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...
Date First Received: April 4, 2006
Last Updated: February 12, 2007
Verified by: Novartis, February 2007
Clinical Trial Phase: Phase 3 | Start Date: March 2006
Overall Status: Completed
Estimated Enrollment: 558
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)”
Condition Keyword(s):
Intervention(s):
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: Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study
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 Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novatis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on August 20, 2008
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
Clinical Trials Authorship and Review
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