Ranolazine SR in Patients With Chronic Angina Who Remain Symptomatic Despite Maximal Treatment With Amlodipine
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.
Timeline
- Start
- 2004-08
- Primary completion
- 2005-02
- Completion
- 2005-02
Outcome
Met primary endpoint
paper Compared with placebo, ranolazine significantly reduced frequency of angina episodes (2.88 +/- 0.19 on ranolazine vs. 3.31 +/- 0.22 on placebo; p = 0.028) PMID 16875985 ↗
Publications
- Results Stone PH, Gratsiansky NA, Blokhin A, Huang IZ, Meng L; ERICA Investigators. Antianginal efficacy of ranolazine when added to treatment with amlodipine: the ERICA (Efficacy of Ranolazine in Chronic Angina) trial. J Am Coll Cardiol. 2006 Aug 1;48(3):566-75. doi: 10.1016/j.jacc.2006.05.044. Epub 2006 Jun 15.
- Kohn CG, Parker MW, Limone BL, Coleman CI. Impact of angina frequency on health utility values of patients with chronic stable angina. Health Qual Life Outcomes. 2014 Mar 14;12:39. doi: 10.1186/1477-7525-12-39.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ranolazine | Small molecule | 1000 mg | — |
Indications
No indication recorded.