Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina

Exclusion Criteria

• •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