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)

Novartis1 site in 1 country582 target enrollmentMarch 2006

ConditionsHypertension

DrugsValsartan Hydrochlorothiazide

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hypertension
Sponsor: Novartis
Enrollment: 582
Locations: 1
Primary Endpoint: Change from baseline in diastolic blood pressure after 8 weeks
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

September 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

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
•Gout Other protocol-defined inclusion/exclusion criteria may apply

Outcomes

Primary Outcomes

Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcomes

Adverse events and serious adverse events at each study visit for 8 weeks
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