A Study of VAH631 in Patients With Essential Hypertension (Factorial Study)

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Valsartan; Drug: Hydrochlorothiazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00311740

CVAH631B1303

Details and patient eligibility

About

The purpose of this study is to compare the effect of the fixed combination of valsartan+hydrochlorothiazide (HCTZ) on blood pressure reduction with valsartan and HCTZ alone and whether the combination treatments are safe and well tolerated. The study aims to establish a dose response relationship for both monotherapies and the combinations.

This study is being conducted in Japan.

Enrollment: 582 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Essential hypertension measured by mercury sphygmomanometer
• Outpatients

Exclusion criteria

• Secondary hypertension or suspected of having secondary hypertension.
• A history of malignant hypertension
• Severe hypertension
• Significant heart, renal, hepatic diseases or significant cerebrovascular disorder
• Gout Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind