Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis
Treatments:
Amlodipine
Amlodipine, Valsartan Drug Combination
Angiotensin Receptor Antagonists
Hydrochlorothiazide
Valsartan
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)