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olmesartan

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Description

olmesartan: an active metabolite of CS 866 [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID158781
CHEMBL ID1516
CHEBI ID48416
SCHEMBL ID94037
MeSH IDM0403284

Synonyms (106)

Synonym
HY-17004
HMS3393K12
olmesartan (usan/inn)
144689-24-7
D05246
MLS001424016
MLS000759446
smr000466337
4-(1-hydroxy-1-methylethyl)-2-propyl-1-{[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl}-1h-imidazole-5-carboxylic acid
olmesartan
DB00275
4-(hydroxy-1-methylethyl)-2-propyl-1-{[2'-(1h-tetrazol-5-yl)-1,1'-biphenyl-4-yl]methyl}-1h-imidazole-5-carboxylic acid
1h-imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-((2'-(1h-tetrazol-5-yl) (1,1'-biphenyl)-4-yl)methyl)-
olmesartan [usan]
votum
rnh-6270
4-(2-hydroxypropan-2-yl)-2-propyl-1-{[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl}-1h-imidazole-5-carboxylic acid
CHEBI:48416 ,
4-(1-hydroxy-1-methylethyl)-2-propyl-1-{[2'-(1h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl}-1h-imidazole-5-carboxylic acid
HMS2051K12
4-(hydroxy-1-methylethyl)-2-propyl-1-{[2''-(1h-tetrazol-5-yl)-1,1''-biphenyl-4-yl]methyl}-1h-imidazole-5-carboxylic acid
bdbm50241364
4-(1-hydroxy-1-methylethyl)-2-propyl-1-{[2''-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl}-1h-imidazole-5-carboxylic acid
4-(1-hydroxy-1-methylethyl)-2-propyl-1-{[2''-(1h-tetrazol-5-yl)[1,1''-biphenyl]-4-yl]methyl}-1h-imidazole-5-carboxylic acid
CHEMBL1516 ,
nsc-759810
olmesartan medoxomil impurity, olmesartan-
rnh 6270
4-(hydroxy-1-methylethyl)-2-propyl-1-((2'-(1h-tetrazol-5-yl)-1,1'-biphenyl-4-yl)methyl)-1h-imidazole-5-carboxylic acid
omesartan
cs-088 ,
L001097
cs 088
4-(2-hydroxypropan-2-yl)-2-propyl-1-({4-[2-(1h-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl)-1h-imidazole-5-carboxylic acid
5-(2-hydroxypropan-2-yl)-2-propyl-3-[[4-[2-(2h-tetrazol-5-yl)phenyl]phenyl]methyl]imidazole-4-carboxylic acid
NCGC00246968-01
nsc759810
pharmakon1600-01505206
de-092
olmesartan medoximil
8w1iqp3u10 ,
hsdb 8214
olmesartan [usan:inn:ban]
(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-((2'-(2h-tetrazol-5-yl)biphenyl-4-yl)methyl)-1h-imidazole-5-carboxylate
ec 646-413-5
unii-8w1iqp3u10
nsc 759810
HMS2235O24
CCG-100868
FT-0631169
NCGC00246968-02
olmesartan medoxomil impurity, olmesartan- [usp impurity]
olmesartan [vandf]
olmesartan medoxomil impurity a [ep impurity]
olmesartan [who-dd]
olmesartan [mi]
olmesartan [inn]
CS-0576
AKOS015900241
olmesartan acid
S5581
HMS3369I09
4-(1-hydroxy-1-methylethyl)-2-propyl-1-{4-[2-(tetrazol-5-yl)phenyl]phenyl}methylimidazole-5-carboxylic acid
4-(1-hydroxy-1-methylethyl) -2-propyl-1-{4-[2-(tetrazole-5-yl)phenyl]phenyl}methylimidazole-5-carboxylic acid
VTRAEEWXHOVJFV-UHFFFAOYSA-N
4-(1-hydroxy-1-methylethyl)-2-propyl-1-{4-[2-(tetrazole-5-yl)phenyl]phenyl}methylimidazole-5-carboxylic acid
4-(1-hydroxy-1-methylethyl) -2-propyl-1-{4-[2-(tetrazole -5-yl)phenyl]phenyl}methylimidazole-5-carboxylic acid
OLM ,
SCHEMBL94037
NC00118
MLS006011945
smr004703526
W-201270
4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(2h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1h-imidazole-5-carboxylic acid
diclofenacdiethylamine
1-((2'-(1h-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1h-imidazole-5-carboxylic acid
AKOS024458255
HMS3604J06
mfcd00914967
DTXSID2040571 ,
C21543
AC-9385
olmesartan, >=98% (hplc)
olmesartan medoxomil imp. a (ep); 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl]-1h-imidazole-5-carboxylic acid; olmesartan; olmesartan acid; olmesartan medoxomil impurity a
4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl]-1h-imidazole-5-carboxylic acid (olmesartan)
1h-imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(2h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-
1-((2'-(1h-tetrazol-5-yl)biphenyl-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1h-imidazole-5-carboxylic acid
benicar;olmetec
Q421156
1-((2'-(2H-TETRAZOL-5-YL)-[1,1'-BIPHENYL]-4-YL)METHYL)-4-(2-HYDROXYPROPAN-2-YL)-2-PROPYL-1H-IMIDAZOLE-5-CARBOXYLIC ACID
AS-10242
O0507
BCP12007
EN300-122328
4-(2-hydroxypropan-2-yl)-2-propyl-1-{[2'-(1h-1,2,3,4-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl]methyl}-1h-imidazole-5-carboxylic acid
CCG-269198
NCGC00246968-04
5-(2-hydroxypropan-2-yl)-2-propyl-3-[[4-[2-(2h-tetrazol-5-yl)phenyl]phenyl]methyl]imidazole-4-carboxylic acid.
O-125
olmesartan 100 microg/ml in acetonitrile:methanol
1h-imidazole-5-carboxylicacid,4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(2h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-
A853148
Z1541758605
4-(1-hydroxy-1-methylethyl)-2-propyl-1-((2'-(1h-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-1h-imidazole-5-carboxylic acid
4-(1-hydroxy-1-methylethyl)-2-propyl-1-((2'-(1h-tetrazol-5-yl)biphenyl-4-yl)methyl)-1h-imidazole-5-carboxylic acid
dtxcid0020571

Research Excerpts

Overview

Olmesartan is an inhibitor of the angiotensin II receptor developed for the treatment of hypertension. Recent studies show that it exerts anti-inflammatory effects in arthritis.

ExcerptReferenceRelevance
"Olmesartan, which is an angiotensin II receptor blocker, reportedly causes spruelike enteropathy, with intestinal villous atrophy as its typical histopathological finding. "( Severe spruelike enteropathy and collagenous colitis caused by olmesartan.
Ehira, N; Kaneko, S; Kishi, K; Kobayashi, H; Matsuda, K; Mizuta, Y; Nakamura, A; Shiratori, S; Uebayashi, M; Yagisawa, M, 2021
)
2.3
"Olmesartan is an inhibitor of the angiotensin II receptor developed for the treatment of hypertension, and recent studies show that it exerts anti-inflammatory effects in arthritis."( The protective effects of Olmesartan against interleukin-29 (IL-29)-induced type 2 collagen degradation in human chondrocytes.
Chen, Q; Liu, J; Liu, Y; Ma, Y; Shang, Y; Yang, X; Zhang, Y, 2022
)
1.74
"Olmesartan is a potent angiotensin II receptor antagonist commonly used in the treatment of high blood pressure. "( [Olmesartan and enteropathy a decade later: a perhaps not so exceptional association].
Albaladejo Blanco, C; Martín García, JA; Martínez Capilla, L,
)
2.48
"Olmesartan is a novel angiotensin receptor blocker with promising antihypertensive properties and has recently been reported to exert anti-inflammatory and antioxidative stress effects."( Olmesartan Prevents Oligomerized Amyloid β (Aβ)-Induced Cellular Senescence in Neuronal Cells.
Wang, J; Yang, S; Zheng, B; Zhou, D, 2021
)
2.79
"Olmesartan is an angiotensin II receptor blocker, approved in 2002 by the Food and Drug Administration for the treatment of hypertension. "( An unusual cause of diarrhoea: case report and literature review of olmesartan-associated enteropathy.
Barbara, G; Bellacosa, L; Capuani, F; Cogliandro, RF; Cremon, C; Marasco, G; Mauloni, PA; Paone, C; Stanghellini, V; Vasuri, F, 2021
)
2.3
"Olmesartan is an effective antihypertensive medication; however, physicians must be mindful of its side effect of causing a sprue-like enteropathy and liver injury."( Sprue-Like Enteropathy and Liver Injury: A Rare Emerging Association with Olmesartan.
Alfraji, N; Odak, M; Udongwo, N; Zaidi, S; Zheng, M,
)
1.08
"Olmesartan is an angiotensin receptor blockers with actions similar to those of losartan; it is used for the treatment of high blood pressure by relaxing blood vessels for this reason blood can flow more easily. "( Olmesartan.
Abdel Aziz, HA; Al-Jallal, AAM; Al-Majed, AA; Bakheit, AHH,
)
3.02
"Olmesartan medoxomil is an antihypertensive drug of the class of angiotensin II type 1 (AT1) receptor antagonists (or blockers), characterized by tight and prolonged binding to AT1 receptor compared to other molecules within the same class. "( Monotherapy and Dual Combination Therapies Based on Olmesartan: A Comprehensive Strategy to Improve Blood Pressure Control.
Battistoni, A; Coluccia, R; Mastromarino, V; Santolamazza, C; Tocci, G; Volpe, M, 2017
)
2.15
"Olmesartan is an angiotensin II type 1 receptor blocker commonly used in the treatment of hypertension. "( [Olmesartan-associated enteropathy: attention to an emerging iatrogenic phenomenon].
Aguiar Losada, B; Elejalde Guerra, JI; González Recio, P; Leturia Frade, I; Modesto Dos Santos, JL; Terry López, OA, 2017
)
2.81
"Olmesartan is an angiotensin II receptor blocker, used to treat arterial hypertension. "( [Olmesartan therapy and enteropathy: About two cases and review of the literature].
Héron, F; Le Besnerais, M; Marie, I; Sadki, A, 2019
)
2.87
"Olmesartan is a long-lasting ARB which proved to achieve a comparable or more effective action in lowering BP when compared to other ARBs."( Management of arterial hypertension with angiotensin receptor blockers: Current evidence and the role of olmesartan.
Omboni, S; Volpe, M, 2018
)
1.42
"Olmesartan is an angiotensin II receptor antagonist, used in the treatment of hypertension. "( Olmesartan-associated severe gastritis and enteropathy.
Shenbagaraj, L; Swift, G, 2018
)
3.37
"Olmesartan is an effective and safe antihypertensive agent, but special attention should be paid to high-risk patients, such as those with coronary disease, to avoid an excessive reduction in blood pressure."( An evaluation of the latest evidence relating to renin-angiotensin system inhibitors.
Barrios, V; Escobar, C, 2013
)
1.11
"Olmesartan medoxomil is an angiotensin receptor blocker (ARB) which is shown to be effective and well tolerated in hypertensive patients. "( Olmesartan: induced maculopapular rash.
Bhushan, A; Ved Bhushan, ST,
)
3.02
"Olmesartan is a promising ARB for BP control in hypertensive type 2 diabetics."( Difference in the effects of switching from candesartan to olmesartan or telmisartan to olmesartan in hypertensive patients with type 2 diabetes: the COTO study.
Daikuhara, H; Fukunaga, K; Ohshima, T, 2014
)
2.09
"Olmesartan is a relatively newer ARB used in hypertension management."( WIN OVER study: Efficacy and safety of olmesartan in Indian hypertensive patients: results of an open label, non-comparative, multi-centric, post marketing observational study.
Kumar, S; Kumbla, DK; Naik, M; Reddy, YV; Trailokya, A,
)
1.12
"Olmesartan is a type of angiotensin II receptor inhibitor that can reduce the incidence of cardiovascular events. "( Effects of olmesartan on endothelial progenitor cell mobilization and function in carotid atherosclerosis.
Fu, YM; Gong, X; Shao, L; Zou, Y, 2015
)
2.25
"The olmesartan is a selective antagonist of angiotensin II indicated for the treatment of essential hypertension. "( [Enteropathy due to olmesartan].
Colardelle, P; Ould Sidi Mohamed, M, 2016
)
1.32
"Olmesartan is an antihypertensive medication belonging to the angiotensin II receptor blocker class of drugs that has recently been associated with severe enteropathy. "( Olmesartan-Associated Enteropathy: A Review of Clinical and Histologic Findings.
Choi, EY; McKenna, BJ, 2015
)
3.3
"Olmesartan is a therapy used for the management of hypertension available since 2002. "( Sprue-like enteropathy linked to olmesartan.
Campos Ruiz, A; Marra-López Valenciano, C; Urtasun Arlegui, L, 2016
)
2.16
"The olmesartan is a selective antagonist of angiotensin II indicated for the treatment of essential hypertension. "( [Enteropathy due to olmesartan].
Colardelle, P; Ould Sidi Mohamed, M, 2016
)
1.32
"Olmesartan medoxomil is an orally given angiotensin II receptor antagonist indicated for the treatment of hypertension."( Population Pharmacokinetic Modeling of Olmesartan, the Active Metabolite of Olmesartan Medoxomil, in Patients with Hypertension.
Kodati, D; Kotakonda, HK; Yellu, N, 2017
)
2.17
"Thus olmesartan/HCTZ is a well-tolerated option for patients who fail to respond to monotherapy and as initial therapy in those who require large reductions in diastolic blood pressure or systolic blood pressure to achieve goal blood pressure."( Clinical efficacy and safety of olmesartan/hydrochlorothiazide combination therapy in patients with essential hypertension.
Ruilope, LM, 2008
)
1.08
"Olmesartan is a potential ARB inducing activation of angiotensin-converting enzyme 2 (ACE2) that hydrolyzes Ang II to Ang 1-7, and has shown a beneficial effect on ventricular remodeling."( Comparison of the long-term effects of candesartan and olmesartan on plasma angiotensin II and left ventricular mass index in patients with hypertension.
Fujii, M; Horie, M; Kawahara, C; Nishiyama, K; Tsutamoto, T; Yamaji, M; Yamamoto, T, 2010
)
1.33
"Olmesartan medoxomil is an angiotensin II (Ang II) receptor blocker (ARB) that has been approved by the US Food and Drug Administration (FDA) for the treatment of hypertension. "( Treatment of hypertension with olmesartan medoxomil, alone and in combination with a diuretic: an update.
Chrysant, SG; Dimas, B; Shiraz, M, 2007
)
2.07
"Olmesartan is a selective angiotensin II type 1 receptor (AT1) antagonist. "( Improvement of stunned myocardium in dogs with olmesartan, an angiotensin II type 1 receptor antagonist, is independent of type 2 receptors.
Ichihara, K; Kaneta, S; Kano, S; Satoh, K, 2008
)
2.05

Effects

Olmesartan (OLM) has potent anti-oxidant and anti-inflammatory characters, yet having limited bioavailability. It has significant blood pressure lowering effect via modulating renin-angiotensin system. Its mechanism of action in DNR-induced renal injury is largely unknown.

ExcerptReferenceRelevance
"Olmesartan has a reverse-remodeling effect on AF-induced structural changes, indicating that it may be useful for preventing AF recurrence after the termination of sustained AF."( Reverse-remodeling effects of angiotensin II type 1 receptor blocker in a canine atrial fibrillation model.
Kumagai, K; Nakashima, H, 2007
)
1.78
"Olmesartan (OLM) has potent anti-oxidant and anti-inflammatory characters, yet having limited bioavailability."( Olmesartan niosomes ameliorates the Indomethacin-induced gastric ulcer in rats: Insights on MAPK and Nrf2/HO-1 signaling pathway.
Darwish, SF; El-Dakroury, WA; Radwan, E; Sallam, AM, 2021
)
2.79
"Olmesartan has significant blood pressure lowering effect via modulating renin-angiotensin system although its mechanism of action in DNR-induced renal injury is largely unknown."( Olmesartan protects against oxidative stress possibly through the Nrf2 signaling pathway and inhibits inflammation in daunorubicin-induced nephrotoxicity in rats.
Arozal, W; Arumugam, S; Gounder, VK; Harima, M; Nomoto, M; Pitchaimani, V; Suzuki, K; Thandavarayan, RA; Watanabe, K, 2014
)
2.57
"Olmesartan has been linked with increased risk of cardiovascular mortality and sprue-like enteropathy. "( Comparative effectiveness of olmesartan and other angiotensin receptor blockers in diabetes mellitus: retrospective cohort study.
Etminan, M; Eurich, DT; Lin, M; Padwal, R, 2014
)
2.14
"Olmesartan use has been associated with chronic diarrhoea and weight loss due to severe sprue-like enteropathy, yet this is still not well known among clinicians. "( An atypical case of chronic diarrhoea: olmesartan-induced sprue-like enteropathy.
Gonzalo, DH; Martelli, MG; Naik, DK; Pannu, D; Sharma, AK, 2015
)
2.13
"Olmesartan has been also widely examined in combination of either hydrochlorothiazide or amlodipine, as well as with both drugs in a single-pill triple combination, showing improvements in antihypertensive efficacy without significant effects on tolerability."( Olmesartan-based therapies: an effective way to improve blood pressure control and cardiovascular protection.
de la Sierra, A; Volpe, M, 2013
)
2.55
"Olmesartan has a reverse-remodeling effect on AF-induced structural changes, indicating that it may be useful for preventing AF recurrence after the termination of sustained AF."( Reverse-remodeling effects of angiotensin II type 1 receptor blocker in a canine atrial fibrillation model.
Kumagai, K; Nakashima, H, 2007
)
1.78

Actions

Olmesartan can increase circulating endothelial progenitor cells number and the serum levels of eNOS and NO. It may suppress atherosclerosis via reducing not only superoxide production but also the overload of oxidative stress in this animal model.

ExcerptReferenceRelevance
"Olmesartan can increase circulating endothelial progenitor cells number and the serum levels of eNOS and NO."( Effects of olmesartan on endothelial progenitor cell mobilization and function in carotid atherosclerosis.
Fu, YM; Gong, X; Shao, L; Zou, Y, 2015
)
1.53
"Olmesartan may increase TAS, yet inhibit oxidative stress, AP-1, inflammatory, and heart rate with improved artery stiffness in elderly hypertensive patients."( The association between oxidative stress, activator protein-1, inflammatory, total antioxidant status and artery stiffness and the efficacy of olmesartan in elderly patients with mild-to-moderate essential hypertension.
Du, Q; Han, L; Liu, Q; Shen, X; Zhang, M; Zhou, S,
)
1.05
"Olmesartan may suppress atherosclerosis via reducing not only superoxide production but also the overload of oxidative stress in this animal model."( Olmesartan, a novel angiotensin II type 1 receptor antagonist, reduces severity of atherosclerosis in apolipoprotein E deficient mice associated with reducing superoxide production.
Fujita, M; Kishimoto, C; Kita, T; Murayama, T; Shimada, K; Yokode, M, 2011
)
3.25
"Olmesartan abolished the increase in p21 expression, whereas neither eplerenone nor hydralazine affected it."( Aldosterone does not contribute to renal p21 expression during the development of angiotensin II-induced hypertension in mice.
Deguchi, K; Hitomi, H; Kitada, K; Kobori, H; Lei, B; Masaki, T; Minamino, T; Mori, H; Nakano, D; Nishiyama, A, 2012
)
1.1

Treatment

Olmesartan treatment induced a 16.2 ± 7.7% decrement of the mean R2* in CKD patients, suggesting that this drug had an intrarenal hypoxia ameliorating effect. Treatment reversed virtually all neuroendocrine and histopathological cardiac changes induced by EAM.

ExcerptReferenceRelevance
"40 olmesartan-treated patients (14.3%) and 53 placebo-treated patients (18.7%) developed secondary cardiovascular outcomes (HR: 0.65, P = 0.042)."( Effects of dual blockade of the renin-angiotensin system on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy and hypertension in the ORIENT: a post-hoc analysis (ORIENT-Hypertension).
Chan, JC; Haneda, M; Harada, A; Imai, E; Ito, S; Kobayashi, F; Makino, H; Yamasaki, T, 2013
)
0.9
"Olmesartan treatment was found to generate beneficial effects on MetS parameters in HT patients but did not produce any significant increases in serum PPAR-γ transcription factor concentration."( Peroxisome proliferator-activated receptor gamma concentrations in newly diagnosed hypertension patients and the metabolic effects of olmesartan.
Akbal, E; Akyürek, N; Akyürek, Ö; Güneş, F, 2014
)
2.05
"Olmesartan treatment (3 mg/kg per day) for 4 weeks significantly lowered systolic blood pressure but did not affect body weight during the study period in KKAy mice."( Effects of the Angiotensin receptor blocker olmesartan on adipocyte hypertrophy and function in mice with metabolic disorders.
Azushima, K; Kanaoka, T; Kobayashi, R; Maeda, A; Matsuda, M; Ohki, K; Ohsawa, M; Tamura, K; Tokita, Y; Tsurumi-Ikeya, Y; Umemura, S; Uneda, K; Wakui, H; Yamashita, A, 2014
)
1.38
"Olmesartan treatment significantly ameliorated blood-brain barrier (BBB) disruption induced by CKD in 5XFAD mice."( Chronic kidney disease accelerates cognitive impairment in a mouse model of Alzheimer's disease, through angiotensin II.
Hasegawa, Y; Kim-Mitsuyama, S; Nakagawa, T; Uekawa, K, 2017
)
1.18
"Olmesartan treatment substantially elevated both the baseline SI and SG levels of the ZF rats."( [Effects of angiotensin II type 1 receptor blocker on triglyceride metabolism in the liver: experiment with Zucker fatty rats].
Feng, Q; Guo, J; Lao, GC; Liu, W; Ran, JM; Xie, B; Xu, G; Zhang, Y, 2008
)
1.07
"Olmesartan treatment significantly lowered the blood pressure of PAH mice, and hypertrophy as well as increased plasma levels of cardiac injury markers were also markedly reduced."( Angiotensin type 1 receptor blockade prevents cardiac remodeling in mice with pregnancy-associated hypertension.
Fukamizu, A; Honjo, K; Inaba, S; Ishida, J; Nakamura, S; Sakairi, A; Sugiyama, F; Yagami, K, 2008
)
1.07
"In olmesartan-treated patients, CBF significantly increased in the affected and unaffected hemispheres, and CRC increased significantly in the affected hemisphere."( Benefits of the angiotensin II receptor antagonist olmesartan in controlling hypertension and cerebral hemodynamics after stroke.
Kawahira, K; Matsumoto, S; Miyata, R; Shimodozono, M, 2009
)
1.12
"Olmesartan treatment significantly decreased SBP to 130.4+/-4.2mm Hg (P < .001) and DBP to 78.2+/-7.0mm Hg (P < .001)."( Olmesartan, an angiotensin II receptor blocker, restores cerebral hypoperfusion in elderly patients with hypertension.
Ikeda, K; Kawabe, K; Nagata, R, 2010
)
2.52
"Olmesartan treatment resulted in a significant decrease in CAVI, serum A-FABP levels, and hsCRP, besides a significant reduction of blood pressure."( Olmesartan reduces arterial stiffness and serum adipocyte fatty acid-binding protein in hypertensive patients.
Doi, M; Hirohata, S; Izumi, R; Kamikawa, S; Kusachi, S; Miyoshi, T; Ninomiya, Y; Ogawa, H; Sakane, K; Usui, S, 2011
)
2.53
"Olmesartan treatment effectively suppressed the myocardial protein expressions of inflammatory markers in comparison to the vehicle-treated rats."( Olmesartan attenuates the development of heart failure after experimental autoimmune myocarditis in rats through the modulation of ANG 1-7 mas receptor.
Gurusamy, N; Kodama, M; Lakshmanan, AP; Ma, M; Nagata, M; Sukumaran, V; Suzuki, K; Takagi, R; Veeraveedu, PT; Watanabe, K; Yamaguchi, K, 2012
)
2.54
"Olmesartan treatment led to a decrease of cystatin C level."( Effect of Olmesartan on serum cystatin C levels in the patients with essential hypertension.
Ahbap, E; Basturk, T; Borlu, F; Damar, AB; Koc, Y; Mazi, E; Sakaci, T; Unsal, A, 2011
)
1.49
"The olmesartan treatment induced a 16.2 ± 7.7% decrement of the mean R2* in CKD patients, suggesting that this drug had an intrarenal hypoxia ameliorating effect."( Angiotensin II receptor blocker partially ameliorated intrarenal hypoxia in chronic kidney disease patients: a pre-/post-study.
Chetsurakarn, S; Eiam-Ong, S; Limkuansuwan, P; Manotham, K; Ongvilawan, B; Tanamai, J; Tungsanga, K; Urusopone, P, 2012
)
0.86
"Olmesartan-treated mice also showed significant attenuation of left ventricular dilatation and dysfunction, as well as significantly greater infarct wall thickness, although the absolute size of the infarct scar was unchanged."( Inhibition of Fas-associated apoptosis in granulation tissue cells accompanies attenuation of postinfarction left ventricular remodeling by olmesartan.
Aoyama, T; Esaki, M; Fujiwara, H; Kanamori, H; Kawasaki, M; Li, Y; Maruyama, R; Minatoguchi, S; Miyata, S; Nakagawa, M; Ogino, A; Okada, H; Takemura, G; Ushikoshi, H, 2007
)
1.26
"Olmesartan treatment significantly ameliorated glomerulosclerosis and dramatically decreased urinary Smad1 (from 3.9 +/- 2.9 to 0.3 +/- 0.3 ng/mg creatinine, P < 0.05)."( Urinary Smad1 is a novel marker to predict later onset of mesangial matrix expansion in diabetic nephropathy.
Abe, H; Arai, H; Araki, M; Doi, T; Fukatsu, A; Iehara, N; Kanamori, H; Kita, T; Matsubara, T; Matsuura, M; Mima, A; Nagai, K; Takahashi, T; Tamura, Y; Tominaga, T; Torikoshi, K, 2008
)
1.07
"Olmesartan treatment reversed virtually all neuroendocrine and histopathological cardiac changes induced by EAM, thus providing a mechanistic insight into this phenomenon."( Angiotensin II receptor antagonism reverts the selective cardiac BNP upregulation and secretion observed in myocarditis.
de Bold, AJ; Georgalis, T; Kuroski de Bold, ML; Ogawa, T; Veinot, JP, 2008
)
1.07
"Olmesartan treatment caused a 61% reduction in the cross-sectional area of the neointima, from 0.27+/-0.01 mm2 in vehicle-treated rats to 0.11+/-0.01 mm2 in olmesartan-treated rats."( Increased expression of angiotensin converting enzyme 2 in conjunction with reduction of neointima by angiotensin II type 1 receptor blockade.
Ferrario, CM; Igase, M; Kohara, K; Miki, T; Nagai, T, 2008
)
1.07
"Treatment with olmesartan/azelnidipine for 2 years resulted in greater improvements in CBP, LVMI, and LV diastolic function, and arterial stiffness compared with olmesartan/amlodipine. "( Azelnidipine plus olmesartan versus amlodipine plus olmesartan on arterial stiffness and cardiac function in hypertensive patients: a randomized trial.
Saito, Y; Takami, T, 2013
)
1.08
"Treatment with olmesartan and nifedipine significantly improved BP."( Olmesartan ameliorates urinary dysfunction in the spontaneously hypertensive rat via recovering bladder blood flow and decreasing oxidative stress.
Dimitriadis, F; Kinoshita, Y; Martin, DT; Ohmasa, F; Oikawa, R; Oiwa, H; Saito, M; Satoh, I; Shimizu, S; Tomita, S; Tsounapi, P, 2014
)
2.18
"Treatment with olmesartan significantly decreased systolic blood pressure and ventricular hypertrophy, attenuated fibrosis, and improved diastolic function (all P < 0.05)."( Olmesartan attenuates cardiac hypertrophy and improves cardiac diastolic function in spontaneously hypertensive rats through inhibition of calcineurin pathway.
Cui, X; Fu, M; Ge, J; Hu, K; Liao, J; Sun, A; Xu, J; Zhou, J; Zhu, H; Zou, Y, 2014
)
2.18
"Treatment with olmesartan reversed tacrolimus-induced changes in the biochemical markers (BUN and creatinine) of nephrotoxicity."( Olmesartan attenuates tacrolimus-induced biochemical and ultrastructural changes in rat kidney tissue.
Al-Harbi, MM; Al-Harbi, NO; Alabidy, AD; Almukhallafi, AF; Imam, F; Iqbal, M; Nadeem, A; Sayed-Ahmed, MM, 2014
)
2.18
"Treatment with olmesartan or valsartan significantly ameliorated these changes in aged SHR."( Blood pressure variability, impaired autonomic function and vascular senescence in aged spontaneously hypertensive rats are ameliorated by angiotensin blockade.
Hasegawa, Y; Katayama, T; Kim-Mitsuyama, S; Koibuchi, N; Ma, M; Maeda, M; Nakagawa, T; Ogawa, H; Sueta, D; Toyama, K; Uekawa, K; Waki, H, 2014
)
0.74
"Treatment with olmesartan for 8 weeks does not improve fatty acid oxidation or the activity of enzymes associated with oxidative metabolism in skeletal muscle from overweight and obese individuals. "( Angiotensin II receptor blockade and skeletal muscle metabolism in overweight and obese adults with elevated blood pressure.
Anderson, AS; Boutagy, NE; Davy, BM; Davy, KP; Frisard, MI; Hulver, MW; Marinik, EL; McMillan, RP; Rivero, JM, 2015
)
0.77
"Posttreatment with olmesartan significantly reduced escape latency (P < 0.01) on water maze test, retention trial latency (P < 0.05) on passive avoidance test, and retention time of outer zone (P < 0.01) on open-field test in 5XFAD subjected to BCCAO."( Transient Mild Cerebral Ischemia Significantly Deteriorated Cognitive Impairment in a Mouse Model of Alzheimer's Disease via Angiotensin AT1 Receptor.
Hasegawa, Y; Kim-Mitsuyama, S; Matsui, K; Nakagata, N; Nakagawa, T; Senju, S; Uekawa, K, 2017
)
0.77
"The treatment with olmesartan normalized insulin signaling, including expression of glucose transporter-4, whereas the treatment with enalapril was ineffective for the insulin receptor and less effective than olmesartan on the insulin-receptor substrate-1, phosphorylated-mammalian target of rapamycin and glucose transporter-4."( Angiotensin receptor blockers improve insulin signaling and prevent microvascular rarefaction in the skeletal muscle of spontaneously hypertensive rats.
Agabiti-Rosei, E; Assanelli, D; Boari, GE; De Ciuceis, C; Favero, G; Flati, V; Martinotti, S; Paiardi, S; Pasini, E; Platto, C; Porteri, E; Rezzani, R; Rizzoni, D; Rodella, LF; Speca, S; Toniato, E, 2008
)
0.66
"Treatment with olmesartan, nifedipine, or both drugs had no effect on systolic blood pressure, and each treatment achieved similar suppression of 4-HNE expression."( Efficacy of olmesartan and nifedipine on recurrent hypoxia-induced left ventricular remodeling in diabetic mice.
Hayashi, T; Kitada, K; Kitaura, Y; Matsumoto, C; Matsumura, Y; Miyamura, M; Mori, T; Okada, Y; Sohmiya, K; Ukimura, A; Yamashita, C; Yoshioka, T, 2010
)
1.08
"Treatment with olmesartan reduced urinary protein-to-creatinine ratio independent of blood glucose and increased average renal vessel lumen diameter in the perfused kidneys of STZ-induced DM rats, predominantly in preglomerular vessels, and then improved renal excretory capability. "( Effects of angiotensin II receptor antagonist olmesartan on renal hemodynamic variables and vascular structural properties in streptozotocin-induced diabetic rats.
Chen, JF; Li, HW; Song, HF; Sun, NL, 2011
)
0.98
"Treatment with olmesartan attenuated the myocardial mRNA expressions of proinflammatory cytokines, [Interleukin (IL)-1β, monocyte chemoattractant protein-1, tumor necrosis factor-α and interferon-γ)] and the protein expression of tumor necrosis factor-α compared with that of vehicle-treated rats."( Olmesartan, an AT1 antagonist, attenuates oxidative stress, endoplasmic reticulum stress and cardiac inflammatory mediators in rats with heart failure induced by experimental autoimmune myocarditis.
Gurusamy, N; Kodama, M; Lakshmanan, AP; Ma, M; Sukumaran, V; Suzuki, K; Thandavarayan, RA; Veeraveedu, PT; Watanabe, K; Yamaguchi, K, 2011
)
2.15
"Treatment with olmesartan delayed the onset of microalbuminuria independent of the baseline BP and the degree of BP reduction."( Prevention of microalbuminuria in patients with type 2 diabetes and hypertension.
Chatzykirkou, C; Haller, H; Ito, S; Izzo, JL; Januszewicz, A; Katayama, S; Menne, J; Mimran, A; Rabelink, TJ; Ritz, E; Ruilope, LM; Rump, LC; Viberti, G, 2012
)
0.72
"Treatment with olmesartan (3 mg/kg per day) significantly inhibited oxidative stress and atherosclerosis, whereas its inhibitory effects were more marked in female than in male or ovariectomized mice."( Inhibitory effects of AT1 receptor blocker, olmesartan, and estrogen on atherosclerosis via anti-oxidative stress.
Horiuchi, M; Ide, A; Iwai, M; Li, HS; Li, JM; Min, LJ; Mogi, M; Okumura, M; Suzuki, H; Suzuki, J; Tsuda, M, 2005
)
0.93
"Treatment with olmesartan (n=9) significantly increased EPCs from 231+/-24 to 465+/-71 per high-power field (P<0.05), but not hematopoietic progenitor cells."( Stimulation of endothelial progenitor cells: a new putative therapeutic effect of angiotensin II receptor antagonists.
Bahlmann, FH; de Groot, K; Fliser, D; Haller, H; Hertel, B; Mueller, O, 2005
)
0.67
"Treatment with olmesartan (10 or 100 mg/kg/day) had no effect on blood pressure but attenuated proteinuria in a dose-dependent manner."( Augmentation of intrarenal angiotensin II levels in uninephrectomized aldosterone/salt-treated hypertensive rats; renoprotective effects of an ultrahigh dose of olmesartan.
Abe, Y; Baba, R; Fan, YY; Fujita, M; Hosomi, N; Kimura, S; Kohno, M; Miyatake, A; Nagai, Y; Nishiyama, A; Sun, GP, 2006
)
0.87
"Treatment with olmesartan or pravastatin reduced the development of atherosclerosis as compared to the control group (-46 and -39%, respectively)."( Olmesartan and pravastatin additively reduce development of atherosclerosis in APOE*3Leiden transgenic mice.
Havekes, LM; Jukema, JW; Kleemann, R; Kooistra, T; Princen, HM; van der Hoorn, JW, 2007
)
2.12
"Treatment with olmesartan significantly decreased serum glucose and cholesterol levels in HSCD mice, with a slight decrease in blood pressure."( Inhibition of cognitive decline in mice fed a high-salt and cholesterol diet by the angiotensin receptor blocker, olmesartan.
Fujita, T; Horiuchi, M; Iwai, M; Iwanami, J; Li, JM; Min, LJ; Mogi, M; Sakata, A; Tsukuda, K, 2007
)
0.89
"Treatment with olmesartan blocked leukocyte recruitment by antagonizing mononuclear cells-associated oxidative stress."( Oxidative stress in mononuclear cells plays a dominant role in their adhesion to mouse femoral artery after injury.
Hagita, S; Osaka, M; Shimokado, K; Yoshida, M, 2008
)
0.69

Toxicity

Olmesartan 20 mg/40 mg is effective and well tolerated without any serious adverse events in patients with hypertension. Treatment with sacubitril/valsartan 200 or 400 mg once daily is effective.

ExcerptReferenceRelevance
" 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
)
0.55
" There were no critical adverse effects in the ARB group throughout the study period."( Safety and efficacy of antihypertensive therapy with add-on angiotensin II type 1 receptor blocker after successful coronary stent implantation.
Arimura, T; Iwata, A; Kawamura, A; Kiya, Y; Miura, S; Nishikawa, H; Saku, K; Sugihara, M; Takamiya, Y; Uehara, Y, 2009
)
0.35
"We assessed the safety of olmesartan by monitoring adverse drug reactions (ADRs)."( Safety and efficacy of olmesartan: an observational pooled-analysis of 156,682 hypertensive patients.
Kreutz, R; Schaefer, A; Scholze, J, 2011
)
0.98
" 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,
)
0.38
"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
)
0.65
" Adverse drug reactions were rare (n = 19), and no serious adverse drug reactions occurred."( Safety, tolerability, and efficacy of a fixed-dose combination of olmesartan 40 mg and hydrochlorothiazide 12.5/25 mg in daily practice.
Bramlage, P; Fronk, EM; Ketelhut, R; Schmieder, RE; Wolf, WP; Zemmrich, C, 2013
)
0.63
"Our data confirm randomized trial data concerning safe and efficient blood pressure reduction using a fixed-dose combination of olmesartan 40 mg and HCTZ 12."( Safety, tolerability, and efficacy of a fixed-dose combination of olmesartan 40 mg and hydrochlorothiazide 12.5/25 mg in daily practice.
Bramlage, P; Fronk, EM; Ketelhut, R; Schmieder, RE; Wolf, WP; Zemmrich, C, 2013
)
0.83
" 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
)
0.64
" All reported adverse events were recorded."( WIN OVER study: Efficacy and safety of olmesartan in Indian hypertensive patients: results of an open label, non-comparative, multi-centric, post marketing observational study.
Kumar, S; Kumbla, DK; Naik, M; Reddy, YV; Trailokya, A,
)
0.4
"08% patients reported the adverse events."( WIN OVER study: Efficacy and safety of olmesartan in Indian hypertensive patients: results of an open label, non-comparative, multi-centric, post marketing observational study.
Kumar, S; Kumbla, DK; Naik, M; Reddy, YV; Trailokya, A,
)
0.4
"Olmesartan 20 mg/40 mg is effective and well tolerated without any serious adverse events in patients with hypertension."( WIN OVER study: Efficacy and safety of olmesartan in Indian hypertensive patients: results of an open label, non-comparative, multi-centric, post marketing observational study.
Kumar, S; Kumbla, DK; Naik, M; Reddy, YV; Trailokya, A,
)
1.84
" The primary endpoint was a composite of fatal and non fatal cardiovascular events, whereas adverse events (AEs) and the percentage of patients who discontinued the allocated treatment were evaluated as secondary endpoints."( Comparison of olmesartan combined with a calcium channel blocker or a diuretic in elderly hypertensive patients (COLM Study): safety and tolerability.
Higaki, J; Ito, S; Matsuoka, H; Ogihara, T; Rakugi, H; Saito, I; Saruta, T; Shimada, K; Shimamoto, K; Teramukai, S, 2015
)
0.78
" 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
)
1
" The overall incidence of adverse events was comparable between the groups."( Efficacy and safety of sacubitril/valsartan in patients with essential hypertension uncontrolled by olmesartan: A randomized, double-blind, 8-week study.
Aizenberg, D; Chen, CW; Cheung, DG; Gorbunov, V; Hafeez, K; Zhang, J, 2018
)
0.7
" Treatment with sacubitril/valsartan 200 or 400 mg once daily is effective and provided superior BP reduction than olmesartan 20 mg in Asian patients with mild-to-moderate hypertension and is generally safe and well tolerated."( Efficacy and safety of sacubitril/valsartan compared with olmesartan in Asian patients with essential hypertension: A randomized, double-blind, 8-week study.
Guo, W; Huo, Y; Li, W; Wang, Q; Webb, R; Zhao, L, 2019
)
0.97
" 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
)
1.15

Pharmacokinetics

The population pharmacokinetic model for olmesartan was developed using Phoenix NLME 1. The method proved highly reproducible and sensitive and was successfully applied after single dose oral administration of olmesartsan and pioglitazone.

ExcerptReferenceRelevance
"8 hours, and the terminal elimination half-life ranged from 12 to 18 hours."( Pharmacokinetics of CS-866, a new angiotensin II receptor blocker, in healthy subjects.
Masonson, HN; Schwocho, LR, 2001
)
0.31
"To develop a population pharmacokinetic model for olmesartan (RNH-6270), the active metabolite of olmesartan medoxomil, in healthy volunteers and hypertensive patients, and to evaluate effects of covariates on the apparent oral clearance (CL/F), with particular emphasis on the effect of race."( Population pharmacokinetics of olmesartan following oral administration of its prodrug, olmesartan medoxomil: in healthy volunteers and hypertensive patients.
Gao, Y; Hisaoka, M; Shiga, H; Wada, DR; Yoshihara, K, 2005
)
0.87
"The pharmacokinetic data of olmesartan were well described by a two-compartment linear model with first-order absorption and an absorption lag-time, parameterised in terms of CL/F (6."( Population pharmacokinetics of olmesartan following oral administration of its prodrug, olmesartan medoxomil: in healthy volunteers and hypertensive patients.
Gao, Y; Hisaoka, M; Shiga, H; Wada, DR; Yoshihara, K, 2005
)
0.91
"The population pharmacokinetic analysis of olmesartan showed that: (i) severe renal impairment (serum creatinine >265 micromol/L [approximately 3 mg/dL]) could cause a clearance decrease of > or =30%; (ii) older age, lower bodyweight and being female were determinants of lower clearance but their effects on olmesartan clearance were within 20%; (iii) no statistically significant difference in clearance was found between Westerners and Japanese."( Population pharmacokinetics of olmesartan following oral administration of its prodrug, olmesartan medoxomil: in healthy volunteers and hypertensive patients.
Gao, Y; Hisaoka, M; Shiga, H; Wada, DR; Yoshihara, K, 2005
)
0.88
" 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
)
0.62
" In conclusion, the effects of olmesartan medoxomil and azelnidipine were modestly correlated with pharmacokinetic profiles, and the pre-treatment PRA level could be a useful determinant of responsiveness in selecting olmesartan medoxomil and azelnidipine."( Comparative pharmacodynamics of olmesartan and azelnidipine in patients with hypertension: a population pharmacokinetic/pharmacodynamic analysis.
Arakawa, K; Kuramoto, K; Tanigawara, Y; Yoshihara, K, 2009
)
0.92
" The pharmacokinetic parameters of IIa were studied and compared with those of olmesartan medoxomil."( Novel amides and esters prodrugs of olmesartan: Synthesis, bioconversion, and pharmacokinetic evaluation.
Chang, JS; Cho, YJ; Choi, WK; Choi, YW; Chung, HJ; El-Gamal, MI; Jeon, HR; Kim, HI; Lee, BS; Lee, J; Lee, WS; Lee, YS; Oh, CH; Park, JH, 2010
)
0.86
" The method proved highly reproducible and sensitive and was successfully applied in a pharmacokinetic study after single dose oral administration of olmesartan and pioglitazone to the rat."( Development and validation of an LC-ESI-MS/MS method for simultaneous quantitation of olmesartan and pioglitazone in rat plasma and its pharmacokinetic application.
Bhaumik, U; Chakraborty, US; Chatterjee, B; Pal, TK; Roy, B; Sarkar, AK; Sengupta, P, 2010
)
0.78
" And the pharmacokinetic parameters for olmesartan after their oral administration were also estimated and compared with those in case of olmesartan medoxomil."( Design, synthesis, bioconversion, and pharmacokinetics evaluation of new ester prodrugs of olmesartan.
Anbar, HS; Chang, JS; Cho, YJ; Choi, YW; Chung, HJ; El-Gamal, MI; Jeon, HR; Kim, HI; Lee, BS; Lee, DJ; Lee, J; Lee, SA; Lee, WS; Moon, JY; Oh, CH, 2011
)
0.86
" A fixed-dose combination (FDC) tablet of these 2 drugs was recently developed to enhance the dosing convenience and to increase patient compliance while yielding pharmacokinetic profiles comparable to coadministration of each drug as individual tablets."( Pharmacokinetics of rosuvastatin/olmesartan fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects.
Chang, H; Kim, J; Lee, D; Park, K; Roh, H; Son, H; Yun, C, 2013
)
0.67
"The goal of present study was to compare the pharmacokinetic profiles of single-dose administration of an FDC tablet containing rosuvastatin/olmesartan 20/40 mg (test formulation) with coadministration of a rosuvastatin 20-mg tablet and a olmesartan 40-mg tablet (reference formulation) in healthy Korean male volunteers, for the purpose of determining bioequivalence."( Pharmacokinetics of rosuvastatin/olmesartan fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects.
Chang, H; Kim, J; Lee, D; Park, K; Roh, H; Son, H; Yun, C, 2013
)
0.87
" Blood samples were collected up to 72 hours after dosing, and pharmacokinetic parameters were determined for rosuvastatin, its active metabolite (N-desmethyl rosuvastatin), and olmesartan."( Pharmacokinetics of rosuvastatin/olmesartan fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects.
Chang, H; Kim, J; Lee, D; Park, K; Roh, H; Son, H; Yun, C, 2013
)
0.86
" The 90% CIs of the geometric mean ratios of the primary pharmacokinetic parameters were as follows: rosuvastatin: AUC(last), 85."( Pharmacokinetics of rosuvastatin/olmesartan fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects.
Chang, H; Kim, J; Lee, D; Park, K; Roh, H; Son, H; Yun, C, 2013
)
0.67
"The pharmacokinetic properties of the newly developed FDC tablet of rosuvastatin/olmesartan 20/40 mg suggest that it is bioequivalent to co-administration of each drug as individual tablets in these healthy Korean male subjects."( Pharmacokinetics of rosuvastatin/olmesartan fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects.
Chang, H; Kim, J; Lee, D; Park, K; Roh, H; Son, H; Yun, C, 2013
)
0.9
" With no information currently available on the interaction between the 2 drugs, a pharmacokinetic study was conducted to investigate the influence of rosuvastatin on olmesartan and vice versa when the 2 drugs were coadministered."( Pharmacokinetic interaction between rosuvastatin and olmesartan: a randomized, open-label, 3-period, multiple-dose crossover study in healthy Korean male subjects.
Chang, H; Lee, D; Park, K; Roh, H; Son, H; Yun, C, 2014
)
0.85
" Blood samples were collected up to 72 hours after dosing, and pharmacokinetic parameters were determined for rosuvastatin, its active metabolite (N-desmethyl rosuvastatin), and olmesartan."( Pharmacokinetic interaction between rosuvastatin and olmesartan: a randomized, open-label, 3-period, multiple-dose crossover study in healthy Korean male subjects.
Chang, H; Lee, D; Park, K; Roh, H; Son, H; Yun, C, 2014
)
0.84
" The 90% CIs of the geometric mean ratios for the primary pharmacokinetic parameters for the coadministration of the 2 drugs to the mono-administration of each drug were 85."( Pharmacokinetic interaction between rosuvastatin and olmesartan: a randomized, open-label, 3-period, multiple-dose crossover study in healthy Korean male subjects.
Chang, H; Lee, D; Park, K; Roh, H; Son, H; Yun, C, 2014
)
0.65
"The aim of the study was to establish a population pharmacokinetic model for olmesartan, the active metabolite of olmesartan medoxomil, in Indian hypertensive patients, and to evaluate effects of covariates on the volume of distribution (V/F) and oral clearance (CL/F) of olmesartan."( Population Pharmacokinetic Modeling of Olmesartan, the Active Metabolite of Olmesartan Medoxomil, in Patients with Hypertension.
Kodati, D; Kotakonda, HK; Yellu, N, 2017
)
0.95
" The pharmacokinetic data of olmesartan was well described by a two-compartment linear pharmacokinetic model with first-order absorption and an absorption lag-time."( Population Pharmacokinetic Modeling of Olmesartan, the Active Metabolite of Olmesartan Medoxomil, in Patients with Hypertension.
Kodati, D; Kotakonda, HK; Yellu, N, 2017
)
1.02
"The final population pharmacokinetic model was demonstrated to be appropriate and effective and it can be used to assess the pharmacokinetic parameters of olmesartan in Indian patients with hypertension."( Population Pharmacokinetic Modeling of Olmesartan, the Active Metabolite of Olmesartan Medoxomil, in Patients with Hypertension.
Kodati, D; Kotakonda, HK; Yellu, N, 2017
)
0.92

Compound-Compound Interactions

Azelnidipine is equally effective as a thiazide diuretic in reducing urinary albumin when used in combination with olmesartan. High-risk hypertensive patients aged 65-84 years were enrolled and were randomized to receive olmesArtan combined with either a CCB (amlodipine or azelnIDipine) or a low-dosediuretic for at least 3 years.

ExcerptReferenceRelevance
" In addition, the BP lowering effect of olmesartan, like the other members of its class, is greatly enhanced in combination with a diuretic."( Treatment of hypertension with olmesartan medoxomil, alone and in combination with a diuretic: an update.
Chrysant, SG; Dimas, B; Shiraz, M, 2007
)
0.89
"The aim of this study was to compare the effects between calcium channel blockers and diuretics when used in combination with angiotensin II receptor blocker on aortic systolic blood pressure (BP) and brachial ambulatory systolic BP."( Differential effects between a calcium channel blocker and a diuretic when used in combination with angiotensin II receptor blocker on central aortic pressure in hypertensive patients.
Eguchi, K; Ishikawa, J; Kario, K; Matsui, Y; Miyashita, H; O'Rourke, MF; Shimada, K, 2009
)
0.35
" In this study, the efficacy of treatment using an angiotensin II receptor antagonist (ARB) combined with a calcium channel blocker (CCB) or a diuretic was compared from multiple perspectives in patients with hypertension."( Angiotensin-II receptor antagonist combined with calcium channel blocker or diuretic for essential hypertension.
Akabane, T; Ishimitsu, T; Masuda, T; Matsuoka, H; Minami, J; Numabe, A; Okamura, A, 2009
)
0.35
" 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
)
0.36
"Ketoconazole and rifampin are the most widely used compounds examined in recent drug-drug interaction (DDI) studies, and they have multiple roles in modulating drug metabolizing enzymes and transporters."( Inhibitory effects of ketoconazole and rifampin on OAT1 and OATP1B1 transport activities: considerations on drug-drug interactions.
Ahn, SH; Bae, MA; Choi, MK; Choi, YL; Jin, QR; Song, IS, 2011
)
0.37
"A thiazide diuretic used in combination with benazepril is superior to amlodipine plus benazepril in reducing albuminuria in hypertensive patients with diabetes."( Kidney-protective effects of azelnidipine versus a diuretic in combination with olmesartan in hypertensive patients with diabetes and albuminuria: a randomized study.
Dohi, Y; Hirota, H; Isaka, N; Ito, M; Kato, T; Kimura, G; Kojima, M; Machida, H; Makino, K; Miyagawa, K; Mizubayashi, R; Mizuno, O; Nakatani, K; Okamoto, S; Okubo, S; Okura, T; Takeuchi, M, 2013
)
0.62
"Azelnidipine is equally effective as a thiazide diuretic in reducing urinary albumin when used in combination with olmesartan."( Kidney-protective effects of azelnidipine versus a diuretic in combination with olmesartan in hypertensive patients with diabetes and albuminuria: a randomized study.
Dohi, Y; Hirota, H; Isaka, N; Ito, M; Kato, T; Kimura, G; Kojima, M; Machida, H; Makino, K; Miyagawa, K; Mizubayashi, R; Mizuno, O; Nakatani, K; Okamoto, S; Okubo, S; Okura, T; Takeuchi, M, 2013
)
0.83
" High-risk hypertensive patients aged 65-84 years were enrolled and were randomized to receive olmesartan combined with either a CCB (amlodipine or azelnidipine) or a low-dose diuretic for at least 3 years."( Comparison of olmesartan combined with a calcium channel blocker or a diuretic in elderly hypertensive patients (COLM Study): safety and tolerability.
Higaki, J; Ito, S; Matsuoka, H; Ogihara, T; Rakugi, H; Saito, I; Saruta, T; Shimada, K; Shimamoto, K; Teramukai, S, 2015
)
1
" During the next 12 weeks, they took olmesartan (1st group) or telmisartan (2nd group) in combination with atorvastatin."( The effect of therapy with olmesartan or telmisartan in patients with arterial hypertension combined with obesity.
Bazylevych, AY; Bochar, OM; Bochar, VT; Faynyk, AF; Kuzminov, YB; Sklyarova, HY, 2020
)
1.13
" After treatment with olmesartan in combination with atorvastatin, the adiponectin content in the blood increased by 41."( The effect of therapy with olmesartan or telmisartan in patients with arterial hypertension combined with obesity.
Bazylevych, AY; Bochar, OM; Bochar, VT; Faynyk, AF; Kuzminov, YB; Sklyarova, HY, 2020
)
1.17
" 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
)
1.12

Bioavailability

The method is sensitive, rapid and suitable for the study of pharmacokinetics and bioavailability of olmesartan. Bioavailability (Cmax and area under the curve) increased approximately in proportion with dose, after single and multiple daily oral doses.

ExcerptReferenceRelevance
" Absolute bioavailability of RNH-6270 after oral administration of CS-866 was 26%."( Pharmacokinetics of CS-866, a new angiotensin II receptor blocker, in healthy subjects.
Masonson, HN; Schwocho, LR, 2001
)
0.31
" Bioavailability (Cmax and area under the curve) increased approximately in proportion with dose, after single and multiple daily oral doses, over the therapeutic dose range (up to 40-80 mg daily), above which systemic availability of olmesartan increased less than proportionally with increase in dose."( The pharmacokinetic and metabolic profile of olmesartan medoxomil limits the risk of clinically relevant drug interaction.
Kirch, W; Laeis, P; Püchler, K, 2001
)
0.75
" We conclude that in NTG-treated rabbits, endothelial nitric oxide production in mesenteric resistance arteries is reduced, possibly through a reduction in the bioavailability of L-arginine via an action mediated by superoxide."( Chronic nitroglycerine administration reduces endothelial nitric oxide production in rabbit mesenteric resistance artery.
Itoh, T; Kajikuri, J; Suzuki, Y; Suzumori, K; Watanabe, Y; Yamamoto, T, 2005
)
0.33
"66 L/h for a typical male Western hypertensive patient), absorption rate constant (1."( Population pharmacokinetics of olmesartan following oral administration of its prodrug, olmesartan medoxomil: in healthy volunteers and hypertensive patients.
Gao, Y; Hisaoka, M; Shiga, H; Wada, DR; Yoshihara, K, 2005
)
0.61
" Human oral bioavailability is an important pharmacokinetic property, which is directly related to the amount of drug available in the systemic circulation to exert pharmacological and therapeutic effects."( Hologram QSAR model for the prediction of human oral bioavailability.
Andricopulo, AD; Moda, TL; Montanari, CA, 2007
)
0.34
"The method is sensitive, rapid and suitable for the study of pharmacokinetics and bioavailability of olmesartan."( [High-performance liquid chromatography-mass spectrometry for determining olmesartan in human plasma].
Chen, BM; Chen, SH; Pei, Q; Tan, HY; Wu, CF; Yang, GP; Yang, L, 2008
)
0.79
" These findings may explain the known interaction of telmisartan with digoxin and suggest that it may modulate the bioavailability of drugs whose absorption is restricted by P-gp and possibly also by BCRP or MRP2."( Interaction of angiotensin receptor type 1 blockers with ATP-binding cassette transporters.
Benndorf, RA; Böger, RH; Divac, N; Haefeli, WE; Herzog, M; Sauer, A; Schwedhelm, E; Weiss, J, 2010
)
0.36
" Higher bioavailability compared to commercial oral tablets with a more sustainment behavior was achieved."( Development and characterization of colloidal soft nano-carriers for transdermal delivery and bioavailability enhancement of an angiotensin II receptor blocker.
Elshafeey, AH; Hathout, RM, 2012
)
0.38
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
" The main challenge was the poor bioavailability of azelnidipine due to its poor aqueous solubility and first-pass effect."( Chronological Delivery of Antihypertensive Drugs in Bilayered Core-in-Cup Buccoadhesive Tablets: In Vitro and In Vivo Evaluation.
Abd El Rehim, RT; El-Gazayerly, ON; Nageeb El-Helaly, S; Rashad, AA, 2019
)
0.51
" Hence, MasR activation may contribute to the favorable effects of AT1R antagonism on NO bioavailability and microvascular remodeling, independently of AT2R activation and blood pressure control."( Mas Receptor Activation Contributes to the Improvement of Nitric Oxide Bioavailability and Vascular Remodeling During Chronic AT1R (Angiotensin Type-1 Receptor) Blockade in Experimental Hypertension.
Arrabito, E; Battistoni, A; Filippini, A; Madaro, L; Nicoletti, C; Parente, R; Savoia, C; Steckelings, UM; Touyz, RM; Volpe, M, 2020
)
0.56

Dosage Studied

The aim of the present study was to use ambulatory blood pressure (BP) monitoring to determine the efficacy of a fixed-dose combination of amlodipine (AML) and olmesartan medoxomil (OM) The reduction from baseline in the 24 h mean systolic (SBP) and DBP was, respectively, 18.5% and 18.7%.

ExcerptRelevanceReference
"Olmesartan medoxomil monotherapy at the recommended dosage of 20 mg once daily is effective and well tolerated in patients with mild-to-moderate hypertension."( Blood pressure reduction with olmesartan in mild-to-moderate essential hypertension: a planned interim analysis of an open label sub-study in German patients.
Böhm, M; Ewald, S, 2006
)
2.07
" Dosing time did not exert statistically significant differences on the efficacy of olmesartan: the reduction from baseline in the 24 h mean systolic (SBP) and DBP was, respectively, 18."( Comparison of the efficacy of morning versus evening administration of olmesartan in uncomplicated essential hypertension.
Hermida, RC; Portaluppi, F; Smolensky, MH, 2007
)
0.8
"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
)
0.89
" Nocturnal BP regulation was significantly better achieved with bedtime as compared to morning dosing of olmesartan."( Administration-time-dependent effects of olmesartan on the ambulatory blood pressure of essential hypertension patients.
Ayala, DE; Chayan, L; Fernandez, JR; Hermida, RC; Mojon, A, 2009
)
0.83
" The authors evaluated the impact on 24-hour blood pressure, NBPF, and albuminuria of olmesartan 40 mg, administered in a morning- vs a nocturnal-based dosing scheme, in type 2 diabetic patients with newly diagnosed hypertension."( 24-hour and nighttime blood pressures in type 2 diabetic hypertensive patients following morning or evening administration of olmesartan.
García De La Villa, B; Tofé Povedano, S, 2009
)
0.78
" Secondary endpoints included: change in ambulatory diastolic BP (DBP) from baseline to Week 12; changes in ambulatory SBP and DBP during daytime, nighttime, and the last 2, 4, and 6 hours of the dosing interval; and achievement of prespecified ambulatory BP targets."( Effects of an olmesartan medoxomil based treatment algorithm on 24-hour blood pressure control in patients with hypertension and type 2 diabetes.
Kereiakes, DJ; Neutel, JM; Shojaee, A; Stoakes, KA; Waverczak, WF; Xu, J, 2010
)
0.72
"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
)
0.85
"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
)
0.79
" 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
)
0.84
" 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
)
0.65
" 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
)
1.81
" 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
)
0.61
" Olmesartan medoxomil showed larger BP reductions in the last 6 h from the dosing interval and higher smoothness indices than ramipril."( Twenty-four hour and early morning blood pressure control of olmesartan vs. ramipril in elderly hypertensive patients: pooled individual data analysis of two randomized, double-blind, parallel-group studies.
Malacco, E; Mallion, JM; Omboni, S; Volpe, M; Zanchetti, A, 2012
)
1.53
" The mean blood pressure in the final 6 hours of the dosing interval dropped from 135."( Reduction of the morning blood pressure surge treated with olmesartan in Chinese patients with mild to moderate essential hypertension--a multicenter, open-label, single treatment group clinical study.
Deng, W; Jiao, Y; Ke, Y; Sun, N; Wang, J; Zhu, J, 2012
)
0.62
"Two reversed phase liquid chromatographic (RP-LC) techniques are presented for the rapid, accurate, precise, simultaneous determination of olmesartan-hydrochlorothiazide and zofenopril-hydrochlorothiazide binary mixtures in their dosage forms."( Simultaneous estimation and validation of some binary mixtures of antihypertensive drugs by RP-LC methods using two new generation silica columns.
Gumustas, M; Kurbanoglu, S; Ozkan, SA, 2013
)
0.59
" A fixed-dose combination (FDC) tablet of these 2 drugs was recently developed to enhance the dosing convenience and to increase patient compliance while yielding pharmacokinetic profiles comparable to coadministration of each drug as individual tablets."( Pharmacokinetics of rosuvastatin/olmesartan fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects.
Chang, H; Kim, J; Lee, D; Park, K; Roh, H; Son, H; Yun, C, 2013
)
0.67
" Randomized and observational studies have shown that OM provides effective BP control across the 24 h dosing interval in the elderly."( Olmesartan in the treatment of hypertension in elderly patients: a review of the primary evidence.
Tocci, G; Volpe, M, 2013
)
1.83
" 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
)
0.65
" 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
)
0.65
"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
)
0.93
" The dosage of olmesartan and azilsartan increased significantly and slightly for 16 weeks (OL group: 20."( Practical efficacy of olmesartan versus azilsartan in patients with hypertension: a multicenter randomized-controlled trial (MUSCAT-4 study).
Hanayama, Y; Kakio, Y; Okuyama, Y; Takeuchi, H; Uchida, HA; Umebayashi, R; Wada, J, 2017
)
1.12
" After all patients received any of OLM 10, 20, and 40 mg/day as an initial dose, the dosage of OLM was titrated up to 40 mg as needed during follow-up period."( [Effects of Olmesartan Medoxomil on Patients with Thoracic and Thoracoabdominal Aortic Aneurysm;Evaluation of Anti-hypertensive Effect and Possible Suppression of Aneurysmal Dilation( OLM 40 Study)].
Adachi, O; Akiyama, M; Kumagai, K; Motoyoshi, N; Saiki, Y; Sasaki, K; Sato, M; Sugawara, Y, 2020
)
0.94
" 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
)
1.26
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
antihypertensive agentAny drug used in the treatment of acute or chronic vascular hypertension regardless of pharmacological mechanism.
angiotensin receptor antagonistA hormone antagonist that blocks angiotensin receptors.
[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 (1)

ClassDescription
biphenylyltetrazoleA member of the class of biphenyls that consists of a biphenyl ring system substituted by a tetrazole ring at an unspecified position.
[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 (4)

PathwayProteinsCompounds
Metabolism14961108
Biological oxidations150276
Phase I - Functionalization of compounds69175
Olmesartan Action Pathway74

Protein Targets (8)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, Beta-lactamaseEscherichia coli K-12Potency44.66840.044717.8581100.0000AID485294
euchromatic histone-lysine N-methyltransferase 2Homo sapiens (human)Potency25.11890.035520.977089.1251AID504332
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusPotency39.81070.009610.525035.4813AID1479145
[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)
Cytochrome P450 2C9 Homo sapiens (human)IC50 (µMol)50.00000.00002.800510.0000AID1210069
Cytochrome P450 2J2Homo sapiens (human)IC50 (µMol)50.00000.01202.53129.4700AID1210069
[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)
Platelet glycoprotein VIHomo sapiens (human)Kd300.00000.04110.04110.0411AID1692279
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Other Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Solute carrier organic anion transporter family member 1B3Homo sapiens (human)Km71.80000.03912.93886.4000AID680212
Solute carrier organic anion transporter family member 1B1Homo sapiens (human)Km42.60000.00763.201810.0000AID680560
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (34)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processCytochrome P450 2C9 Homo sapiens (human)
steroid metabolic processCytochrome P450 2C9 Homo sapiens (human)
cholesterol metabolic processCytochrome P450 2C9 Homo sapiens (human)
estrogen metabolic processCytochrome P450 2C9 Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 2C9 Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2C9 Homo sapiens (human)
urea metabolic processCytochrome P450 2C9 Homo sapiens (human)
monocarboxylic acid metabolic processCytochrome P450 2C9 Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2C9 Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 2C9 Homo sapiens (human)
amide metabolic processCytochrome P450 2C9 Homo sapiens (human)
icosanoid biosynthetic processCytochrome P450 2C9 Homo sapiens (human)
oxidative demethylationCytochrome P450 2C9 Homo sapiens (human)
omega-hydroxylase P450 pathwayCytochrome P450 2C9 Homo sapiens (human)
fatty acid metabolic processCytochrome P450 2J2Homo sapiens (human)
icosanoid metabolic processCytochrome P450 2J2Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 2J2Homo sapiens (human)
regulation of heart contractionCytochrome P450 2J2Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2J2Homo sapiens (human)
linoleic acid metabolic processCytochrome P450 2J2Homo sapiens (human)
organic acid metabolic processCytochrome P450 2J2Homo sapiens (human)
positive regulation of platelet aggregationPlatelet glycoprotein VIHomo sapiens (human)
enzyme-linked receptor protein signaling pathwayPlatelet glycoprotein VIHomo sapiens (human)
platelet activationPlatelet glycoprotein VIHomo sapiens (human)
collagen-activated tyrosine kinase receptor signaling pathwayPlatelet glycoprotein VIHomo sapiens (human)
collagen-activated signaling pathwayPlatelet glycoprotein VIHomo sapiens (human)
platelet aggregationPlatelet glycoprotein VIHomo sapiens (human)
immune response-regulating signaling pathwayPlatelet glycoprotein VIHomo sapiens (human)
xenobiotic metabolic processSolute carrier organic anion transporter family member 1B3Homo sapiens (human)
monoatomic ion transportSolute carrier organic anion transporter family member 1B3Homo sapiens (human)
organic anion transportSolute carrier organic anion transporter family member 1B3Homo sapiens (human)
bile acid and bile salt transportSolute carrier organic anion transporter family member 1B3Homo sapiens (human)
heme catabolic processSolute carrier organic anion transporter family member 1B3Homo sapiens (human)
sodium-independent organic anion transportSolute carrier organic anion transporter family member 1B3Homo sapiens (human)
transmembrane transportSolute carrier organic anion transporter family member 1B3Homo sapiens (human)
xenobiotic metabolic processSolute carrier organic anion transporter family member 1B1Homo sapiens (human)
monoatomic ion transportSolute carrier organic anion transporter family member 1B1Homo sapiens (human)
organic anion transportSolute carrier organic anion transporter family member 1B1Homo sapiens (human)
bile acid and bile salt transportSolute carrier organic anion transporter family member 1B1Homo sapiens (human)
prostaglandin transportSolute carrier organic anion transporter family member 1B1Homo sapiens (human)
heme catabolic processSolute carrier organic anion transporter family member 1B1Homo sapiens (human)
sodium-independent organic anion transportSolute carrier organic anion transporter family member 1B1Homo sapiens (human)
transmembrane transportSolute carrier organic anion transporter family member 1B1Homo sapiens (human)
thyroid hormone transportSolute carrier organic anion transporter family member 1B1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (30)

Processvia Protein(s)Taxonomy
monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
iron ion bindingCytochrome P450 2C9 Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2C9 Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 2C9 Homo sapiens (human)
arachidonic acid 14,15-epoxygenase activityCytochrome P450 2C9 Homo sapiens (human)
arachidonic acid 11,12-epoxygenase activityCytochrome P450 2C9 Homo sapiens (human)
oxidoreductase activityCytochrome P450 2C9 Homo sapiens (human)
(S)-limonene 6-monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
(S)-limonene 7-monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
caffeine oxidase activityCytochrome P450 2C9 Homo sapiens (human)
(R)-limonene 6-monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
aromatase activityCytochrome P450 2C9 Homo sapiens (human)
heme bindingCytochrome P450 2C9 Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2C9 Homo sapiens (human)
monooxygenase activityCytochrome P450 2J2Homo sapiens (human)
iron ion bindingCytochrome P450 2J2Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
arachidonic acid 14,15-epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
arachidonic acid 11,12-epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
isomerase activityCytochrome P450 2J2Homo sapiens (human)
linoleic acid epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
hydroperoxy icosatetraenoate isomerase activityCytochrome P450 2J2Homo sapiens (human)
arachidonic acid 5,6-epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
heme bindingCytochrome P450 2J2Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2J2Homo sapiens (human)
transmembrane signaling receptor activityPlatelet glycoprotein VIHomo sapiens (human)
protein bindingPlatelet glycoprotein VIHomo sapiens (human)
collagen bindingPlatelet glycoprotein VIHomo sapiens (human)
signaling receptor activityPlatelet glycoprotein VIHomo sapiens (human)
collagen receptor activityPlatelet glycoprotein VIHomo sapiens (human)
protein tyrosine kinase bindingPlatelet glycoprotein VIHomo sapiens (human)
serine-type endopeptidase inhibitor activitySolute carrier organic anion transporter family member 1B3Homo sapiens (human)
organic anion transmembrane transporter activitySolute carrier organic anion transporter family member 1B3Homo sapiens (human)
bile acid transmembrane transporter activitySolute carrier organic anion transporter family member 1B3Homo sapiens (human)
sodium-independent organic anion transmembrane transporter activitySolute carrier organic anion transporter family member 1B3Homo sapiens (human)
organic anion transmembrane transporter activitySolute carrier organic anion transporter family member 1B1Homo sapiens (human)
bile acid transmembrane transporter activitySolute carrier organic anion transporter family member 1B1Homo sapiens (human)
prostaglandin transmembrane transporter activitySolute carrier organic anion transporter family member 1B1Homo sapiens (human)
sodium-independent organic anion transmembrane transporter activitySolute carrier organic anion transporter family member 1B1Homo sapiens (human)
thyroid hormone transmembrane transporter activitySolute carrier organic anion transporter family member 1B1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (12)

Processvia Protein(s)Taxonomy
endoplasmic reticulum membraneCytochrome P450 2C9 Homo sapiens (human)
plasma membraneCytochrome P450 2C9 Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C9 Homo sapiens (human)
cytoplasmCytochrome P450 2C9 Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C9 Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2J2Homo sapiens (human)
extracellular exosomeCytochrome P450 2J2Homo sapiens (human)
cytoplasmCytochrome P450 2J2Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2J2Homo sapiens (human)
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
membrane raftPlatelet glycoprotein VIHomo sapiens (human)
plasma membranePlatelet glycoprotein VIHomo sapiens (human)
cell surfacePlatelet glycoprotein VIHomo sapiens (human)
extracellular exosomePlatelet glycoprotein VIHomo sapiens (human)
tetraspanin-enriched microdomainPlatelet glycoprotein VIHomo sapiens (human)
plasma membranePlatelet glycoprotein VIHomo sapiens (human)
plasma membraneSolute carrier organic anion transporter family member 1B3Homo sapiens (human)
basal plasma membraneSolute carrier organic anion transporter family member 1B3Homo sapiens (human)
basolateral plasma membraneSolute carrier organic anion transporter family member 1B3Homo sapiens (human)
plasma membraneSolute carrier organic anion transporter family member 1B1Homo sapiens (human)
basal plasma membraneSolute carrier organic anion transporter family member 1B1Homo sapiens (human)
membraneSolute carrier organic anion transporter family member 1B1Homo sapiens (human)
basolateral plasma membraneSolute carrier organic anion transporter family member 1B1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (93)

Assay IDTitleYearJournalArticle
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
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.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
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.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID680560TP_TRANSPORTER: transport in OATP1B1-expressing oocytes2006Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 34, Issue:5
OATP1B1, OATP1B3, and mrp2 are involved in hepatobiliary transport of olmesartan, a novel angiotensin II blocker.
AID568788Binding affinity to angiotensin AT1 receptor in bovine adrenal cortex membranes2010Bioorganic & medicinal chemistry, Dec-15, Volume: 18, Issue:24
Angiotensin II receptor type 1 (AT1) selective nonpeptidic antagonists--a perspective.
AID1217705Time dependent inhibition of CYP2B6 (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.
AID1211555In vitro apparent biliary clearance in sandwich cultured Sprague-Dawley rat hepatocytes after 15 mins by LC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
In vivo biliary clearance should be predicted by intrinsic biliary clearance in sandwich-cultured hepatocytes.
AID1211548In vivo apparent biliary clearance in iv dosed Sprague-Dawley rat by LC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
In vivo biliary clearance should be predicted by intrinsic biliary clearance in sandwich-cultured hepatocytes.
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.
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.
AID1216814Metabolic activation assessed as CYP2C9 activation-induced cytotoxicity in human HepG2 cells transfected with human AdCYP2C9 at MOI 10 for 2 days in presence of siNrf2 at 25 to 100 uM after 24 hrs by WST-8 assay2011Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 39, Issue:5
CYP2C9-mediated metabolic activation of losartan detected by a highly sensitive cell-based screening assay.
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.
AID183748Inhibitory activity against AII-Induced Pressor response at 1 mg/Kg at 6 hour1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
Nonpeptide angiotensin II receptor antagonists: synthesis, biological activities, and structure-activity relationships of imidazole-5-carboxylic acids bearing alkyl, alkenyl, and hydroxyalkyl substituents at the 4-position and their related compounds.
AID183742Inhibitory activity against AII-Induced Pressor response at 0.3 mg/Kg at 1 hr1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
Nonpeptide angiotensin II receptor antagonists: synthesis, biological activities, and structure-activity relationships of imidazole-5-carboxylic acids bearing alkyl, alkenyl, and hydroxyalkyl substituents at the 4-position and their related compounds.
AID183745Inhibitory activity against AII-Induced Pressor response at 0.3 mg/Kg at 6 hour1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
Nonpeptide angiotensin II receptor antagonists: synthesis, biological activities, and structure-activity relationships of imidazole-5-carboxylic acids bearing alkyl, alkenyl, and hydroxyalkyl substituents at the 4-position and their related compounds.
AID1211549Unbound fraction in Sprague-Dawley rat plasma at 100 uM by equilibrium dialysis method2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
In vivo biliary clearance should be predicted by intrinsic biliary clearance in sandwich-cultured hepatocytes.
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.
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.
AID568885Antagonist activity at angiotensin AT1 receptor in guinea pig aorta assessed as reduction of angiotensin 2-induced contractile response2010Bioorganic & medicinal chemistry, Dec-15, Volume: 18, Issue:24
Angiotensin II receptor type 1 (AT1) selective nonpeptidic antagonists--a perspective.
AID1211554Biliary excretion index in sandwich cultured Sprague-Dawley rat hepatocytes after 15 mins by LC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
In vivo biliary clearance should be predicted by intrinsic biliary clearance in sandwich-cultured hepatocytes.
AID1737435Agonist activity at human PPARgammaDEF receptor expressed in african green monkey COS7 cells transfected with pGal5-TK-pGL3/pRenilla-CMV assessed as intrinsic activity measured after 39 hrs by dual luciferase reporter assay2020European journal of medicinal chemistry, Jun-01, Volume: 195Identification and development of non-cytotoxic cell death modulators: Impact of sartans and derivatives on PPARγ activation and on growth of imatinib-resistant chronic myelogenous leukemia cells.
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.
AID680780TP_TRANSPORTER: transport in hCMV cells2006Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 34, Issue:5
OATP1B1, OATP1B3, and mrp2 are involved in hepatobiliary transport of olmesartan, a novel angiotensin II blocker.
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.
AID182953In vivo inhibitory activity against angiotensin II induced pressor response in anesthetized normotensive rats1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
Nonpeptide angiotensin II receptor antagonists: synthesis, biological activities, and structure-activity relationships of imidazole-5-carboxylic acids bearing alkyl, alkenyl, and hydroxyalkyl substituents at the 4-position and their related compounds.
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.
AID1737443Cytotoxicity against human HS5 cells assessed as cell death at 10 uM measured after 72 hrs by Propidium iodide stain based FACS analysis2020European journal of medicinal chemistry, Jun-01, Volume: 195Identification and development of non-cytotoxic cell death modulators: Impact of sartans and derivatives on PPARγ activation and on growth of imatinib-resistant chronic myelogenous leukemia cells.
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.
AID183743Inhibitory activity against AII-Induced Pressor response at 0.3 mg/Kg at 3 hour1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
Nonpeptide angiotensin II receptor antagonists: synthesis, biological activities, and structure-activity relationships of imidazole-5-carboxylic acids bearing alkyl, alkenyl, and hydroxyalkyl substituents at the 4-position and their related compounds.
AID680781TP_TRANSPORTER: transport in MRP2-expressing vesicles2006Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 34, Issue:5
OATP1B1, OATP1B3, and mrp2 are involved in hepatobiliary transport of olmesartan, a novel angiotensin II blocker.
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.
AID588962Substrates of transporters of clinical importance in the absorption and disposition of drugs, OATP1B12010Nature reviews. Drug discovery, Mar, Volume: 9, Issue:3
Membrane transporters in drug development.
AID679052TP_TRANSPORTER: biliary excretion in EHBR rat2006Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 34, Issue:5
OATP1B1, OATP1B3, and mrp2 are involved in hepatobiliary transport of olmesartan, a novel angiotensin II blocker.
AID1211551Drug uptake in sandwich cultured Sprague-Dawley rat hepatocytes by LC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
In vivo biliary clearance should be predicted by intrinsic biliary clearance in sandwich-cultured hepatocytes.
AID588963Substrates of transporters of clinical importance in the absorption and disposition of drugs, OATP1B32010Nature reviews. Drug discovery, Mar, Volume: 9, Issue:3
Membrane transporters in drug development.
AID679564TP_TRANSPORTER: transport in NTCP-transfected HEK-293 cells2006Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 34, Issue:5
OATP1B1, OATP1B3, and mrp2 are involved in hepatobiliary transport of olmesartan, a novel angiotensin II blocker.
AID183746Inhibitory activity against AII-Induced Pressor response at 1 mg/Kg at 1 hr1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
Nonpeptide angiotensin II receptor antagonists: synthesis, biological activities, and structure-activity relationships of imidazole-5-carboxylic acids bearing alkyl, alkenyl, and hydroxyalkyl substituents at the 4-position and their related compounds.
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.
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.
AID39641In vitro for inhibition of [125I]-angiotensin II (0.1 nM) binding to angiotensin II receptor type 1 in membrane fractions of bovine adrenal cortex1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
Nonpeptide angiotensin II receptor antagonists: synthesis, biological activities, and structure-activity relationships of imidazole-5-carboxylic acids bearing alkyl, alkenyl, and hydroxyalkyl substituents at the 4-position and their related compounds.
AID1282228Displacement of 125I-[Sar1, Ile8] AngII from rat AT1 receptor expressed in COS1 cells2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
Tactical Approaches to Interconverting GPCR Agonists and Antagonists.
AID1211552In vitro intrinsic biliary clearance in sandwich cultured Sprague-Dawley rat hepatocytes by LC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
In vivo biliary clearance should be predicted by intrinsic biliary clearance in sandwich-cultured hepatocytes.
AID311524Oral bioavailability in human2007Bioorganic & medicinal chemistry, Dec-15, Volume: 15, Issue:24
Hologram QSAR model for the prediction of human oral bioavailability.
AID680212TP_TRANSPORTER: transport in OATP1B3-expressing oocytes2006Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 34, Issue:5
OATP1B1, OATP1B3, and mrp2 are involved in hepatobiliary transport of olmesartan, a novel angiotensin II blocker.
AID183747Inhibitory activity against AII-Induced Pressor response at 1 mg/Kg at 3 hour1996Journal of medicinal chemistry, Jan-05, Volume: 39, Issue:1
Nonpeptide angiotensin II receptor antagonists: synthesis, biological activities, and structure-activity relationships of imidazole-5-carboxylic acids bearing alkyl, alkenyl, and hydroxyalkyl substituents at the 4-position and their related compounds.
AID568884Displacement of radiolabeled angiotensin 2 from angiotensin AT1 receptor in bovine adrenal cortex membranes2010Bioorganic & medicinal chemistry, Dec-15, Volume: 18, Issue:24
Angiotensin II receptor type 1 (AT1) selective nonpeptidic antagonists--a perspective.
AID1737437Cytotoxicity against African green monkey COS7 cells assessed as effect on metabolic activity at 20 uM measured after 72 hrs by MTT assay2020European journal of medicinal chemistry, Jun-01, Volume: 195Identification and development of non-cytotoxic cell death modulators: Impact of sartans and derivatives on PPARγ activation and on growth of imatinib-resistant chronic myelogenous leukemia cells.
AID1692279Binding affinity to recombinant GP6 (unknown origin) at protein to compound ratio of 1 : 1 to 1 : 10 by 2D 15N-1H TROSY-HSQC NMR spectroscopy2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Progress toward a Glycoprotein VI Modulator for the Treatment of Thrombosis.
AID588210Human drug-induced liver injury (DILI) modelling dataset from Ekins et al2010Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 38, Issue:12
A predictive ligand-based Bayesian model for human drug-induced liver injury.
AID588977Substrates of transporters of clinical importance in the absorption and disposition of drugs, MRP22010Nature reviews. Drug discovery, Mar, Volume: 9, Issue:3
Membrane transporters in drug development.
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.
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.
AID1211553Drug uptake in iv dosed Sprague-Dawley rat liver after 5 hrs by LC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
In vivo biliary clearance should be predicted by intrinsic biliary clearance in sandwich-cultured hepatocytes.
AID1210069Inhibition of human recombinant CYP2J2 assessed as reduction in astemizole O-demethylation by LC-MS/MS method2013Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1
Discovery and characterization of novel, potent, and selective cytochrome P450 2J2 inhibitors.
AID1737434Agonist activity at human PPARgammaDEF receptor expressed in african green monkey COS7 cells transfected with pGal5-TK-pGL3/pRenilla-CMV assessed as maximal activation at 10 uM measured after 39 hrs by dual luciferase reporter assay relative to pioglitazo2020European journal of medicinal chemistry, Jun-01, Volume: 195Identification and development of non-cytotoxic cell death modulators: Impact of sartans and derivatives on PPARγ activation and on growth of imatinib-resistant chronic myelogenous leukemia cells.
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.
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.
AID1217706Time dependent inhibition of CYP2C9 (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.
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.
AID1737436Cytotoxicity against African green monkey COS7 cells assessed as effect on metabolic activity at 10 uM measured after 72 hrs by MTT assay2020European journal of medicinal chemistry, Jun-01, Volume: 195Identification and development of non-cytotoxic cell death modulators: Impact of sartans and derivatives on PPARγ activation and on growth of imatinib-resistant chronic myelogenous leukemia cells.
AID1211550In vivo intrinsic biliary clearance in iv dosed Sprague-Dawley rat by LC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 40, Issue:3
In vivo biliary clearance should be predicted by intrinsic biliary clearance in sandwich-cultured hepatocytes.
AID1745854NCATS anti-infectives library activity on HEK293 viability as a counter-qHTS vs the C. elegans viability qHTS2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1745855NCATS anti-infectives library activity on the primary C. elegans qHTS viability assay2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
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.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (803)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's1 (0.12)18.2507
2000's187 (23.29)29.6817
2010's532 (66.25)24.3611
2020's83 (10.34)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 123.15

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 Index123.15 (24.57)
Research Supply Index6.93 (2.92)
Research Growth Index6.91 (4.65)
Search Engine Demand Index225.60 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (123.15)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials185 (22.00%)5.53%
Reviews64 (7.61%)6.00%
Case Studies99 (11.77%)4.05%
Observational23 (2.73%)0.25%
Other470 (55.89%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (133)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis [NCT00382213]Phase 3210 participants Interventional2000-06-30Completed
Prospective, Multicentric, Large Scale Observational Study to Evaluate the Effectiveness & Safety of Xirtam H in Indian Patients Suffering From Hypertension. [NCT01219556]8,704 participants (Actual)Observational2010-11-30Completed
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
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
Single Dose Crossover Comparative Bioavailability Study of Olmesartan Medoxomil 40 mg Film-coated Tablets in Healthy Adult Subjects Under Fasting Conditions. [NCT03951051]Phase 132 participants (Actual)Interventional2019-05-06Completed
A Phase 3, Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Azilsartan Compared to Olmesartan Medoxomil in Chinese Participants With Grade I or II Essential Hypertension [NCT02407210]Phase 3304 participants (Anticipated)Interventional2015-01-31Recruiting
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
Olmesartan Versus Nebivolol in Management of Hypertension in Acute Ischemic Stroke [NCT03655964]Phase 260 participants (Actual)Interventional2018-08-20Completed
Efficacy Study of Olmesartan Medoxomil on Coronary Atherosclerosis Progression and Epicardial Adipose Tissue(EAT) Volume Reduction in Patients With Coronary Atherosclerosis Detected by Coronary CT Angiography(CCTA) [NCT02360956]Phase 4100 participants (Anticipated)Interventional2014-12-31Recruiting
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 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 Multi-center, Prospective, Observational Study to Evaluate the Therapeutic Effectiveness and Safety of Olomax Tab. for Patients With Hypertension and Dyslipidemia [NCT05184179]7,000 participants (Anticipated)Observational2019-12-01Enrolling by invitation
Use of Impedance Cardiography and Applanation Tonometry for Prediction of the Antihypertensive Effect. Comparison Between an ATII Receptor Antagonist and a Diuretic. [NCT03560804]60 participants (Actual)Interventional2014-11-10Completed
A Prospective, Open Label, Single Arm Study to Evaluate the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen in Type II Diabetic Patients With Hypertension [NCT00403481]Phase 4192 participants (Actual)Interventional2006-11-30Completed
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 Phase 3, Double-Blind, Randomized, Efficacy and Safety Study Comparing the TAK-491 Plus Chlorthalidone Fixed-Dose Combination vs Benicar HCT® (Olmesartan Medoxomil-Hydrochlorothiazide) in Subjects With Moderate to Severe Essential Hypertension [NCT00846365]Phase 31,085 participants (Actual)Interventional2009-03-31Completed
A Randomized, Double-blind, Active Control, 3-parallel Group, Forced Titration, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Fimasartan Versus Valsartan Monotherapy in Patients With Mild to Moderate Essential Hypertension [NCT02495324]Phase 4369 participants (Actual)Interventional2015-06-30Completed
An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of Olmesartan Medoxomil Tablets 40 mg [Torrent,India] Versus Benicar 40 mg Tablets [Daiichi Sankyo Inc., USA] in Healthy Subjects-Fed Condition. [NCT03319706]Phase 134 participants (Actual)Interventional2010-08-31Completed
Phase 4 Study on Olmesartan, an Angiotensin Receptor Blocker, on Ambulatory Blood Pressure Change, Vitamin D Levels and Urinary Sodium Excretion of Patients With Hypertension [NCT00854763]100 participants (Anticipated)Observational2009-04-30Not yet recruiting
Efficacy and Safety of Hydrochlorothiazide (HCTZ) Used as Add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil (OM) 40 mg Monotherapy [NCT00430508]Phase 3972 participants (Actual)Interventional2007-02-28Completed
Comparison of the Efficacy of Olmesartan Medoxomil Versus Nitrendipine on Systolic Blood Pressure in Elderly and Very Elderly Patients With Isolated Systolic Hypertension [NCT00751829]Phase 3417 participants (Actual)Interventional2003-07-31Completed
Add-on Study of CCBs or Diuretics in Essential Hypertension Not Achieving Target Blood Pressure on Olmesartan Medoxomil Alone [NCT00858702]Phase 4105 participants (Actual)Interventional2005-02-28Completed
Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide Combination 20/25 mg Versus 40/25 mg in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 40 mg Monotherapy [NCT00430950]Phase 31,011 participants (Actual)Interventional2007-02-28Completed
A Prospective, Open Label, Single Arm Study to Evaluation the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen in Elderly Patients With Hypertension [NCT00412932]Phase 4178 participants (Actual)Interventional2006-12-31Completed
Effects of Angiotensin-Receptor Blockade With Olmesartan on Carotid Atherosclerosis in Patients With Hypertension: The Confirmatory Olmesartan Plaque Regression Study [NCT01132768]Phase 4114 participants (Actual)Interventional2010-05-31Terminated(stopped due to Low recruitment)
A Post Marketing Surveillance, Multicenter, Open-Label, Dose-Titrating, 4-Week Study Evaluating The Efficacy, Tolerability And Safety Of Olmesartan Medoxomil 20mg In Combination With 12.5mg Hydrochlorothiazide In Subjects With Stage 1 To Stage 2 Hypertens [NCT00796159]1,723 participants (Actual)Observational2007-07-31Completed
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
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 in Subjects With Essential Hypertension [NCT00696241]Phase 31,275 participants (Actual)Interventional2007-06-30Completed
A Phase 3, Open-Label, Randomized, Long-Term Comparison of the Safety and Tolerability of the TAK-491 Plus Chlorthalidone Fixed-Dose Combination vs. Olmesartan Medoxomil-Hydrochlorothiazide Fixed-Dose Combination in Subjects With Essential Hypertension [NCT00996281]Phase 3837 participants (Actual)Interventional2009-10-31Completed
Effect of Olmesartan Medoxomil on Arterial Stiffness and Thickness in Subjects With Metabolic Syndrome [NCT00676845]Phase 3133 participants (Actual)Interventional2008-08-31Completed
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
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 Non-interventional, Multi Center, Prospective Observational Study to Evaluate the Effect of Improving Systolic Blood Pressure and Low-density Lipoprotein Cholesterol Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar [NCT05411887]3,000 participants (Anticipated)Observational2022-06-20Recruiting
Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY Disease [NCT04394117]Phase 4787 participants (Actual)Interventional2020-06-19Completed
An Open Label, Randomized, 2-Sequence, Multiple-Dose, Cross-Over Study to Investigate the Drug-Drug Interaction of Sevikar and Crestor in Healthy Adult Volunteers [NCT02089399]Phase 132 participants (Actual)Interventional2014-05-31Completed
Comparison of the Efficacy of Olmesartan Medoxomil Versus Losartan on Diastolic Blood Pressure in Elderly and Very Elderly Patients With Essential Hypertension. [NCT00751751]Phase 3441 participants (Actual)Interventional2003-06-30Completed
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study of the Efficacy, Safety, and Tolerability of TAK-536 in Patients With Mild to Moderate Uncomplicated Essential Hypertension [NCT00759551]Phase 2555 participants (Actual)Interventional2004-08-31Completed
Vascular Improvement With Olmesartan Medoxomil Study [NCT00772499]Phase 4100 participants (Actual)Interventional2002-11-30Completed
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia [NCT02735707]Phase 310,000 participants (Anticipated)Interventional2016-04-11Recruiting
CS-866DM Phase 3 Clinical Study: A Double-Blind Controlled Trial in Patients With Diabetic Nephropathy and Overt Proteinuria Secondary to Type 2 Diabetes Mellitus [NCT00141453]Phase 3577 participants (Actual)Interventional2003-04-30Completed
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
Single-Dose Fed In Vivo Bioequivalence Study of Olmesartan Medoxomil Tablets (40 mg; Mylan) to Benicar® Tablets (40 mg; Sankyo) in Healthy Volunteers [NCT00648219]Phase 136 participants (Actual)Interventional2005-12-31Completed
Single-Dose Fasting In Vivo Bioequivalence Study of Olmesartan Medoxomil Tablets (40 mg; Mylan) to Benicar® Tablets (40 mg; Sankyo) in Healthy Volunteers [NCT00649623]Phase 136 participants (Actual)Interventional2005-12-31Completed
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 Randomized, Double-blind, Double-dummy, Multi-center Study to Investigate the Safety and Efficacy of Olmesartan Medoxomil Compared With Losartan Potassium in Patients With Mild to Moderate Essential Hypertension [NCT00856271]Phase 3287 participants (Actual)Interventional2004-08-31Completed
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
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Study of the Efficacy, Safety and Tolerability of TAK-491 in Subjects With Mild to Moderate Uncomplicated Essential Hypertension [NCT00362115]Phase 2449 participants (Actual)Interventional2006-05-31Completed
A Double-Blind, Randomized, Placebo-Controlled, 5-Arm Titration Study to Evaluate the Efficacy and Safety of TAK-491 When Compared With Valsartan and Olmesartan in Subjects With Essential Hypertension [NCT00696436]Phase 31,291 participants (Actual)Interventional2008-04-30Completed
A 24-Week Multicentre, Randomized, Double-Blind, Controlled, Parallel Group Non-Inferiority Study to Assess the Efficacy and Safety of Olmesartan Medoxomil Versus Candesartan Cilexetil in Patients With Symptomatic Heart Failure (NYHA II-IV) [NCT00679484]Phase 3400 participants (Anticipated)Interventional2008-06-30Terminated(stopped due to Lack of subject recruitment)
Effects of Mineralocorticoid and AT-1 Receptor Antagonism on the Aldosterone-Renin Ratio (ARR) In Primary Aldosteronism Patients (EMIRA Study): Rationale and Design [NCT04185857]50 participants (Actual)Observational2018-01-01Completed
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
A Multi-center, Randomized, Double-blind, Double-dummy, With Olmesartan Medoxomil as Positive Control Parallel Clinical Study to Evaluate the the Safety and Efficacy of Azilsartan in Chinese Patients With Primary Mild and Moderate Hypertension [NCT02609490]Phase 3304 participants (Actual)Interventional2015-09-30Completed
Prognostic Value of the Circadian Pattern of Ambulatory Blood Pressure for Multiple Risk Assessment [NCT00741585]Phase 421,983 participants (Actual)Interventional2008-09-01Completed
A Phase 3b, Double-Blind, Randomized, 12-Week Efficacy and Safety Study Comparing the TAK-491 Plus Chlorthalidone Fixed-Dose Combination vs Olmesartan Medoxomil-Hydrochlorothiazide in Subjects With Moderate to Severe Hypertension [NCT01033071]Phase 31,071 participants (Actual)Interventional2010-01-31Completed
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)
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
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
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
Effect of Olmesartan Medoxomil on Vascular Markers in Hypertensive Patients With Metabolic Syndrome [NCT00891267]Phase 360 participants (Anticipated)Interventional2008-10-31Completed
Single-Dose Fed Bioequivalence Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets (40 mg/25 mg; Mylan) to Benicar HCT® Tablets (40 mg/25 mg; Sankyo) in Healthy Volunteers [NCT01019590]Phase 136 participants (Actual)Interventional2006-11-30Completed
Single-Dose Fasting Bioequivalence Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets (40 mg/25 mg; Mylan) to Benicar HCT® Tablets (40 mg/25 mg; Sankyo) in Healthy Volunteers [NCT01020214]Phase 136 participants (Actual)Interventional2006-11-30Completed
A Randomized, Double-blind, Active-comparator, 8-week Forced-titration Study of the Efficacy and Safety of Olmesartan Medoxomil Versus Losartan Potassium in Hypertensive Subjects [NCT00949884]Phase 4941 participants (Actual)Interventional2009-08-31Completed
Single Dose Crossover Comparative Bioavailability Study of Olmesartan Medoxomil/Hydrochlorothiazide 40 mg/25 mg Film-Coated Tablets in Healthy Adult Subjects / Fasting State [NCT04138888]Phase 132 participants (Anticipated)Interventional2019-10-31Recruiting
An Exploratory Study of CS-3150 to Evaluate the Relation Between Antihypertensive Effect and Baseline Factors Compared to Olmesartan Medoxomil in Patients With Essential Hypertension [NCT02848170]40 participants (Actual)Interventional2016-08-31Completed
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
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
Phase III Study of Irbersartan for the Early Treatment of Severe Sepsis Patients [NCT01992796]Phase 3300 participants (Anticipated)Interventional2014-01-31Not yet recruiting
Efficacy and Safety of Olmesartan Medoxomil Compared With Losartan in Patients With Hypertension and Mild to Moderate Renal Impairment [NCT00151827]Phase 3393 participants (Actual)Interventional2003-08-31Completed
A Randomized, Double-blind, Double-dummy, Multicenter Clinical Trial to Evaluate the Additional Efficacy and Safety of Olmesartan Medoxomil 20mg / Hydrochlorothiazide 12.5mg in the Treatment of Chinese Patients With Mild to Moderate Essential Hypertension [NCT00872586]Phase 3304 participants (Actual)Interventional2006-08-31Completed
Prospective, Multicentric, Open Clinic Essay to Evaluate the Use of OLMETEC® (Olmesartan Medoxomile) and OLMETEC PLUS® (Olmesartan Medoxomile Hydrochlorothiazide) in Stade I and II, According to JNC VII [NCT00811226]450 participants (Anticipated)Observational2007-04-30Completed
Comparison of the Effects of Different Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea [NCT01028534]150 participants (Anticipated)Interventional2010-07-31Completed
A Double-Blind, Randomized, Placebo Controlled, Parallel Group Study to Compare the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen to Placebo in Patients With Stage I and Stage II Hypertension [NCT00430638]Phase 4278 participants (Actual)Interventional2006-12-31Completed
Evaluation of Vascular Function, Effects of Exercise Training and Angiotensin Receptor II Antagonist in Patients With Type II Diabetes and Hypertension by Using Near-infrared Spectroscopy, Rapid Laser Doppler Blood Flow Imaging and Circulating Biomarkers [NCT01053026]15 participants (Actual)Observational2009-12-31Completed
Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection? [NCT04606563]Phase 3341 participants (Actual)Interventional2020-10-09Terminated(stopped due to DSMC recommendation due to futility)
Effect of Probenecid on Pharmacokinetics, and Tolerability of Olmesartan in Healthy Chinese Volunteers [NCT01907373]Phase 412 participants (Actual)Interventional2009-08-31Completed
Open-label, Randomized, Single Center, Paralleled Clinical Study to Evaluate Adherence Improvement Fixed-dose Combination of Olostar Tab. in Patients With Hypertension and Dyslipidemia [NCT04061824]Phase 4150 participants (Actual)Interventional2016-05-24Completed
The Japan-Combined Treatment With Olmesartan and a Calcium Channel Blocker Versus Olmesartan and Diuretics Randomized Efficacy Study (J-CORE) [NCT00607035]Phase 4220 participants (Actual)Interventional2006-05-31Completed
The Relative Effects of Single Doses of Olmesartan Medoxomil, Irbesartan and Valsartan at High Dosage Levels on the Renin-Angiotensin-Aldosterone System in Healthy Normal Subjects [NCT00185055]Phase 420 participants Interventional2004-11-30Completed
The Effects of Olmesartan Medoxomil, Losartan Potassium, and Atenolol on Insulin Sensitivity in Overweight and Obese Subjects With Hypertension [NCT00185094]Phase 460 participants Interventional2004-02-29Completed
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
An Open-label Study of Olmesartan Medoxomil (CS-866) in Normotensive Patients With Chronic Glomerulonephritis or Diabetic Nephropathy [NCT00914524]Phase 249 participants (Actual)Interventional2005-01-31Completed
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
Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP) [NCT00185159]Phase 34,449 participants (Actual)Interventional2004-10-31Completed
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
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
Multi-Omics to Predict the Blood Pressure Response to Antihypertensives [NCT05917275]Phase 496 participants (Anticipated)Interventional2023-10-31Not yet recruiting
[NCT01831479]Phase 136 participants (Actual)Interventional2011-08-31Completed
Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue [NCT02996916]Phase 4100 participants (Anticipated)Interventional2015-12-31Recruiting
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
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
A Phase III, Multicenter, Open-Label, Dose-Titrating, 16-Week Study Evaluating The Efficacy, Tolerability and Safety of Olmesartan Medoxomil 20 Mg and 40 Mg Alone or in Combination With 12.5 Mg to 25 Mg of Hydrochlorothiazide in Subjects With Mild to Mode [NCT00139698]Phase 3410 participants Interventional2005-09-30Completed
Efficacy and Safety of Olmesartan: Reduction of Blood Pressure in the Treatment of Patients Suffering From Mild to Moderate Essential Hypertension [NCT00185172]Phase 32,333 participants (Actual)Interventional2002-01-31Completed
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
A Randomized, Open-Label, Phase 3 Study to Compare Long-Term Safety and Tolerability of the TAK-491 and Chlorthalidone Fixed-Dose Combination Versus Olmesartan Medoxomil and Hydrochlorothiazide Fixed-Dose Combination in Hypertensive Subjects With Moderate [NCT01309828]Phase 3153 participants (Actual)Interventional2011-03-31Completed
Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation Trial (ANTIPAF Trial) [NCT00098137]Phase 3422 participants (Actual)Interventional2005-01-31Completed
A Prospective, Open Label, Titration Study to Assess the Efficacy and Safety of Benicar® and Benicar ®HCT in Patients With Stage II Systolic Hypertension [NCT00185068]Phase 4110 participants Interventional2004-03-31Completed
Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE) [NCT00185185]Phase 3165 participants (Actual)Interventional2001-11-30Completed
Optimization of Blood Pressure Management After Acute Ischemic Stroke and Its Prognostic Significance: Prospective, Randomized, Open, Blinded Outcome Evaluation, and Feasibility Trial [NCT03024476]Phase 267 participants (Actual)Interventional2016-09-01Completed
Effect of Olmesartan or Amlodipine on Serum Angiotensin(1-7) Levels and Vascular Functions in Patients With Type 2 Diabetes and Hypertension [NCT05189015]Phase 480 participants (Actual)Interventional2021-01-01Completed
Supplemental Benefit of Angiotensin II Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan (SUPPORT Trial) [NCT00417222]Phase 31,145 participants (Actual)Interventional2006-11-30Completed
Prognostic Value of Ambulatory Blood Pressure Monitoring in the Prediction of Cardiovascular Events and Effects of Chronotherapy in Relation to Risk (the MAPEC Study). [NCT00295542]Phase 43,344 participants (Actual)Interventional2000-03-31Completed
Randomized, Single-Blind, Multicenter, Phase III, Non-Inferiority Clinical Trial to Evaluate the Efficacy and Safety of the Fixed-dose Combination of Olmesartan + Indapamide When Compared to the Isolated Drugs in the Treatment of Hypertension. [NCT05110898]Phase 3400 participants (Anticipated)Interventional2022-08-01Not yet recruiting
Multi-institutional, Randomized, Double-Blind, Placebo-Control, Factorial Design, 4-arms, 8 Week Administration, Phase 3 Clinical Study for Patients With Hypertension Associated With Dyslipidemia [NCT01764295]Phase 3150 participants (Anticipated)Interventional2012-09-30Completed
Prospective Monitoring of Angiotensin Receptor Neprilysin Inhibitor in Older Adults With Heart Failure and Frailty [NCT04743063]40,000 participants (Anticipated)Observational2021-01-14Active, not recruiting
Angiotensin II Blockade and Adipose Tissue Inflammation in Obesity [NCT01684748]Phase 420 participants (Actual)Interventional2009-02-28Completed
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
"A Multi-center, Double Blind, Efficacy, and Safety Study of the Oral Angiotensin II Receptor Blocker Olmesartan Medoxomil Versus Losartan in Patients With Mild to Moderate Essential Hypertension" [NCT00857285]Phase 3130 participants (Actual)Interventional2002-05-31Completed
Efficacy and Safety Evaluation of the New Association on Fixed Dose of Olmesartan Medoxomil + Chlorthalidone (40mg + 12.5mg and 40mg + 25mg) Compared With BENICAR HCT® in Hypertension Control [NCT02483936]Phase 3348 participants (Anticipated)Interventional2023-04-30Not yet recruiting
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)
An Open-label Study of the Single-dose Pharmacokinetics of Olmesartan Medoxomil in Pediatric Patients With Hypertension [NCT00151814]Phase 124 participants (Actual)Interventional2005-09-30Completed
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
CVD Risk and Prevention in Early Glucose Intolerance [NCT00122447]84 participants (Actual)Interventional2005-05-31Completed
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
Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan 40 mg / Amlodipine 10 mg in Patients With Insufficiently Controlled Hypertension Under Monotherapy With Candesartan 32 mg - an Open Phase IIIb Trial [NCT01613209]Phase 383 participants (Actual)Interventional2011-12-31Completed
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
A 14 Week, Randomized, Double-blind, Multi-center, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension [NCT01615198]Phase 3588 participants (Actual)Interventional2012-08-31Completed
Effect of Different Doses of Olmesartan Medoxomil Compared to Losartan on Proteinuria, Renal Function and Inflammatory Markers in Type 2 Diabetics With Nephropathy [NCT00362960]Phase 3300 participants Interventional2003-05-31Completed
[NCT02373462]Phase 41 participants (Actual)Interventional2015-08-25Terminated(stopped due to The data of the paper referenced in the preparation of the protocols in this task were manipulated and the paper was withdrawn.)
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
Lowering Blood Pressure in Primary Care in Vienna [NCT02377661]Phase 4229 participants (Actual)Interventional2015-03-31Completed
Dose-ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents With Hypertension [NCT00151775]Phase 2/Phase 3362 participants (Actual)Interventional2005-05-31Completed
A Multi-center, Randomized, Double-blind, Active-controlled, 8-week Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Patients With Essential Hypertension [NCT01785472]Phase 31,438 participants (Actual)Interventional2013-04-30Completed
Efficacy and Safety Evaluation of the New Association on Fixed Dose of Olmesartan + Chlorthalidone, Produced by EMS S.A,in Arterial Hypertension Control [NCT02493322]Phase 3261 participants (Anticipated)Interventional2023-04-30Not yet recruiting
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
A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Cross-over Design Clinical Trial to Evaluate the Safety and Pharmacokinetic Interaction of ATB-1011 and ATB-1012 in Healthy Adult Volunteers [NCT04856969]Phase 138 participants (Actual)Interventional2021-03-30Completed
A Randomized 8-week Double-blind, Parallel-group, Active-controlled, Multicenter Study to Evaluate Efficacy and Safety of LCZ696 200 mg in Comparison With Olmesartan 20 mg in Essential Hypertensive Patients Not Responsive to Olmesartan [NCT01876368]Phase 3376 participants (Actual)Interventional2013-09-30Completed
The Effect of Rosuvastatin and Olmesartan on the Progression of Coronary Atherosclerotic Disease by Smart Angioplasty Research Team: SMART-ROAD Trial [NCT02516826]Phase 2504 participants (Anticipated)Interventional2015-08-31Not yet recruiting
An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of Olmesartan Medoxomil Tablets 40 mg [Torrent,India] Versus Benicar 40 mg Tablets [Daiichi Sankyo Inc., USA] in Healthy Subjects-Fasted Condition [NCT03318354]Phase 134 participants (Actual)Interventional2010-05-31Completed
Efficacy and Safety of s086 Tablets in the Treatment of Mild to Moderate Essential Hypertension:a Randomized,Double-blind,Placebo-controlled,Multicenter Phase II Clinical Trial [NCT05033535]Phase 210 participants (Anticipated)Interventional2020-07-01Recruiting
A Multi-center, Randomized, Double-blind, Active-controlled, 8-week Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension [NCT01599104]Phase 31,161 participants (Actual)Interventional2012-06-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00122447 (2) [back to overview]AIM 1: Change in hsCRP (High Sensitivity C-reactive Peptide) Level
NCT00122447 (2) [back to overview]AIM 1: Change in Flow Mediated Dilation (FMD) (%)
NCT00141453 (4) [back to overview]Number of Participants Experiencing Cardiovascular Composite Outcomes
NCT00141453 (4) [back to overview]The Change in Proteinuria
NCT00141453 (4) [back to overview]Renal Composite Outcomes
NCT00141453 (4) [back to overview]Reciprocal (1/Serum Creatinine) of Serum Creatinine
NCT00151775 (6) [back to overview]Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3
NCT00151775 (6) [back to overview]Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)
NCT00151775 (6) [back to overview]Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3
NCT00151775 (6) [back to overview]Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)
NCT00151775 (6) [back to overview]Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks)
NCT00151775 (6) [back to overview]Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)
NCT00151814 (8) [back to overview]For Olmesartan, the Apparent Oral Clearance
NCT00151814 (8) [back to overview]For Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase
NCT00151814 (8) [back to overview]For Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity
NCT00151814 (8) [back to overview]For Olmesartan, the Elimination Half-life of the Drug in Plasma
NCT00151814 (8) [back to overview]For Olmesartan, the Elimination Constant Rate
NCT00151814 (8) [back to overview]For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)
NCT00151814 (8) [back to overview]For Olmesartan, the Apparent Oral Volume of Distribution
NCT00151814 (8) [back to overview]Foe Olmesartan, the Time of Maximum Plasma Concentration
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
NCT00362115 (20) [back to overview]Change From Baseline in the 24-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00362115 (20) [back to overview]Change From Baseline in the 24-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00362115 (20) [back to overview]Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00362115 (20) [back to overview]Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00362115 (20) [back to overview]Change From Baseline in the 10-12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00362115 (20) [back to overview]Change From Baseline in Standing Clinic Systolic Blood Pressure.
NCT00362115 (20) [back to overview]Change From Baseline in Standing Clinic Diastolic Blood Pressure.
NCT00362115 (20) [back to overview]Change From Baseline in Sitting Clinic Systolic Blood Pressure.
NCT00362115 (20) [back to overview]Change From Baseline in Sitting Clinic Diastolic Blood Pressure.
NCT00362115 (20) [back to overview]Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00362115 (20) [back to overview]Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00362115 (20) [back to overview]Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00362115 (20) [back to overview]Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00362115 (20) [back to overview]Change From Baseline in the 10-12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00362115 (20) [back to overview]Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00362115 (20) [back to overview]Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00362115 (20) [back to overview]Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00362115 (20) [back to overview]Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00362115 (20) [back to overview]Change From Baseline in the 34-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00362115 (20) [back to overview]Change From Baseline in the 34-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00403481 (9) [back to overview]Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 4 Hours of the Last (Week 12 ) 24-hour Dosing Period.
NCT00403481 (9) [back to overview]Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 6 Hours of the Last (Week 12 ) 24-hour Dosing Period.
NCT00403481 (9) [back to overview]Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic)
NCT00403481 (9) [back to overview]Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.
NCT00403481 (9) [back to overview]Change in Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 During the Last 2 Hours of the Last (Week 12 ) 24-hour Dosing Period.
NCT00403481 (9) [back to overview]Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic).
NCT00403481 (9) [back to overview]Change in Ambulatory BP (Diastolic) From Baseline to Week 12 During the Last (Week 12 ) 4 and 6 Hours of the Last 24-hour Dosing Period.
NCT00403481 (9) [back to overview]Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12
NCT00403481 (9) [back to overview]Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 2 Hours of the Last (Week 12) 24-hour Dosing Period.
NCT00412932 (7) [back to overview]Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10 Pm-6am) Ambulatory Blood Pressure Monitored Diastolic Blood Pressure After 12 Weeks of Active Treatment
NCT00412932 (7) [back to overview]Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment
NCT00412932 (7) [back to overview]Number of Subjects Who Achieved Mean 24-hour Ambluatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment
NCT00412932 (7) [back to overview]Number of Subjects Who Achieved Mean Daytime (8am - 4pm) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.
NCT00412932 (7) [back to overview]Number of Subjects Who Achieved Mean Nighttime (10pm - 6am) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.
NCT00412932 (7) [back to overview]Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment.
NCT00412932 (7) [back to overview]Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment
NCT00430508 (8) [back to overview]Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
NCT00430508 (8) [back to overview]Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
NCT00430508 (8) [back to overview]Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
NCT00430508 (8) [back to overview]Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.
NCT00430508 (8) [back to overview]Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.
NCT00430508 (8) [back to overview]Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16
NCT00430508 (8) [back to overview]Number of Patients Achieving Target Blood Pressure at Week 16
NCT00430508 (8) [back to overview]Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.
NCT00430638 (10) [back to overview]The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Non-Black Participants.
NCT00430638 (10) [back to overview]The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 2 Hypertensives
NCT00430638 (10) [back to overview]The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 1 Hypertensives
NCT00430638 (10) [back to overview]The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Less Than 65 Years Old.
NCT00430638 (10) [back to overview]The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Greater Than or Equal to 65 Years Old.
NCT00430638 (10) [back to overview]The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Males.
NCT00430638 (10) [back to overview]The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Females.
NCT00430638 (10) [back to overview]The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Black Participants.
NCT00430638 (10) [back to overview]Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.
NCT00430638 (10) [back to overview]Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.
NCT00430950 (5) [back to overview]Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12
NCT00430950 (5) [back to overview]Number of Participants Achieving Blood Pressure Goal.
NCT00430950 (5) [back to overview]Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.
NCT00430950 (5) [back to overview]Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.
NCT00430950 (5) [back to overview]Change in Mean Trough Sitting Diastolic Blood Pressure
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 Core 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 Diastolic Blood Pressure (msDBP) During the Extension 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]Change in Sitting Pulse Pressure During the Core 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]Change in Sitting Pulse Rate 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]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
NCT00523744 (12) [back to overview]Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study
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 Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg 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 5mg Group.
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 Daytime and Nighttime Ambulatory Systolic Blood Pressure
NCT00649389 (4) [back to overview]Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP).
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]Change in Seated Systolic Blood Pressure From Baseline to Week 12
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
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 Nighttime 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 Seated Systolic and Diastolic Blood Pressure Reductions at Week 15
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 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions
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 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]Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12
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]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]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 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 3
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]Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9
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 Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15
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 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 6
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 Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18
NCT00696241 (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.
NCT00696241 (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.
NCT00696241 (15) [back to overview]Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00696241 (15) [back to overview]Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00696241 (15) [back to overview]Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
NCT00696241 (15) [back to overview]Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
NCT00696241 (15) [back to overview]Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure
NCT00696241 (15) [back to overview]Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure
NCT00696241 (15) [back to overview]Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00696241 (15) [back to overview]Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00696241 (15) [back to overview]Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00696241 (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
NCT00696241 (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
NCT00696241 (15) [back to overview]Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response
NCT00696241 (15) [back to overview]Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00696436 (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
NCT00696436 (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
NCT00696436 (15) [back to overview]Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response
NCT00696436 (15) [back to overview]Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00696436 (15) [back to overview]Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure
NCT00696436 (15) [back to overview]Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.
NCT00696436 (15) [back to overview]Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00696436 (15) [back to overview]Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00696436 (15) [back to overview]Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00696436 (15) [back to overview]Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00696436 (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.
NCT00696436 (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.
NCT00696436 (15) [back to overview]Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00696436 (15) [back to overview]Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00696436 (15) [back to overview]Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
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 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 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 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 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 Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 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 Previously on a Beta 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 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 Diuretic 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 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 Nondihydropyridine Calcium Channel Blocker 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 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 II Receptor Blocker Achieving the Blood Pressure Goals 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 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 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 Diastolic 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 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 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 Diastolic 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 Systolic 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 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 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 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]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]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]Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values
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 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]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]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 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 Diastolic 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 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 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 Diastolic 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 Systolic 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 Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 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 Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 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
NCT00846365 (16) [back to overview]Percentage of Participants Who Achieve a Clinic Diastolic AND Systolic Blood Pressure Response, Defined as <140/90 mm Hg for Participants Without Diabetes or Chronic Kidney Disease (CKD) or <130/80 mm Hg for Participants With Diabetes or CKD
NCT00846365 (16) [back to overview]Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure
NCT00846365 (16) [back to overview]Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as Defined as <90 mm Hg for Participants Without Diabetes or CKD or <80 mm Hg for Participants With Diabetes or CKD
NCT00846365 (16) [back to overview]Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as <140 mm Hg for Participants Without Diabetes or CKD or <130 mm Hg for Participants With Diabetes or CKD
NCT00846365 (16) [back to overview]Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00846365 (16) [back to overview]Change From Baseline in 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00846365 (16) [back to overview]Change From Baseline in 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00846365 (16) [back to overview]Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure.
NCT00846365 (16) [back to overview]Change From Baseline to Week 4 in Trough, Sitting, Clinic Systolic Blood Pressure.
NCT00846365 (16) [back to overview]Change From Baseline in 24-hour Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.
NCT00846365 (16) [back to overview]Change From Baseline in Daytime Mean (6am to 10pm) Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00846365 (16) [back to overview]Change From Baseline in Daytime Mean (6am to 10pm) Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00846365 (16) [back to overview]Change From Baseline in Nighttime Mean (12am to 6am) Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00846365 (16) [back to overview]Change From Baseline in Nighttime Mean (12am to 6am) Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
NCT00846365 (16) [back to overview]Change From Baseline in Trough Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00846365 (16) [back to overview]Change From Baseline in Trough Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
NCT00857285 (1) [back to overview]Mean Change of Sitting dBP From Baseline to Week 12
NCT00858702 (3) [back to overview]Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)
NCT00858702 (3) [back to overview]Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)
NCT00858702 (3) [back to overview]The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85
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)
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 (Olmesartan 20 mg Monotherapy)
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)
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]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]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]Number of Subjects Achieving Blood Pressure (BP) Goal at Week 16.
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.
NCT00902538 (10) [back to overview]In Non-responders, the Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.
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 18 to Week 22
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]Number of Subjects Reaching Blood Pressure Goal From Week 18 to Week 22
NCT00923091 (10) [back to overview]Change in Seated Diastolic 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]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 Diastolic Blood Pressure (SeDBP).
NCT00949884 (16) [back to overview]Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
NCT00949884 (16) [back to overview]Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
NCT00949884 (16) [back to overview]Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
NCT00949884 (16) [back to overview]Percentage of Participants Achieving Blood Pressure Goals at Week 4
NCT00949884 (16) [back to overview]Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8
NCT00949884 (16) [back to overview]Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure
NCT00949884 (16) [back to overview]Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8
NCT00949884 (16) [back to overview]Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8
NCT00949884 (16) [back to overview]Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4
NCT00949884 (16) [back to overview]Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4
NCT00949884 (16) [back to overview]Percentage of Participants Achieving Blood Pressure Goals at Week 8
NCT00949884 (16) [back to overview]Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8
NCT00949884 (16) [back to overview]Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4
NCT00949884 (16) [back to overview]Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
NCT00949884 (16) [back to overview]Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
NCT00949884 (16) [back to overview]Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
NCT00996281 (2) [back to overview]Percentage of Participants With at Least 1 Adverse Event
NCT00996281 (2) [back to overview]Percentage of Participants With Serum Creatinine Elevations Greater Than 50% From Baseline and Greater Than the Upper Limit of Normal (ULN)
NCT01033071 (18) [back to overview]Change From Baseline in 24-hour Mean Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
NCT01033071 (18) [back to overview]Change From Baseline in 24-hour Mean Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
NCT01033071 (18) [back to overview]Change From Baseline in Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
NCT01033071 (18) [back to overview]Change From Baseline in Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
NCT01033071 (18) [back to overview]Change From Baseline in Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
NCT01033071 (18) [back to overview]Change From Baseline in Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
NCT01033071 (18) [back to overview]Change From Baseline in Mean Trough Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
NCT01033071 (18) [back to overview]Change From Baseline in Mean Trough Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
NCT01033071 (18) [back to overview]Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring.
NCT01033071 (18) [back to overview]Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring.
NCT01033071 (18) [back to overview]Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.
NCT01033071 (18) [back to overview]Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring.
NCT01033071 (18) [back to overview]Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring.
NCT01033071 (18) [back to overview]Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure.
NCT01033071 (18) [back to overview]Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.
NCT01033071 (18) [back to overview]Percent of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline and Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline.
NCT01033071 (18) [back to overview]Percentage of Participants Who Reached Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline.
NCT01033071 (18) [back to overview]Percentage of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline.
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]Change From Baseline in SBP and DBP at Week 12 With Last Observation Carried Forward (LOCF)
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
NCT01200407 (4) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01309828 (4) [back to overview]Number of Participants With at Least 1 Adverse Event (AE)
NCT01309828 (4) [back to overview]Percentage of Participants at Final Visit Who Achieved Target Diastolic Blood Pressure <80 mm Hg
NCT01309828 (4) [back to overview]Percentage of Participants at Final Visit Who Achieve Target Systolic Blood Pressure <130 mm Hg
NCT01309828 (4) [back to overview]Percentage of Participants at Final Visit Who Achieved Both a Clinic Systolic and Diastolic Blood Pressure Response
NCT01599104 (11) [back to overview]Percentage of Participants Achieving a Successful msDBP Response
NCT01599104 (11) [back to overview]Change From Baseline in Office Pulse Pressure
NCT01599104 (11) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
NCT01599104 (11) [back to overview]Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT01599104 (11) [back to overview]Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8
NCT01599104 (11) [back to overview]Number of Patients With Adverse Events, Serious Adverse Events and Death
NCT01599104 (11) [back to overview]Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8
NCT01599104 (11) [back to overview]Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure
NCT01599104 (11) [back to overview]Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8
NCT01599104 (11) [back to overview]Percentage of Participants Achieving a Successful msSBP Response
NCT01599104 (11) [back to overview]Change From Baseline in maSBP and maDBP for Daytime/Nighttime
NCT01615198 (12) [back to overview]Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
NCT01615198 (12) [back to overview]Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
NCT01615198 (12) [back to overview]Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
NCT01615198 (12) [back to overview]Change From Baseline in Mean Sitting Pulse Pressure
NCT01615198 (12) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
NCT01615198 (12) [back to overview]Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
NCT01615198 (12) [back to overview]Number of Participants Achieving Successful Response in msSBP and msDBP
NCT01615198 (12) [back to overview]Number of Participants With Adverse Events, Serious Adverse Events and Death
NCT01615198 (12) [back to overview]Change From Baseline in Daytime and Nighttime maSBP/maDBP
NCT01615198 (12) [back to overview]Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
NCT01615198 (12) [back to overview]Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
NCT01615198 (12) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
NCT01684748 (2) [back to overview]Collagen Gene Expression in Skeletal Muscle (Change Over Time)
NCT01684748 (2) [back to overview]Insulin Sensitivity by Intravenous Glucose Tolerance Testing (Change Over Time)
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 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 Sitting Pulse Pressure (msPP)
NCT01692301 (11) [back to overview]Change From Baseline in Mean 24-hour Systolic Blood Pressure (maSBP)
NCT01692301 (11) [back to overview]Change From Baseline in Mean Arterial Pressure (MAP)
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 Pulse (CPP) Pressure
NCT01692301 (11) [back to overview]Change From Baseline in Mean Pulse Wave Velocity (PWV)
NCT01785472 (13) [back to overview]Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
NCT01785472 (13) [back to overview]Number of Patients Achieving Successful Blood Pressure Control
NCT01785472 (13) [back to overview]Change From Baseline in Office Pulse Pressure (msPP)
NCT01785472 (13) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg
NCT01785472 (13) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg
NCT01785472 (13) [back to overview]Change From Baseline in Ambulatory Pulse Pressure
NCT01785472 (13) [back to overview]Number of Patients With Adverse Events, Serious Adverse Events, and Death as Assessment of Safety and Tolerability
NCT01785472 (13) [back to overview]Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
NCT01785472 (13) [back to overview]Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
NCT01785472 (13) [back to overview]Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
NCT01785472 (13) [back to overview]Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg
NCT01785472 (13) [back to overview]Change From Baseline in Mean 24-hour Ambulatory Blood Pressure
NCT01785472 (13) [back to overview]Number of Responders
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 Central Blood Pressure 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 Ascending Aorta Distensibility at 52 Week
NCT01870739 (10) [back to overview]Number of Patients With Reported Adverse Events, Serious Adverse Events and Death
NCT01870739 (10) [back to overview]Change From Baseline in Local Aortic Strain at 52 Weeks
NCT01870739 (10) [back to overview]Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks
NCT01876368 (11) [back to overview]Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response
NCT01876368 (11) [back to overview]Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control
NCT01876368 (11) [back to overview]Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response
NCT01876368 (11) [back to overview]Number of Patients Achieving Successful Overall Blood Pressure Control
NCT01876368 (11) [back to overview]Number of Patients With Total Adverse Events, Serious Adverse Events and Death
NCT01876368 (11) [back to overview]Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)
NCT01876368 (11) [back to overview]Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
NCT01876368 (11) [back to overview]Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)
NCT01876368 (11) [back to overview]Change From Baseline in Office Pulse Pressure
NCT01876368 (11) [back to overview]Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control
NCT01876368 (11) [back to overview]Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

AIM 1: Change in hsCRP (High Sensitivity C-reactive Peptide) Level

Inflammatory marker (NCT00122447)
Timeframe: 12 months of intervention

Interventionmg/L (Mean)
Aspirin (ASA) 325 mg PO Once Daily-1.27
Olmesartan (ARB) 40 mg PO Once Daily-2.34
Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily0.23
Placebo0.32

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AIM 1: Change in Flow Mediated Dilation (FMD) (%)

Surrogate measure of endothelial function defined as the percent change in dilation of the brachial artery after cuff compression of arm compared to before cuff compression (NCT00122447)
Timeframe: 12 months of intervention

Interventionpercentage of arterial dilation change (Mean)
Aspirin (ASA) 325 mg PO Once Daily-0.0012
Olmesartan (ARB) 40 mg PO Once Daily0.018
Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily0.014
Placebo0.0053

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Number of Participants Experiencing Cardiovascular Composite Outcomes

Number of participants experiencing the first occurence of any of the following: Cardiovascular death; non-fatal stroke; non-fatal myocardial infarction; hospitalization for unstable angina; lower extremity amputation; coronary/carotid/peripheral revascularization. (NCT00141453)
Timeframe: Within 5 years

Interventionparticipants (Number)
Olmesartan Medoxomil40
Placebo Comparator53

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The Change in Proteinuria

The median percentage change from baseline value in urinary protein:creatinine ratio (NCT00141453)
Timeframe: Randomization to 5 years

,
InterventionMedian percentage change in ratio (Number)
12-week value48-week value144 -week value
Olmesartan Medoxomil-19.5-20.0-24.9
Placebo Comparator12.66.93.1

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Renal Composite Outcomes

first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease (NCT00141453)
Timeframe: Randomization to 5 years

Interventionparticipants (Number)
Olmesartan Medoxomil116
Placebo Comparator129

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Reciprocal (1/Serum Creatinine) of Serum Creatinine

The amount of serum creatinine was determined by blood tests periodically during the study. The amount of creatinine is an indication of kidney function. The reciprocal of serum creatinine is used in an equation to determine the change in kidney function from baseline. The reciprocal of the serum creatinine was monitored to detect kidney function changes over duration of the study. (NCT00141453)
Timeframe: Randomization to 5 years

InterventiondL/mg/year (Median)
Olmesartan Medoxomil-0.071
Placebo Comparator-0.089

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Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3

Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined. (NCT00151775)
Timeframe: Week 3 (period 3 baseline) to week 5 (end of Period 3)

,,,,,
Interventionmm Hg (Mean)
Change in Systolic Blood PressureChange in Diastolic Blood Pressure
Cohort A: OM Period 30.430.24
Cohort A: Placebo Period 34.934.43
Cohort B: OM Period 31.371.94
Cohort B: Placebo Period 33.793.25
Cohorts A + B: OM Period 30.770.85
Cohorts A + B: Placebo Period 34.503.99

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Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)

Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort C. (NCT00151775)
Timeframe: Day 0 to week 51 week (end of study)

Interventionmm Hg (Mean)
Change in Systolic Blood PressureChange in Diastolic Blood Pressure
Cohort C: OM (Olmesartan Medoxomil)-15.7-13.3

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Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3

Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort C. (NCT00151775)
Timeframe: Week 3 (period 3 baseline) to week 5 (end of Period 3)

,
Interventionmm Hg (Mean)
Seated Systolic Blood PressureSeated Diastolic Blood Pressure
Cohort C: OM Period 31.360.31
Cohort C: Placebo Period 34.953.77

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Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)

Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined. (NCT00151775)
Timeframe: Day 0 to week 51 (end of study)

,,
Interventionmm Hg (Mean)
Change in Systolic Blood PressureChange in Diastolic Blood Pressure
Cohort A: Period 4 Open-label OM-10.8-7.4
Cohort B: Period 4 Open-label OM-7.7-5.1
Cohorts A + B: Period 4 Open-label OM-9.7-6.6

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Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks)

Mean change from baseline to the end of the dose ranging period in systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined. (NCT00151775)
Timeframe: Day 0 (baseline) to 3 weeks

,,,,,
Interventionmm Hg (Mean)
Change in Systolic Blood PressureChange in Diastolic Blood Pressure
Cohort A: High Dose OM-12.58-9.50
Cohort A: Low Dose OM-7.76-5.52
Cohort B: High Dose OM-10.68-7.58
Cohort B: Low Dose OM-4.73-3.49
Cohorts A + B: High Dose OM-11.87-8.78
Cohorts A + B: Low Dose OM-6.63-4.76

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Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)

The efficacy dose response change in trough seated systolic blood pressure (both non-weight adjusted and weight adjusted results) from baseline to the end of the dose-ranging period (Period 2). Non-weight adjusted dose was the fixed olmesartan medoxomil dose; weight adjusted dose calculated mg of olmesartan medoxomil per kg of weight at baseline. (NCT00151775)
Timeframe: Day 0 to 3 weeks

,,
Interventionmm Hg (Least Squares Mean)
Non-weight adjusted dosageWeight adjusted dosage
Cohort A-0.69-8.97
Cohort B-0.85-7.17
Cohorts A + B-0.75-8.36

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For Olmesartan, the Apparent Oral Clearance

(NCT00151814)
Timeframe: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

InterventionL/hr (Mean)
6-12 Years of Age Olmesartan Group4.3
13-16 Years of Age Olmesartan Group6.1

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For Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase

(NCT00151814)
Timeframe: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

Interventionng/mL (Mean)
6-12 Years of Age Olmesartan Group1227
13-16 Years of Age Olmesartan Group895

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For Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity

(NCT00151814)
Timeframe: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

Interventionng/mL*hr (Mean)
6-12 Years of Age Olmesartan Group7988
13-16 Years of Age Olmesartan Group5982

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For Olmesartan, the Elimination Half-life of the Drug in Plasma

(NCT00151814)
Timeframe: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

Interventionhr (Mean)
6-12 Years of Age Olmesartan Group8.4
13-16 Years of Age Olmesartan Group9.1

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For Olmesartan, the Elimination Constant Rate

(NCT00151814)
Timeframe: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

InterventionL/hr (Mean)
6-12 Years of Age Olmesartan Group0.090
13-16 Years of Age Olmesartan Group0.079

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For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)

(NCT00151814)
Timeframe: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

Interventionng/mL*hr (Mean)
6-12 Years of Age Olmesartan Group7874
13-16 Years of Age Olmesartan Group5851

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For Olmesartan, the Apparent Oral Volume of Distribution

(NCT00151814)
Timeframe: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

InterventionL (Mean)
6-12 Years of Age Olmesartan Group50.9
13-16 Years of Age Olmesartan Group81.3

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Foe Olmesartan, the Time of Maximum Plasma Concentration

(NCT00151814)
Timeframe: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

Interventionhr (Mean)
6-12 Years of Age Olmesartan Group2.8
13-16 Years of Age Olmesartan Group2.5

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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 the 24-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in the 24-36-hour mean systolic blood pressure measured at week 8 relative to the 12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 24 to 36 hours after dosing; the 12-hour mean is the average of the first 12 hours after dosing. (NCT00362115)
Timeframe: Baseline and Week 8.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-9.4
Azilsartan Medoxomil 10 mg QD-12.0
Azilsartan Medoxomil 20 mg QD-11.5
Azilsartan Medoxomil 40 mg QD-14.6
Azilsartan Medoxomil 80 mg QD-13.5
Olmesartan 20 mg QD-8.9
Placebo QD-1.4

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Change From Baseline in the 24-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in the 24-36-hour mean diastolic blood pressure measured at week 8 relative to the 12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 24 to 36 hours after dosing; the 12-hour mean is the average of the first 12 hours after dosing. (NCT00362115)
Timeframe: Baseline and Week 8.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-5.6
Azilsartan Medoxomil 10 mg QD-7.9
Azilsartan Medoxomil 20 mg QD-8.6
Azilsartan Medoxomil 40 mg QD-9.5
Azilsartan Medoxomil 80 mg QD-7.9
Olmesartan 20 mg QD-6.5
Placebo QD-0.4

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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 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. (NCT00362115)
Timeframe: Baseline and Week 8.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-7.2
Azilsartan Medoxomil 10 mg QD-13.0
Azilsartan Medoxomil 20 mg QD-11.8
Azilsartan Medoxomil 40 mg QD-17.2
Azilsartan Medoxomil 80 mg QD-13.0
Olmesartan 20 mg QD-7.4
Placebo QD0.6

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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. (NCT00362115)
Timeframe: Baseline and Week 8.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-3.6
Azilsartan Medoxomil 10 mg QD-7.3
Azilsartan Medoxomil 20 mg QD-8.0
Azilsartan Medoxomil 40 mg QD-10.0
Azilsartan Medoxomil 80 mg QD-8.7
Olmesartan 20 mg QD-5.1
Placebo QD0.6

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Change From Baseline in the 10-12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in the 10 to 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 10-12-hour mean is the average of all measurements recorded after dosing during these 2 hours. (NCT00362115)
Timeframe: Baseline and Week 8.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-3.8
Azilsartan Medoxomil 10 mg QD-5.7
Azilsartan Medoxomil 20 mg QD-7.4
Azilsartan Medoxomil 40 mg QD-9.1
Azilsartan Medoxomil 80 mg QD-8.8
Olmesartan 20 mg QD-4.7
Placebo QD0.5

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Change From Baseline in Standing Clinic Systolic Blood Pressure.

The change in standing clinic systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough standing systolic blood pressure measurements. (NCT00362115)
Timeframe: Baseline and Week 8.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-11.4
Azilsartan Medoxomil 10 mg QD-13.4
Azilsartan Medoxomil 20 mg QD-16.1
Azilsartan Medoxomil 40 mg QD-14.6
Azilsartan Medoxomil 80 mg QD-14.0
Olmesartan 20 mg QD-11.4
Placebo QD-3.3

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Change From Baseline in Standing Clinic Diastolic Blood Pressure.

The change in standing clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough standing diastolic blood pressure measurements. (NCT00362115)
Timeframe: Baseline and Week 8.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-9.2
Azilsartan Medoxomil 10 mg QD-11.0
Azilsartan Medoxomil 20 mg QD-10.2
Azilsartan Medoxomil 40 mg QD-11.3
Azilsartan Medoxomil 80 mg QD-11.2
Olmesartan 20 mg QD-10.8
Placebo QD-6.9

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Change From Baseline in Sitting Clinic Systolic Blood Pressure.

The change in sitting clinic systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements. (NCT00362115)
Timeframe: Baseline and Week 8

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-11.0
Azilsartan Medoxomil 10 mg QD-15.7
Azilsartan Medoxomil 20 mg QD-14.7
Azilsartan Medoxomil 40 mg QD-17.1
Azilsartan Medoxomil 80 mg QD-13.3
Olmesartan 20 mg QD-13.5
Placebo QD-4.9

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Change From Baseline in Sitting Clinic Diastolic Blood Pressure.

The change in sitting clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements. (NCT00362115)
Timeframe: Baseline and Week 8.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-10.8
Azilsartan Medoxomil 10 mg QD-13.1
Azilsartan Medoxomil 20 mg QD-11.5
Azilsartan Medoxomil 40 mg QD-13.6
Azilsartan Medoxomil 80 mg QD-11.6
Olmesartan 20 mg QD-11.0
Placebo QD-7.9

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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 8 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. (NCT00362115)
Timeframe: Baseline and Week 8.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-7.8
Azilsartan Medoxomil 10 mg QD-13.0
Azilsartan Medoxomil 20 mg QD-11.6
Azilsartan Medoxomil 40 mg QD-17.3
Azilsartan Medoxomil 80 mg QD-13.1
Olmesartan 20 mg QD-8.6
Placebo QD0.7

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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 8 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. (NCT00362115)
Timeframe: Baseline and Week 8.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-4.2
Azilsartan Medoxomil 10 mg QD-7.7
Azilsartan Medoxomil 20 mg QD-8.0
Azilsartan Medoxomil 40 mg QD-10.6
Azilsartan Medoxomil 80 mg QD-8.7
Olmesartan 20 mg QD-6.0
Placebo QD0.7

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

The change in 24-hour mean systolic 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 24-hour mean is the average of all measurements recorded for 24 hours after dosing. (NCT00362115)
Timeframe: Baseline and Week 8.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-7.5
Azilsartan Medoxomil 10 mg QD-12.1
Azilsartan Medoxomil 20 mg QD-11.1
Azilsartan Medoxomil 40 mg QD-15.8
Azilsartan Medoxomil 80 mg QD-12.4
Olmesartan 20 mg QD-9.3
Placebo QD1.0

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

The change in 24-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 24-hour mean is the average of all measurements recorded for 24 hours after dosing. (NCT00362115)
Timeframe: Baseline and Week 8.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-4.2
Azilsartan Medoxomil 10 mg QD-7.3
Azilsartan Medoxomil 20 mg QD-7.5
Azilsartan Medoxomil 40 mg QD-9.6
Azilsartan Medoxomil 80 mg QD-8.2
Olmesartan 20 mg QD-6.2
Placebo QD1.2

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Change From Baseline in the 10-12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in the 10 to 12-hour mean systolic 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 10-12-hour mean is the average of all measurements recorded after dosing during these 2 hours. (NCT00362115)
Timeframe: Baseline and Week 8.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-8.0
Azilsartan Medoxomil 10 mg QD-11.4
Azilsartan Medoxomil 20 mg QD-12.2
Azilsartan Medoxomil 40 mg QD-17.4
Azilsartan Medoxomil 80 mg QD-13.7
Olmesartan 20 mg QD-7.8
Placebo QD0.1

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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 8 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. (NCT00362115)
Timeframe: Baseline and Week 8

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-10.9
Azilsartan Medoxomil 10 mg QD-14.9
Azilsartan Medoxomil 20 mg QD-12.0
Azilsartan Medoxomil 40 mg QD-18.8
Azilsartan Medoxomil 80 mg QD-13.9
Olmesartan 20 mg QD-13.8
Placebo QD-1.5

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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 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 trough mean is the average of all measurements recorded from 22 to 24 hours after dosing. (NCT00362115)
Timeframe: Baseline and Week 8.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-7.6
Azilsartan Medoxomil 10 mg QD-11.3
Azilsartan Medoxomil 20 mg QD-8.9
Azilsartan Medoxomil 40 mg QD-14.0
Azilsartan Medoxomil 80 mg QD-9.0
Olmesartan 20 mg QD-9.6
Placebo QD-0.3

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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 8 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. (NCT00362115)
Timeframe: Baseline and Week 8.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-7.3
Azilsartan Medoxomil 10 mg QD-11.1
Azilsartan Medoxomil 20 mg QD-10.4
Azilsartan Medoxomil 40 mg QD-13.1
Azilsartan Medoxomil 80 mg QD-11.4
Olmesartan 20 mg QD-10.6
Placebo QD1.3

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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 8 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. (NCT00362115)
Timeframe: Baseline and Week 8.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-4.8
Azilsartan Medoxomil 10 mg QD-7.4
Azilsartan Medoxomil 20 mg QD-6.8
Azilsartan Medoxomil 40 mg QD-8.5
Azilsartan Medoxomil 80 mg QD-7.8
Olmesartan 20 mg QD-6.1
Placebo QD1.9

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Change From Baseline in the 34-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in the 34-36-hour mean systolic blood pressure measured at week 8 relative to the 10-12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 34 to 36 hours after dosing; the 10-12-hour mean is the average from these 2 hours after dosing. (NCT00362115)
Timeframe: Baseline and Week 8

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-10.1
Azilsartan Medoxomil 10 mg QD-11.2
Azilsartan Medoxomil 20 mg QD-9.8
Azilsartan Medoxomil 40 mg QD-13.5
Azilsartan Medoxomil 80 mg QD-11.8
Olmesartan 20 mg QD-7.4
Placebo QD-0.9

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Change From Baseline in the 34-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in the 34-36-hour mean diastolic blood pressure measured at week 8 relative to the 10-12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 34 to 36 hours after dosing; the 10-12-hour mean is the average from these 2 hours after dosing. (NCT00362115)
Timeframe: Baseline and Week 8.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 5 mg QD-0.4
Azilsartan Medoxomil 10 mg QD0.3
Azilsartan Medoxomil 20 mg QD0.9
Azilsartan Medoxomil 40 mg QD0.4
Azilsartan Medoxomil 80 mg QD-0.6
Olmesartan 20 mg QD1.9
Placebo QD2.4

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Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 4 Hours of the Last (Week 12 ) 24-hour Dosing Period.

Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study. (NCT00403481)
Timeframe: baseline and 12 weeks

Interventionmm Hg (Mean)
Overall Study Population-18.2

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Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 6 Hours of the Last (Week 12 ) 24-hour Dosing Period.

Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study. (NCT00403481)
Timeframe: baseline and 12 weeks

Interventionmm Hg (Mean)
Overall Study Population-18.6

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Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic)

Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study. (NCT00403481)
Timeframe: baseline and 12 weeks

Interventionmm Hg (Mean)
Overall Study Population-11.1

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Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.

Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study. (NCT00403481)
Timeframe: baseline and 12 weeks

Interventionmm Hg (Mean)
Overall Study Population-20.4

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Change in Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 During the Last 2 Hours of the Last (Week 12 ) 24-hour Dosing Period.

Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study. (NCT00403481)
Timeframe: baseline and 12 Weeks

Interventionmm Hg (Mean)
Overall Study Population-10.6

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Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic).

Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study. (NCT00403481)
Timeframe: baseline and 12 weeks

Interventionmm Hg (Mean)
DaytimeNighttime
Overall Study Population-22.3-18.8

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Change in Ambulatory BP (Diastolic) From Baseline to Week 12 During the Last (Week 12 ) 4 and 6 Hours of the Last 24-hour Dosing Period.

Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study. (NCT00403481)
Timeframe: baseline and 12 weeks

Interventionmm Hg (Mean)
4 hours6 hours
Overall Study Population-10.7-10.8

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Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12

Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study. (NCT00403481)
Timeframe: baseline and 12 weeks

Interventionmm Hg (Mean)
DaytimeNighttime
Overall Study Population-12.0-10.2

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Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 2 Hours of the Last (Week 12) 24-hour Dosing Period.

Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study. (NCT00403481)
Timeframe: baseline and 12 weeks

Interventionmm Hg (Mean)
Overall Study Population-18.6

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Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10 Pm-6am) Ambulatory Blood Pressure Monitored Diastolic Blood Pressure After 12 Weeks of Active Treatment

All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. (NCT00412932)
Timeframe: baseline to 12 weeks

Interventionmm Hg (Mean)
DaytimeNighttime
Overall Study-13.0-11.5

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Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment

All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. (NCT00412932)
Timeframe: baseline to 12 weeks

Interventionmm Hg (Mean)
DaytimeNighttime
Overall Study-26.5-24.4

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Number of Subjects Who Achieved Mean 24-hour Ambluatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment

All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. (NCT00412932)
Timeframe: baseline to 12 weeks

Interventionparticipants (Number)
BP<140/90 mm HgSBP<140 mm HgDBP<90 mm Hg
Overall Study133133149

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Number of Subjects Who Achieved Mean Daytime (8am - 4pm) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.

All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. (NCT00412932)
Timeframe: baseline to 12 weeks

Interventionparticipants (Number)
BP<140/90 mm HgSBP<140 mm HgDBP<90 mm Hg
Overall Study120120145

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Number of Subjects Who Achieved Mean Nighttime (10pm - 6am) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.

All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. (NCT00412932)
Timeframe: baseline to 12 weeks

Interventionparticipants (Number)
BP<140/90 mm HgSBP<140 mm HgDBP<90 mm Hg
Overall Study143143149

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Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment.

All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. (NCT00412932)
Timeframe: baseline to 12 weeks

Interventionmm Hg (Mean)
Overall Study-12.3

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Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment

All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. (NCT00412932)
Timeframe: baseline to 12 weeks

Interventionmm Hg (Mean)
Overall Study-25.7

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Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.

Change = Week 16 - Week 8 (baseline). (NCT00430508)
Timeframe: 8 weeks, change = week 16 - week 8

Interventionmm Hg (Mean)
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo-7.2
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo-5.3
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo-4.1
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo-2.0

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Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.

Change = Week 16 - Week 8 (baseline). (NCT00430508)
Timeframe: 8 weeks, change = week 16 - week 8

Interventionmm Hg (Mean)
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo-7.0
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo-5.5
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo-4.0
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo-1.8

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Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.

Change = Week 16 - Week 8 (baseline). (NCT00430508)
Timeframe: 8 weeks, change = week 16 - week 8

Interventionmm Hg (Mean)
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo-7.9
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo-4.5
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo-4.2
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo-2.3

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Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.

Change = Week 12 - Week 8 (baseline). (NCT00430508)
Timeframe: 4 weeks, change = week 12 - week 8

Interventionmm Hg (Mean)
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo-8.74
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo-7.72
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo-6.66
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo-4.47

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Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.

Change = Week 12 - Week 8 (baseline). (NCT00430508)
Timeframe: 4 weeks, change = week 12 - week 8

Interventionmm Hg (Mean)
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo-13.16
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo-10.90
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo-9.65
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo-6.60

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Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16

Change = Week 16 - Week 8 (baseline). (NCT00430508)
Timeframe: 8 weeks, change = week 16 - week 8

Interventionmm Hg (Mean)
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo-11.16
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo-9.13
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo-8.10
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo-5.66

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Number of Patients Achieving Target Blood Pressure at Week 16

Target Blood Pressure is diastolic blood pressure (dBP) < 90 mmHg and systolic blood pressure (sBP) < 140 mmHg for non-diabetics, and dBP < 80 mmHg and sBP < 130 mmHg for diabetics (NCT00430508)
Timeframe: 8 weeks

Interventionparticipants (Number)
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo59
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo110
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo88
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo68

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Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.

Change = Week 16 - Week 8 (baseline). (NCT00430508)
Timeframe: 8 weeks, change = week 16 - week 8

Interventionmm Hg (Mean)
OM/HCTZ 40/25mg + 20/12.5 Matching Placebo-16.17
OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo-13.52
OM/HCTZ 20/12.5mg + 40/0 Matching Placebo-11.46
OM/HCTZ 40/0mg + 20/12.5 Matching Placebo-8.85

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The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Non-Black Participants.

(NCT00430638)
Timeframe: Baseline to 12 weeks

Interventionmm Hg (Least Squares Mean)
Systolic blood pressureDiastolic blood pressure
Olmesartan vs. Placebo-22.3-12.8

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The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 2 Hypertensives

(NCT00430638)
Timeframe: Baseline to 12 months

Interventionmm Hg (Least Squares Mean)
Systolic blood pressureDiastolic blood pressure
Olmesartan vs. Placebo-22.5-13.2

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The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 1 Hypertensives

(NCT00430638)
Timeframe: Baseline to 12 weeks

Interventionmm Hg (Least Squares Mean)
Systolic blood pressureDiastolic blood pressure
Olmesartan vs. Placebo-22.1-12.2

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The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Less Than 65 Years Old.

(NCT00430638)
Timeframe: Baseline to 12 weeks

Interventionmm Hg (Least Squares Mean)
Systolic blood pressureDiastolic blood pressure
Olmesartan vs. Placebo-23.8-13.6

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The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Greater Than or Equal to 65 Years Old.

(NCT00430638)
Timeframe: Baseline to 12 weeks

Interventionmm Hg (Least Squares Mean)
Systolic blood pressureDiastolic blood pressure
Olmesartan vs. Placebo-16.1-9.0

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The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Males.

The difference in the change from baseline to week 12 in seated systolic and diastolic blood pressure for males in the olmesartan group vs. the placebo group was analyzed. (NCT00430638)
Timeframe: Baseline to week 12

Interventionmm Hg (Least Squares Mean)
Systolic Blood PressureDiastolic Blood Pressure
Olmesartan vs. Placebo-22.6-13.5

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The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Females.

The difference in the change from baseline to week 12 in seated blood pressure for females in the olmesartan group vs. the placebo group was analyzed. (NCT00430638)
Timeframe: Baseline to week 12

Interventionmm Hg (Least Squares Mean)
Systolic blood pressureDiastolic blood pressure
Olmesartan vs. Placebo-21.6-12.0

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The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Black Participants.

(NCT00430638)
Timeframe: Baseline to week 12

Interventionmm Hg (Least Squares Mean)
Systolic blood pressureDiastolic blood pressure
Olmesartan vs. Placebo-21.3-12.5

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Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.

The change from baseline in mean systolic blood pressure (SBP) after 12 weeks of randomized treatment was compared between the olmesartan based treatment group and the placebo treatment group. (NCT00430638)
Timeframe: baseline to 12 weeks

Interventionmm Hg (Least Squares Mean)
Placebo-0.1
Olmesartan Group-22.3

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Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.

Change from study baseline (average of triplicate DBP measurements at the last 2 qualifying visits during placebo run-in period) in DBP to the end of 12 weeks of randomized treatment using a last observation carried forward (LOCF) approach. (NCT00430638)
Timeframe: baseline to 12 weeks

Interventionmm Hg (Least Squares Mean)
Placebo Group-0.8
Olmesartan Group-12.1

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Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12

Change = Week 12 - Week 8 (baseline). (NCT00430950)
Timeframe: 4 weeks

Interventionmm Hg (Mean)
OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo-9.32
OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo-8.83

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Number of Participants Achieving Blood Pressure Goal.

(NCT00430950)
Timeframe: 8 weeks

Interventionparticipants (Number)
OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo260
OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo255

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Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.

Change = Week 16 - Week 8 (baseline). (NCT00430950)
Timeframe: 8 weeks

,
Interventionmm Hg (Mean)
Change from Week 8 to Wk 16 in mean 24-hr ABPM dBPChange from Week 8 to wk16 in daytime ABPM dBPChange from Week 8 to wk16 in nighttime ABPM dBPChange from Week 8 to wk16 in mean 24-hr ABPM sBPChange from Week 8 to wk16 in daytime ABPM sBPChange from Week 8 to wk16 in nighttime ABPM sBP
OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo-7.6-7.7-7.0-12.0-12.3-10.7
OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo-9.2-9.3-8.6-14.7-15.0-13.4

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Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.

4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline). (NCT00430950)
Timeframe: 8 weeks

,
Interventionmm Hg (Mean)
Change from baseline (Week 8) to Week 16 in sBPChange from baseline (Week 8) to Week 12 in sBP
OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo-17.09-13.80
OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo-17.41-14.07

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Change in Mean Trough Sitting Diastolic Blood Pressure

"Change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline.~Change = Week 16 - Week 8 (baseline)." (NCT00430950)
Timeframe: 8 weeks

Interventionmm Hg (Mean)
OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo-11.16
OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo-10.45

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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 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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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 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 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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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 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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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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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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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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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 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 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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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 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 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 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 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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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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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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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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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 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 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 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 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 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 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 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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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 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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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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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 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 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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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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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 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 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 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 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 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 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 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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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. (NCT00696241)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20 mg QD-11.10
Azilsartan Medoxomil 40 mg QD-12.39
Azilsartan Medoxomil 80 mg QD-13.35
Olmesartan 40 mg QD-12.13
Placebo QD-0.97

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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. (NCT00696241)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20 mg QD-6.98
Azilsartan Medoxomil 40 mg QD-7.90
Azilsartan Medoxomil 80 mg QD-7.79
Olmesartan 40 mg QD-7.62
Placebo QD-0.96

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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. (NCT00696241)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20 mg QD-12.15
Azilsartan Medoxomil 40 mg QD-13.48
Azilsartan Medoxomil 80 mg QD-14.62
Olmesartan 40 mg QD-12.56
Placebo QD-1.40

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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. (NCT00696241)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20 mg QD-7.47
Azilsartan Medoxomil 40 mg QD-8.38
Azilsartan Medoxomil 80 mg QD-8.61
Olmesartan 40 mg QD-7.74
Placebo QD-0.69

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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. (NCT00696241)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20 mg QD-12.72
Azilsartan Medoxomil 40 mg QD-14.05
Azilsartan Medoxomil 80 mg QD-15.18
Olmesartan 40 mg QD-13.07
Placebo QD-1.36

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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 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. (NCT00696241)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20 mg QD-7.72
Azilsartan Medoxomil 40 mg QD-8.63
Azilsartan Medoxomil 80 mg QD-8.88
Olmesartan 40 mg QD-7.86
Placebo QD-0.47

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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. (NCT00696241)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20 mg QD-14.28
Azilsartan Medoxomil 40 mg QD-14.47
Azilsartan Medoxomil 80 mg QD-17.58
Olmesartan 40 mg QD-14.87
Placebo QD-2.06

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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. (NCT00696241)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20 mg QD-6.82
Azilsartan Medoxomil 40 mg QD-6.86
Azilsartan Medoxomil 80 mg QD-8.42
Olmesartan 40 mg QD-6.91
Placebo QD0.21

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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. (NCT00696241)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20 mg QD-12.57
Azilsartan Medoxomil 40 mg QD-13.75
Azilsartan Medoxomil 80 mg QD-14.96
Olmesartan 40 mg QD-12.73
Placebo QD-1.54

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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. (NCT00696241)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20 mg QD-7.71
Azilsartan Medoxomil 40 mg QD-8.43
Azilsartan Medoxomil 80 mg QD-8.87
Olmesartan 40 mg QD-7.82
Placebo QD-0.59

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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. (NCT00696241)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20 mg QD-12.15
Azilsartan Medoxomil 40 mg QD-12.39
Azilsartan Medoxomil 80 mg QD-13.42
Olmesartan 40 mg QD-11.10
Placebo QD-1.21

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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, 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 the 3 trough sitting diastolic blood pressure measurements. (NCT00696241)
Timeframe: Baseline and Week 6.

Interventionpercentage of participants (Number)
Azilsartan Medoxomil 20 mg QD67.5
Azilsartan Medoxomil 40 mg QD71.0
Azilsartan Medoxomil 80 mg QD73.5
Olmesartan 40 mg QD73.9
Placebo QD47.9

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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, 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. (NCT00696241)
Timeframe: Baseline and Week 6.

Interventionpercentage of participants (Number)
Azilsartan Medoxomil 20 mg QD47.8
Azilsartan Medoxomil 40 mg QD50.4
Azilsartan Medoxomil 80 mg QD56.6
Olmesartan 40 mg QD53.2
Placebo QD17.1

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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, 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. (NCT00696241)
Timeframe: Baseline and Week 6.

Interventionpercentage of participants (Number)
Azilsartan Medoxomil 20 mg QD42.7
Azilsartan Medoxomil 40 mg QD45.3
Azilsartan Medoxomil 80 mg QD52.0
Olmesartan 40 mg QD47.5
Placebo QD14.3

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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 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 trough mean is the average of all measurements recorded from 22 to 24 hours after dosing. (NCT00696241)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20 mg QD-7.96
Azilsartan Medoxomil 40 mg QD-7.93
Azilsartan Medoxomil 80 mg QD-8.68
Olmesartan 40 mg QD-7.56
Placebo QD-1.12

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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, 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 the 3 trough sitting diastolic blood pressure measurements. (NCT00696436)
Timeframe: Baseline and Week 6.

Interventionpercentage of participants (Number)
Azilsartan Medoxomil 40 mg QD68.8
Azilsartan Medoxomil 80 mg QD71.1
Valsartan 320 mg QD63.8
Olmesartan 40 mg QD68.2
Placebo QD43.9

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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, 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. (NCT00696436)
Timeframe: Baseline and Week 6.

Interventionpercentage of participants (Number)
Azilsartan Medoxomil 40 mg QD56.5
Azilsartan Medoxomil 80 mg QD57.8
Valsartan 320 mg QD48.7
Olmesartan 40 mg QD48.8
Placebo QD22.3

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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, 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. (NCT00696436)
Timeframe: Baseline and Week 6.

Interventionpercentage of participants (Number)
Azilsartan Medoxomil 40 mg QD49.1
Azilsartan Medoxomil 80 mg QD52.6
Valsartan 320 mg QD43.9
Olmesartan 40 mg QD44.5
Placebo QD18.2

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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. (NCT00696436)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD-8.96
Azilsartan Medoxomil 80 mg QD-9.80
Valsartan 320 mg QD-7.23
Olmesartan 40 mg QD-7.82
Placebo QD0.01

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Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure

The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline. (NCT00696436)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD-6.97
Azilsartan Medoxomil 80 mg QD-8.27
Valsartan 320 mg QD-5.11
Olmesartan 40 mg QD-6.10
Placebo QD-0.76

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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. (NCT00696436)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD-16.38
Azilsartan Medoxomil 80 mg QD-16.74
Valsartan 320 mg QD-11.31
Olmesartan 40 mg QD-13.20
Placebo QD-1.83

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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 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. (NCT00696436)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD-9.16
Azilsartan Medoxomil 80 mg QD-10.13
Valsartan 320 mg QD-7.42
Olmesartan 40 mg QD-7.82
Placebo QD0.01

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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. (NCT00696436)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD-14.03
Azilsartan Medoxomil 80 mg QD-15.55
Valsartan 320 mg QD-10.44
Olmesartan 40 mg QD-12.23
Placebo QD-0.10

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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. (NCT00696436)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD-8.65
Azilsartan Medoxomil 80 mg QD-9.43
Valsartan 320 mg QD-7.09
Olmesartan 40 mg QD-7.74
Placebo QD-0.07

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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. (NCT00696436)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD-13.42
Azilsartan Medoxomil 80 mg QD-14.53
Valsartan 320 mg QD-10.22
Olmesartan 40 mg QD-11.99
Placebo QD-0.25

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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. (NCT00696436)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD-7.65
Azilsartan Medoxomil 80 mg QD-8.54
Valsartan 320 mg QD-6.26
Olmesartan 40 mg QD-7.82
Placebo QD0.10

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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. (NCT00696436)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD-12.28
Azilsartan Medoxomil 80 mg QD-13.32
Valsartan 320 mg QD-9.66
Olmesartan 40 mg QD-11.90
Placebo QD-0.31

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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 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 trough mean is the average of all measurements recorded from 22 to 24 hours after dosing. (NCT00696436)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD-8.69
Azilsartan Medoxomil 80 mg QD-8.61
Valsartan 320 mg QD-6.22
Olmesartan 40 mg QD-8.25
Placebo QD-0.69

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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. (NCT00696436)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD-12.46
Azilsartan Medoxomil 80 mg QD-13.38
Valsartan 320 mg QD-9.14
Olmesartan 40 mg QD-11.65
Placebo QD-0.55

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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. (NCT00696436)
Timeframe: Baseline and Week 6.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 40 mg QD-13.73
Azilsartan Medoxomil 80 mg QD-15.02
Valsartan 320 mg QD-10.26
Olmesartan 40 mg QD-12.16
Placebo QD-0.11

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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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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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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 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 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 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 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 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 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 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 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

[back to top]

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 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

[back to top]

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 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

[back to top]

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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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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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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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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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 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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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 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

[back to top]

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

[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

[back to top]

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

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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 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

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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 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 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 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

[back to top]

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

[back to top]

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 Participants Who Achieve a Clinic Diastolic AND Systolic Blood Pressure Response, Defined as <140/90 mm Hg for Participants Without Diabetes or Chronic Kidney Disease (CKD) or <130/80 mm Hg for Participants With Diabetes or CKD

Percentage of participants who achieve both a clinic diastolic blood pressure response, defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) or <130/80 mm Hg for participants with diabetes or CKD at each time frame relative to baseline. (NCT00846365)
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8.

,,
Interventionpercentage of participants (Number)
Week 2 (n=343; n=334; n=345)Week 4 (n=360; n=347; n=352)Week 6 (n=362; n=350; n=353)Week 8 (n=363; n=350; n=353)
Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD51.358.168.869.4
Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD48.561.465.468.9
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD35.944.655.554.7

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Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure

The change in trough diastolic blood pressure measured at week 4 and week 8 relative to baseline. Diastolic blood pressure is the average of the 3 serial trough sitting diastolic blood pressure measurements. (NCT00846365)
Timeframe: Baseline, Week 4 and Week 8.

,,
InterventionmmHg (Least Squares Mean)
Week 4 (n=360; n=347; n=352)Week 8 (n=363; n=350; n=353)
Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD-13.6-16.1
Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD-14.2-16.5
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-10.4-12.8

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Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as Defined as <90 mm Hg for Participants Without Diabetes or CKD or <80 mm Hg for Participants With Diabetes or CKD

Percentage of participants who achieve a clinic diastolic blood pressure response, defined as defined as <90 mm Hg for participants without diabetes or CKD or <80 mm Hg for participants with diabetes or CKD at each time frame relative to baseline. (NCT00846365)
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8.

,,
Interventionpercentage of participants (Number)
Week 2 (n=343; n=334; n=345)Week 4 (n=360; n=347; n=352)Week 6 (n=362; n=350; n=353)Week 8 (n=363; n=350; n=353)
Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD63.671.477.979.9
Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD66.273.876.979.1
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD47.858.266.966.0

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Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as <140 mm Hg for Participants Without Diabetes or CKD or <130 mm Hg for Participants With Diabetes or CKD

Percentage of participants who achieve a clinic systolic blood pressure response, defined as <140 mm Hg for participants without diabetes or CKD or <130 mm Hg for participants with diabetes or CKD at each time frame relative to baseline. (NCT00846365)
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8.

,,
Interventionpercentage of participants (Number)
Week 2 (n=343; n=334; n=345)Week 4 (n=360; n=347; n=352)Week 6 (n=362; n=350; n=353)Week 8 (n=363; n=350; n=353)
Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD60.366.176.876.0
Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD57.268.973.476.0
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD44.952.364.964.6

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

The change in the 0 to 24-hours-after-dosing mean diastolic blood pressure measured at Week 4 and Week 8 relative to baseline. . Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average of measurements collected over the subsequent 24 hours. (NCT00846365)
Timeframe: Baseline, Week 4 and Week 8.

,,
InterventionmmHg (Least Squares Mean)
Week 4 (n=223; n=227; n=219)Week 8 (n=290; n=278; n=281)
Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD-13.9-15.1
Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD-14.4-16.4
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-10.5-12.0

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Change From Baseline in 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in the 0 to 12 hours-after-dosing mean Systolic Blood Pressure measured at Week 4 and Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night The mean consists of the average (arithmetic mean) of measurements collected at each time frame and includes all observations recorded over the subsequent 12 hours. (NCT00846365)
Timeframe: Baseline, Week 4 and Week 8.

,,
InterventionmmHg (Least Squares Mean)
Week 4 (n=223; n=227; n=219)Week 8 (n=290; n=278; n=281)
Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD-25.0-27.1
Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD-25.5-28.8
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-19.2-21.1

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Change From Baseline in 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in the 0 to 12 hours-after-dosing mean diastolic blood pressure measured at Week 4 and Week 8 to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each time frame and includes all observations recorded over the subsequent 12 hours. (NCT00846365)
Timeframe: Baseline, Week 4 and Week 8.

,,
InterventionmmHg (Least Squares Mean)
Week 4 (n=223; n=227; n=219)Week 8 (n=290; n=278; n=281)
Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD-14.4-15.4
Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD-14.8-16.9
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-10.8-12.1

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Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure.

The change in trough systolic blood pressure measured at week 8 or final visit relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements. (NCT00846365)
Timeframe: Baseline and Week 8.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD-37.6
Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD-38.2
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-31.5

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Change From Baseline to Week 4 in Trough, Sitting, Clinic Systolic Blood Pressure.

The change in trough systolic blood pressure measured at week 4 relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements. (NCT00846365)
Timeframe: Baseline and Week 4.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD-33.0
Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD-34.1
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-26.9

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

The change in the 24-hour mean systolic blood pressure at week4 and week 8 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. (NCT00846365)
Timeframe: Baseline, Week 4 and Week 8.

,,
InterventionmmHg (Least Squares Mean)
Week 4 (n=223; n=227; n=219)Week 8 (n=290; n=278; n=281)
Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD-24.1-26.4
Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD-24.4-27.9
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-18.4-20.7

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Change From Baseline in Daytime Mean (6am to 10pm) Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in the daytime, while awake (6am to 10pm) mean diastolic blood pressure measured at Week 4 and Week 8relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive) included in the 24-hour mean calculations. (NCT00846365)
Timeframe: Baseline, Week 4 and Week 8.

,,
InterventionmmHg (Least Squares Mean)
Week 4 (n=223; n=227; n=219)Week 8 (n=290; n=278; n=281)
Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD-14.2-15.3
Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD-14.7-16.6
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-10.7-12.1

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Change From Baseline in Daytime Mean (6am to 10pm) Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in the daytime, while awake (6am to 10pm) mean systolic blood pressure measured at Week 4 and Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night Daytime mean is the average of measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive) included in the 24-hour mean calculations. (NCT00846365)
Timeframe: Baseline, Week 4 and Week 8.

,,
InterventionmmHg (Least Squares Mean)
Week 4 (n=223; n=227; n=219)Week 8 (n=290; n=278; n=281)
Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD-24.5-26.7
Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD-25.1-28.4
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-18.9-21.0

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

The change in the nighttime, while asleep (12am to 6am) mean diastolic blood pressure measured at Week 4 and Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive) included in the 24-hour mean calculations. (NCT00846365)
Timeframe: Baseline, Week 4 and Week 8.

,,
InterventionmmHg (Least Squares Mean)
Week 4 (n=223; n=227; n=219)Week 8 (n=290; n=278; n=281)
Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD-13.4-14.9
Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD-13.3-15.8
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-9.6-11.8

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

The change in the nighttime, while asleep (12am to 6am) mean systolic blood pressure measured at Week 4 and Week 8 to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive) included in the 24-hour mean calculations. (NCT00846365)
Timeframe: Baseline, Week 4 and Week 8.

,,
InterventionmmHg (Least Squares Mean)
Week 4 (n=223; n=227; n=219)Week 8 (n=290; n=278; n=281)
Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD-22.3-25.2
Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD-21.9-26.3
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-16.6-19.7

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Change From Baseline in Trough Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in trough systolic blood pressure measured at week 4 and week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing. (NCT00846365)
Timeframe: Baseline, Week 4 and Week 8.

,,
InterventionmmHg (Least Squares Mean)
Week 4 (n=223; n=227; n=219)Week 8 (n=290; n=278; n=281)
Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD-13.4-14.6
Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD-14.6-15.9
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-10.9-12.0

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Change From Baseline in Trough Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

The change in trough systolic blood pressure measured at week 4 and week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing. (NCT00846365)
Timeframe: Baseline, Week 4 and Week 8.

,,
InterventionmmHg (Least Squares Mean)
Week 4 (n=223; n=227; n=219)Week 8 (n=290; n=278; n=281)
Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD-22.4-24.9
Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD-23.6-26.8
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-17.4-19.6

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Mean Change of Sitting dBP From Baseline to Week 12

The difference in the sitting diastolic blood pressure (dBP) at trough, i.e. 24±2 hours after drug administration, from base line to Week 12. (NCT00857285)
Timeframe: Baseline to 12 weeks

InterventionmmHg (Mean)
Olmesartan Medoxomil-14.80
Losartan Potassium-11.60

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The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85

(NCT00858702)
Timeframe: Baseline to week 8

InterventionPercent of participants (Number)
Olmesartan Tablets and a Calcium Channel Blocker Tablet34.0
Olmesartan Medoxomil Tablets and a Diuretic59.2

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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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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 (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 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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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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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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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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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 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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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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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 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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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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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 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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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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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 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 From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)

The change from baseline in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. (NCT00949884)
Timeframe: Day 0, Week 8

InterventionmmHg (Least Squares Mean)
Olmesartan-9.8
Combined Olmesartan-9.7
Losartan-7.1

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Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)

The change from baseline in trough SSBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. (NCT00949884)
Timeframe: Day 0, Week 4

InterventionmmHg (Least Squares Mean)
Olmesartan-12.3
Combined Olmesartan-12.0
Losartan-8.5

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Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)

The change from baseline in trough SDBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. (NCT00949884)
Timeframe: Day 0, Week 4

InterventionmmHg (Least Squares Mean)
Olmesartan-9.0
Combined Olmesartan-8.8
Losartan-6.2

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Percentage of Participants Achieving Blood Pressure Goals at Week 4

"Percentage of participants who achieved the following goals:~Systolic blood pressure: <140 mmHg, <135 mmHg, <130 mmHg, <120 mmHg Diastolic blood pressure: <90 mmHg, <85 mmHg, <80 mmHg Blood pressure: <140/90 mmHg, <135/80 mmHg, <130/80 mmHg" (NCT00949884)
Timeframe: Week 4

,,
Interventionpercentage of participants analyzed (Number)
Systolic BP <140 mmHgSystolic BP <135 mmHgSystolic BP <130 mmHgSystolic BP <120 mmHgDiastolic BP <90 mmHgDiastolic BP <85 mmHgDiastolic BP <80 mmHgBlood pressure <140/90 mmHgBlood pressure <135/80 mmHgBlood pressure <130/80 mmHg
Combined Olmesartan36.727.116.53.538.823.910.426.57.65.9
Losartan25.614.17.22.024.513.04.614.32.21.5
Olmesartan37.928.116.83.139.624.210.627.37.45.5

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Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8

Participants from pre-selected sites had 24-hour ambulatory blood pressure readings collected. Daytime readings were results collected between 8am and 4pm. Nighttime readings were results collected between 10pm and 6am. (NCT00949884)
Timeframe: Week 8

,,
Interventionpercentage of population (Number)
Mean 24-hourMean DaytimeMean Nighttime
Combined Olmesartan58.532.177.4
Losartan40.921.866.4
Olmesartan59.232.776.5

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Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure

The change from baseline in trough systolic and diastolic blood pressure at Week 2 as measured by the Omron monitor. Morning doses of study medication were taken after the exam, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. (NCT00949884)
Timeframe: Baseline, Week 2

,
InterventionmmHg (Least Squares Mean)
Diastolic blood pressureSystolic blood pressure
Olmesartan-8.3-11.9
Placebo Followed by Olmesartan-4.0-3.3

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Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8

In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized. (NCT00949884)
Timeframe: Baseline, Week 8

,,
InterventionmmHg (Least Squares Mean)
Daytime systolic blood pressureDaytime diastolic blood pressureNighttime systolic blood pressureNighttime diastolic blood pressure
Combined Olmesartan-8.7-6.1-9.3-6.1
Losartan-5.2-3.7-6.3-4.1
Olmesartan-8.7-6.2-9.3-6.2

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Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8

In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized. (NCT00949884)
Timeframe: Baseline, Week 8

,,
InterventionmmHg (Least Squares Mean)
2 hour systolic blood pressure2 hour diastolic blood pressure4 hour systolic blood pressure4 hour diastolic blood pressure6 hour systolic blood pressure6 hour diastolic blood pressure
Combined Olmesartan-9.5-6.0-10.1-6.7-9.7-6.5
Losartan-7.2-4.0-6.9-4.1-6.5-4.0
Olmesartan-10.0-6.3-10.5-7.1-10.0-6.8

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Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4

In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized. (NCT00949884)
Timeframe: Baseline, Week 4

,,
InterventionmmHg (Least Squares Mean)
2 hour systolic blood pressure2 hour diastolic blood pressure4 hour systolic blood pressure4 hour diastolic blood pressure6 hour systolic blood pressure6 hour diastolic blood pressure
Combined Olmesartan-8.4-5.6-8.3-5.6-8.0-5.4
Losartan-6.8-3.8-6.5-4.1-6.2-3.9
Olmesartan-8.7-5.8-8.4-5.8-8.0-5.5

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Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4

In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized. (NCT00949884)
Timeframe: Baseline, Week 4

,,
InterventionmmHg (Least Squares Mean)
Daytime systolic blood pressureDaytime diastolic blood pressureNighttime systolic blood pressureNighttime diastolic blood pressure
Combined Olmesartan-7.5-5.2-6.8-4.3
Losartan-5.8-3.5-5.5-3.4
Olmesartan-7.6-5.4-6.7-4.4

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Percentage of Participants Achieving Blood Pressure Goals at Week 8

"Percentage of participants who achieved the following goals:~Systolic blood pressure: <140 mmHg, <135 mmHg, <130 mmHg, <120 mmHg Diastolic blood pressure: <90 mmHg, <85 mmHg, <80 mmHg Blood pressure: <140/90 mmHg, <135/80 mmHg, <130/80 mmHg, <120/80 mmHg" (NCT00949884)
Timeframe: Week 8

,,
Interventionpercentage of participants analyzed (Number)
Systolic BP <140 mmHgSystolic BP <135 mmHgSystolic BP <130 mmHgSystolic BP <120 mmHgDiastolic BP <90 mmHgDiastolic BP <85 mmHgDiastolic BP <80 mmHgBlood pressure <140/90 mmHgBlood pressure <135/80 mmHgBlood pressure <130/80 mmHgBlood pressure <120/80 mmHg
Combined Olmesartan41.030.018.46.642.522.911.831.69.97.54.7
Losartan28.920.413.13.830.515.56.619.54.94.52.3
Olmesartan41.129.918.26.843.222.912.232.610.27.64.9

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Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8

In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. (NCT00949884)
Timeframe: Baseline, Week 8

,,
InterventionmmHg (Least Squares Mean)
Systolic blood pressureDiastolic blood pressure
Combined Olmesartan-9.2-6.1
Losartan-5.6-3.6
Olmesartan-9.1-6.1

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Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4

In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. (NCT00949884)
Timeframe: Baseline, Week 4

,,
InterventionmmHg (Least Squares Mean)
Systolic blood pressureDiastolic blood pressure
Combined Olmesartan-7.3-4.8
Losartan-5.9-3.7
Olmesartan-7.3-4.9

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Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)

The change from Week 4 in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. (NCT00949884)
Timeframe: Week 4, Week 8

InterventionmmHg (Least Squares Mean)
Olmesartan-1.1
Combined Olmesartan-1.4
Losartan0.0

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Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)

The change from Week 4 in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. (NCT00949884)
Timeframe: Week 4, Week 8

InterventionmmHg (Least Squares Mean)
Olmesartan-0.8
Combined Olmesartan-0.9
Losartan0.0

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Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)

The change from baseline in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. (NCT00949884)
Timeframe: Day 0, Week 8

InterventionmmHg (Least Squares Mean)
Olmesartan-13.6
Combined Olmesartan-13.6
Losartan-9.7

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Percentage of Participants With at Least 1 Adverse Event

An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product without regard to causality. (NCT00996281)
Timeframe: From Week 0 (Day 1) to Week 52.

Interventionpercentage of participants (Number)
Azilsartan Medoxomil and Chlorthalidone78.5
Olmesartan Medoxomil and Hydrochlorothiazide76.4

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Percentage of Participants With Serum Creatinine Elevations Greater Than 50% From Baseline and Greater Than the Upper Limit of Normal (ULN)

Serum creatinine was measured at every visit and evaluated as a laboratory parameter of special interest. The percentage of participants with creatinine increase ≥50% from Baseline and greater than ULN was summarized: - At any visit (includes transient and persistent elevations). - At the Final Visit (includes persistent elevations and participants whose first elevation may have been at the Final Visit). - At least 2 consecutive visits (includes only persistent elevations). (NCT00996281)
Timeframe: Baseline and Week 52

,
Interventionpercentage of participants (Number)
At any postbaseline visitat the Final Visit≥2 consecutive elevations
Azilsartan Medoxomil and Chlorthalidone14.25.95.1
Olmesartan Medoxomil and Hydrochlorothiazide5.81.01.2

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

The change in 24-hour mean diastolic blood pressure measured at week 12 or final visit 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. (NCT01033071)
Timeframe: Baseline and Week 12.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD-19.4
Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD-20.7
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-16.2

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

The change in 24-hour mean systolic blood pressure measured at week 12 or final visit 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. (NCT01033071)
Timeframe: Baseline and Week 12.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD-33.9
Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD-36.3
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-27.5

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Change From Baseline in Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.

The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 12 or final visit 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 (inclusive) and 10 PM (exclusive). (NCT01033071)
Timeframe: Baseline and Week 12.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD-20.1
Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD-21.8
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-17.0

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Change From Baseline in Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.

The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 12 or final visit 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 (inclusive) and 10 PM (exclusive). (NCT01033071)
Timeframe: Baseline and Week 12.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD-35.3
Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD-37.9
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-28.8

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

The change in the mean nighttime (12am to 6am) diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Mean nighttime is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive). (NCT01033071)
Timeframe: Baseline and Week 12.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD-17.5
Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD-18.0
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-14.0

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

The change in the mean nighttime (12am to 6am) systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Mean nighttime is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive). (NCT01033071)
Timeframe: Baseline and Week 12.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD-29.6
Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD-31.8
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-23.9

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Change From Baseline in Mean Trough Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.

The change in trough diastolic blood pressure measured at week 12 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing. (NCT01033071)
Timeframe: Baseline and Week 12.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD-19.8
Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD-20.2
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-16.0

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Change From Baseline in Mean Trough Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.

The change in trough systolic blood pressure measured at week 12 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing. (NCT01033071)
Timeframe: Baseline and Week 12.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD-32.9
Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD-34.9
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-25.9

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Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring.

The change in the mean 12 hour diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements. (NCT01033071)
Timeframe: Baseline and Week 12.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD-20.4
Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD-22.2
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-17.5

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Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring.

The change in the mean 12 hour systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements. (NCT01033071)
Timeframe: Baseline and Week 12.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD-36.2
Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD-38.8
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-29.7

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Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.

The change in sitting trough clinic systolic blood pressure measured at week 12 or final visit relative to baseline. Trough blood pressure is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements. (NCT01033071)
Timeframe: Baseline and Week 12.

InterventionmmHg (Least Squares Mean)
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD-42.5
Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD-44.0
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-37.1

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Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring.

The change from baseline for each hour interval of the 24-hour ambulatory blood pressure monitoring measured at week 12 or final visit. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each hour. (NCT01033071)
Timeframe: Baseline and Week 12.

,,
InterventionmmHg (Least Squares Mean)
0 to 1 Hour (n=232; n=212; n=237)1 to 2 Hour (n=232; n=214; n=238)2 to 3 Hour (n=232; n=214; n=238)3 to 4 Hour (n=232; n=214; n=238)4 to 5 Hour (n=232; n=214; n=238)5 to 6 Hour (n=232; n=214; n=238)6 to 7 Hour (n=232; n=214; n=238)7 to 8 Hour (n=232; n=214; n=238)8 to 9 Hour (n=232; n=214; n=238)9 to 10 Hour (n=232; n=214; n=238)10 to 11 Hour (n=232; n=214; n=238)11 to 12 Hour (n=232; n=214; n=238)12 to 13 Hour (n=232; n=214; n=238)13 to 14 Hour (n=232; n=214; n=238)14 to 15 Hour (n=232; n=214; n=238)15 to 16 Hour (n=232; n=214; n=238)16 to 17 Hour (n=232; n=214; n=238)17 to 18 Hour (n=231; n=214; n=238)18 to 19 Hour (n=232; n=214; n=238)19 to 20 Hour (n=232; n=214; n=238)20 to 21 Hour (n=232; n=214; n=238)21 to 22 Hour (n=232; n=214; n=238)22 to 23 Hour (n=232; n=214; n=238)23 to 24 Hour (n=232; n=214; n=238)
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD-18.2-18.8-21.2-20.8-21.7-20.9-20.8-20.5-20.7-21.0-19.7-19.3-19.2-19.6-18.9-17.8-17.2-16.6-17.4-17.8-16.7-17.8-19.5-20.2
Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD-20.4-20.9-23.4-23.7-23.7-23.6-22.0-21.9-21.5-21.9-20.7-21.2-20.3-19.5-19.7-18.6-16.9-17.1-18.1-18.5-18.4-18.5-19.6-21.0
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-15.2-15.9-17.7-18.2-17.9-19.0-18.0-17.7-17.9-18.3-16.7-17.0-16.0-15.3-15.4-14.5-13.9-13.2-14.3-13.8-13.9-14.7-15.6-16.4

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Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring.

The change from baseline for each hour interval of the 24-hour ambulatory blood pressure monitoring measured at week 12 or final visit. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each hour. (NCT01033071)
Timeframe: Baseline and Week 12.

,,
InterventionmmHg (Least Squares Mean)
0 to 1 Hour (n=232; n=212; n=237)1 to 2 Hour (n=232; n=214; n=238)2 to 3 Hour (n=232; n=214; n=238)3 to 4 Hour (n=232; n=214; n=238)4 to 5 Hour (n=232; n=214; n=238)5 to 6 Hour (n=232; n=214; n=238)6 to 7 Hour (n=232; n=214; n=238)7 to 8 Hour (n=232; n=214; n=238)8 to 9 Hour (n=232; n=214; n=238)9 to 10 Hour (n=232; n=214; n=238)10 to 11 Hour (n=232; n=214; n=238)11 to 12 Hour (n=232; n=214; n=238)12 to 13 Hour (n=232; n=214; n=238)13 to 14 Hour (n=232; n=214; n=238)14 to 15 Hour (n=232; n=214; n=238)15 to 16 Hour (n=232; n=214; n=238)16 to 17 Hour (n=232; n=214; n=238)17 to 18 Hour (n=231; n=214; n=238)18 to 19 Hour (n=232; n=214; n=238)19 to 20 Hour (n=232; n=214; n=238)20 to 21 Hour (n=232; n=214; n=238)21 to 22 Hour (n=232; n=214; n=238)22 to 23 Hour (n=232; n=214; n=238)23 to 24 Hour (n=232; n=214; n=238)
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD-33.6-33.4-36.7-36.6-36.8-37.2-36.3-37.2-37.3-36.9-36.1-35.2-34.8-34.1-33.4-30.9-29.6-28.5-29.5-29.7-28.2-30.6-32.9-33.1
Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD-36.2-36.4-39.3-40.3-40.8-41.2-38.6-38.5-38.1-38.0-37.6-38.2-36.2-35.3-35.0-32.9-31.1-30.8-31.9-32.5-31.2-32.8-34.0-35.8
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-26.8-27.5-30.0-29.6-30.1-31.5-29.8-29.7-30.5-30.8-29.4-29.3-27.7-26.4-26.2-25.3-24.5-23.1-24.3-23.5-23.0-24.6-25.9-26.1

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Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure.

The change in sitting trough clinic diastolic blood pressure measured at each week indicated relative to baseline. Trough blood pressure is the average (arithmetic mean) of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements. (NCT01033071)
Timeframe: Baseline, Week 4, Week 8 and Week 12.

,,
InterventionmmHg (Least Squares Mean)
Week 4 (n=343; n=330; n=352)Week 8 (n=344; n=330; n=353)Week 12 (n=344; n=330; n=354)
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD-14.9-17.0-18.8
Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD-15.8-17.7-20.5
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-11.7-13.9-16.4

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Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.

The change in sitting trough clinic systolic blood pressure measured at each week indicated relative to baseline. Trough blood pressure is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements. (NCT01033071)
Timeframe: Baseline, Week 4 and Week 8.

,,
InterventionmmHg (Least Squares Mean)
Week 4 (n=343; n=330; n=352)Week 8 (n=344; n=330; n=353)
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD-34.7-39.1
Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD-36.7-39.4
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD-29.7-33.5

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Percent of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline and Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline.

Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at each week indicated, 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 non-missing values of the 3 serial trough sitting blood pressure measurements. (NCT01033071)
Timeframe: Baseline, Week 4, Week 8 and Week 12.

,,
Interventionpercent of participants (Number)
Week 4 (n=343; n=330; n=352)Week 8 (n=344; n=330; n=353)Week 12 (n=344; n=330; n=354)
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD81.388.191.3
Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD84.887.392.4
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD74.481.084.7

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Percentage of Participants Who Reached Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline.

Percentage of participants who achieve a clinic diastolic blood pressure response measured at each week indicated, 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 the non-missing values of the 3 serial trough sitting diastolic blood pressure measurements. (NCT01033071)
Timeframe: Baseline, Week 4, Week 8 and Week 12.

,,
Interventionpercentage of participants (Number)
Week 4 (n=343; n=330; n=352)Week 8 (n=344; n=330; n=353)Week 12 (n=344; n=330; n=354)
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD89.290.794.5
Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD89.790.995.8
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD85.287.891.5

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Percentage of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline.

Percentage of participants who achieve a clinic systolic blood pressure response measured at each week indicated, 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 non-missing values of the 3serial trough sitting systolic blood pressure measurements. (NCT01033071)
Timeframe: Baseline, Week 4, Week 8 and Week 12.

,,
Interventionpercentage of participants (Number)
Week 4 (n=343; n=330; n=352)Week 8 (n=344; n=330; n=353)Week 12 (n=344; n=330; n=354)
Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD87.893.393.0
Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD90.092.494.2
Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD79.885.689.3

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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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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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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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Number of Participants With at Least 1 Adverse Event (AE)

An AE is any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have a causal relationship with this treatment. A serious AE is defined as any untoward medical occurrence that resulted in death, was life threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, led to a congenital anomaly/birth defect or was an important medical event that may have required intervention to prevent any of items above. (NCT01309828)
Timeframe: From the first dose of open-label study drug until 14 days (or 30 days for a serious adverse event) after the last dose of open- label study drug (up to 56 weeks).

,
Interventionparticipants (Number)
Adverse EventsAdverse Events Leading to DiscontinuationSerious Adverse EventsSerious Adverse Events Leading to DiscontinuationDeath
Azilsartan Medoxomil + Chlorthalidone6817850
Olmesartan Medoxomil + Hydrochlorothiazide5815941

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Percentage of Participants at Final Visit Who Achieved Target Diastolic Blood Pressure <80 mm Hg

Diastolic blood pressure is the arithmetic mean of the 3 serial sitting diastolic blood pressure measurements. Percentage of participants at Week 52 who achieved a sitting clinic diastolic blood pressure response, defined as less than 80 mm Hg. (NCT01309828)
Timeframe: Week 52

Interventionpercentage of participants (Number)
Azilsartan Medoxomil + Chlorthalidone80.0
Olmesartan Medoxomil + Hydrochlorothiazide87.8

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Percentage of Participants at Final Visit Who Achieve Target Systolic Blood Pressure <130 mm Hg

Systolic blood pressure is the arithmetic mean of the 3 serial sitting systolic blood pressure measurements. Percentage of participants who achieve a sitting clinic systolic blood pressure response defined as less than 130 mm Hg at Week 52. (NCT01309828)
Timeframe: Week 52

Interventionpercentage of participants (Number)
Azilsartan Medoxomil + Chlorthalidone69.3
Olmesartan Medoxomil + Hydrochlorothiazide78.4

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Percentage of Participants at Final Visit Who Achieved Both a Clinic Systolic and Diastolic Blood Pressure Response

Systolic/diastolic blood pressure is the arithmetic mean of the 3 serial sitting systolic/diastolic blood pressure measurements. Percentage of participants who achieved both a sitting clinic systolic and diastolic blood pressure response, defined as systolic blood pressure less than 130 mm Hg and diastolic blood pressure less than 80 mm Hg at Week 52. (NCT01309828)
Timeframe: Week 52

Interventionpercentage of participants (Number)
Azilsartan Medoxomil + Chlorthalidone58.7
Olmesartan Medoxomil + Hydrochlorothiazide73.0

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Percentage of Participants Achieving a Successful msDBP Response

Successfull msDBP response was defined as <90 mmHg or ≥10 mmHg reduction from baseline. (NCT01599104)
Timeframe: 8 weeks

InterventionPercentage of participants (Number)
LCZ696 200 mg69.5
LCZ696 400 mg70.1
Olmesartan 20 mg60.7

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Change From Baseline in Office Pulse Pressure

Office pulse pressure was calculated as msSBP minus msDBP. Sitting blood pressure (BP) measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and then averaged to calculate the mean BP value. The baseline PP value was subtracted from the week 8 PP value to determine the change from baseline in PP. (NCT01599104)
Timeframe: Baseline, 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 200 mg-10.49
LCZ696 400 mg-11.30
Olmesartan 20 mg-7.34

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

Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline. (NCT01599104)
Timeframe: Baseline, 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 200 mg-18.21
LCZ696 400 mg-20.18
Olmesartan 20 mg-13.20

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

Sitting BP measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline. (NCT01599104)
Timeframe: Baseline, 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 200 mg-7.76
LCZ696 400 mg-8.79
Olmesartan 20 mg-5.91

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Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8

Ambulatory blood pressure monitoring (ABPM) over a 24-hour period was conducted at two time-points during the study in a subset of participants. (NCT01599104)
Timeframe: Baseline, 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 200 mg-13.44
LCZ696 400 mg-14.99
Olmesartan 20 mg-8.78

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Number of Patients With Adverse Events, Serious Adverse Events and Death

Participants were monitored for adverse events, serious adverse events and deaths throughout the study. (NCT01599104)
Timeframe: 8 weeks

,,
InterventionParticipants (Number)
Adverse Events (serious and non-serious)Seroius Adverse EventsDeaths
LCZ696 200 mg13510
LCZ696 400 mg13610
Olmesartan 20 mg15270

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Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8

ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. (NCT01599104)
Timeframe: Baseline, 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 200 mg-7.65
LCZ696 400 mg-8.44
Olmesartan 20 mg-5.56

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Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure

Ambulatory pulse pressure was calculated as hourly ambulatory SBP minus hourly ambulatory DBP in a subset of participants. (NCT01599104)
Timeframe: Baseline, 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 200 mg-5.79
LCZ696 400 mg-6.57
Olmesartan 20 mg-3.20

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Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8

A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg. (NCT01599104)
Timeframe: 8 weeks

InterventionPercentage of participants (Number)
LCZ696 200 mg43.9
LCZ696 400 mg46.5
Olmesartan 20 mg32.9

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Percentage of Participants Achieving a Successful msSBP Response

Successful msSBP response was defined as < 140 mmHg or ≥ 20 mmHg reduction from baseline. (NCT01599104)
Timeframe: 8 weeks

InterventionPercentage of participants (Number)
LCZ696 200 mg57.9
LCZ696 400 mg63.1
Olmesartan 20 mg42.9

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Change From Baseline in maSBP and maDBP for Daytime/Nighttime

ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. (NCT01599104)
Timeframe: Baseline, 8 weeks

,,
InterventionmmHg (Least Squares Mean)
maSBP daytimemaSBP nighttimemaDBP daytimemaDBP nighttime
LCZ696 200 mg-12.60-15.13-7.01-8.82
LCZ696 400 mg-14.44-16.09-8.00-9.42
Olmesartan 20 mg-7.87-10.65-4.95-6.79

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Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)

ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement. (NCT01615198)
Timeframe: Baseline, 10 weeks

InterventionmmHg (Least Squares Mean)
LCZ696-6.95
Olmesartan-4.47

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Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers

ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement. (NCT01615198)
Timeframe: Baseline, 10 weeks

,
InterventionmmHg (Mean)
maSBP, hour 1 (n=58,66)maSBP, hour 2 (n=62,66)maSBP, hour 3 (n=62,68)maSBP, hour 4 (n=62,68)maSBP, hour 5 (n=61,67)maSBP, hour 6 (n=62,68)maSBP, hour 7 (n=62,68)maSBP, hour 8 (n=62,67)maSBP, hour 9 (n=62,68)maSBP, hour 10 (n=62,68)maSBP, hour 11 (n=62,68)maSBP, hour 12 (n=62,68)maSBP, hour 13 (n=62,68)maSBP, hour 14 (n=62,68)maSBP, hour 15 (n=62,67)maSBP, hour 16 (n=62,68)maSBP, hour 17 (n=62,68)maSBP, hour 18 (n=61,68)maSBP, hour 19 (n=62,68)maSBP, hour 20 (n=62,68)maSBP, hour 21 (n=62,67)maSBP, hour 22 (n=62,68)maSBP, hour 23 (n=60,66)maSBP, hour 24 (n=57,67)maDBP, hour 1 (n=58,66)maDBP, hour 2 (n=62,66)maDBP, hour 3 (n=62,68)maDBP, hour 4 (n=62,68)maDBP, hour 5 (n=61,67)maDBP, hour 6 (n=62,68)maDBP, hour 7 (n=62,68)maDBP, hour 8 (n=62,67)maDBP, hour 9 (n=62,68)maDBP, hour 10 (n=62,68)maDBP, hour 11 (n=62,68)maDBP, hour 12 (n=62,68)maDBP, hour 13 (n=-62,68)maDBP, hour 14 (n=62,68)maDBP, hour 15 (n=62,67)maDBP, hour 16 (n=62,68)maDBP, hour 17 (n=62,68)maDBP, hour 18 (n=61,68)maDBP, hour 19 (n=62,68)maDBP, hour 20 (n=62,68)maDBP, hour 21 (n=62,67)maDBP, hour 22 (n=62,68)maDBP, hour 23 (n=60,66)maDBP, hour 24 (n=57,67)
LCZ696-18.48-20.75-17.44-16.90-16.70-18.11-17.60-15.81-14.06-15.55-13.17-12.36-8.71-7.10-9.05-9.90-9.88-11.19-12.38-15.18-13.71-19.28-16.88-17.28-8.34-9.13-8.41-7.35-8.17-8.39-9.14-7.50-7.01-7.83-8.08-7.38-4.36-2.70-4.02-4.84-5.71-5.36-6.10-6.75-6.91-10.22-7.85-7.83
Olmesartan-14.15-17.26-12.65-14.83-16.16-15.00-14.74-16.37-13.55-13.50-13.32-13.43-10.84-9.96-8.68-7.81-5.49-4.88-6.69-9.40-9.04-9.61-10.54-16.03-7.30-7.80-8.21-8.98-8.35-8.09-7.35-8.50-6.65-6.70-6.65-7.64-7.16-6.28-3.05-3.88-3.74-1.65-3.42-4.00-4.40-4.48-5.11-6.62

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Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers

ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement. (NCT01615198)
Timeframe: Baseline, 10 weeks

,
InterventionmmHg (Mean)
maSBP, hour 1 (n=84,84)maSBP, hour 2 (n=89,85)maSBP, hour 3 (n=90,88)maSBP, hour 4 (n=91,88)maSBP, hour 5 (n=90,88)maSBP, hour 6 (n=90,89)maSBP, hour 7 (n=91,89)maSBP, hour 8 (n=91,88)maSBP, hour 9 (n=91,89)maSBP, hour 10 (n=92,89)maSBP, hour 11 (n=92,89)maSBP, hour 12 (n=92,88)maSBP, hour 13 (n=92,89)maSBP, hour 14 (n=92,88)maSBP, hour 15 (n=92,89)maSBP, hour 16 (n=92,89)maSBP, hour 17 (n=92,89)maSBP, hour 18 (n=92,88)maSBP, hour 19 (n=91,89)maSBP, hour 20 (n=92,89)maSBP, hour 21 (n=91,89)maSBP, hour 22 (n=91,89)maSBP, hour 23 (n=92,85)maSBP, hour 24 (n=86,85)msDBP, hour 1 (n=84,84)msDBP, hour 2 (n=89,85)msDBP, hour 3 (n=90,88)msDBP, hour 4 (n=91,88)msDBP, hour 5 (n=90,88)msDBP, hour 6 (n=90,89)msDBP, hour 7 (n=91,89)msDBP, hour 8 (n=91,88)msDBP, hour 9 (n=91,89)msDBP, hour 10 (n=92,89)msDBP, hour 11 (n=92,89)msDBP, hour 12 (n=92,88)msDBP, hour 13 (n=92,89)msDBP, hour 14 (n=92,88)msDBP, hour 15 (n=92,89)msDBP, hour 16 (n=92,89)msDBP, hour 17 (n=92,89)msDBP, hour 18 (n=92,88)msDBP, hour 19 (n=91,89)msDBP, hour 20 (n=92,89)msDBP, hour 21 (n=91,89)msDBP, hour 22 (n=91,89)msDBP, hour 23 (n=92,85)msDBP, hour 24 (n=86,85)
LCZ696-13.42-15.60-13.17-13.93-12.90-12.96-12.68-12.65-13.51-12.96-12.69-13.82-16.51-19.39-19.33-17.95-17.34-16.45-15.81-15.33-14.78-13.99-10.93-14.19-7.01-7.39-6.61-7.08-5.75-7.06-5.69-6.13-7.05-5.28-6.18-6.36-8.63-9.68-9.60-8.48-7.60-8.60-7.46-6.21-7.63-6.97-5.72-6.57
Olmesartan-9.53-8.57-6.33-4.98-4.68-5.49-6.64-7.45-7.81-7.63-6.89-3.92-5.49-5.16-5.92-6.57-12.03-8.54-9.33-6.77-7.10-6.05-8.48-7.98-4.59-3.32-3.77-2.24-1.53-2.00-1.70-3.04-3.62-3.14-3.18-1.61-2.41-1.69-2.85-2.54-5.44-4.25-3.93-3.10-2.81-2.60-2.12-3.91

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Change From Baseline in Mean Sitting Pulse Pressure

Pulse rate was with automated BP device after the 4th blood pressure measurement at each visit. (NCT01615198)
Timeframe: Baseline, 4 weeks, 10 weeks, 14 weeks

,
InterventionmmHg (Least Squares Mean)
week 4week 10week 14
LCZ696-11.57-14.21-14.65
Olmesartan-10.38-9.76-10.90

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Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)

Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicated improvement. (NCT01615198)
Timeframe: Baseline, 4 weeks, 14 weeks

,
InterventionmmHg (Least Squares Mean)
msSBP, week 4msDBP, week 4msSBP, week 14msDBP, week 14
LCZ696-17.64-6.08-22.53-7.92
Olmesartan-15.81-5.58-16.75-5.97

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Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)

A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg. (NCT01615198)
Timeframe: 4 weeks, 10 weeks, 14 weeks

,
InterventionParticipants (Number)
4 weeks10 weeks14 weeks
LCZ696140175173
Olmesartan120130126

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Number of Participants Achieving Successful Response in msSBP and msDBP

Blood pressure response in msSBP was defined as a mean sitting BP < 140 mmHg or a >=20 mmHg reduction from baseline. Blood pressure response in msDBP was defined as a mean sitting diastolic blood pressure, 90 mmHg or >=10 mmHg reduction from baseline. (NCT01615198)
Timeframe: 4 weeks,10 weeks, 14 weeks

,
InterventionParticipants (Number)
msSBP, week 4msSBP, week 10msSBP, week 14msDBP, week 4msDBP, week 10msDBP, week 14
LCZ696162208205264275268
Olmesartan146142144245254246

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Number of Participants With Adverse Events, Serious Adverse Events and Death

Adverse event monitoring was conducted throughout the study. (NCT01615198)
Timeframe: 14 weeks

,
InterventionParticipants (Number)
Adverse events (non-serious and serious)Serious adverse eventsDeaths
LCZ69614170
Olmesartan11320

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Change From Baseline in Daytime and Nighttime maSBP/maDBP

ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement. (NCT01615198)
Timeframe: Baseline, 10 weeks

,
InterventionmmHg (Least Squares Mean)
maSBP, daytimemaSBP, nighttimemaDBP, daytimemaDBP, nighttime
LCZ696-14.32-13.97-7.04-6.70
Olmesartan-10.02-7.68-4.88-3.61

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Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)

ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement. (NCT01615198)
Timeframe: Baseline, 10 weeks

InterventionmmHg (Least Squares Mean)
LCZ696-14.23
Olmesartan-9.14

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

Sitting BP measurements was performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement. (NCT01615198)
Timeframe: Baseline, 10 weeks

InterventionmmHg (Least Squares Mean)
LCZ696-8.58
Olmesartan-6.49

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

Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement. (NCT01615198)
Timeframe: Baseline, 10 weeks

InterventionmmHg (Least Squares Mean)
LCZ696-22.71
Olmesartan-16.11

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Collagen Gene Expression in Skeletal Muscle (Change Over Time)

RNA extraction and quantification were determined using an RNeasy Mini Fibrous Kit and DNase I treatment (Qiagen, Valencia, CA, USA) in accordance to the manufacturer's directions for mRNA extraction. Quantitative real-time polymerase chain reaction (qRT-PCR) measured the expression of collagen III using an ABI PRISM 7900 Sequence Detection System instrument and TaqMan Universal PCR Master Mix according to the manufacturer's instructions (Applied Biosystems, Foster City, CA, USA). Relative gene expression levels were determined using the number of cycles necessary to reach threshold and results were normalized to cyclophilin B RNA levels. (NCT01684748)
Timeframe: Baseline testing to post-testing after 8-week intervention

InterventionArbitrary unit (AU) (Mean)
Pre-Olmesartan medoxomilPost-Olmesartan medoxomil
Olmesartan Medoxomil1491774

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Insulin Sensitivity by Intravenous Glucose Tolerance Testing (Change Over Time)

Data collected from the intravenous glucose tolerance tests included blood concentrations of glucose and insulin. Glucose was measured immediately on a YSI glucose analyzer and insulin was measured via ELISA colormetric kits once all study samples were collected. To analyze changes in insulin sensitivity, the MINMOD software was used. The MINMOD software uses Bergman's minimal model to determine insulin sensitivity during an intravenous glucose tolerance test. Both glucose and insulin values were inserted at each timepoint collected (33 in total over the 3-hour protocol) and the software was run to generate the insulin sensitivity value at baseline and post-test. This information was then used to calculate the change of insulin sensitivity from baseline to post-testing after each 8-week intervention. (NCT01684748)
Timeframe: Baseline testing to post-testing after 8-week intervention

Interventionmu/L/min (Mean)
Olmesartan Medoxomil0.253
No Drug Intervention-0.804

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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 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 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 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 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 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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Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.

Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement (NCT01785472)
Timeframe: baseline, 8 weeks

,,
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
LCZ696 200 mg-7.93-8.47-9.24-6.86-5.27-7.83-7.15-8.00-8.88-6.89-5.22-402-6.84-4.34-4.53-3.91-6.68-5.87-5.32-5.17-6.97-7.57-6.12-5.23
LCZ696 400 mg-7.38-10.19-9.90-8.65-10.79-11.47-9.13-8.90-9.56-8.14-8.69-7.39-6.33-6.73-5.51-7.20-7.21-6.94-7.61-10.45-9.44-11.37-9.95-8.62
Olmesartan 20 mg-5.99-10.49-9.28-9.80-8.54-5.55-6.23-7.44-6.83-7.07-5.41-5.64-6.69-3.97-3.85-2.60-4.43-6.36-3.94-3.06-6.33-6.61-9.89-7.19

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Number of Patients Achieving Successful Blood Pressure Control

Successful blood pressure control is defined as msSBP <140 mmHg and msDBP <90 mmHg. (NCT01785472)
Timeframe: 8 weeks

InterventionNumber of participants (Number)
LCZ696 200 mg256
LCZ696 400 mg270
Olmesartan 20 mg235

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Change From Baseline in Office Pulse Pressure (msPP)

Four separate sitting BP measurements should be obtained with a full two minute interval between measurements. (NCT01785472)
Timeframe: baseline, 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 200 mg-12.35
LCZ696 400 mg-12.93
Olmesartan 20 mg-11.25

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Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg

Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements (NCT01785472)
Timeframe: baseline, 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 400 mg-21.67
Olmesartan 20 mg-18.15

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Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg

Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements. (NCT01785472)
Timeframe: baseline, 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 200 mg-20.48
Olmesartan 20 mg-18.15

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Change From Baseline in Ambulatory Pulse Pressure

Ambulatory pulse pressure (PP) is calculated by hourly ambulatory SBP and hourly ambulatory DBP over a 24-hour period. (NCT01785472)
Timeframe: baseline, 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 200 mg-5.78
LCZ696 400 mg-5.98
Olmesartan 20 mg-4.58

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Number of Patients With Adverse Events, Serious Adverse Events, and Death as Assessment of Safety and Tolerability

Participants were monitored for adverse events, serious adverse events and deaths throughout the study. (NCT01785472)
Timeframe: baseline, 8 weeks

,,
InterventionParticipants (Number)
Adverse events (non-serious and seriousSerious adverse eventsDeaths
LCZ696 200 mg14350
LCZ696 400 mg13230
Olmesartan 20 mg13460

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Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.

Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement (NCT01785472)
Timeframe: baseline, 8 weeks

,,
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
LCZ696 200 mg-5.93-5.41-3.95-3.68-3.53-4.10-4.85-6.07-4.34-5.53-4.53-5.43-5.57-6.18-7.29-7.68-7.28-8.38-9.02-8.92-8.05-7.16-6.34-5.86
LCZ696 400 mg-6.57-551-4.20-3.53-3.14-3.55-3.31-2.22-4.78-4.48-4.10-4.42-5.01-5.91-5.95-7.26-7.84-8.81-8.77-7.12-7.24-6.55-5.19-6.05
Olmesartan 20 mg-4.57-5.49-4.44-4.70-3.81-2.94-2.71-3.44-4.54-3.57-5.51-4.50-6.04-5.26-7.52-6.96-6.14-5.28-5.20-5.80-6.49-5.65-6.26-4.96

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Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.

Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement (NCT01785472)
Timeframe: baseline, 8 weeks

,,
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
LCZ696 200 mg-13.22-17.24-14.99-13.09-11.19-13.66-11.74-13.84-16.33-13.81-12.98-8.99-12.46-9.64-7.73-4.92-10.20-9.84-8.94-8.03-9.47-12.62-9.23-8.43
LCZ696 400 mg-15.02-18.11-16.83-16.37-18.88-19.19-18.07-16.12-15.6415.13-15.93-15.54-13.28-12.33-10.12-12.82-12.43-11.70-12.20-15.04-14.33-17.20-16.63-15.76
Olmesartan 20 mg-9.07-13.95-14.51-14.63-14.64-11.54-11.74-12.99-13.33-10.89-7.66-10.51-11.49-6.66-7.81-4.40-7.19-8.90-5.76-4.83-9.97-9.95-14.09-12.71

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Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.

Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement (NCT01785472)
Timeframe: baseline, 8 weeks

,,
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
LCZ696 200 mg-11.29-10.51-10.03-8.79-7.84-8.71-9.07-11.07-10.31-11.48-10.01-12.37-13.49-13.20-14.01-15.15-14.00-15.93-16.45-15.29-14.10-13.97-11.91-13.07
LCZ696 400 mg-10.38-11.07-9.82-5.77-8.15-7.77-8.27-8.30-10.65-10.68-8.96-11.5510.64-13.34-11.95-14.04-14.71-15.37-16.04-14.20-15.26-12.79-9.55-11.81
Olmesartan 20 mg-9.37-10.26-9.10-7.55-6.40-6.51-6.93-6.36-8.70-7.55-9.49-8.25-9.82-10.24-12.62-12.52-11.71-9.97-10.37-10.90-10.52-10.67-10.77-7.57

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Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg

Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement (NCT01785472)
Timeframe: baseline, 8 weeks

InterventionmmHg (Mean)
LCZ696 200 mg-8.10
LCZ696 400 mg-8.80
Olmesartan 20 mg-6.86

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Change From Baseline in Mean 24-hour Ambulatory Blood Pressure

In this analysis, mean 24 hour ambulatory systolic blood pressure maSBP, mean 24 hour ambulatory diastolic blood pressure maDBP, daytime and nightime maSBP and maDBP will be reported. Ambulatory blood pressure monitoring over a 24 hour period will be conducted at two time points during the study. (NCT01785472)
Timeframe: baseline, 8 weeks

,,
InterventionmmHg (Least Squares Mean)
maSBPmaDBP
LCZ696 200 mg-12.07-6.36
LCZ696 400 mg-12.76-6.82
Olmesartan 20 mg-10.26-5.61

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Number of Responders

Responders are patients with msSBP response (<140 mmHg or ≥20 mmHg reduction from baseline) and msDBP response (<90 mmHg or ≥10 mmHg reduction from baseline) (NCT01785472)
Timeframe: baseline, 8 weeks

InterventionParticipants (Number)
LCZ696 200 mg312
LCZ696 400 mg314
Olmesartan 20 mg290

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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 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 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 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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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 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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Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response

Successful mean sitting diastolic blood pressure response is defined as msDBP <90 mmHg or a reduction ≥10 mmHg from baseline. (NCT01876368)
Timeframe: baseline, 8 weeks

InterventionParticipants (Number)
LCZ696 200 mg137
Olmesartan 20 mg115

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Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control

Successful mean sitting systolic blood pressure control is defined as msSBP <140 mmHg (NCT01876368)
Timeframe: 8 weeks

InterventionParticipants (Number)
LCZ696 200 mg84
Olmesartan 20 mg58

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Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response

Successful mean sitting systolic blood pressure response is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline. (NCT01876368)
Timeframe: baseline, 8 weeks

InterventionParticipants (Number)
LCZ696 200 mg90
Olmesartan 20 mg65

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Number of Patients Achieving Successful Overall Blood Pressure Control

Successful overall blood pressure control is defined as both msSBP/msDBP <140/90 mmHg (NCT01876368)
Timeframe: 8 weeks

InterventionParticipants (Number)
LCZ696 200 mg76
Olmesartan 20 mg52

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Number of Patients With Total Adverse Events, Serious Adverse Events and Death

Number of patients with total adverse events, serious adverse events and death were reported. (NCT01876368)
Timeframe: 8 weeks

,
InterventionNumber of participants (Number)
Adverse events (serious and non-serious)Serious Adverse EventsDeaths
LCZ696 200 mg4400
Olmesartan 20 mg4120

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Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)

Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The 24-hour ABPM measurements are performed beginning 24 hours prior to baseline and week 8 visits. (NCT01876368)
Timeframe: baseline, 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 200 mg-2.27
Olmesartan 20 mg-0.35

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

Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean (NCT01876368)
Timeframe: baseline, 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 200 mg-14.21
Olmesartan 20 mg-10.03

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Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)

Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit. (NCT01876368)
Timeframe: baseline, 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 200 mg-4.26
Olmesartan 20 mg-1.04

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Change From Baseline in Office Pulse Pressure

Mean sitting pulse pressure (msPP) will be calculated at screening through end of study at every visit. Mean sitting pulse pressure is calculated as msSBP-msDBP. (NCT01876368)
Timeframe: baseline, 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 200 mg-6.67
Olmesartan 20 mg-5.54

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Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control

Successful mean sitting diastolic blood pressure control is defined as msDBP <90 mmHg (NCT01876368)
Timeframe: 8 weeks

InterventionParticipants (Number)
LCZ696 200 mg133
Olmesartan 20 mg112

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

Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean (NCT01876368)
Timeframe: baseline, 8 weeks

InterventionmmHg (Least Squares Mean)
LCZ696 200 mg-7.52
Olmesartan 20 mg-4.47

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