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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00446563 |
This study will evaluate the safety and efficacy of amlodipine plus valsartan in patients with hypertension and left ventricular hypertrophy
Condition | Intervention | Phase |
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Hypertension; Hypertrophy, Left Ventricular |
Drug: Amlodipine + Valsartan Drug: Losartan + Hydrochlorothiazide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Amlodipine in Combination With Valsartan Compared to Losartan in Combination With Hydrochlorothiazide Given for 52 Weeks on the Regression of Left Ventricular Hypertrophy in Patients With Mild to Moderate Hypertension |
Estimated Enrollment: | 150 |
Study Start Date: | March 2007 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Study ID Numbers: | CVAA489ADE02 |
Study First Received: | March 12, 2007 |
Last Updated: | September 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00446563 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Left ventricular hypertrophy, hypertension, valsartan, amlodipine |
Pathological Conditions, Anatomical Hypertrophy, Left Ventricular Losartan Heart Diseases Vascular Diseases Angiotensin II Hydrochlorothiazide |
Amlodipine Calcium, Dietary Hypertrophy Cardiomegaly Valsartan Hypertension |
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Calcium Channel Blockers Cardiovascular Agents Antihypertensive Agents |
Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Cardiovascular Diseases Anti-Arrhythmia Agents |