A Study of VAH631 in Patients With Essential Hypertension (Factorial Study)
Information source: Novartis
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Valsartan (Drug); Hydrochlorothiazide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novatis Pharmaceuticals
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.
Clinical Details
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)
Study design: Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in diastolic blood pressure after 8 weeks
Secondary outcome: Change from baseline in systolic blood pressure after 8 weeksDiastolic 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
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Novartis Pharmaceuticals, tokyo, Japan
Novartis Pharmaceuticals, tokyo, Japan
Additional Information
Starting date: March 2006
Ending date: January 2007
Last updated: February 12, 2007
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