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

This study has been completed.

First Received: September 8, 2004 Last Updated: January 11, 2008 History of Changes

Sponsored by:	CV Therapeutics
Information provided by:	CV Therapeutics
ClinicalTrials.gov Identifier:	NCT00091429

Purpose

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	Intervention	Phase
Angina	Drug: Ranolazine	Phase III

MedlinePlus related topics: Angina

Drug Information available for: Amlodipine Ranolazine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of Ranolazine SR at a Dose of 1000 mg Twice a Day in Patients With Chronic Angina Who Remain Symptomatic Despite Treatment With Amlodipine 10 mg Once a Day

Further study details as provided by CV Therapeutics:

Estimated Enrollment:	500
Study Start Date:	August 2004
Study Completion Date:	February 2005
Primary Completion Date:	February 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2006 Jun 15.

Responsible Party:	CV Therapeutics ( Carol D. Karp, Senior VP, Regulatory Affairs, Quality and Drug Safety )
Study ID Numbers:	CVT 3037
Study First Received:	September 8, 2004
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00091429 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by CV Therapeutics:

Angina
Chest Pain
Coronary Artery Disease
Heart Disease

Study placed in the following topic categories:

Ranolazine
Coronary Disease
Signs and Symptoms
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Angina Pectoris
Pain
Ischemia
Coronary Artery Disease
Amlodipine
Chest Pain

Additional relevant MeSH terms:

Ranolazine
Signs and Symptoms
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Vascular Diseases

Angina Pectoris
Enzyme Inhibitors
Pain
Cardiovascular Diseases
Pharmacologic Actions
Chest Pain

ClinicalTrials.gov processed this record on May 06, 2009