (NCT01316419)
Timeframe: baseline and 24±2 weeks

Interventionmg/dl (Mean)
Twynsta (Telmisartan and Amlodipine FDC) Tablets-9.17

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Mean Blood Lipid Change - Total Cholesterol

Mean blood lipid change - Total Cholesterol (NCT01316419)
Timeframe: baseline and 24±2 weeks

Interventionmg/dl (Mean)
Twynsta (Telmisartan and Amlodipine FDC) Tablets-9.62

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Mean Blood Lipid Change - Triglyceride

Mean blood lipid change - Triglyceride (NCT01316419)
Timeframe: baseline and 24±2 weeks

Interventionmg/dl (Mean)
Twynsta (Telmisartan and Amlodipine FDC) Tablets-3.76

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Mean Blood Pressure Change Diastolic Blood Pressure (DBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal.

"The primary endpoint is the mean blood pressure change DBP from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal.~Baseline is defined as data collected on baseline visit." (NCT01316419)
Timeframe: baseline and 24±2 weeks

InterventionmmHg (Mean)
Twynsta (Telmisartan and Amlodipine FDC) Tablets-13.48

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Mean Blood Pressure Change Systolic Blood Pressure (SBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal.

"The primary endpoint is the mean blood pressure change SBP from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal.~Baseline is defined as data collected on baseline visit." (NCT01316419)
Timeframe: baseline and 24±2 weeks

InterventionmmHg (Mean)
Twynsta (Telmisartan and Amlodipine FDC) Tablets-21.81

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Percentage of Patients Achieving DBP Response

Percentage of patients achieving DBP response (defined as mean seated DBP < 90 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint. (NCT01316419)
Timeframe: 24±2 weeks

Interventionpercentage of participants (Number)
Twynsta (Telmisartan and Amlodipine FDC) Tablets88.99

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Percentage of Patients Achieving Normal Body Mass Index (BMI)

Percentage of patients achieving normal BMI (18.5 kg/sq.m to 24.9 kg/sq.m) are presented (NCT01316419)
Timeframe: 24±2 weeks

Interventionpercentage of participants (Number)
Twynsta (Telmisartan and Amlodipine FDC) Tablets45.62

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Percentage of Patients Achieving SBP Response

Percentage of patients achieving SBP response (defined as mean seated SBP < 140 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint. (NCT01316419)
Timeframe: 24±2 weeks

Interventionpercentage of participants (Number)
Twynsta (Telmisartan and Amlodipine FDC) Tablets87.18

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Incidence and Severity of Reported Adverse Events.

Incidence as per the severity of reported adverse events is presented. (NCT01316419)
Timeframe: 24±2 weeks

Interventionparticipants (Number)
MildModerateSevere
Twynsta (Telmisartan and Amlodipine FDC) Tablets220739

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Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease

Percentage of patients achieving SBP/DBP < 130/80 mmHg among patients with diabetes or kidney disease (NCT01316419)
Timeframe: 24±2 weeks

Interventionpercentage of participants (Number)
Diabetes (N=269)Kidney Disease (N=20)Diabetes + Kidney disease (N=10)
Twynsta (Telmisartan and Amlodipine FDC) Tablets41.2640.0050.00

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Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks

Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks (NCT01316419)
Timeframe: 12±2 weeks

Interventionpercentage of participants (Number)
Physical activityWell balanced dietDietary sodium reductionModeration of alcohol consumption
Twynsta (Telmisartan and Amlodipine FDC) Tablets71.8784.3371.0882.38

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Steady-state Area Under the Plasma Concentration Versus Time Curve (AUC0-24hr) for MK-4618

Blood samples were collected on Day 7 predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose for the determination of plasma MK-4618 concentration. The hypothesis for this outcome is that the steady-state AUC0-24hr for MK-4618 is >=0.47 uM*hr. (NCT01337674)
Timeframe: Predose and up to 24 hours postdose on Day 7

InterventionuM*hr (Geometric Mean)
Panel A: MK-4618 + Met2.60
Panel B: MK-4618 + Amlo4.60

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Maximum Change From Baseline in Semi-recumbent and Standing Systolic Blood Pressure: Panel A

Semi-recumbent and standing systolic blood pressure was measured predose and at intervals up to 24 hours postdose on Day 1 and Day 7. The baseline value is the average of measurements taken in the hour before dosing. Participants were to rest quietly in a semi-recumbent position for at least 10 minutes before each semi-recumbent measurement. (NCT01337674)
Timeframe: Baseline (predose) and up to 24 hours postdose on Day 1 and Day 7

,
InterventionmmHg (Mean)
Semi-recumbent, Day 1Semi-recumbent, Day 7Standing, Day 1Standing, Day 7
Panel A: MK-4618 + Met16.0314.3814.796.12
Panel A: PBO + Met17.2512.1013.147.21

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Maximum Change From Baseline in Semi-recumbent and Standing Systolic Blood Pressure: Panel B

Semi-recumbent and standing systolic blood pressure was measured predose and at intervals up to 24 hours postdose on Day 1 and Day 7. The baseline value is the average of measurements taken in the hour before dosing. Participants were to rest quietly in a semi-recumbent position for at least 10 minutes before each semi-recumbent measurement. (NCT01337674)
Timeframe: Baseline (predose) and up to 24 hours postdose on Day 1 and Day 7

,
InterventionmmHg (Mean)
Semi-recumbent, Day 1Semi-recumbent, Day 7Standing, Day 1Standing, Day 7
Panel B: MK-4618 + Amlo14.6910.526.506.33
Panel B: PBO + Amlo12.7416.4312.757.90

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Percentage of Participants With a Clinical or Laboratory Adverse Experience

An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product is also an adverse experience. The percentage of participants with a clinical or laboratory adverse experience was recorded. (NCT01337674)
Timeframe: Up to 42 days

InterventionPercentage of participants (Number)
Panel A: MK-4618 + Met33.3
Panel A: PBO + Met53.8
Panel B: MK-4618 + Amlo41.7
Panel B: PBO + Amlo61.5

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Change From Baseline in Mean Sitting Diastolic Blood Pressure (MsDBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)

Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit. (NCT01365481)
Timeframe: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)

Interventionmillimeter(s) of mercury (mmHg) (Mean)
Valsartan + Antihypertensive Group-10.3
Valsartan Alone-10.8

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Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)

Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit. (NCT01365481)
Timeframe: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)

Interventionmillimeter(s) of mercury (mmHg) (Mean)
Valsartan + Antihypertensive Group-13.3
Valsartan Alone-15.5

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Percentage of Chronic Kidney Disease (CKD) Patients Who Had >=50% Reduction in Urine Albumin/Creatinine Ratio (UACR) From Baseline to End Point

Percentage of Patients with CKD who had Urine albumin creatinine reduction >/= 50% from baseline (NCT01365481)
Timeframe: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)

InterventionPercentage of patients (Number)
Valsartan + Antihypertensive Group50.0
Valsartan Alone41.9

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Percentage of Chronic Kidney Disease (CKD) Patients Who Had Estimated Glomerular Filtration Rate (eGFR) Decrease > 25 % From Baselinefrom Baseline to End Point

Percentage of Patients with CKD who had eGFR decrease > 25 % from Baseline (NCT01365481)
Timeframe: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)

InterventionPercentage of patients (Number)
Valsartan + Antihypertensive Group30.4
Valsartan Alone27.5

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Number of Participants With MSSBP, MSDBP and (MSSBP and MSDBP Combined) < 95th Percentile for Gender, Age, and Height

Number of Participants with Mean sitting systolic (MSSBP) and mean sitting diastolic(MSDBP) blood pressure and both combined less than the 95th percentile for age, gender and height (NCT01365481)
Timeframe: End Point (Week 78 or Last observation carried forward (LOCF)

,
InterventionNumber of Participants (Number)
MSSBP (n=39, 105)MSDBP (n=28, 51)MSSBP and MSDBP combined (n=40, 105)
Valsartan + Antihypertensive Group232022
Valsartan Alone904788

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Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone

(NCT01368536)
Timeframe: 12 weeks

,,
InterventionParticipants (Number)
Adverse EventsSerious Adverse EventsDeath
Valturna6200
Valturna + Amlodipine5400
Valturna + Chlorthalidone5800

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Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).

(NCT01556997)
Timeframe: Day 0 to Day 42

InterventionmmHg (Mean)
XOMA 985-23.4
Amlodipine Besylate (AMLb)-19.6
Perindopril Erbumine (PERe)-13.4

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Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).

(NCT01556997)
Timeframe: Day 0 to Day 42

InterventionmmHg (Mean)
XOMA 985-15.7
Amlodipine Besylate (AMLb)-13.2
Perindopril Erbumine (PERe)-9.5

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Number of Participants With Adverse Events, Serious Adverse Events and Deaths

Adverse event monitoring was conducted throughout the study. (NCT01631864)
Timeframe: 8 weeks

,
InterventionParticipants (Number)
Adverse events (serious and non-serious)Serious adverse eventsDeaths
Amlodipine3710
LCZ6963010

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Change From Baseline in Insulin Sensitivity Index

The insulin sensitivity index was assessed by hyperinsulinemic euglycemic clamp (HEGC). A positive change from baseline indicates improvement. (NCT01631864)
Timeframe: baseline, 8 weeks

Interventionug/kg*min/(mmol/L*pmol/L) (Mean)
LCZ6960.192
Amlodipine0.065

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Oxidative Metabolism

Oxidative metabolism was assessed by indirect calorimetry. (NCT01631864)
Timeframe: 57 days

Interventioncarbon dioxide to oxygen ratio (Least Squares Mean)
LCZ6960.787
Amlodipine0.775

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Local Adipose Tissue Lipolysis, Glycerol Concentrations

Lipolysis was assessed through subcutaneous adipose tissue microdialysis. The actual measure type is adjusted geometric mean. (NCT01631864)
Timeframe: 57 days

Interventionmicro mol/L (Geometric Mean)
LCZ69682.46
Amlodipine65.91

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Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic

At each study visit (approximately every 30 days), participants' BP will be checked. If BP is controlled (<140mmHG systolic and <90mmHG diastolic), then current medication will continue. If BP is uncontrolled, medication will be revised every 30 days (up to 120) until BP control is achieved. (NCT01658657)
Timeframe: 4 months

Interventionparticipants (Number)
PRA-guided Therapy3
Fixed-dose Combination Treatment-guided Therapy1

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Number of Participants Achieving Successful Response in msDBP (< 90 mmHg or a Reduction ≥ 10 mmHg From Baseline)

The number of participants who achieved successful treatment response in msDBP of < 90mmHg or a reduction ≥ 10mmHg from baseline after completing study treatment was measured. Participants who achieved either of the above targets were deemed as having a successful response. (NCT01663233)
Timeframe: 8 weeks of treatment

InterventionParticipants (Number)
LCZ696 and Amlodipine112
Amlodipine95

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Number of Participants Achieving Successful Response in msSBP (< 140 mmHg or a Reduction ≥ 20 mmHg From Baseline)

The number of participants who achieved successful treatment response in the msSBP of < 140mmHg or a reduction ≥ 20 mmHg from baseline after completing study treatment was measured. Participants who achieved either of the above targets were deemed as a having a successful response. (NCT01663233)
Timeframe: 8 weeks

InterventionParticipants (Number)
LCZ696 and Amlodipine98
Amlodipine53

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Number of Participants Achieving Systolic and Diastolic Blood Pressure Control (< 140/90 mmHg)

The number of participants achieving a systolic and diastolic blood pressure < 140/90 mmHg was measured. This outcome measure shows how well a given blood pressure treatment can achieve a given blood pressure target or goal. Participants who achieved the target blood pressure were determined based on the mean SBP and DBP measurements taken at the end of the study. If the participants' BP measurement was below the above target, they were considered to have successful blood pressure control. (NCT01663233)
Timeframe: 8 weeks

InterventionParticipants (Number)
LCZ696 and Amlodipine89
Amlodipine46

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Number of Participants With Adverse Event

Participants were monitored for adverse events, serious adverse events and death. (NCT01663233)
Timeframe: 8 weeks

,
InterventionParticipants (Number)
Adverse Events (serious and non-serious)Serious Adverse EventsDeaths
Amlodipine2900
LCZ696 and Amlodipine2600

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Change in Mean 24-hour ABPM Diastolic Blood Pressure (maDBP)

The change in mean 24 hour maDBP from baseline to end of the study was measured. A reduction from baseline indicates a positive treatment effect. (NCT01663233)
Timeframe: 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 and Amlodipine-8.03
Amlodipine-0.33

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Change in Mean Sitting Diastolic Blood Pressure (msDBP)

The change in the patient's msDBP from baseline to end of the study was measured. A reduction from baseline indicates a positive treatment effect. (NCT01663233)
Timeframe: 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 and Amlodipine-9.22
Amlodipine-3.96

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Change in Mean Sitting Systolic Blood Pressure (msSBP)

The change in the patient's msSBP from baseline to end of the study was measured. A reduction from baseline indicates a positive treatment effect. (NCT01663233)
Timeframe: 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 and Amlodipine-19.60
Amlodipine-9.34

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Change in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (maSBP)

The change in mean 24 hour ambulatory systolic blood pressure (maSBP) from baseline to end of the study (week 8) in the 2 groups was measured. A greater reduction from baseline in the LCZ696 group indicates a positive treatment effect. (NCT01663233)
Timeframe: 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 and Amlodipine-13.93
Amlodipine-0.82

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Change in Sitting Pulse Pressure (PP)

The change in the patient's mean sitting PP from baseline to end of the study was measured. Pulse pressure measures the difference in mean sitting systolic blood pressure and mean sitting diastolic blood pressure. (NCT01663233)
Timeframe: 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 and Amlodipine-10.31
Amlodipine-5.46

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Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

At the first study visit, the patient had his/her blood pressure (BP) measured in both arms; the arm in which the highest sitting SBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit. (NCT01692301)
Timeframe: baseline, 12 weeks, and 52 weeks

,
InterventionmmHg (Least Squares Mean)
Baseline to week 12 (n=226, 222)Baseline to week 52 (n=226,223)
LCZ696 (Sacubitril/Valsartan)-20.84-23.91
Olmesartan-14.57-21.45

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Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 12 Weeks

"Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software.~At the first study visit, the arm with the highest systolic blood pressure (SBP) was used for all subsequent PWA. Brachial PWA measurements were performed on the same arm that the office blood pressures were taken. Two pulse waveform measurements, meeting all quality control criteria were captured at baseline and at week 12 visits." (NCT01692301)
Timeframe: baseline, 12 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 (Sacubitril/Valsartan)-12.57
Olmesartan-8.90

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Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 52 Weeks

"Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software.~At the first study visit, the arm with the highest systolic blood pressure (SBP) was used for all subsequent PWA. Brachial PWA measurements were performed on the same arm that the office blood pressures were taken. Two pulse waveform measurements, meeting all quality control criteria were captured at baseline and at week 12 visits." (NCT01692301)
Timeframe: baseline, 52 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 (Sacubitril/Valsartan)-16.18
Olmesartan-14.70

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Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (maPP)

Mean 24 hour ambulatory pulse pressure was calculated as the difference between the mean 24 hour systolic and diastolic ambulatory blood pressure in corresponding visits i.e. baseline, week 12 and week 52. (NCT01692301)
Timeframe: Baseline, 12 weeks, and 52 weeks

,
InterventionmmHg (Least Squares Mean)
Baseline to Week 12 (n=164, 162 )Baseline to week 52 (n=174, 176)
LCZ696 (Sacubitril/Valsartan)-5.77-5.26
Olmesartan-3.69-5.91

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Change From Baseline in Mean 24-hour Diastolic Blood Pressure (maDBP)

An Ambulatory Blood Pressure Monitor (ABPM) measured a participant's blood pressure over a 24 hour period using an automated validated monitoring device at baseline, week 12 and at week 52 starting one day before each visit. The 24 hour maDBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24 hour period. (NCT01692301)
Timeframe: Baseline, 12 weeks, and 52 weeks

,
InterventionmmHg (Least Squares Mean)
Baseline to week 12 (n= 164, 162)Baseline to week 52 (n= 174, 176)
LCZ696 (Sacubitril/Valsartan)-7.44-8.85
Olmesartan-5.48-8.44

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Change From Baseline in Mean Arterial Pressure (MAP)

Mean arterial pressure (MAP) was calculated from mean sitting systolic BP (msSBP) and mean sitting diastolic BP (msDBP) as (2 * msDBP + msSBP)/3. (NCT01692301)
Timeframe: baseline, 12 weeks, and 52 weeks

,
InterventionmmHg (Least Squares Mean)
Baseline to week 12 (n=226, 222)Baseline to week 52 (n=226, 223)
LCZ696 (Sacubitril/Valsartan)-12.19-13.92
Olmesartan-8.57-12.38

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Change From Baseline in Mean Central Pulse (CPP) Pressure

(NCT01692301)
Timeframe: Baseline, 12 weeks, and 52 weeks

,
InterventionmmHg (Least Squares Mean)
Baseline to Week 12 (n = 207, 206)Baseline to Week 52 (n = 209, 208)
LCZ696 (Sacubitril/Valsartan)-6.41-7.16
Olmesartan-3.96-6.65

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Change From Baseline in Mean Pulse Wave Velocity (PWV)

"Pulse wave velocity recordings were performed on patient while in a supine, face-up position.~Tonometry was performed on the carotid simultaneously with the cuff inflation over the femoral artery. Two pulse wave velocity measures, meeting all quality control criteria were captured at baseline, week 12 and week 52." (NCT01692301)
Timeframe: baseline, 12 weeks, and 52 weeks

,
Interventionmeter/second (Least Squares Mean)
Baseline to week 12 (n= 192, 196)Baseline to week 52 ( n= 199, 199)
LCZ696 (Sacubitril/Valsartan)-0.68-0.83
Olmesartan-0.570.77

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Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

At the first study visit, the patient had his/her blood pressure (BP) measured in both arms; the arm in which the highest sitting SBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, DBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit. (NCT01692301)
Timeframe: baseline, 12 weeks, and 52 weeks

,
InterventionmmHg (Least Squares Mean)
Baseline to week 12 (n=226, 222)Baseline to week 52 (n=226,223)
LCZ696 (Sacubitril/Valsartan)-7.86-8.92
Olmesartan-5.58-7.85

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Change From Baseline in Mean Sitting Pulse Pressure (msPP)

Mean sitting pulse pressure for each patient and visit was calculated as the difference between the calculated values of mean sitting systolic blood pressure and mean sitting diastolic blood pressure. (NCT01692301)
Timeframe: baseline, 12 weeks, and 52 weeks

,
InterventionmmHg (Least Squares Mean)
Baseline to week 12 (n=226,222)Baseline to week 52 (n= 226, 223)
LCZ696 (Sacubitril/Valsartan)-13.13-15.02
Olmesartan-8.86-13.58

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Change From Baseline in Mean 24-hour Systolic Blood Pressure (maSBP)

An Ambulatory Blood Pressure Monitor (ABPM) measured a participant's blood pressure over a 24 hour period using an automated validated monitoring device at baseline, week 12 and at week 52 starting one day before each visit. The 24 hour maSBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24 hour period. (NCT01692301)
Timeframe: Baseline, 12 weeks, and 52 weeks

,
InterventionmmHg (Least Squares Mean)
Baseline to week 12 (n= 164, 162)Baseline to week 52 (n= 174, 176)
LCZ696 (Sacubitril/Valsartan)-13.25-14.15
Olmesartan-9.14-14.32

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Change in Nocturnal Diastolic Blood Pressure Level

Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) (NCT01762501)
Timeframe: Baseline and 8 weeks

InterventionmmHg (Mean)
Azilsartan-7.1
Amlodipine-8.9

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Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall**

"Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) *The targeted value has been set as the median of the dipping rate, normal type of nocturnal blood pressure variation, rate of nocturnal blood pressure fall (10-20 percent)~** Rate of nocturnal blood pressure fall: calculated as (awake SBP-sleep SBP)/awake SBP" (NCT01762501)
Timeframe: Baseline and 8 weeks

,
InterventionmmHg (Mean)
risernon-dipperdipperextreme dipper
Amlodipine-10.1-2.13.1-3.1
Azilsartan-7.3-0.74.5-1.9

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Change in Nocturnal Systolic Blood Pressure Level

"Change at the end of a treatment period (Week 8) from the beginning point of an observation period~*Nocturnal systolic blood pressure level: the mean value of systolic arterial pressure during night (during sleeping)" (NCT01762501)
Timeframe: Baseline and 8 weeks

InterventionmmHg (Mean)
Azilsartan-12.6
Amlodipine-17.5

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Change in 24-hour Mean Systolic Blood Pressure Level

Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) (NCT01762501)
Timeframe: Baseline and 8 weeks

InterventionmmHg (Mean)
Azilsartan-14.0
Amlodipine-17.5

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Change in 24-hour Mean Diastolic Blood Pressure Level

Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) (NCT01762501)
Timeframe: Baseline and 8 weeks

InterventionmmHg (Mean)
Azilsartan-7.9
Amlodipine-8.9

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Maximum Observed Concentration (Cmax) of Raltegravir and Amlodipine Without and With Co-administration of the Other Studied Drug.

"To investigate the pharmacokinetics of raltegravir and amlodipine co-administration. The pharmacokinetic parameters calculated for raltegravir and amlodipine will be trough concentration (Ctrough), defined as the concentration at 24 hours after the observed drug dose, the maximum observed plasma concentration (Cmax), elimination half-life (t1/2), time point at Cmax (Tmax), and total drug exposure, expressed as the area under the plasma concentration-time curve from 0-24 hours after dosing (AUC0-24h).~All pharmacokinetic parameters will be calculated using non-compartmental modeling techniques (WinNonlin®) and all statistical calculations performed and analyzed using SAS version 9.1 or SPSS V17.0." (NCT01841593)
Timeframe: Day 7 of each intervention (0 (pre-dose), 2, 4, 8 and 12 hours post dose (both drugs) and 24 hours post dose (amlodipine only))

Interventionng/mL (Geometric Mean)
Raltegravir PK (Alone)1178
Raltegravir PK (Administered With Amlodipine)1866
Amlodipine PK (Alone)8.47
Amlodipine PK (Administered With Raltegravir)8.49

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Raltegravir AUC(0-12h )

AUC0-12h: Area under the concentration time curve over 12 hours in the absence, and presence, of amlodipine. (NCT01841593)
Timeframe: Post dose after day 7 of daily dosing

Interventionng*h/mL (Geometric Mean)
Raltegravir PK (Alone)4600
Raltegravir PK (Administered With Amlodipine)6410

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Raltegravir C12h

measured concentration 12 hours after dose in the absence, and presence, of amlodipine. (NCT01841593)
Timeframe: 12 hours post-dose on day 7 of daily dosing.

Interventionng/mL (Geometric Mean)
Raltegravir PK (Alone)48
Raltegravir PK (Administered With Amlodipine)37

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Amlodipine AUC(0-24h)

AUC0-24h: Area under the concentration time curve 24 hours in the absence, and presence, of raltegravir (NCT01841593)
Timeframe: Post-dose on day 7 of daily dosing

Interventionng*h/mL (Geometric Mean)
Amlodipine PK (Alone)166.0
Amlodipine PK (Administered With Raltegravir)165.9

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Amlodipine C24h

measured concentration 24 hours after dose in the absence, and presence, of raltegravir (NCT01841593)
Timeframe: 12 hours post-dose on day 7 of daily dosing.

Interventionng/mL (Geometric Mean)
Amlodipine PK (Alone)4.91
Amlodipine PK (Administered With Raltegravir)4.55

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Change From Baseline in Local Aortic Strain at 52 Weeks

Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic strain. Local aortic strain was measured by assessing ascending aorta strain, proximal descending aorta strain and distal descending aorta strain. (NCT01870739)
Timeframe: Baseline, 52 weeks

,
Interventionpercent (Least Squares Mean)
Ascending Aorta StrainProximal Descending Aorta StrainDistal Descending Aorta Strain
Olmesartan0.453-0.0660.225
Sacubitril/Valsartan (LCZ696)-0.830-0.284-1.092

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Change From Baseline in Augmentation Index at 52 Weeks

Augmentation index (Alx) is the percentage of the central pulse pressure due to wave reflection. (NCT01870739)
Timeframe: Baseline, 52 weeks

Interventionpercent (Least Squares Mean)
Sacubitril/Valsartan (LCZ696)-2.385
Olmesartan-1.515

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Change From Baseline in Augmentation Pressure at 52 Weeks

Augmentation pressure is the added pressure during systole due to wave reflection. (NCT01870739)
Timeframe: Baseline, 52 weeks

InterventionmmHg (Least Squares Mean)
Sacubitril/Valsartan (LCZ696)-2.443
Olmesartan-1.437

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Change From Baseline in Carotid-femoral Pulse Wave Velocity at 52 Weeks

For pulse wave velocity calculation, the pressure waveform at the femoral site (using a partially inflated custom blood pressure cuff) and the carotid site (using hand -held applanation tonometry) were measured simultaneously. Pulse wave analysis was performed on the central aortic pressure waveform as derived from the brachial pressure waveform recorded in a partially-inflated blood pressure cuff around the upper arm. (NCT01870739)
Timeframe: Baseline, 52 weeks

Interventionmeters per second (m/s) (Least Squares Mean)
Sacubitril/Valsartan (LCZ696)-0.428
Olmesartan-0.434

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Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks

Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Distal descending aorta distensibility was one of the 3 components for measuring local arota distensibility. (NCT01870739)
Timeframe: Baseline, 52 weeks

Intervention10^(-3) x mmHg^(-1) (Least Squares Mean)
Sacubitril/Valsartan (LCZ696)0.417
Olmesartan0.498

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Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks

Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Proximal descending aorta distensibility was one of the 3 components for measuring local arota distensibility. (NCT01870739)
Timeframe: Baseline, 52 weeks

Intervention10^(-3) x mmHg^(-1) (Least Squares Mean)
Sacubitril/Valsartan (LCZ696)0.510
Olmesartan0.547

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Change From Baseline in Regional Aortic Pulse Wave Velocity at 52 Weeks

Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of regional aortic pulse wave velocity. (NCT01870739)
Timeframe: Baseline, 52 weeks

Interventionmeters per second (m/s) (Least Squares Mean)
Sacubitril/Valsartan (LCZ696)-2.086
Olmesartan-1.085

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Change From Baseline in Central Blood Pressure at 52 Weeks

Central blood pressure was determined by measuring central systolic blood pressure , diastolic blood pressure and pulse pressure. (NCT01870739)
Timeframe: Baseline, 52 weeks

,
InterventionmmHg (Least Squares Mean)
Central systolic blood pressureCentral diastolic blood pressureCentral pulse pressure
Olmesartan-13.625-10.432-3.041
Sacubitril/Valsartan (LCZ696)-16.655-10.318-6.539

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Change From Baseline in Ascending Aorta Distensibility at 52 Week

Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Ascending aorta distensibility was one of the 3 components for measuring local arota distensibility. (NCT01870739)
Timeframe: Baseline, 52 weeks

Intervention10^(-3) x mmHg^(-1) (Least Squares Mean)
Sacubitril/Valsartan (LCZ696)0.269
Olmesartan0.330

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Number of Patients With Reported Adverse Events, Serious Adverse Events and Death

This outcome measure summarizes patients with any adverse events, serious adverse events and death. (NCT01870739)
Timeframe: 12 weeks

,,,,,
InterventionPatients (Number)
Any Adverse eventsSerious Adverse EventsDeath
Initiation Dose : Sacubitril/Valsartan (LCZ696 200mg)1300
Initiation Dose: Olmesartan 20mg1620
Maintenance Dose: Olmesartan 40 mg2820
Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)2100
Olmesartan 40mg +/- Amlodipine3850
Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine3160

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The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks of Extension Period.

"The number of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.~The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'." (NCT01911780)
Timeframe: Reference baseline (week 0) and week 60 (end of extension period)

,
InterventionParticipants (Number)
YesNo
Telmisartan + HCTZ + Amlodipine4124
Telmisartan + HCTZ + Placebo3328

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The Percentage of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 8 Weeks of Double-blind Period.

The percentage of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'. (NCT01911780)
Timeframe: Double-blind and 8 weeks

InterventionParticipants (Number)
Telmisartan + HCTZ + Amlodipine44.8
Telmisartan + HCTZ + Placebo21.9

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Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the Extension Period.

"Change from baseline in mean seated diastolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.~The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'." (NCT01911780)
Timeframe: Reference baseline (week 0) and week 60 (end of extension period)

,
InterventionmmHg (Mean)
MeanAdjusted mean
Telmisartan + HCTZ + Amlodipine + Ext-11.4-10.9
Telmisartan + HCTZ + Placebo + Ext-10.0-10.5

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Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.

Change from baseline in mean seated diastolic blood pressure (DBP) at trough (24-hour post dosing) after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'. (NCT01911780)
Timeframe: baseline and 8 weeks

InterventionmmHg (Mean)
Telmisartan + HCTZ + Amlodipine-8.8
Telmisartan + HCTZ + Placebo-1.3

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Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.

Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'. (NCT01911780)
Timeframe: baseline and 8 weeks

InterventionmmHg (Mean)
Telmisartan + HCTZ + Amlodipine-10.6
Telmisartan + HCTZ + Placebo-2.1

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Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the Extension Period.

"Change from baseline in mean seated systolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.~The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'." (NCT01911780)
Timeframe: Reference baseline (week 0) and week 60 (end of extension period)

,
InterventionmmHg (Mean)
MeanAdjusted mean
Telmisartan + HCTZ + Amlodipine + Ext-14.8-13.6
Telmisartan + HCTZ + Placebo + Ext-14.3-15.9

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Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.

Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints. (NCT01975246)
Timeframe: baseline and week 8

InterventionmmHg (Mean)
Telmisartan and Amlodipine+HCTZ-8.4
Telmisartan+Amlodipine-4.5

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The Proportion of Patients With DBP<90 mmHg and SBP<140 mmHg as Seated Blood Pressure at Trough After 8 Weeks of the Double-blind Period

Patients with trough seated DBP =>90 mmHg or trough seated SBP >=140 mmHg at baseline were analysed. (NCT01975246)
Timeframe: baseline and week 8

Interventionpercentage of participants (Number)
Telmisartan and Amlodipine+HCTZ51.7
Telmisartan+Amlodipine36.9

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Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.

Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints. (NCT01975246)
Timeframe: baseline and week 8

InterventionmmHg (Mean)
Telmisartan and Amlodipine+HCTZ-12.3
Telmisartan+Amlodipine-6.9

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Mean Reduction In Systolic Blood Pressure (SBP) After 18 Weeks of Treatment From Baseline

Baseline was defined as the latest SBP under monotherapy. (NCT01977794)
Timeframe: Baseline, Week 18

,
Interventionmillimeters of mercury (mmHg) (Mean)
BaselineChange at Week 18
Amlodipine Failed Group150.6-24.7
Bisoprolol Failed Group151.6-25.9

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Percentage of Subjects With Controlled Blood Pressure

(NCT01977794)
Timeframe: Baseline up to Week 18

,
Interventionpercentage of subjects (Number)
Week 6Week 12Week 18
Amlodipine Failed Group85.686.886.7
Bisoprolol Failed Group80.887.989.0

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Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Discontinuation and AEs Leading to Death

An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs was AEs that started or worsened in severity on or after the date of first dose of IMP until the end of the study. AEs leading to death and discontinued were also presented. (NCT01977794)
Timeframe: Baseline up to Day 127 (end of trial)

,
Interventionsubjects (Number)
TEAEsSerious TEAEsAEs leading to discontinuationAEs leading to death
Amlodipine Failed Group78131
Bisoprolol Failed Group71231

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Change From Baseline in Heart Rate (HR) After 18 Weeks of Treatment

Baseline was defined as the latest HR before study treatment administration (NCT01977794)
Timeframe: Baseline, Week 18

,
Interventionbeats per minute (Mean)
BaselineChange from baseline at Week 18
Amlodipine Failed Group73.6-11.5
Bisoprolol Failed Group69.9-6.6

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Change From Baseline in Diastolic Blood Pressure (DBP) After 18 Weeks of Treatment

Baseline was defined as the latest DBP before study treatment administration. (NCT01977794)
Timeframe: Baseline, Week 18

,
InterventionmmHg (Mean)
BaselineChange at Week 18
Amlodipine Failed Group90.5-13.0
Bisoprolol Failed Group92.0-14.0

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Muscle Sympathetic Nerve Activity During Exercise

measurement of sympathetic nerve activity by microneurography (intraneural microelectrodes) during arm cycling exercise (NCT01996449)
Timeframe: 8 weeks post treatment initiation

Interventionbursts/minute (Mean)
Amlodipine47
Eplerenone51

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Muscle Sympathetic Nerve Activity at Rest

measurement of sympathetic nerve activity by microneurography (intraneural microelectrodes) (NCT01996449)
Timeframe: 8 weeks post treatment initiation

Interventionbursts/minute (Mean)
Amlodipine41
Eplerenone43.8

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Insulin Secretion

Hyperglycemic clamp- acute insulin response (AIR) during time 0-10 minutes (NCT02034435)
Timeframe: After 8 days of diet or drug

InterventionuU/mL*10min (Median)
Aim 1- Low Sodium293.1
Aim 1- High Sodium234.7
Aim 2- Eplerenone330.8
Aim 2- Amlodipine300.4

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Insulin Sensitivity

Hyperinsulinemic clamp- glucose infusion rate during insulin administration (NCT02034435)
Timeframe: after 8 days of diet or medication

Interventionmg/kg/min (Median)
Aim 1- Low Sodium6.6
Aim 1- High Sodium6.9
Aim 2- Eplerenone6.4
Aim 2- Amlodipine6.3

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Change in Urine Microalbumin Creatinine Ratio

Kidney function will be assessed throughout the study to assess changes in function prior to the washout of ACE/ARB medication and reintroduction of the ACE/ARB medication. (NCT02046395)
Timeframe: Visit 1 (Baseline), Visit 3 (Day 60)

Interventionmg/g (Mean)
Alternate Antihypertensive Arm15

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Change in the Level of Urinary Free Light Chains

In relation to kidney function and washout/reintroduction of ACE/ARB medication the level of urinary free light chains will be assessed. (NCT02046395)
Timeframe: Visit 1 (Baseline), Visit 3 (Day 60)

Interventionmg/g (Mean)
Alternate Antihypertensive Arm1.14

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Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8

Change in systolic blood pressure measured in office from baseline at week 4 and 8. (NCT02062645)
Timeframe: baseline, week 4, week 8

InterventionmmHg (Mean)
Systolic blood pressure (SBP) Day 0 (n=100)Systolic blood pressure (SBP) Week 4 (n=100)Systolic blood pressure (SBP) Week 8 (n=91)Systolic blood pressure (SBP) Week 8 LOCF (n=100)Decrease in Systolic Week 4 (n=100)Decrease in Systolic Week 8 (n=91)Decrease in Systolic BP Week 8 LOCF (n=100)
Amlodipine/Valsartan164.3140.17134.04134.7124.1530.2229.61

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SBP and DBP in Patients With High Sodium Intake at Week 4 and 8

Change in systolic and diastolic blood pressure measured in office from baseline at week 4 and 8. (NCT02062645)
Timeframe: At week 4 and 8

InterventionmmHg (Mean)
SBP at Week 4 (n=70)SBP at Week 8 (n=64)SBP at Week 8 LOCF (n=70)DBP at Week 4 (n=70)DBP at Week 8 (n=64)DBP at Week 8 LOCF (n=70)
Amlodipine/Valsartan140.01134.20134.8481.7381.2381.47

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Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8

Control rate of BP is defined as blood pressure lower than 140/90 mmHg at office visits in patients with high sodium intake (>100 mEq/day) (NCT02062645)
Timeframe: At week 4 and 8

InterventionPercentage of participants (Number)
Week 4 (n=70)Week 8 (n=64)Week 8 LOCF (n=70)
Amlodipine/Valsartan68.664.162.9

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Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8

Control rate of BP defined as BP lower than 140/90 mmHg at office visits (NCT02062645)
Timeframe: At week 4 and 8

InterventionPercentage of Participants (Number)
Week 4 Systolic (n=100)Week 4 Diastolic (n=100)Week 4 Overall Blood Pressure(n=100)Week 8 Systolic(n=91)Week 8 Diastolic (n=91)Week 8 Overall Blood Pressure (n=91)Week 8 Systolic (LOCF) (n=100)Week 8 Diastolic (LOCF) (n=100)Week 8 Overall Blood Pressure (LOCF) (n=100)
Amlodipine/Valsartan47.078.045.070.382.467.068.081.065.0

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Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8

Change in diastolic blood pressure measured in office from baseline at week 4 and week 8. (NCT02062645)
Timeframe: baseline, week 4, week 8

InterventionmmHg (Mean)
Diastolic blood pressure (DBP) Day 0 (n=100)Diastolic blood pressure (DBP) Week 4 (n=100)Diastolic blood pressure (DBP) Week 8 (n=91)Diastolic blood pressure (DBP) Week 8 LOCF (n=100)Decrease in Diastolic BP Week 4 (n=100)Decrease in Diastolic BP Week 8 (n=91)Decrease in Diastolic BP Week 8 LOCF (n=100)
Amlodipine/Valsartan96.6682.081.0481.3714.6615.5415.29

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Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)

ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. (NCT02068495)
Timeframe: Up to 12 Months

InterventionParticipants (Count of Participants)
Candesartan Cilexetil/Amlodipine85

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Changes From Baseline in Diastolic Blood Pressure (DBP) at Final Assessment

Reported data are changes in DBP from baseline at final assessment (up to 12 months). (NCT02068495)
Timeframe: Baseline and final assessment (up to 12 Months)

InterventionmmHg (Mean)
Candesartan Cilexetil/Amlodipine-7.2

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Changes From Baseline in Pulse Rate at Final Assessment

Reported data are changes in Pulse Rate from baseline at final assessment (up to 12 months). (NCT02068495)
Timeframe: Baseline and final assessment (up to 12 Months)

InterventionBeats per minute (Mean)
Candesartan Cilexetil/Amlodipine-1.2

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Changes From Baseline in Systolic Blood Pressure (SBP) at Final Assessment

Reported data are changes in SBP from baseline at final assessment (up to 12 months). (NCT02068495)
Timeframe: Baseline and final assessment (up to 12 Months)

InterventionmmHg (Mean)
Candesartan Cilexetil/Amlodipine-14.6

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Number of Participants Who Experience at Least One Adverse Events

(NCT02068495)
Timeframe: Up to 12 Months

InterventionParticipants (Count of Participants)
Candesartan Cilexetil/Amlodipine286

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Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment

Reported data are percentage of participants who meet targeted blood pressure level at baseline and final assessment in analysis population. Targeted blood pressure level of SBP/DBP was less than 140/90 mmHg. (NCT02068495)
Timeframe: Baseline and final assessment (up to 12 Months)

InterventionPercentage of Participants (Number)
BaselineFinal Assessment
Candesartan Cilexetil/Amlodipine28.566.9

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24 Hour Blood Pressure Average at the End of 4 Month Participation.

(NCT02121041)
Timeframe: Participants will be on study average of 4 months.

Interventionmm Hg (Mean)
Usual Care134
ABPM Guided132

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Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration After Single Administration of T80/A5/H12.5 mg FDC Tablet

Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration after single administration of T80/A5/H12.5 mg FDC tablet (NCT02129192)
Timeframe: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only

,
Interventionng*h/mL (Geometric Mean)
TelmisartanAmlodipineHCTZ
T80/A5/H12.5 FDC Fasted2350157575
T80/A5/H12.5 mg FDC Fed1500156515

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Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration

Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration (NCT02129192)
Timeframe: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only

,
Interventionng*h/mL (Geometric Mean)
TelmisartanAmlodipineHCTZ
T80/A5/H12.5 mg FDC2580159600
T80/H12.5 FDC + A5 Capsule2600157598

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Maximum Measured Concentration (Cmax) of the Analytes in Plasma

Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma (NCT02129192)
Timeframe: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only

,
Interventionng/mL (Geometric Mean)
TelmisartanAmlodipineHCTZ
T80/A5/H12.5 mg FDC6973.6298.5
T80/H12.5 FDC + A5 Capsule7263.5796.6

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Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity After Single Administration of T80/A5/H12.5 mg FDC Tablet

Area under the concentration-time curve (AUC 0-infinity) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to extrapolated infinity after single administration of T80/A5/H12.5 mg FDC tablet (NCT02129192)
Timeframe: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only

,
Interventionng*h/mL (Geometric Mean)
Telmisartan ( N = 35, 36 )Amlodipine ( N = 36, 36 )HCTZ ( N = 36, 36 )
T80/A5/H12.5 FDC Fasted2530169603
T80/A5/H12.5 mg FDC Fed1670168542

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Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity

Area under the concentration-time curve (AUC 0-infinity) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to extrapolated infinity (NCT02129192)
Timeframe: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only

,
Interventionng*h/mL (Geometric Mean)
Telmisartan ( N = 142, 142)Amlodipine ( N = 142, 142)HCTZ ( N = 141, 142)
T80/A5/H12.5 mg FDC2750172626
T80/H12.5 FDC + A5 Capsule2730170624

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Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet

Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma after single oral administration of T80/A5/H12.5 mg FDC tablet (NCT02129192)
Timeframe: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only

,
Interventionng/mL (Geometric Mean)
TelmisartanAmlodipineHCTZ
T80/A5/H12.5 FDC Fasted6053.6094.6
T80/A5/H12.5 mg FDC Fed1823.5475.4

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Mean Change in Average 24-hour Ambulatory Systolic Blood Pressure (SBP24h)

(NCT02172040)
Timeframe: Baseline and 2 weeks

InterventionmmHg (Mean)
Amlodipine+Celecoxib-10.3
Amlodipine+Placebo-8.02
Placebo+Celecoxib-0.5
Placebo+Placebo-1.19

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Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Diastolic Blood Pressure (DBPday)

(NCT02172040)
Timeframe: Baseline and 2 weeks

InterventionmmHg (Mean)
Amlodipine+Celecoxib-7.5
Amlodipine+Placebo-5.53
Placebo+Celecoxib-1.5
Placebo+Placebo-0.32

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Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday) - Primary Endpoint

(NCT02172040)
Timeframe: Baseline and 2 weeks

InterventionmmHg (Mean)
Amlodipine+Celecoxib-10.6
Amlodipine+Placebo-8.83
Placebo+Celecoxib-0.5
Placebo+Placebo-2.11

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Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday) - Secondary Endpoint

(NCT02172040)
Timeframe: Baseline and 2 weeks

InterventionmmHg (Mean)
Amlodipine+Celecoxib-10.6
Amlodipine+Placebo-8.83
Placebo+Celecoxib-0.5
Placebo+Placebo-2.11

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Mean Change in Average Night-time (01:00 to 06:00) Ambulatory Diastolic Blood Pressure (DBPnight)

(NCT02172040)
Timeframe: Baseline and 2 weeks

InterventionmmHg (Mean)
Amlodipine+Celecoxib-7.0
Amlodipine+Placebo-3.23
Placebo+Celecoxib0.3
Placebo+Placebo0.01

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Mean Change in Average Night-time (01:00 to 06:00) Ambulatory Systolic Blood Pressure (SBPnight)

(NCT02172040)
Timeframe: Baseline and 2 weeks

InterventionmmHg (Mean)
Amlodipine+Celecoxib-10.5
Amlodipine+Placebo-6.35
Placebo+Celecoxib-1.7
Placebo+Placebo-1.42

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Mean Log-transformed Amlodipine Plasma Concentration

(NCT02172040)
Timeframe: 24 hours post-dose on Day 14

Interventionlog(pg/mL) (Mean)
Amlodipine+Celecoxib9.634
Amlodipine+Placebo10.025

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Mean Log-transformed Celecoxib Plasma Concentration

(NCT02172040)
Timeframe: 24 hours post-dose on Day 14

Interventionlog(ng/mL) (Mean)
Amlodipine+Celecoxib4.785
Placebo+Celecoxib4.636

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Mean Non-transformed Amlodipine Plasma Concentration

(NCT02172040)
Timeframe: 24 hours post-dose on Day 14

Interventionpg/mL (Mean)
Amlodipine+Celecoxib15,800.83
Amlodipine+Placebo23,453

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Mean Non-transformed Celecoxib Plasma Concentration

(NCT02172040)
Timeframe: 24 hours post-dose on Day 14

Interventionng/mL (Mean)
Amlodipine+Celecoxib139.708
Placebo+Celecoxib138.667

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Frequency of Adverse Events (Number of Participants Affected/Number of Participants at Risk)

Including any untoward medical occurrence in a participant administered study drug, which do not necessarily have a causal relationship with the study drug [i.e., any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug]. (NCT02172040)
Timeframe: 1 month

InterventionParticipants (Count of Participants)
Amlodipine+Celecoxib27
Amlodipine+Placebo28
Placebo+Celecoxib14
Placebo+Placebo10

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Mean Change in Average 24-hour Ambulatory Diastolic Blood Pressure (DBP24h)

(NCT02172040)
Timeframe: Baseline and 2 weeks

InterventionmmHg (Mean)
Amlodipine+Celecoxib-7.1
Amlodipine+Placebo-4.8
Placebo+Celecoxib-0.5
Placebo+Placebo0.22

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Percentage of Participants Who Had One or More Adverse Events

(NCT02181816)
Timeframe: Up to Month 12

InterventionPercentage of Participants (Number)
Azilsartan/Amlodipine8.34

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Diastolic Office Blood Pressure

Diastolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported. (NCT02181816)
Timeframe: Baseline, Month 1, and final assessment point (up to Month 12)

InterventionmmHg (Mean)
BaselineMonth 1Final Assessment Point
Azilsartan/Amlodipine83.377.475.0

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Systolic Office Blood Pressure

Systolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported. (NCT02181816)
Timeframe: Baseline, Month 1, and final assessment point (up to Month 12)

InterventionMillimeter of Mercury (mmHg) (Mean)
BaselineMonth 1Final Assessment Point
Azilsartan/Amlodipine149.5137.2133.0

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Amount of HCTZ Excreted in Urine at Steady State From 0 to 24 Hours

Amount of HCTZ excreted in urine over the time interval from 0 to 24 hours at steady state (NCT02183675)
Timeframe: 0-6 hours (h), 6-12h and 12-24h after drug administration on day 10

Interventionmg (Geometric Mean)
T80-A5-H12.510.4
T80-H12.59.9

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Maximum Measured Concentration (Cmax) at Steady State for Telmisartan

Maximum measured concentration (Cmax) of telmisartan in plasma at steady state over the dosing interval tau (NCT02183675)
Timeframe: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration

Interventionng/mL (Geometric Mean)
T80-A5-H12.5970
T80-A5857
T80-H12.5895

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Maximum Measured Concentration (Cmax) at Steady State for HCTZ

Maximum measured concentration (Cmax) of HCTZ in plasma at steady state over the dosing interval tau (NCT02183675)
Timeframe: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration

Interventionng/mL (Geometric Mean)
T80-A5-H12.5107
T80-H12.5102

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Maximum Measured Concentration (Cmax) at Steady State for Amlodipine

Maximum measured concentration (Cmax) of amlodipine in plasma at steady state over the dosing interval tau (NCT02183675)
Timeframe: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration

Interventionng/mL (Geometric Mean)
T80-A5-H12.511.8
T80-A511.3

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Area Under the Plasma Concentration Curve at Steady State for Telmisartan

Area under the plasma concentration curve (AUC) of telmisartan in plasma at steady state over the dosing interval tau (NCT02183675)
Timeframe: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration

Interventionng*h/mL (Geometric Mean)
T80-A5-H12.52510
T80-A52570
T80-H12.52580

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Area Under the Plasma Concentration Curve at Steady State for HCTZ

Area under the plasma concentration curve (AUC) of HCTZ in plasma at steady state over the dosing interval tau (NCT02183675)
Timeframe: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration

Interventionng*h/mL (Geometric Mean)
T80-A5-H12.5584
T80-H12.5565

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Area Under the Plasma Concentration Curve at Steady State for Amlodipine

Area under the plasma concentration curve (AUC) of amlodipine in plasma at steady state over the dosing interval tau (NCT02183675)
Timeframe: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration

Interventionng*h/mL (Geometric Mean)
T80-A5-H12.5230
T80-A5223

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LDL Cholesterol

polypill versus usual care (NCT02278471)
Timeframe: 2 months

Interventionmg/dL (Mean)
Usual Care108
Polypill90

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LDL Cholesterol

Polypill versus usual care (NCT02278471)
Timeframe: 12 months

Interventionmg/dL (Mean)
Usual Care109
Polypill98

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Medication Adherence-Percentage of Pills Taken

polypill arm-evaluation via pill counts. (NCT02278471)
Timeframe: 12 months

Interventionpercentage of pills taken (Median)
Polypill86

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Systolic Blood Pressure

polypill versus usual care (NCT02278471)
Timeframe: 2 months

Interventionmm Hg (Mean)
Usual Care133
Polypill128

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Systolic Blood Pressure

polypill versus usual care (NCT02278471)
Timeframe: 12 months

Interventionmm Hg (Mean)
Usual Care138
Polypill131

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Medication Adherence

polypill-percentage of pills taken, evaluated via pill counts (NCT02278471)
Timeframe: 2 months

Interventionpercentage of pills taken (Median)
Polypill98

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Drug Level/Concentration in Infant Blood (Amlodipine Level/Concentration)

Infant amlodipine level/concentration will be determined. (NCT02353806)
Timeframe: Infant blood sample drawn at approximately 36 hours of life

Interventionng/mL (Mean)
Pregnant Women Taking AmlodipineNA

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Neonatal Birth Weight

The neonatal weight at birth was collected. (NCT02353806)
Timeframe: Neonatal weight at the time of birth.

Interventiongrams (Mean)
Infant's Born to Women Taking Amlodipine Besylate3281

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Amlodipine Concentration in Breastmilk

The concentration of amlodipine besylate was measured in breastmilk samples. (NCT02353806)
Timeframe: Breast milk samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing

Interventionng/mL (Mean)
Pregnant Women Taking AmlodipineNA

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Area Under the Curve for Amlodipine in the Maternal Serum

The time to peak amlodipine concentration in the maternal serum in the peripartum period was be measured. (NCT02353806)
Timeframe: Maternal blood samples will be obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing

Intervention(hr*ng)/mL (Mean)
Pregnant Women Taking Amlodipine53.4

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Clearance Rate of Plasma Amlodipine

The clearance rate of amlodipine from the maternal plasma was measured. (NCT02353806)
Timeframe: Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing

InterventionL/hr (Mean)
Pregnant Women Taking Amlodipine109.7

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Half-life of Amlodipine in Maternal Plasma

The half-life of amlodipine in the maternal plasma in the peripartum period was measured. (NCT02353806)
Timeframe: Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing

InterventionHours (Mean)
Pregnant Women Taking Amlodipine13.7

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Infant Gestational Age at Delivery.

The mean gestational age of infants born to mothers taking Amlodipine besylate 5 mg daily was collected. (NCT02353806)
Timeframe: Gestational age at the time of birth

Interventionweeks (Mean)
Infant's Born to Women Taking Amlodipine Besylate38.2

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Infant Length of Stay.

The length of stay of infants born to women taking amlodipine besylate will be collected. (NCT02353806)
Timeframe: Time from birth to hospital discharge

InterventionDays (Mean)
Infant's Born to Women Taking Amlodipine Besylate3.6

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Maximal Amlodipine Maternal Serum Concentration

The maximum concentration of amlodipine detected in the maternal serum in the peripartum period was measured. (NCT02353806)
Timeframe: Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing

Interventionng/mL (Mean)
Pregnant Women Taking Amlodipine2.0

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Time to Maximal Concentration in the Maternal Serum.

The time to reach maximal amlodipine concentration in the maternal serum in the peripartum period was measured. (NCT02353806)
Timeframe: Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing

InterventionHours (Mean)
Pregnant Women Taking Amlodipine7.5

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Drug Levels/Concentration in Cord Blood (Amlodipine Levels/Concentrations)

Maternal and cord blood amlodipine levels/concentrations will be determined. (NCT02353806)
Timeframe: Pair maternal blood sample and cord blood sample will draw within 1 hour of delivery

Interventionng/mL (Mean)
Infant cord blood plasma amlodipine concentrationMaternal serum amlodipine concentration
Pregnant Women Taking Amlodipine0.491.27

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Major Infant Complications

Any major complications experienced by infants born to women taking amlodipine besylate including NICU admission, intraventricular hemorrhage, neonatal seizures, need for respiratory support and apnea were collected. (NCT02353806)
Timeframe: During neonatal hospitalization

InterventionParticipants (Number)
Admission to the NICUMajor neonatal complications (IVH, apnea, seizure)
Infant's Born to Women Taking Amlodipine Besylate00

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AUClast

AUClast(Area under the curve to the last measurable concentration) (NCT02387554)
Timeframe: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

InterventionRatio(Comb/Alone) (Geometric Mean)
HGP09041.0360
HGP06081.1606
HGP14051.0266
EXP31741.0902

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The Number of Patients for Whom Each Drug is Selected as the Preferred Therapy

For each n-of-1 trial, the preferred drug is defined as that which produces normal ambulatory blood pressure (by pediatric Ambulatory blood pressure monitoring (ABPM) standards), with the greatest magnitude of wake mean systolic BP reduction, and without unacceptable side effects. (NCT02412761)
Timeframe: The outcome of BP control and side effect tolerability will be assessed 2 weeks after starting each drug. Participants will be followed for an average of 10-12 weeks.

InterventionParticipants (Count of Participants)
Lisinopril16
Amlodipine8
Hydrochlorothiazide4

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Passive Emptying of Left Atrium

Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm). (NCT02734355)
Timeframe: 7 days

Interventioncm (Mean)
Therapy14.7
Placebo20.9

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Diastolic Function

E/A ratio of transmitral flow (NCT02734355)
Timeframe: 7 days

Interventionratio (Mean)
Therapy1.62
Placebo2.64

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Left Atrial Reservoir Function

Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole. (NCT02734355)
Timeframe: 7 days

Interventioncm (Mean)
Therapy19.1
Placebo13.3

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Quality of Life

The average of eight scores of 36-Item Short Form Health Survey (SF-36). In every case all of eight scores (which ranges from 0 to 100) was summarized, then the sum was divided by 8. Thus the outcome also ranges from 0 (worse outcome) to 100 (better outcome). (NCT02734355)
Timeframe: 7 days

Interventionunits on a scale (Mean)
Therapy92
Placebo85

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Active Emptying of Left Atrium

Velocity time integral of transmitral flow during atrial contraction (VTI A, cm). (NCT02734355)
Timeframe: 7 days

Interventioncm (Mean)
Therapy7.4
Placebo5.4

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Pulmonary Vein Flow Emptying

S/D ratio of right superior pulmonary vein flow (NCT02734355)
Timeframe: 7 days

Interventionratio (Mean)
Therapy1.3
Placebo1.46

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Left Atrial Pressure Load

Mean left atrial pressure (MLAP, mm Hg). (NCT02734355)
Timeframe: 7 days

Interventionmm Hg (Mean)
Therapy9
Placebo13.8

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Left Atrial Dimensions

Left atrial antero-posterior diameter (LAD, cm) (NCT02734355)
Timeframe: 7 days

Interventioncm (Mean)
Therapy3.9
Placebo4.1

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Left Atrial Contractility

Left atrial active emptying fraction (LAAEF, %) (NCT02734355)
Timeframe: 7 days

Interventionpercentage of LA maximum volume (Mean)
Therapy40
Placebo31.6

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Isovolumic Relaxation

Left ventricular isovolumic relaxation time (IVRT, ms). (NCT02734355)
Timeframe: 7 days

Interventionms (Mean)
Therapy117
Placebo98

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Pulmonary Circulation Pressure Load

Right ventricular systolic pressure (RVSP, mm Hg). (NCT02734355)
Timeframe: 7 days

Interventionmm Hg (Mean)
Therapy16.7
Placebo31.6

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Exercise Tolerance

six-minute walk distance in meters (NCT02734355)
Timeframe: 7 days

Interventionm (Mean)
Therapy403
Placebo345

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Retrograde Flow in Pulmonary Veins

Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm) (NCT02734355)
Timeframe: 7 days

Interventioncm (Mean)
Therapy4.1
Placebo1.5

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Dose Limiting Toxicities (DLTs) and Other Adverse Events

Describe the DLTs and other adverse events associated with L-NMMA when combined with docetaxel/amlodipine, as assessed by the CTCAE v4.03 Any Grade ≥ 3 Adverse Events (AE) unless there is clear alternative evidence that the AE was not caused by the study treatment. (NCT02834403)
Timeframe: The approximate length of the study from Cycle 1, Day 1 will be approximately seven months (approximately four months of treatment plus three months of follow-up).

,,,,,,
InterventionGrade ≥ 3 AE (Count of Units)
ConstitutionalPeripheral neuropathyDermatologicalInfectiousRenalElevation of AST/ALTDehydrationGastricCardiacVascular
Experimental: L-NMMA 10 mg/kg and Docetaxel 75 mg/m20010000000
Experimental: L-NMMA 12.5 mg/kg and Docetaxel 75 mg/m20000000000
Experimental: L-NMMA 15 mg/kg and Docetaxel 75 mg/m20000000000
Experimental: L-NMMA 17.5 mg/kg and Docetaxel 100 mg/m22000001121
Experimental: L-NMMA 20 mg/kg and Docetaxel 100 mg/m21000101000
Experimental: L-NMMA 7.5 mg/kg and Docetaxel 75 mg/m20000000000
Experimental: Phase II: RP2D Determined in the Phase Ib0110000010

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Time to Maximum Plasma Concentration of L-NMMA and Docetaxel

Determine the time to maximum plasma concentration of the L-NMMA and docetaxel combination. (NCT02834403)
Timeframe: Blood samples will be collected predose (10-30 minutes before L-NMMA infusion) on Days 1, 2, and 5 of Cycle 1 and Days 1 and 5 of Cycle 2 for determination of L-NMMA plus docetaxel plasma PK.

,
InterventionHours (Mean)
Tmax for LNMMATmas for Docetaxel
Experimental: L-NMMA 15 mg/kg and Docetaxel 75 mg/m224
Experimental: L-NMMA 17.5 mg/kg and Docetaxel 100 mg/m224

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Clinical Benefit Rate

"Primary Outcome Measure for Phase II: Determine the number of participants with complete response, partial response, or stable disease after 6 cycles of L-NMMA combined with taxane chemotherapy (docetaxel, paclitaxel, or nab-paclitaxel)/amlodipine, as assessed by the RECIST 1.1.~CR (complete response) = disappearance of all target lesions~PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions~PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions~SD (stable disease) = small changes that do not meet above criteria~Treatment Failure: taken off the study because of adverse events before the first restaging scan after cycle 2" (NCT02834403)
Timeframe: The approximate length of the study from Cycle 1, Day 1 will be approximately seven months (approximately four months of treatment plus three months of follow-up).

InterventionParticipants (Count of Participants)
Metastatic breast cancer72594113Locally advanced breast cancer72594113
Complete ResponseStable DiseaseProgressive DiseaseTreatment FailurePartial Response
Experimental0
Experimental3
Experimental6
Experimental2
Experimental4
Experimental5
Experimental1

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Asses the Maximum Tolerated Dose (MTD) of L-NMMA When Combined With Docetaxel/Amlodipine in the Treatment of Refractory Locally Advanced or Metastatic TNBC Patients, Based on the Number of Dose Limiting Toxicities (DLTs) Per Dose Level.

The Phase Ib portion of the study is designed to investigate the combination at two dose levels of docetaxel (75 and 100 mg/m2) and 7 dose levels of L-NMMA (5, 7.5, 10, 12.5, 15, 17.5, and 20 mg/kg). The starting dose will be L-NMMA at 7.5 mg/kg and docetaxel at 75 mg/m2. As patients are accrued, a standard Bayesian model averaging continual reassessment method (CRM) approach will be used to determine the appropriate dosage. For a dose level to be chosen as the MTD, at least 4 patients must have received said dose without experiencing a significant number of DLTs based on the Bayesian Model Averaging Continual Reassessment Method. (NCT02834403)
Timeframe: DLTs assessment window is the duration required for completing one full cycle (through Day 21).

Interventionmg/kg (Number)
Phase Ib - Dose Finding - L-NMMA20

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Asses the Maximum Tolerated Dose (MTD) of Docetaxel When Combined With L-NMMA/Amlodipine in the Treatment of Refractory Locally Advanced or Metastatic TNBC Patients, Based on the Number of Dose Limiting Toxicities (DLTs) Per Dose Level.

The Phase Ib portion of the study is designed to investigate the combination at two dose levels of docetaxel (75 and 100 mg/m2) and 7 dose levels of L-NMMA (5, 7.5, 10, 12.5, 15, 17.5, and 20 mg/kg). The starting dose will be L-NMMA at 7.5 mg/kg and docetaxel at 75 mg/m2. As patients are accrued, a standard Bayesian model averaging continual reassessment method (CRM) approach will be used to determine the appropriate dosage. For a dose level to be chosen as the MTD, at least 4 patients must have received said dose without experiencing a significant number of DLTs based on the Bayesian Model Averaging Continual Reassessment Method. (NCT02834403)
Timeframe: DLTs assessment window is the duration required for completing one full cycle (through Day 21).

Interventionmg/m^2 (Number)
Phase Ib - Dose Finding - Docetaxel100

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Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday)

An ambulatory blood pressure monitor (ABPM) fitted to upper arm was used for continuous recording of blood pressure over three 25-hour periods: Days -1 to 0 (Baseline), Days 6 to 7, & Days 13 to 14. The ABPM recorded blood pressure every 20 minutes between 09:00 and 21:59 and every 30 minutes between 22:00 and 08:59. SBPday was calculated by averaging all of the systolic blood pressure measurements between the protocol-defined first & last study measurements of the period that fell between 9:00 and 21:00; measurements during the first hour (white-coat window) were not included. Change in SBPday was calculated by subtracting the Baseline value from the end of study value (Day 13 to Day 14 period). If the Day 13 to Day 14 value was not available, the Day 6 to Day 7 value was used [last observation carried forward (LOCF) method]. A negative value for change in SBPday indicates a decrease in systolic blood pressure and a positive value indicates an increase. (NCT02979197)
Timeframe: Baseline and 14 days

InterventionmmHg (Mean)
Amlodipine+Celecoxib-8.0
Amlodipine+Placebo-9.8

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Occurrence of Treatment Emergent Adverse Events

Treatment emergent adverse events (TEAEs) included any untoward medical occurrence that initiated or worsened after the first dose of study drugs and within 14 days of the last dose of study drugs. (NCT02979197)
Timeframe: 1 month

InterventionParticipants (Count of Participants)
Amlodipine+Celecoxib35
Amlodipine+Placebo32
Placebo+Placebo6

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Non-transformed Plasma Concentration of Amlodipine

A venous blood sample was collected 24 hours ± 1 hour after the last dose of study drugs (i.e., on Day 14). The blood sample was processed to plasma and the concentration of amlodipine measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The resulting concentrations, without logarithmic transformation, were used for the comparison between the amlodipine+celecoxib and amlodipine+placebo arms to evaluate the effect of celecoxib on the mean non-transformed plasma concentrations of amlodipine. (NCT02979197)
Timeframe: 24 hours post-dose on Day 14

Interventionng/mL (Mean)
Amlodipine+Celecoxib15.9
Amlodipine+Placebo18.3

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Log-transformed Plasma Concentration of Amlodipine

A venous blood sample was collected 24 hours ± 1 hour after the last dose of study drugs (i.e., on Day 14). The blood sample was processed to plasma and the concentration of amlodipine measured using a validated LC-MS/MS method. The concentrations were logarithmically transformed and used for the comparison between the amlodipine+celecoxib and amlodipine+placebo arms to evaluate the effect of celecoxib on the mean log-transformed plasma concentrations of amlodipine. (NCT02979197)
Timeframe: 24 hours post-dose on Day 14

Interventionng/mL (Mean)
Amlodipine+Celecoxib2.7
Amlodipine+Placebo2.8

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Change in Serum Creatinine

Subjects had blood collected for the measurement of creatinine at the Initial Screening Visit (Day -10 to -14), at Baseline (Day 0), and at Days 7 and 14. Change in serum creatinine was calculated by subtracting the Baseline value from the end of treatment value (recorded on Day 14). A negative value for change in serum creatinine indicates a decrease in creatinine and a positive value indicates an increase. (NCT02979197)
Timeframe: Baseline and 14 Days

Interventionμmol/L (Mean)
Amlodipine+Celecoxib-2.8
Amlodipine+Placebo-2.4
Placebo+Placebo-1.9

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Change in Creatinine Clearance

Subjects had blood collected for the measurement of creatinine at the Initial Screening Visit (Day -10 to -14), at Baseline (Day 0), and at Days 7 and 14. Estimated creatinine clearance was calculated using Cockcroft-Gault equation: (140 - age) X body weight (kg)/72 X serum creatinine concentration (mg/dL); multiplied by 0.85 for women. Change in creatinine clearance was calculated by subtracting the Baseline value from the end of treatment value (recorded on Day 14). If the Day 14 value was not available, the Day 7 value was used (LOCF method). A negative value for change in creatinine clearance indicates a decrease in creatinine clearance and a positive value indicates an increase. (NCT02979197)
Timeframe: Baseline and 14 days

InterventionmL/min (Mean)
Amlodipine+Celecoxib4.9
Amlodipine+Placebo3.4

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Change in Average 24-hour Ambulatory Diastolic Blood Pressure (DBP24h)

An ABPM fitted to upper arm was used for continuous recording of blood pressure over three 25-hour periods: Days -1 to 0 (Baseline), Days 6 to 7, & Days 13 to 14. The ABPM recorded blood pressure every 20 minutes between 09:00 and 21:59 and every 30 minutes between 22:00 and 08:59. DBP24h was calculated by averaging all of the diastolic blood pressure measurements between the protocol-defined first & last study measurements of the period; measurements during the first hour (white-coat window) were not included. Change in DBP24h was calculated by subtracting the Baseline value from the end of study value (Day 13 to Day 14 period). If the Day 13 to Day 14 value was not available, the Day 6 to Day 7 value was used (LOCF method). A negative value for change in DBP24h indicates a decrease in diastolic blood pressure and a positive value indicates an increase. (NCT02979197)
Timeframe: Baseline and 14 days

InterventionmmHg (Mean)
Amlodipine+Celecoxib-4.4
Amlodipine+Placebo-3.8

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Change in Body Weight

Body weight was measured at the Initial Screening Visit (Day -10 to -14), at Baseline (Day 0), and at Days 7 and 14. The measurements were made using a calibrated scale with the subject wearing underwear and a light gown. Change in body weight was calculated by subtracting the Baseline value from the end of treatment value (recorded on Day 14). If the Day 14 value was not available, the Day 7 value was used (LOCF method). A negative value for change in body weight indicates a decrease in body weight and a positive value indicates an increase. (NCT02979197)
Timeframe: Baseline and 14 days

Interventionkg (Mean)
Amlodipine+Celecoxib0.3
Amlodipine+Placebo-0.3
Placebo+Placebo-1.5

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Change in Average 24-hour Ambulatory Systolic Blood Pressure (SBP24h)

An ABPM fitted to upper arm was used for continuous recording of blood pressure over three 25-hour periods: Days -1 to 0 (Baseline), Days 6 to 7, & Days 13 to 14. The ABPM recorded blood pressure every 20 minutes between 09:00 and 21:59 and every 30 minutes between 22:00 and 08:59. SBP24h was calculated by averaging all of the systolic blood pressure measurements between the protocol-defined first & last study measurements of the period; measurements during the first hour (white-coat window) were not included. Change in SBP24h was calculated by subtracting the Baseline value from the end of study value (Day 13 to Day 14 period). If the Day 13 to Day 14 value was not available, the Day 6 to Day 7 value was used (LOCF method). A negative value for change in SBP24h indicates a decrease in systolic blood pressure and a positive value indicates an increase. (NCT02979197)
Timeframe: Baseline and 14 days

InterventionmmHg (Mean)
Amlodipine+Celecoxib-8.2
Amlodipine+Placebo-8.5

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Extrapolated Part of Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUCextra%) of Bisoprolol and Amlodipine

AUCextra% was calculated as area under the curve from time tlast extrapolated to infinity given as percentage of AUC 0-infinity. Here, tlast is the last sampling time at which the concentration is at or above the lower limit of quantification. (NCT03226275)
Timeframe: Pre-dose (Baseline) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose for each treatment period

,,,
Interventionpercentage of AUC0-inf (Geometric Mean)
BisoprololAmlodipine
Fasting: Bisoprolol and Amlodipine Separately3.2410.8
Fasting: Bisoprolol-Amlodipine FDC3.6010.9
Fed: Bisoprolol and Amlodipine Separately3.946.81
Fed: Bisoprolol-Amlodipine FDC3.838.58

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Maximum Observed Plasma Concentration (Cmax) of Bisoprolol and Amlodipine

(NCT03226275)
Timeframe: Pre-dose (Baseline) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose for each treatment period

,,,
Interventionng/mL (Geometric Mean)
BisoprololAmlodipine
Fasting: Bisoprolol and Amlodipine Separately26.64.17
Fasting: Bisoprolol-Amlodipine FDC26.14.17
Fed: Bisoprolol and Amlodipine Separately21.93.19
Fed: Bisoprolol-Amlodipine FDC20.53.34

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Death, and AEs Leading to Discontinuation

An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration. TEAEs included both Serious TEAEs and non-serious TEAEs. (NCT03226275)
Timeframe: Baseline up to Day 29

,,,
InterventionParticipants (Count of Participants)
TEAEsSerious TEAEsAEs Leading to DeathAEs Leading to Discontinuation
Fasting: Bisoprolol and Amlodipine Separately0000
Fasting: Bisoprolol-Amlodipine FDC0000
Fed: Bisoprolol and Amlodipine Separately0000
Fed: Bisoprolol-Amlodipine FDC0000

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Time to Reach Maximum Plasma Concentration (Tmax) of Bisoprolol and Amlodipine

(NCT03226275)
Timeframe: Pre-dose (Baseline) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose for each treatment period

,,,
Interventionhours (Median)
BisoprololAmlodipine
Fasting: Bisoprolol and Amlodipine Separately1.006.00
Fasting: Bisoprolol-Amlodipine FDC1.006.00
Fed: Bisoprolol and Amlodipine Separately3.006.00
Fed: Bisoprolol-Amlodipine FDC3.006.00

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Apparent Total Body Clearance From Plasma (CL/f) of Bisoprolol and Amlodipine

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. (NCT03226275)
Timeframe: Pre-dose (Baseline) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose for each treatment period

,,,
Interventionliter per hour (Geometric Mean)
BisoprololAmlodipine
Fasting: Bisoprolol and Amlodipine Separately16.423.1
Fasting: Bisoprolol-Amlodipine FDC16.421.3
Fed: Bisoprolol and Amlodipine Separately17.427.4
Fed: Bisoprolol-Amlodipine FDC17.826.0

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Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/f) of Bisoprolol and Amlodipine

Vz/f is defined as the distribution of a study drug between plasma and the rest of the body after oral dosing. (NCT03226275)
Timeframe: Pre-dose (Baseline) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose for each treatment period

,,,
Interventionliter (Geometric Mean)
BisoprololAmlodipine
Fasting: Bisoprolol and Amlodipine Separately2091660
Fasting: Bisoprolol-Amlodipine FDC2091590
Fed: Bisoprolol and Amlodipine Separately2231710
Fed: Bisoprolol-Amlodipine FDC2431750

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Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC 0-inf) of Bisoprolol and Amlodipine

(NCT03226275)
Timeframe: Pre-dose (Baseline) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose for each treatment period

,,,
Interventionng*h/mL (Geometric Mean)
BisoprololAmlodipine
Fasting: Bisoprolol and Amlodipine Separately306216
Fasting: Bisoprolol-Amlodipine FDC306235
Fed: Bisoprolol and Amlodipine Separately287182
Fed: Bisoprolol-Amlodipine FDC281192

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Area Under the Plasma Concentration-Time Curve From Time Zero to Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Bisoprolol and Amlodipine

(NCT03226275)
Timeframe: Pre-dose (Baseline) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose for each treatment period

,,,
Interventionnanogram hour per milliliter (ng*h/mL) (Geometric Mean)
BisoprololAmlodipine
Fasting: Bisoprolol and Amlodipine Separately295212
Fasting: Bisoprolol-Amlodipine FDC294205
Fed: Bisoprolol and Amlodipine Separately275167
Fed: Bisoprolol-Amlodipine FDC270174

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Apparent Terminal Half-life (t1/2) of Bisoprolol and Amlodipine

Apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination. Terminal half-life was calculated as ln(2)/λz, where λz is a terminal rate constant, which was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. (NCT03226275)
Timeframe: Pre-dose (Baseline) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose for each treatment period

,,,
Interventionhours (Geometric Mean)
BisoprololAmlodipine
Fasting: Bisoprolol and Amlodipine Separately8.8449.7
Fasting: Bisoprolol-Amlodipine FDC8.8751.8
Fed: Bisoprolol and Amlodipine Separately8.8643.2
Fed: Bisoprolol-Amlodipine FDC9.4946.7

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Apparent Terminal Elimination Rate Constant (λz) of Bisoprolol and Amlodipine

λz was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method. (NCT03226275)
Timeframe: Pre-dose (Baseline) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose for each treatment period

,,,
Intervention1 per hour (Geometric Mean)
BisoprololAmlodipine
Fasting: Bisoprolol and Amlodipine Separately0.07840.0139
Fasting: Bisoprolol-Amlodipine FDC0.07810.0134
Fed: Bisoprolol and Amlodipine Separately0.07830.0160
Fed: Bisoprolol-Amlodipine FDC0.07310.0148

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Change in Mean Wake Ambulatory Systolic Blood Pressure

To assess mean wake ambulatory blood pressure, participants wear a 24-hour blood pressure monitor, which records blood pressure at regular intervals throughout a 24 hour period, throughout wake and sleep. The mean of all recordings that occur while the participant is awake during the 24-hour period is calculated for both baseline and 6 months, and then the mean wake systolic blood pressure at 6 months minus the mean wake systolic blood pressure at baseline is calculated per participant. The average difference is reported, with a negative value indicating a reduction in blood pressure over time. (NCT03461003)
Timeframe: baseline, 6 months

InterventionmmHg (Mean)
NICHE Method-10.5
Usual Care-6.2

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Patient Satisfaction With Intervention as Assessed by a Survey

Patient satisfaction is scored from 0 to 10, where 0 is the worst health care possible and 10 is the best health care possible. (NCT03461003)
Timeframe: 6 months

Interventionscore on a scale (Mean)
NICHE Method9.929
Usual Care9.667

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Change in Mean 24-hour Ambulatory Systolic Blood Pressure

To assess 24-hour mean ambulatory blood pressure, participants wear a 24-hour blood pressure monitor, which records blood pressure at regular intervals throughout a 24-hour period, while awake and while asleep. The mean of all recordings over the 24-hour period is calculated per participant for both baseline and 6 months, and then the mean 24-hour systolic blood pressure at 6 months minus the mean 24-hour systolic blood pressure at baseline is calculated per participant. The average difference is reported, with a negative value indicating a reduction in blood pressure over time. (NCT03461003)
Timeframe: baseline, 6 months

InterventionmmHg (Mean)
NICHE Method-10.6
Usual Care-5.1

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Number of Participants Who Reported That Side Effects From Medication Led Them to Discontinue Medication

(NCT03461003)
Timeframe: from baseline to 6 months

InterventionParticipants (Count of Participants)
NICHE Method0
Usual Care3

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Number of Participants Who Self-reported Adherence to Intervention

Adherence is reported as the number of participants who self-reported at the 6-month visit that they had not missed any doses of their medication in the preceding month. (NCT03461003)
Timeframe: from month 5 to month 6

InterventionParticipants (Count of Participants)
NICHE Method5
Usual Care6

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The Mean Standardized Score of the Physical Component of the Quality of Life Questionnaire The Short Form (36) Health Survey at Visit 4 vs Baseline

"Change in the mean score of the of the physical component of the The Short Form (36) Health Survey (SF-36) survey.~The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability." (NCT03722524)
Timeframe: Baseline, 3 months

Interventionscore on a scale (Mean)
Patients With Arterial Hypertension13.64

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The Mean Systolic BP Changes (mm Hg) at the Visit 4 vs. Baseline

Changes in the mean office systolic BP levels (in mm Hg) in the sitting position Blood pressure was measured in accordance with the guidelines of the European Society of Hypertension (ESH) using the auscultatory or oscillometric method and a semi-automated sphygmomanometer. Before taking measurements, the patient remained in a sitting position for 3-5 minutes. Blood pressure was determined on each arm, and the arm with the highest value was taken as the reference. Measurements were taken thrice in the sitting position of a patient, and the average of the second and third BP measurements on the reference arm with an interval of at least 1-2 minutes was recorded. (NCT03722524)
Timeframe: Baseline, 3 months

Interventionmm Hg (Mean)
Patients With Arterial Hypertension33.47

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The Mean Diastolic BP Changes (mm Hg) at the Visit 4 vs Baseline.

Changes in the mean office diastolic BP levels (in mm Hg) in the sitting position (NCT03722524)
Timeframe: Baseline, 3 months

Interventionmm Hg (Mean)
Patients With Arterial Hypertension14.34

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Percentage of Patients Who Achieved the Target Office BP Levels (SBP <140 mm Hg and DBP <90 mm Hg) at Visit 4 vs Baseline

The assessment of the target office BP levels (SBP <140 mm Hg and DBP <90 mm Hg) was performed in accordance with ESC Guidelines for the management of arterial hypertension (2013) (NCT03722524)
Timeframe: Baseline, 3 months

Interventionpercentage of patients (Number)
Patients With Arterial Hypertension93.38

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The Mean Standardized Score of the Mental Component of the Quality of Life Questionnaire The Short Form (36) Health Survey at Visit 4 vs Baseline

"Change in the mean score of the of the physical component of the SF-36 survey Change in the mean score of the of the physical component of the The Short Form (36) Health Survey (SF-36) survey.~The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability." (NCT03722524)
Timeframe: Baseline, 3 months

Interventionscore on a scale (Mean)
Patients With Arterial Hypertension23.57

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