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

Condition(s) targeted: Hypertension

Intervention: valsartan and amlodipine (Drug); valsartan and amlodipine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Suzanne Oparil, MD et al, Principal Investigator, Affiliation: University of Alabama at Birmingham

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

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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

Secondary outcome:

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

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

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

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Egan Healthcare, Metairie, Louisiana 70002, United States

Starting date: March 2008
Last updated: April 19, 2011