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Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00523744 |
This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: amlodipine and valsartan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Multicenter Study to Evaluate the Efficacy and Tolerability of a 4 Week Therapy With the Fixed Dose Combination of Amlodipine 10 mg Plus Valsartan 160 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With the Free Combination of an Angiotensin Receptor Blocker (Olmesartan 20 mg) Plus Amlodipine 10 mg |
Enrollment: | 256 |
Study Start Date: | August 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
amlodipine and valsartan
|
Drug: amlodipine and valsartan |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply.
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CVAA489ADE06 |
Study First Received: | August 30, 2007 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00523744 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
hypertension, valsartan, amlodipine |
Calcium, Dietary Vascular Diseases Olmesartan medoxomil |
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 |