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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00311740

Collaborator

(none)

582

Enrollment

Location

Duration (Months)

96.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Valsartan Drug: Hydrochlorothiazide	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

582 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Multi-center, Factorial Study to Evaluate Efficacy & Safety of 8 Wks Treatment With VAH631 [Valsartan (40 & 80 mg) and Hydrochlorothiazide (6.25 & 12.5 mg) Combined & Alone in Essential Hypertensive Patients] - Double-blind Study of VAH631 in Patients With Essential Hypertension (Factorial Study)

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Sep 1, 2006

Actual Study Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

Change from baseline in diastolic blood pressure after 8 weeks []

Secondary Outcome Measures

Change from baseline in systolic blood pressure after 8 weeks []
Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic blood pressure after 8 weeks []
Change from baseline in standing diastolic blood pressure after 8 weeks []
Change from baseline in standing systolic blood pressure after 8 weeks []
Adverse events and serious adverse events at each study visit for 8 weeks []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

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