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

This study has been completed.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00091429
First received: September 8, 2004
Last updated: November 24, 2009
Last verified: November 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

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

Publications:

Responsible Party: Philip Sager, Vice President, Clinical Research, Gilead Sciences
ClinicalTrials.gov Identifier: NCT00091429     History of Changes
Other Study ID Numbers: CVT 3037
Study First Received: September 8, 2004
Last Updated: November 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Angina
Chest Pain
Coronary Artery Disease
Heart Disease

Additional relevant MeSH terms:
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Amlodipine
Ranolazine
 Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013