A Study of VAH631 in Patients With Essential Hypertension (Factorial Study)
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...
Brief Summary
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)”
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
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: September 2006
Intervention(s) in this Clinical Trial
- Drug: Valsartan
- Drug: Hydrochlorothiazide
Outcome Measures for this Clinical Trial
Primary Measures
- Change from baseline in diastolic blood pressure after 8 weeks
Secondary Measures
- 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
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: 80 Years
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novatis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00311740
Study ID Number: CVAH631B1303
ClinicalTrials.gov Identifier: NCT00311740
Health Authority: Japan: Ministry of Health, Labor and Welfare
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00311740
