The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: valsartan and amlodipine

• Registration Number: NCT00666536
• Lead Sponsor: Novartis

Brief Summary

The purpose of this trial is to compare blood pressure lowering efficacy of moderate Valsartan + Amlodipine treatment regimen (160 / 5 mg) with that of aggressive regimen (320 / 10 mg) in patients uncontrolled on ARB monotherapy, other than Valsartan

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-24
• Study First Posted: 2008-04-25
• Primary Completion: 2009-01
• Results First Submitted: 2010-11-16
• Results First Submitted QC: 2010-11-17
• Results First Posted: 2010-12-10
• Status Verified: 2011-04
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 728

Inclusion Criteria

• Male and female outpatients
• 18 Years of age or older
• Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 150 mmHg and lower than 200 mmHg while on Angiotensin-Receptor Blocker monotherapy for a minimum period of 28 days prior to randomization

Exclusion Criteria

• Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 200 mmHg and/or Mean Sitting Diastolic Blood Pressure greater than or equal to 120 mmHg
• Transient ischemic attack (mini-stroke), myocardial infarction (heart attack), all types of revascularization procedures in the last 6 months
• Treatment with valsartan or any combination antihypertensive treatment with 28 days prior to screening (Visit 1)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aggressive treatment regimen (5/320 mg to 10/320 mg)	valsartan and amlodipine	Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
Moderate treatment regimen (5/160 mg)	valsartan and amlodipine	Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)	Baseline and Week 4

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12	Weeks 2, 4, 8 and 12
Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12	Weeks 2, 4, 8 and 12
Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)	Baseline and Week 4
Change From Baseline to Weeks 2, 8 and 12 in MSDBP	Baseline and Weeks 2, 8 and 12
Change From Baseline to Weeks 2, 8 and 12 in MSSBP	Baseline and Weeks 2, 8 and 12

Trial Locations

Locations (1)

Egan Healthcare; 🇺🇸 Metairie, Louisiana, United States