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NCT00311740 Clinical Trial

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

Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00311740
Other study ID # CVAH631B1303
Secondary ID
Status Completed
Phase Phase 3
First received April 4, 2006
Last updated February 21, 2017
Start date March 2006
Est. completion date September 2006

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 582
Est. completion date September 2006
Est. primary completion date September 2006
Accepts healthy volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Valsartan

• Hydrochlorothiazide

Locations
Country Name City State
Japan Novartis Pharmaceuticals Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in diastolic blood pressure after 8 weeks
Secondary Change from baseline in systolic blood pressure after 8 weeks
Secondary Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic blood pressure after 8 weeks
Secondary Change from baseline in standing diastolic blood pressure after 8 weeks
Secondary Change from baseline in standing systolic blood pressure after 8 weeks
Secondary Adverse events and serious adverse events at each study visit for 8 weeks
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