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

NCT00091429 | Completed Phase 3

• 1 other identifier: CVT 3037
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Angina

Keywords

Angina; Chest Pain; Coronary Artery Disease; Heart Disease

Interventions

Ranolazine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gilead Sciences: lead

Related Publications (2)

• 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.

  PMID: 16875985 RESULT

• 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.

  PMID: 24628859 DERIVED

MeSH Terms

Conditions

Angina Pectoris; Chest Pain; Coronary Artery Disease; Heart Diseases

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2004
• First Posted: September 10, 2004
• Study Start: August 1, 2004
• Primary Completion: February 1, 2005
• Study Completion: February 1, 2005
• Last Updated: November 26, 2009

Record last verified: 2009-11