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

NCT ID: NCT00311740

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 582 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2006-09-30

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Valsartan

Intervention Type: DRUG

Hydrochlorothiazide

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novatis Pharmaceuticals

Locations

Novartis Pharmaceuticals

Tokyo, , Japan

Countries

Japan

Other Identifiers

CVAH631B1303

Identifier Type: -

Identifier Source: org_study_id