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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00350168 |
The purpose of this study is to evaluate the blood pressure lowering effects of a valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of stage II hypertensive patients (MSSBP ≥ 160 mmHg).
Condition | Intervention | Phase |
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Hypertension |
Drug: valsartan + amlodipine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An 8-Week Multicenter Study to Evaluate the Efficacy and Safety of Orally Administered Valsartan/Amlodipine Combination Based Therapy Versus Amlodipine Monotherapy in Patients With Stage II Hypertension |
Estimated Enrollment: | 636 |
Study Start Date: | June 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
United States, New Jersey | |
Novartis Pharmaceuticals Corp | |
E. Hanover, New Jersey, United States, 07936 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Study ID Numbers: | CVAA489A2403 |
Study First Received: | July 7, 2006 |
Last Updated: | April 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00350168 |
Health Authority: | United States: Food and Drug Administration |
Blood pressure Venous pressure Systolic pressure Diastolic pressure Pulse pressure |
Calcium, Dietary Vascular Diseases Valsartan Amlodipine Hypertension |
Membrane Transport Modulators Vasodilator Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Calcium Channel Blockers |
Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |