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	Treatment or Intervention	Phase
Angina	Drug: Ranolazine	Phase III

Further Study Details: 

Expected Total Enrollment:  500

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Study ID Numbers:  CVT 3037
Record last reviewed:  November 2004
Last Updated:  November 26, 2004
Record first received:  September 8, 2004
ClinicalTrials.gov Identifier:  NCT00091429
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08