Ranolazine SR in Patients With Chronic Angina Who Remain Symptomatic Despite Maximal Treatment With Amlodipine

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Amlodipine; Ranolazine

Criteria

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.