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| Sponsored by: |
CV Therapeutics |
|---|---|
| Information provided by: | CV Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00091429 |
Purpose
The study will be a multi-national, double-blind, randomized, placebo-controlled, parallel group study to evaluate the effectiveness of ranolazine (1000 mg twice daily) in approximately 500 patients with chronic angina who remain symptomatic despite daily treatment with the maximum labeled dose of amlodipine (10 mg daily), a calcium channel blocker approved for the treatment of chronic angina. Eligible patients will be randomized to receive ranolazine 1000 mg or placebo twice daily, in addition to a daily dose of 10 mg of amlodipine. Participation in the study will last approximately 3 months.
| Condition | Intervention | Phase |
|---|---|---|
|
Angina |
Drug: Ranolazine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of Ranolazine SR at a Dose of 1000 mg Twice a Day in Patients With Chronic Angina Who Remain Symptomatic Despite Treatment With Amlodipine 10 mg Once a Day |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Eligible patients must have a diagnosis of chronic angina, with documented evidence of coronary artery disease or prior myocardial infarction, in addition to other study entry criteria. Prior to entering the study, patients will be required to have had at least two weeks of treatment with amlodipine 10 mg daily, with the discontinuation of all other anti-anginal therapy for the duration of the study.
Contacts and Locations More Information
| Responsible Party: | CV Therapeutics ( Carol D. Karp, Senior VP, Regulatory Affairs, Quality and Drug Safety ) |
| Study ID Numbers: | CVT 3037 |
| Study First Received: | September 8, 2004 |
| Last Updated: | January 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00091429 |
| Health Authority: | United States: Food and Drug Administration |
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Angina Chest Pain Coronary Artery Disease Heart Disease |
|
Ranolazine Coronary Disease Signs and Symptoms Heart Diseases Myocardial Ischemia Vascular Diseases |
Angina Pectoris Pain Ischemia Coronary Artery Disease Amlodipine Chest Pain |
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Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Cardiovascular Diseases Pharmacologic Actions |
