A Study of VAH631 in Patients With Essential Hypertension (Factorial Study)
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00311740
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 582
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
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Change from baseline in diastolic blood pressure after 8 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇯🇵Tokyo, Japan