The purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. The study will investigate the dose response relationship for the combinations, monotherapies and placebo...
Date First Received: January 22, 2007
Last Updated: June 9, 2008
Verified by: Novartis, June 2008
Clinical Trial Phase: Phase 2/Phase 3 | Start Date: November 2006
Overall Status: Completed
Estimated Enrollment: 1404
Brief Summary
Official Title: “A Multi-Center, Factorial Study to Evaluate the Efficacy and Safety of 8-Week Treatment With VAA489 [Valsartan (40 and 80 mg) and Amlodipine (2.5 and 5 mg) Combined] and Alone in Essential Hypertensive Patients - Double-Blind Study of VAA489 in Patients With Essential Hypertension (Factorial Study)”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. The study will investigate the dose response relationship for the combinations, monotherapies and placebo.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Study Primary Completion Date: March 2008
Intervention(s) in this Clinical Trial
- Drug: Valsartan + Amlodipine besilate
Outcome Measures for this Clinical Trial
Primary Measures
- Change from baseline in mean sitting diastolic blood pressure at 8 weeks.
Secondary Measures
- Change from baseline in mean sitting systolic blood pressure (MSSBP) at trough at 8 weeks.
- Responder rate for achieving MSDBP < 90 mmHg or a ≥ 10 mmHg decrease compared to baseline.
- Diastolic control rate for achieving MSDBP < 90mmHg.
- Blood pressure control rate for achieving MSDBP <90 mmHg and MSSBP <140 mmHg.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Essential hypertension
- 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
- 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
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Japan Study Chair Sponsor GmbH
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00425373
Study ID Number: CVAA489A1301
ClinicalTrials.gov Identifier: NCT00425373
Health Authority: Japan: Ministry of Health, Labor and Welfare
Clinical Trials Authorship and Review
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