Compounds > amlodipine, valsartan drug combination
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amlodipine, valsartan drug combination

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Description

Amlodipine, Valsartan Drug Combination: A pharmaceutical preparation of amlodipine and valsartan that is used for the treatment of HYPERTENSION. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID11354874
SCHEMBL ID3688911
MeSH IDM0522574

Synonyms (11)

Synonym
amlodipine, valsartan drug combination
amlodipine / valsartan
dafiro
copalia
amlodipine valsartan
imprida
254972-16-2
SCHEMBL3688911
DTXSID10180185
amlodipine/valsartan
3-o-ethyl 5-o-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate;(2s)-3-methyl-2-[pentanoyl-[[4-[2-(2h-tetrazol-5-yl)phenyl]phenyl]methyl]amino]butanoic acid

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" All adverse events (AEs) were resolved without sequelae; no serious AEs were reported."( Pharmacokinetics, tolerability, and safety of the single oral administration of AGSAV301 vs Exforge: a randomized crossover study of healthy male volunteers.
Bae, KS; Choi, HY; Kim, MJ; Kim, YH; Lee, SH; Lim, HS; Noh, YH, 2014)		0.4
" Incidence of adverse events (AEs) and serious AEs (SAEs) was recorded as safety variables."( Real-life effectiveness, safety, and tolerability of amlodipine/valsartan or amlodipine/valsartan/hydrochlorothiazide single-pill combination in patients with hypertension from Pakistan.
Abid, R; Afzal, J; Iktidar, S; Khan, W; Kumar, K; Maheshwary, N; Moin, N; Qadir, M; Sakrani, J; Siddiqi, A, 2014)		0.4
" Safety assessments included recording and measurement of all adverse events (AEs) and vital signs in the safety population."( Efficacy and safety of valsartan/amlodipine single-pill combination in 11,422 Chinese patients with hypertension: an observational study.
Hu, D; Li, W; Liu, L, 2014)		0.4
" Adverse events (AEs) and serious AEs were reported in 5 patients (1%) and 1 patient (0."( Effectiveness and safety of valsartan/amlodipine in hypertensive patients with stroke: China Status II subanalysis.
Song, Y; Xu, J; Zhang, W, 2017)		0.46

Pharmacokinetics

ExcerptReferenceRelevance
"The steady-state pharmacokinetic (PK) interaction potential between amlodipine (10 mg), valsartan (320 mg), and hydrochlorothiazide (HCTZ; 25 mg) was evaluated in patients with hypertension in a multicenter, multiple-dose, open-label, 4-cohort, parallel-group study."( Evaluation of pharmacokinetic interactions between amlodipine, valsartan, and hydrochlorothiazide in patients with hypertension.
Ayalasomayajula, S; Bhad, P; Jarugula, V; Karan, R; Leon, S; Riviere, GJ; Sunkara, G, 2011)		0.37
" In China, where the prevalence of hypertension is increasing the pharmacokinetic study of valsartan, amlodipine assumes significance."( Pharmacokinetics of single and multiple oral doses of valsartan/amlodipine (80/5 mg) in healthy Chinese subjects.
Chen, J; Duan, J; Karan, R; Meiser, K; Smith, HT; Sunkara, G; Yin, Q, 2012)		0.38
"Following the single-dose oral administration of valsartan/amlodipine 80/5 mg, valsartan and amlodipine plasma concentrations reached peak levels at median tmax of 3 and 6 h, respectively."( Pharmacokinetics of single and multiple oral doses of valsartan/amlodipine (80/5 mg) in healthy Chinese subjects.
Chen, J; Duan, J; Karan, R; Meiser, K; Smith, HT; Sunkara, G; Yin, Q, 2012)		0.38
" The objective of this study was to compare the pharmacokinetic (PK) characteristics of S-amlodipine and valsartan when administered as one tablet each of Exforge and AGSAV301 to healthy male subjects."( Pharmacokinetics, tolerability, and safety of the single oral administration of AGSAV301 vs Exforge: a randomized crossover study of healthy male volunteers.
Bae, KS; Choi, HY; Kim, MJ; Kim, YH; Lee, SH; Lim, HS; Noh, YH, 2014)		0.4
"The aim of this study was to compare pharmacokinetic characteristics of fixed-dose combination (FDC) of two different salt form of amlodipine, amlodipine adipate/valsartan and amlodipine besylate/ valsartan, in healthy Korean volunteers under fasting conditions."( Pharmacokinetic comparison of amlodipine adipate/valsartan fixed-dose combination with amlodipine besylate/valsartan fixed-dose combination in healthy volunteers.
Ghim, JL; Han, SK; Kim, EJ; Kim, EY; Kim, HJ; Kim, HS; Nam, JH; Oh, M; Shin, JG; Song, GS, 2015)		0.42

Bioavailability

ExcerptReferenceRelevance
" Here, we present the effect of food on the oral bioavailability of these two fixed dose combination tablets from two separate clinical studies in healthy subjects."( Effect of food on the oral bioavailability of amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide fixed dose combination tablets in healthy subjects.
Ayalasomayajula, S; Jarugula, V; Jiang, X; Ligueros-Saylan, M; Reynolds, C; Serra, D; Sunkara, G; Winter, S; Zhang, Y, 2014)		0.4

Dosage Studied

ExcerptRelevanceReference
" Amlodipine/valsartan, at approved dosage regimens, achieved significantly greater reductions in mean sitting diastolic and systolic blood pressure (BP) than amlodipine or valsartan monotherapy, or placebo in two randomized, double-blind, factorial trials in patients with mild to moderate hypertension."( Amlodipine/Valsartan: fixed-dose combination in hypertension.
Plosker, GL; Robinson, DM, 2008)		0.35
"This study compared the effects of morning and evening dosing of amlodipine/valsartan combination on 24-h blood pressure (BP) in patients uncontrolled by amlodipine (5 mg)."( Efficacy of morning and evening dosing of amlodipine/valsartan combination in hypertensive patients uncontrolled by 5 mg of amlodipine.
Achouba, A; Asmar, R; Gosse, P; Queré, S, 2011)		0.37
"Morning and evening dosing with amlodipine/valsartan had equivalent effects on systolic BP (mean 24 h, daytime, night-time, and 24-30 h) and diastolic BP (mean 24 h, daytime, night-time, and 24-30 h)."( Efficacy of morning and evening dosing of amlodipine/valsartan combination in hypertensive patients uncontrolled by 5 mg of amlodipine.
Achouba, A; Asmar, R; Gosse, P; Queré, S, 2011)		0.37
"In this first randomized trial evaluating the effects of intensive versus moderate dosing of the combination of amlodipine/valsartan, our data suggest that ABPM was a better method for assessing between-treatment differences than clinic or home BP recordings, although measurement of home BP as a single recording was a limitation of our trial."( The role of ambulatory blood pressure monitoring compared with clinic and home blood pressure measures in evaluating moderate versus intensive treatment of hypertension with amlodipine/valsartan for patients uncontrolled on angiotensin receptor blocker mo
Giles, TD; Hilkert, R; Ofili, EO; Oparil, S; Pitt, B; Purkayastha, D; Samuel, R; Sowers, JR, 2011)		0.37
"In the observation program AESCULAP using the fixed-dose combination of amlodipine/valsartan as different dosage regimens (5/160 and 10/160 mg) and/or a diuretic, there was a marked antihypertensive effect in different subgroups of patients with previously uncontrolled hypertension and the BP goals being achieved in 79."( [On the way to achieve hypertension treatment goals: results of the open observational program AESCULAP (exforge--clinical safety and efficiency of using a double combination of antihypertensive drugs in patients with uncontrolled blood pressure)].
Chazova, IE; Martynyuk, TV, 2013)		0.39
" Cox proportional hazards regression analysis was used to analyze the likelihood of HAMA/HAMD scales, SPCs, control group, and daily dosage number."( Chart review of patients receiving valsartan-amlodipine single-pill combination versus valsartan and amlodipine combination for blood pressure goal achievement and effects on the Hamilton anxiety rating/Hamilton depression rating scales.
Han, N; Li, Y; Xu, W; Yin, G, 2019)		0.51
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (55)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's5 (9.09)29.6817
2010's49 (89.09)24.3611
2020's1 (1.82)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 44.76

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 strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index44.76 (24.57)
Research Supply Index4.41 (2.92)
Research Growth Index5.42 (4.65)
Search Engine Demand Index65.04 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (44.76)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials26 (47.27%)5.53%
Reviews7 (12.73%)6.00%
Case Studies1 (1.82%)4.05%
Observational5 (9.09%)0.25%
Other16 (29.09%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (20)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
An Open-label, Randomized, Single-dose, 3-period Replicated Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of CJ-30061 Alone and Co-administration of Amlodipine/Valsartan and Atorvastatin in Healthy Adult Volunteers [NCT03657472]Phase 142 participants (Actual)Interventional2016-09-19Completed
An Open-label, Postmarketing Study of Amlodipine/Valsartan Single-Pill Combination for the Treatment of Hypertension [NCT02058446]Phase 436 participants (Actual)Interventional2013-10-31Completed
An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CJ-30060 in Healthy Subjects [NCT03757390]Phase 152 participants (Anticipated)Interventional2018-11-09Recruiting
Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects [NCT03648333]Phase 127 participants (Actual)Interventional2013-12-31Completed
A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects [NCT02060019]Phase 157 participants (Actual)Interventional2014-03-31Completed
An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerabillity of CJ-30060 in Healthy Male Subjects [NCT03639493]Phase 152 participants (Actual)Interventional2018-04-06Completed
A Multicenter, Double-blind, Controlled, Randomized Trial to Evaluate the Association Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension [NCT05920005]Phase 3698 participants (Anticipated)Interventional2023-08-22Recruiting
A Multicenter, Randomized, Double Blind, Parallel Design Trial to Evaluate the Blood Pressure Lowering Efficacy Comparing Moderate Versus Aggressive Treatment Regimen of Valsartan + Amlodipine in Patients Uncontrolled on ARB Monotherapy [NCT00666536]Phase 4728 participants (Actual)Interventional2008-03-31Completed
Comparative Open-label,Randomized, Fasting/Fed, Single Dose, Three-way Crossover Bioequivalence Study of Valsartan and Amlodipine Tablets (Hua Yuan Pharmaceutical LLC, China) and Valsartan and Amlodipine Tablets (Ⅰ) (Novartis Pharma Schweiz AG, Switzerlan [NCT04085627]Phase 184 participants (Actual)Interventional2018-10-08Active, not recruiting
A Phase IV Clinical Trial of Intensified Blood Pressure Management in Primary Care Using Valsartan Alone and as Combination Anti-Hypertensive Therapy [NCT00902304]Phase 42,337 participants (Actual)Interventional2009-07-31Completed
A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet After a Single Oral Administration in Healthy Male Volu [NCT01494727]Phase 148 participants (Anticipated)Interventional2012-02-29Completed
Clinical Trial to Assess the Pharmacokinetic Characteristics of CJ-30060 in Healthy Male Subjects [NCT03009474]Phase 152 participants (Actual)Interventional2015-02-28Completed
A Single Dose, Randomized, Open-label, 2x2 Crossover Study to Evaluate the Bioavailability and Safety of AGSAV301 Tablet in Healthy Male Volunteers [NCT01536353]Phase 130 participants (Actual)Interventional2012-01-31Completed
[NCT01652339]Phase 140 participants (Actual)Interventional2012-07-31Completed
A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet After a Single Oral Administration in Healthy Male Volu [NCT01735890]Phase 148 participants (Actual)Interventional2012-09-30Completed
A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers [NCT01776047]Phase 151 participants (Actual)Interventional2012-07-31Completed
[NCT01819220]Phase 416 participants (Actual)Interventional2009-04-30Completed
Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects [NCT01819779]Phase 153 participants (Actual)Interventional2013-03-31Completed
Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Amlodipine / Valsartan From Amlodipine/Valsartan 10/160 Tablets (Pharmacare, Palestine) and Exforge Tablets (Novartis Pharma, USA) [NCT02519010]Phase 136 participants (Actual)Interventional2011-03-31Completed
A Single-Arm Open-Label Multicenter Phase IV Clinical Trial to Explore the Blood Pressure Lowering Effect of Exforge® (Amlodipine/Valsartan: AMLO/VAL) in Hypertensive Patients [NCT02062645]Phase 4115 participants (Actual)Interventional2014-02-28Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00666536 (6) [back to overview]Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)
NCT00666536 (6) [back to overview]Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)
NCT00666536 (6) [back to overview]Change From Baseline to Weeks 2, 8 and 12 in MSDBP
NCT00666536 (6) [back to overview]Change From Baseline to Weeks 2, 8 and 12 in MSSBP
NCT00666536 (6) [back to overview]Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12
NCT00666536 (6) [back to overview]Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12
NCT00902304 (12) [back to overview]Change in Absolute Cardiovascular Risk Score
NCT00902304 (12) [back to overview]Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26
NCT00902304 (12) [back to overview]Change in Mean Sitting Diastolic Blood Pressure
NCT00902304 (12) [back to overview]Change in Mean Sitting Systolic Blood Pressure
NCT00902304 (12) [back to overview]Change in the EQ-5D Score
NCT00902304 (12) [back to overview]Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy
NCT00902304 (12) [back to overview]Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target
NCT00902304 (12) [back to overview]Change in Self-care Behavior Score From Baseline to Week 26
NCT00902304 (12) [back to overview]Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments
NCT00902304 (12) [back to overview]Number of Patients With Depression
NCT00902304 (12) [back to overview]Number of Patients With Major Clinical Endpoints
NCT00902304 (12) [back to overview]Participants With End Organ Disease at Baseline and Week 26
NCT02062645 (5) [back to overview]Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8
NCT02062645 (5) [back to overview]Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
NCT02062645 (5) [back to overview]Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
NCT02062645 (5) [back to overview]SBP and DBP in Patients With High Sodium Intake at Week 4 and 8
NCT02062645 (5) [back to overview]Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8

Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)

(NCT00666536)
Timeframe: Baseline and Week 4

,
InterventionmmHg (Mean)
Baseline MSDBPWeek 4 MSDBPChange From Baseline to Week 4 in MSDBP
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)95.584.8-10.7
Moderate Treatment Regimen (5/160 mg)95.086.2-8.8

[back to top]

Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)

(NCT00666536)
Timeframe: Baseline and Week 4

,
InterventionmmHg (Mean)
Baseline MSSBPWeek 4 MSSBPChange From Baseline to Week 4 in MSSBP
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)163.9140.9-23.0
Moderate Treatment Regimen (5/160 mg)163.3144.4-18.9

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Change From Baseline to Weeks 2, 8 and 12 in MSDBP

(NCT00666536)
Timeframe: Baseline and Weeks 2, 8 and 12

,
InterventionmmHg (Mean)
Baseline MSDBPWeek 2 MSDBPChange From Baseline to Week 2 in MSDBPWeek 8 MSDBPChange From Baseline to Week 8 in MSDBPWeek 12 MSDBPChange From Baseline to Week 12 in MSDBP
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)95.588.2-7.381.6-13.981.5-14.0
Moderate Treatment Regimen (5/160 mg)95.087.1-7.984.0-11.083.8-11.2

[back to top]

Change From Baseline to Weeks 2, 8 and 12 in MSSBP

(NCT00666536)
Timeframe: Baseline and Weeks 2, 8 and 12

,
InterventionmmHg (Mean)
Baseline MSSBPWeek 2 MSSBPChange From Baseline to Week 2 in MSSBPWeek 8 MSSBPChange From Baseline to Week 8 in MSSBPWeek 12 MSSBPChange From Baseline to Week 12 in MSSBP
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)163.9147.0-16.9136.0-27.9135.7-28.1
Moderate Treatment Regimen (5/160 mg)163.3146.0-17.3140.5-22.8139.2-24.1

[back to top]

Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12

(NCT00666536)
Timeframe: Weeks 2, 4, 8 and 12

,
InterventionPercentage of Patients (Number)
Week 2Week 4Week 8Week 12
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)31.149.266.162.8
Moderate Treatment Regimen (5/160 mg)32.537.549.655.7

[back to top]

Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12

(NCT00666536)
Timeframe: Weeks 2, 4, 8 and 12

,
InterventionPercentage of Patients (Number)
Week 2Week 4Week 8Week 12
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)25.143.761.759.8
Moderate Treatment Regimen (5/160 mg)25.831.146.250.7

[back to top]

Change in Absolute Cardiovascular Risk Score

"The absolute cardiovascular risk assessment uses the Framingham Risk Equation to predict risk of a cardiovascular event over the next 5 years. A score of <10% is a low risk, 10 to 15% is a moderate risk, and >15% is a high risk.~A decrease indicates improvement." (NCT00902304)
Timeframe: Baseline and 26 weeks

Interventionpercentage risk score change (Mean)
Usual Care-2.6
Monotherapy (Initial Monotherapy Arm)-3.3
Combination (Initial Combination Therapy Arm)-3.9

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Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26

"The CES-D score was from 0 to 30, with a higher score indicating a higher level of depression.~The categories for the score are: 0 to 9 suggests no depression; 10 to 15 suggests mild depression; 16 to 24 suggests moderate depression; 24 or above suggests severe depression." (NCT00902304)
Timeframe: Baseline and week 26

Interventionchange in CES-D score (Mean)
Usual Care1.03
Monotherapy (Initial Monotherapy Arm)-1.12
Combination (Initial Combination Therapy Arm)1.19

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Change in Mean Sitting Diastolic Blood Pressure

The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization. (NCT00902304)
Timeframe: Baseline and 26 weeks

InterventionmmHg (Least Squares Mean)
Usual Care-5.45
Monotherapy (Initial Monotherapy Arm)-6.9
Combination (Initial Combination Therapy Arm)-8.29

[back to top]

Change in Mean Sitting Systolic Blood Pressure

The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization. (NCT00902304)
Timeframe: Baseline and 26 weeks

InterventionmmHg (Least Squares Mean)
Usual Care-10
Monotherapy (Initial Monotherapy Arm)-11.6
Combination (Initial Combination Therapy Arm)-14.4

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Change in the EQ-5D Score

The EQ-5D total indexed score (AUS) measures self-reported quality of life with the following 5 dimensions: mobility (range 1,2,3), self-care (range 1,2,3), usual activity (range 1,2,3), pain/discomfort (range 1,2,3) and anxiety/depression (range 1,2,3), where a 1 indicates no problems, a 2 indicates moderate problems, and a 3 indicates severe problems. The range of possible utility scores are between -0.217 (derived from worse responses from all 5 dimensions with severe problems ie 3,3,3,3,3) and 1.000 (no problems for all 5 dimensions) for each dimension. An increase in EQ-5D indexed score (AUS) indicates improvement. (NCT00902304)
Timeframe: Baseline and 26 weeks

Interventionchange in EQ-5D score (Mean)
Usual Care-0.007
Monotherapy (Initial Monotherapy Arm)0.017
Combination (Initial Combination Therapy Arm)0.011

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Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy

The rate of all adverse events by preferred terms as determined by the General Practice investigators to be related to study intervention therapy was reported. Percentage of adverse events was calculated based on the number of participants analyzed. 41 adverse events were not reported as inadequate information was supplied to allow determination of drug treatment at onset. (NCT00902304)
Timeframe: 26 weeks

Interventionparticipants (Number)
Usual Care70
Monotherapy (Initial Monotherapy Arm)70
Combination (Initial Combination Therapy Arm)169

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Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target

BP target groups were: <= 125/75mmHg, <= 130/80mmHg and <= 140/90mmHg. The BP target was based on the patient's clinical risk profile as specified by National Heart Foundation of Australia guidelines. (NCT00902304)
Timeframe: 26 weeks

Interventionpercentage of participants (Number)
Usual Care27.4
Monotherapy (Initial Monotherapy Arm)33.0
Combination (Initial Combination Therapy Arm)37.9

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Change in Self-care Behavior Score From Baseline to Week 26

A modified self-care behavior tool (questionnaire) was used to calculate 2 domain scales: maintenance and confidence. Each domain has a standardized score between 0 and 100. Self-care is best represented by maintenance. Confidence is an important process that moderates the relationship between self-care and outcomes. Higher index score suggests better self-care. A score of 70 or greater can be used as the cut-point to judge self-care adequacy. (NCT00902304)
Timeframe: Baseline and week 26

,,
InterventionChange in score (Mean)
Maintenance scoreConfidence score (N = 422, 269, 520)
Combination (Initial Combination Therapy Arm)3.17-0.71
Monotherapy (Initial Monotherapy Arm)2.27-0.72
Usual Care2.590.93

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Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments

A comparison of the early responders was made based on the blood pressure measurements taken at the week 6 visit window according to gender and guideline targets. The guideline targets were: patients with renal impairment: 125/75 mmHg; patients with end-organ damage/cardiovascular disease: 130/80 mmHg; others: 140/90 mmHg. (NCT00902304)
Timeframe: 26 weeks

,,
InterventionParticipants (Number)
Male patients with a target of <125/75 mmHgMale patients with a target of <130/80 mmHgMale patients with a target of <140/90 mmHgFemale patients with a target of <125/75 mmHgFemale patients with a target of <130/80 mmHgFemale patients with a target of <140/90 mmHg
Combination (Initial Combination Therapy Arm)6344823442
Monotherapy (Initial Monotherapy Arm)314222511
Usual Care3273121618

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Number of Patients With Depression

Patients with depression refers to potential depressive symptoms, not clinically diagnosed depression. The 2 question Arrol screening tool was used to determine if the patient had potential depressive symptoms. The 2 questions are: During the last month have you often been bothered by feeling down, depressed or hopeless? During the past month have you often been bothered by little interest or pleasure in doing things? The presence of potential depressive symptoms was determined by a 'yes' answer to either of these questions. (NCT00902304)
Timeframe: Baseline and week 26

,,
Interventionparticipants (Number)
BaselineWeek 26
Combination (Initial Combination Therapy Arm)185151
Monotherapy (Initial Monotherapy Arm)9678
Usual Care154129

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Number of Patients With Major Clinical Endpoints

Major clinical endpoints measured were all-cause mortality and fatal and non-fatal cardiovascular events (e.g. acute myocardial infarction, stroke and heart failure). (NCT00902304)
Timeframe: 26 weeks

,,
Interventionparticipants (Number)
All-cause mortalityNon-fatal cardiovascular events
Combination (Initial Combination Therapy Arm)013
Monotherapy (Initial Monotherapy Arm)16
Usual Care015

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Participants With End Organ Disease at Baseline and Week 26

"A patient was considered to have end organ damage with either of the following: 1) proteinuria (dipstick = 1+ or more or protein/creatinine ratio > 30mg/mol or 24h urine protein > 0.3g); 2) no proteinuria, but presence of microalbuminuria (urine albumin/creatinine ratio 3.6 to 25mg/mol(male) or 3.6 to 35mg/mol (female) detected; 3) no proteinuria or microalbuminuria, but presence of macroalbuminuria (urine albumin/creatinine ratio > 25mg/mol(male) or >35mg/mol (female) detected OR 4) ECG evidence of LVH (Sokolow-Lyon voltage criteria values >= 38mm).~Baseline potential for end organ damage was calculated in all 1562 randomised patients based on the criteria outlined above. If no investigation/data available, assumed no end-organ damage.~It is important to note that given the limited number of ECGs at 26 weeks, between group comparisons should be limited to the two time points (baseline and 26 weeks)." (NCT00902304)
Timeframe: Baseline and week 26

,,
Interventionparticipants (Number)
BaselineWeek 26 (N = 433, 277, 536)
Combination (Initial Combination Therapy Arm)315177
Monotherapy (Initial Monotherapy Arm)14688
Usual Care226157

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Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8

Change in diastolic blood pressure measured in office from baseline at week 4 and week 8. (NCT02062645)
Timeframe: baseline, week 4, week 8

InterventionmmHg (Mean)
Diastolic blood pressure (DBP) Day 0 (n=100)Diastolic blood pressure (DBP) Week 4 (n=100)Diastolic blood pressure (DBP) Week 8 (n=91)Diastolic blood pressure (DBP) Week 8 LOCF (n=100)Decrease in Diastolic BP Week 4 (n=100)Decrease in Diastolic BP Week 8 (n=91)Decrease in Diastolic BP Week 8 LOCF (n=100)
Amlodipine/Valsartan96.6682.081.0481.3714.6615.5415.29

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Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8

Control rate of BP defined as BP lower than 140/90 mmHg at office visits (NCT02062645)
Timeframe: At week 4 and 8

InterventionPercentage of Participants (Number)
Week 4 Systolic (n=100)Week 4 Diastolic (n=100)Week 4 Overall Blood Pressure(n=100)Week 8 Systolic(n=91)Week 8 Diastolic (n=91)Week 8 Overall Blood Pressure (n=91)Week 8 Systolic (LOCF) (n=100)Week 8 Diastolic (LOCF) (n=100)Week 8 Overall Blood Pressure (LOCF) (n=100)
Amlodipine/Valsartan47.078.045.070.382.467.068.081.065.0

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Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8

Control rate of BP is defined as blood pressure lower than 140/90 mmHg at office visits in patients with high sodium intake (>100 mEq/day) (NCT02062645)
Timeframe: At week 4 and 8

InterventionPercentage of participants (Number)
Week 4 (n=70)Week 8 (n=64)Week 8 LOCF (n=70)
Amlodipine/Valsartan68.664.162.9

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SBP and DBP in Patients With High Sodium Intake at Week 4 and 8

Change in systolic and diastolic blood pressure measured in office from baseline at week 4 and 8. (NCT02062645)
Timeframe: At week 4 and 8

InterventionmmHg (Mean)
SBP at Week 4 (n=70)SBP at Week 8 (n=64)SBP at Week 8 LOCF (n=70)DBP at Week 4 (n=70)DBP at Week 8 (n=64)DBP at Week 8 LOCF (n=70)
Amlodipine/Valsartan140.01134.20134.8481.7381.2381.47

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Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8

Change in systolic blood pressure measured in office from baseline at week 4 and 8. (NCT02062645)
Timeframe: baseline, week 4, week 8

InterventionmmHg (Mean)
Systolic blood pressure (SBP) Day 0 (n=100)Systolic blood pressure (SBP) Week 4 (n=100)Systolic blood pressure (SBP) Week 8 (n=91)Systolic blood pressure (SBP) Week 8 LOCF (n=100)Decrease in Systolic Week 4 (n=100)Decrease in Systolic Week 8 (n=91)Decrease in Systolic BP Week 8 LOCF (n=100)
Amlodipine/Valsartan164.3140.17134.04134.7124.1530.2229.61

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SubstanceRelationship StrengthStudiesTrialsClassesRoles
amlodipine
Amlodipine: A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.. amlodipine : A fully substituted dialkyl 1,4-dihydropyridine-3,5-dicarboxylate derivative, which is used for the treatment of hypertension, chronic stable angina and confirmed or suspected vasospastic angina.		14.14120dihydropyridine;
ethyl ester;
methyl ester;
monochlorobenzenes;
primary amino compound		antihypertensive agent;
calcium channel blocker;
vasodilator agent
bisoprolol
Bisoprolol: A cardioselective beta-1 adrenergic blocker. It is effective in the management of HYPERTENSION and ANGINA PECTORIS.		4.3711secondary alcohol;
secondary amine		anti-arrhythmia drug;
antihypertensive agent;
beta-adrenergic antagonist;
sympatholytic agent
hydrochlorothiazide
Hydrochlorothiazide: A thiazide diuretic often considered the prototypical member of this class. It reduces the reabsorption of electrolytes from the renal tubules. This results in increased excretion of water and electrolytes, including sodium, potassium, chloride, and magnesium. It is used in the treatment of several disorders including edema, hypertension, diabetes insipidus, and hypoparathyroidism.. hydrochlorothiazide : A benzothiadiazine that is 3,4-dihydro-2H-1,2,4-benzothiadiazine 1,1-dioxide substituted by a chloro group at position 6 and a sulfonamide at 7. It is diuretic used for the treatment of hypertension and congestive heart failure.		9.53146benzothiadiazine;
organochlorine compound;
sulfonamide		antihypertensive agent;
diuretic;
environmental contaminant;
xenobiotic
indapamide
Indapamide: A benzamide-sulfonamide-indole derived DIURETIC that functions by inhibiting SODIUM CHLORIDE SYMPORTERS.. indapamide : A sulfonamide formed by condensation of the carboxylic group of 4-chloro-3-sulfamoylbenzoic acid with the amino group of 2-methyl-2,3-dihydro-1H-indol-1-amine.		4.522indoles;
organochlorine compound;
sulfonamide		antihypertensive agent;
diuretic
losartan
Losartan: An antagonist of ANGIOTENSIN TYPE 1 RECEPTOR with antihypertensive activity due to the reduced pressor effect of ANGIOTENSIN II.. losartan : A biphenylyltetrazole where a 1,1'-biphenyl group is attached at the 5-position and has an additional trisubstituted imidazol-1-ylmethyl group at the 4'-position		3.1910biphenylyltetrazole;
imidazoles		angiotensin receptor antagonist;
anti-arrhythmia drug;
antihypertensive agent;
endothelin receptor antagonist
nifedipine
Nifedipine: A potent vasodilator agent with calcium antagonistic action. It is a useful anti-anginal agent that also lowers blood pressure.		5.422C-nitro compound;
dihydropyridine;
methyl ester		calcium channel blocker;
human metabolite;
tocolytic agent;
vasodilator agent
valine
Valine: A branched-chain essential amino acid that has stimulant activity. It promotes muscle growth and tissue repair. It is a precursor in the penicillin biosynthetic pathway.. valine : A branched-chain amino acid that consists of glycine in which one of the hydrogens attached to the alpha-carbon is substituted by an isopropyl group.. L-valine : The L-enantiomer of valine.		7.8983L-alpha-amino acid zwitterion;
L-alpha-amino acid;
proteinogenic amino acid;
pyruvate family amino acid;
valine		algal metabolite;
Escherichia coli metabolite;
human metabolite;
micronutrient;
mouse metabolite;
nutraceutical;
Saccharomyces cerevisiae metabolite
n-vinyl-2-pyrrolidinone
N-vinyl-2-pyrrolidinone: monomer of POVIDONE; structure given in first source		2.1710pyrrolidin-2-ones
sulfosalicylic acid
5-sulfosalicylic acid : An arenesulfonic acid that is benzoic acid substituted by a hydroxy at position C-2 and a sulfo group at C-5.		2.1510arenesulfonic acid;
benzoic acids;
phenols		metabolite
canrenone
Canrenone: A synthetic pregnadiene compound with anti-aldosterone activity.		3.4811steroid lactone
atorvastatin
[no description available]		3.6411aromatic amide;
dihydroxy monocarboxylic acid;
monofluorobenzenes;
pyrroles;
statin (synthetic)		environmental contaminant;
xenobiotic
valsartan
Valsartan: A tetrazole derivative and ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to treat HYPERTENSION.. valsartan : A monocarboxylic acid amide consisting of L-valine in which the amino hydrogens have been replaced by a pentanoyl and a [2'-(1H-tetrazol-5-yl)biphenyl]-4-yl]methyl group. It exhibits antihypertensive activity.		8.91107biphenylyltetrazole;
monocarboxylic acid amide;
monocarboxylic acid		angiotensin receptor antagonist;
antihypertensive agent;
environmental contaminant;
xenobiotic
perindopril
Perindopril: An angiotensin-converting enzyme inhibitor. It is used in patients with hypertension and heart failure.. perindopril : An alpha-amino acid ester that is the ethyl ester of N-{(2S)-1-[(2S,3aS,7aS)-2-carboxyoctahydro-1H-indol-1-yl]-1-oxopropan-2-yl}-L-norvaline		4.1931alpha-amino acid ester;
dicarboxylic acid monoester;
ethyl ester;
organic heterobicyclic compound		antihypertensive agent;
EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor
olmesartan medoxomil
Olmesartan Medoxomil: An ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to manage HYPERTENSION.		2.110biphenyls
exforge hct
Exforge HCT: Antihypertensive; a fixed dose combination of Amlodipine/valsartan/hydrochlorothiazide		2.4920
salicylates
Salicylates: The salts or esters of salicylic acids, or salicylate esters of an organic acid. Some of these have analgesic, antipyretic, and anti-inflammatory activities by inhibiting prostaglandin synthesis.. hydroxybenzoate : Any benzoate derivative carrying a single carboxylate group and at least one hydroxy substituent.. salicylates : Any salt or ester arising from reaction of the carboxy group of salicylic acid, or any ester resulting from the condensation of the phenolic hydroxy group of salicylic acid with an organic acid.. salicylate : A monohydroxybenzoate that is the conjugate base of salicylic acid.		2.1510monohydroxybenzoateplant metabolite
ConditionIndicatedRelationship StrengthStudiesTrials
Blood Pressure, High
[description not available]		013.934318
Anxiety
Feelings or emotions of dread, apprehension, and impending disaster but not disabling as with ANXIETY DISORDERS.		02.2110
Depression
Depressive states usually of moderate intensity in contrast with MAJOR DEPRESSIVE DISORDER present in neurotic and psychotic disorders.		02.2110
Hypertension
Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.		013.934318
Apoplexy
[description not available]		02.520
Stroke
A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810)		02.520
Albuminuria
The presence of albumin in the urine, an indicator of KIDNEY DISEASES.		04.4822
Kidney Diseases
Pathological processes of the KIDNEY or its component tissues.		04.4722
Hypertension, Essential
[description not available]		04.5422
Essential Hypertension
Hypertension that occurs without known cause, or preexisting renal disease. Associated polymorphisms for a number of genes have been identified, including AGT, GNB3, and ECE1. OMIM: 145500		04.5422
Chronic Kidney Diseases
[description not available]		03.4711
Renal Insufficiency, Chronic
Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)		03.4711
Diabetes Mellitus, Adult-Onset
[description not available]		03.4811
Diabetes Mellitus, Type 2
A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.		03.4811
Anasarca
[description not available]		02.4920
Bilateral Headache
[description not available]		02.110
Edema
Abnormal fluid accumulation in TISSUES or body cavities. Most cases of edema are present under the SKIN in SUBCUTANEOUS TISSUE.		02.4920
Headache
The symptom of PAIN in the cranial region. It may be an isolated benign occurrence or manifestation of a wide variety of HEADACHE DISORDERS.		02.110
Cardiac Failure
[description not available]		02.110
Heart Failure
A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.		02.110
Cardiovascular Diseases
Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.		02.4920
Circulatory Collapse
[description not available]		02.1110
Shock
A pathological condition manifested by failure to perfuse or oxygenate vital organs.		02.1110
Drug Overdose
Accidental or deliberate use of a medication or street drug in excess of normal dosage.		02.1110
Cardiometabolic Syndrome
A cluster of symptoms that are risk factors for CARDIOVASCULAR DISEASES and TYPE 2 DIABETES MELLITUS. The major components not only include metabolic dysfunctions of METABOLIC SYNDROME but also HYPERTENSION, and ABDOMINAL OBESITY.		03.511
Metabolic Syndrome
A cluster of symptoms that are risk factors for CARDIOVASCULAR DISEASES and TYPE 2 DIABETES MELLITUS. The major components of metabolic syndrome include ABDOMINAL OBESITY; atherogenic DYSLIPIDEMIA; HYPERTENSION; HYPERGLYCEMIA; INSULIN RESISTANCE; a proinflammatory state; and a prothrombotic (THROMBOSIS) state.		03.511
Overweight
A status with BODY WEIGHT that is above certain standards. In the scale of BODY MASS INDEX, overweight is defined as having a BMI of 25.0-29.9 kg/m2. Overweight may or may not be due to increases in body fat (ADIPOSE TISSUE), hence overweight does not equal over fat.		03.511
Left Ventricular Hypertrophy
[description not available]		03.4311
Hypertrophy, Left Ventricular
Enlargement of the LEFT VENTRICLE of the heart. This increase in ventricular mass is attributed to sustained abnormal pressure or volume loads and is a contributor to cardiovascular morbidity and mortality.		03.4311
Cardiovascular Stroke
[description not available]		02.0610
Myocardial Infarction
NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).		02.0610
Tachyarrhythmia
[description not available]		03.4611
Tachycardia
Abnormally rapid heartbeat, usually with a HEART RATE above 100 beats per minute for adults. Tachycardia accompanied by disturbance in the cardiac depolarization (cardiac arrhythmia) is called tachyarrhythmia.		03.4611