Status:
COMPLETED
Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina
Lead Sponsor:
Gilead Sciences
Conditions:
Angina Pectoris
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will evaluate the effect of ranolazine compared to placebo on the average weekly angina frequency in subjects with chronic stable angina and coronary artery disease (CAD) who have a history...
Detailed Description
Participants who meet the eligibility criteria at screening will enter a 4-to 6-week Qualifying Period. The allowed concomitant antianginal medication(s) must be maintained at a stable dose throughout...
Eligibility Criteria
Inclusion
- Written informed consent
- Males and females aged at least 18 years
- At least a 3-month history of chronic stable angina triggered by physical effort and relieved by rest and/or sublingual nitroglycerin
- CAD documented by one or more of the following:
- Angiographic evidence of ≥ 50% stenosis of one or more major coronary arteries
- History of myocardial infarction (MI) documented by positive myocardial muscle creatine kinase (CK-MB) enzymes, troponins, or electrocardiogram (ECG) changes
- Cardiac imaging study or exercise test diagnostic for CAD
- Treatment with up to 2 antianginal therapies at a stable dose for at least 2 weeks prior to the Qualifying Period.
- Documented history of T2DM
- Willing to maintain stable tobacco usage habits throughout the study
- Willing to maintain stable activity levels throughout the study
- Females of childbearing potential must agree to utilize highly effective contraception methods from Screening throughout the duration of study treatment and for 14 days following the last dose of study drug.
Exclusion
- New York Heart Association (NYHA) Class III and IV
- Acute coronary syndrome in the prior 2 months or planned coronary revascularization during the study period
- Stroke or transient ischemic attack within 6 months prior to Screening
- QTc \> 500 milliseconds
- Uncontrolled hypertension (seated systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg)
- Systolic blood pressure \< 100 mmHg
- Clinically significant hepatic impairment
- Prior treatment with ranolazine, or known hypersensitivity or intolerance to ranolazine
- Females who are breastfeeding
- Positive serum pregnancy test
- Participation in another investigational drug or device study within 1 month prior to Screening
- Current treatment with trimetazidine, ivabradine, or nicorandil. Subjects will need to discontinue these medications 2 weeks prior to the Qualifying Period.
- Current treatment with potent inhibitors of cytochrome (CYP)3A (eg, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir)
- Current treatment with CYP3A and P glycoprotein (Pgp) inducers (eg, rifampicin/rifampin, carbamazepine, and St. John's wort \[Hypericum perforatum\])
- Current treatment with CYP3A4 substrates with a narrow therapeutic range (eg, cyclosporine, tacrolimus, and sirolimus)
- Subjects taking simvastatin who cannot reduce the dose to 20 mg once daily or who cannot switch to another statin
- Current treatment with Class I or III antiarrhythmic medications
- History of illicit drug use or alcohol abuse within 1 year of Screening
- Any other conditions that, in the opinion of the investigator, are likely to prevent compliance with the study protocol or pose a safety concern if the subject participates in the study
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
949 Patients enrolled
Trial Details
Trial ID
NCT01425359
Start Date
September 1 2011
End Date
October 1 2012
Last Update
November 4 2014
Active Locations (135)
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1
Cardiology and Medicine Clinic
Little Rock, Arkansas, United States, 72204
2
Merced Heart Associates
Merced, California, United States, 95340
3
Spectrum Clinical Research Institute, Inc
Moreno Valley, California, United States, 92553
4
Sacramento Heart and Vascular Research Center
Sacramento, California, United States, 95825