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

Phase 3

Completed

• Conditions: Angina

• Registration Number: NCT00091429
• Lead Sponsor: Gilead Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2004-09-08
• Study First Submitted QC: 2004-09-09
• Study First Posted: 2004-09-10
• Primary Completion: 2005-02
• Study Completion: 2005-02
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-24
• Last Update Posted: 2009-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL