Safety and Efficacy of Aliskiren in Post Myocardial Infarction Patients (ASPIRE)

Core Study Inclusion Criteria:

• Male or female patients 18 years and older.

• Patients within 7-42 days of an acute myocardial infarction associated with leftventricular systolic dysfunction.

• Documented left ventricular systolic dysfunction associated with the qualifying acutemyocardial.

• Patients must be on stable doses of the following concomitant medications for at least 2 weeks prior to Visit 1 unless contraindicated due to intolerance:

• A Beta-blocker

• An Anti-platelet agent

• A Statin

• An evidence-based dose of an Angiotensin Converting Enzyme Inhibitor (ACEI) orAngiotensin Receptor Blocker (ARB) but not both.

• Qualifying Echocardiogram at Visit 1:

Core Study Exclusion Criteria:

• Patients requiring both Angiotensin Converting Enzyme Inhibitor (ACEI) and AngiotensinReceptor Blocker (ARB) combination therapy at V1 or any time during the study.

• Severe refractory hypertension defined as mean sitting systolic blood pressure (MSSBP) ≥ 180 mmHg and/or mean sitting diastolic blood pressure (MSDBP) ≥ 110 mmHg) at Visit

• Cardiogenic shock or systolic BP < 100 mmHg or diastolic < 60 mmHg within the 24 hoursprior to Visits 1 or 2

• Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2 using the MDRD formulaat Visit 1.

• Stroke or transient ischemic event (TIA) within 6 months of Study Visit 1 Extension Study Inclusion Criteria:

• Male or female patients who completed the core study through Visit 10 while ondouble-blind study drug

• Patients who were able to participate in the study, and who consented to do so afterthe purpose and nature of the study had been clearly explained to them (writteninformed consent) Extension Study Exclusion Criteria:

• New York Heart Association (NYHA) class IV Congestive Heart Failure at Visit 1 (Corestudy Visit 10)

• Symptomatic hypotension or reported systolic blood pressure (BP) < 90 mmHg within 24hours prior to Visit 1 (Core study Visit 10)

• Known Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73m^2 using theModification of Diet in Renal Disease (MDRD) formula at Visit 1 (Core study Visit 10)

• Pregnant or nursing (lactating) women, where pregnancy was defined as the state of afemale after conception and until the termination of gestation, confirmed by apositive hCG laboratory test (> 5 mIU/mL)

• Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant Unless post-menopausal or using an acceptable method ofcontraception

• Any surgical or medical condition that in the opinion of the investigator may placethe patient at higher risk from his/her participation in the study or was likely toprevent the patient from complying with the requirements or completing the study Other protocol-defined inclusion/exclusion criteria applied