A Study on the Effects of Ranolazine on Exercise Duration in Subjects With Chronic Stable Angina and Coronary Artery Disease (CAD) With Type 2 Diabetes Mellitus (T2DM)

Exclusion Criteria

• •Inability to exercise or having exercise limitation due to other co-morbidities that may interfere with ability to perform required ETT (e.g., morbid obesity, significant chronic lung disease, prior hospitalization for acute exacerbation of chronic lung disease or home oxygen use, chronic oral steroid therapy that can limit exercise capacity, osteoarthritis, peripheral artery disease, etc.)
• •Any absolute contraindication to ETT
• •Presence of electrocardiographic or other abnormalities that interfere with ECG interpretation or may cause a false positive stress test (e.g., ≥ 1 mm horizontal or down-sloping ST segment depression at rest in any standard ECG lead, Lown-Ganong-Levine syndrome, Wolff-Parkinson-White syndrome, left bundle branch block, left ventricular hypertrophy with repolarization abnormality, ventricular pacemaker, etc.)
• •Decompensated heart failure
• •Clinically significant valvular heart disease or congenital cardiac defects
• •Acute coronary syndrome in the prior 2 months or coronary revascularization within the prior 6 months or planned coronary revascularization during the study period
• •Stroke or transient ischemic attack within 6 months prior to Screening
• •History of serious ventricular dysrhythmias or a history of life-threatening ventricular arrhythmia
• •Atrial fibrillation
• •QTc \> 0.5 seconds
• •Hypertrophic cardiomyopathy
• •Uncontrolled hypertension (seated systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 110 mm Hg)
• •Systolic blood pressure \< 90 mm Hg
• •Inability to discontinue current antianginal medications and remain on one allowed antianginal therapy
• •Clinically significant hepatic impairment
• •Creatinine clearance (CLCr) \< 30 ml/min
• •Prior treatment with ranolazine
• •Participation in another investigational drug or device study within 1 month prior to Screening
• •Females who are breastfeeding
• •Positive serum pregnancy test
• •Current treatment with potent inhibitors of CYP3A (e.g., ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir)
• •Current treatment with CYP3A and P glycoprotein (Pgp) inducers (e.g., rifampicin/rifampin, carbamazepine, St. John's wort)
• •History of illicit drug use or alcohol abuse within one 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