8-week Study to Evaluate Safety and Efficacy of Various Combinations of Valsartan, HCTZ, and Amlodipine in Patients With Moderate to Severe Hypertension

Novartis

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Drug: Valsartan + HCTZ

Drug: Valsartan + amlodipine

Drug: Valsartan + amlodipine + HCTZ

Drug: Amlodipine + HCTZ

Study type

Interventional

Funder types

Industry

Identifiers

NCT00327587

CVEA489A2302

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficacy of the various combinations of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.

Enrollment

2,279 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Diagnosis of moderate to severe hypertension (MSDBP ≥ 100 mmHg and < 120 mmHg, MSSBP ≥ 145 mmHg and < 200 mmHg).

Exclusion criteria

Patients on two or more antihypertensive drugs with MSSBP ≥ 180 mmHg and/or MSDBP ≥ 110 mmHg at Visit 1.
Patients on three or more antihypertensive drugs with MSDBP ≥ 90 mmHg and < 110 mmHg, and/or MSSBP ≥ 140 mmHg and < 180 mmHg at Visit 1.
Patients on four or more antihypertensive drugs at Visit 1.
Arm circumference > 42 cm for patients participating in ABPM.

Other protocol-defined exclusion criteria may apply.