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Last Updated: October 21, 2019

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CLINICAL TRIALS PROFILE FOR RANOLAZINE

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Clinical Trials for Ranolazine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00091429 Ranolazine SR in Patients With Chronic Angina Who Remain Symptomatic Despite Maximal Treatment With Amlodipine Completed Gilead Sciences Phase 3 2004-08-01 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.
NCT00099788 Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes Completed The TIMI Study Group Phase 3 2004-10-01 MERLIN-TIMI 36 is a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of ranolazine during acute and long-term treatment in approximately 5,500 patients with non-ST elevation acute coronary syndromes (ACS) treated with standard therapy. The primary efficacy endpoint in MERLIN-TIMI 36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation ACS receiving standard therapy. The study also evaluates the safety of long-term treatment with ranolazine compared to placebo.
NCT00099788 Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes Completed Gilead Sciences Phase 3 2004-10-01 MERLIN-TIMI 36 is a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of ranolazine during acute and long-term treatment in approximately 5,500 patients with non-ST elevation acute coronary syndromes (ACS) treated with standard therapy. The primary efficacy endpoint in MERLIN-TIMI 36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation ACS receiving standard therapy. The study also evaluates the safety of long-term treatment with ranolazine compared to placebo.
NCT00570089 Microvascular Coronary Disease In Women: Impact Of Ranolazine Completed CV Therapeutics Phase 2 2007-04-01 1. To evaluate the impact of ranolazine extended-release tablets in women with subendocardial ischemia due to microvascular endothelial dysfunction on myocardial ischemia (Cardiac Magnetic Resonance (CMR) extent, severity. 2. To evaluate the impact of ranolazine extended-release tablets in women with subendocardial ischemia due to microvascular endothelial dysfunction on the outcomes of angina (Seattle Angina Questionnaire (SAQ), WISE angina frequency, Duke Activity Status Inventory(DASI) and SF-36).
NCT00570089 Microvascular Coronary Disease In Women: Impact Of Ranolazine Completed Cedars-Sinai Medical Center Phase 2 2007-04-01 1. To evaluate the impact of ranolazine extended-release tablets in women with subendocardial ischemia due to microvascular endothelial dysfunction on myocardial ischemia (Cardiac Magnetic Resonance (CMR) extent, severity. 2. To evaluate the impact of ranolazine extended-release tablets in women with subendocardial ischemia due to microvascular endothelial dysfunction on the outcomes of angina (Seattle Angina Questionnaire (SAQ), WISE angina frequency, Duke Activity Status Inventory(DASI) and SF-36).
NCT00574756 Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction Unknown status University of California, San Diego N/A 2007-12-01 The purpose of this study is to evaluate the effects of ranolazine, an FDA-approved medication for the treatment of angina, on heart function by using echocardiography.
NCT00644332 An Open-label, Multi-center Study Evaluating the Validity, Reliability, and Responsiveness of a New Female-specific Angina Questionnaire in Women With Chronic Angina Treated With Ranolazine Extended-release Tablets (CVT 3041) Completed Gilead Sciences Phase 4 2007-11-01 According to the American Heart Association (AHA) 2011 update of heart disease and stroke statistics, more than 9 million adult patients in the United States (US) have angina. This update also notes that a study of 4 national cross-sectional health examination studies found that, among Americans 40 to 74 years of age, the age-adjusted prevalence of angina was higher among women than men. Per ACC/AHA guidelines, the goal of antianginal therapy is the complete or near complete elimination of anginal chest pain and a return to normal activities and functional capacity. However, evaluating angina and responses to antianginal therapy is often not straightforward. This is particularly true of female patients with angina. Because angina and response to antianginal therapy may differ in men and women, an instrument designed specifically to address symptomatology in women with angina could enhance our understanding and characterization of angina and responses to therapy in this population. The current study will evaluate the validity, reliability, and responsiveness of the newly developed Women's Ischemia Symptom Questionnaire (WISQ) based on changes in angina symptomatology in a female angina population treated with ranolazine, compared with the widely used Seattle Angina Questionnaire (SAQ).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ranolazine

Condition Name

Condition Name for Ranolazine
Intervention Trials
Coronary Artery Disease 12
Angina 9
Type 2 Diabetes Mellitus 8
Myocardial Ischemia 5
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Condition MeSH

Condition MeSH for Ranolazine
Intervention Trials
Coronary Artery Disease 22
Myocardial Ischemia 22
Coronary Disease 15
Angina Pectoris 12
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Clinical Trial Locations for Ranolazine

Trials by Country

Trials by Country for Ranolazine
Location Trials
United States 291
Poland 36
Canada 23
Mexico 15
Germany 12
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Trials by US State

Trials by US State for Ranolazine
Location Trials
Florida 19
California 19
Texas 12
Louisiana 12
Maryland 11
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Clinical Trial Progress for Ranolazine

Clinical Trial Phase

Clinical Trial Phase for Ranolazine
Clinical Trial Phase Trials
Phase 4 24
Phase 3 14
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Ranolazine
Clinical Trial Phase Trials
Completed 35
Recruiting 16
Unknown status 9
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Clinical Trial Sponsors for Ranolazine

Sponsor Name

Sponsor Name for Ranolazine
Sponsor Trials
Gilead Sciences 46
Brigham and Women's Hospital 5
University of Maryland 4
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Sponsor Type

Sponsor Type for Ranolazine
Sponsor Trials
Other 75
Industry 54
U.S. Fed 4
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