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

Novartis582 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

582

Conditions

Hypertension

Interventions

ValsartanDRUG

HydrochlorothiazideDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Pharmaceuticals

Tokyo, Japan

Outcomes

Primary Outcomes

Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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