Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 36-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Including a 2 Year Extension Study to Evaluate Efficacy and Safety of Aliskiren on the Prevention of Left Ventricular Remodeling in High Risk Post-acute Myocardial Infarction Patients When Added to Optimized Standard Therapy
Brief Summary: The core and extension studies assessed the safety and efficacy of aliskiren when added to optimized standard therapy in patients that have had a high risk acute myocardial infarction (heart attack).


Options:
A: Inclusion Criteria:

* Male and female outpatients 18 years of age and older
* Patients who are eligible and able to participate in the study

Exclusion Criteria:

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined inclusion/exclusion criteria may apply
B: Inclusion Criteria:

* Patients with essential hypertension

Exclusion Criteria:

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of myocardial infarction.
* Other protocol-defined inclusion exclusion criteria also apply.
C: Inclusion Criteria:

* Male and/or female subjects between the ages of 30-80 years with a diagnosis of type 2 diabetes (World Health Organization criteria)
* Body mass index (BMI) within the range of 20 and 32.
* Incipient or overt diabetic nephropathy (urinary albumin excretion ≥ 100 but ≤ 2000 mg/day).
* Glomerular filtration rate (GFR) ≥ 40 ml/min documented in the last 4 months prior to randomization
* To be eligible for randomization, patients must fulfill the following criteria:

  1. Patients on ongoing hypertensive therapy must have a blood pressure ≥ 135/85 mmHg but lower than 170/105 mmHg at Visit 2 (Day -1) AND patients must be on stable antihypertensive medications for at least 8 weeks prior to Visit 2 (run-in period).
  2. Newly diagnosed hypertensive patients must have a blood pressure ≥ 135/85 mmHg but lower than 170/105 mmHg at Visit 2 (Day -1).
* Patients must be on stable hypoglycemic medications for at least 8 weeks prior to Visit 2 (Day -1).
* Patients must be willing and medically able to discontinue all angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), aldosterone receptor antagonist and potassium sparing diuretic medications for the duration of the study.
* Female patients must be postmenopausal, have had a bilateral oophorectomy, or have been surgically sterilized or hysterectomized at least 6 months prior to screening.
* Oral body temperature within the range of 35.0-37.5 °C
* Able to provide written informed consent prior to study participation.
* Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion Criteria:

* Severe hypertension, Grade 3 World Health Organization (WHO) classification (mean sitting diastolic blood pressure \[MSDBP\] ≥ 110 mmHg and/or mean sitting systolic blood pressure \[MSSBP\] ≤ 180 mmHg)
* Acetylsalicylic acid (ASA) treatment \> 1 g/day or regular use of nonsteroidal anti-inflammatory drugs (NSAIDs)
* Kidney disease not caused by diabetes or hypertension
* Serum potassium \< 3.5 or \> 5.1 mEq/L
* GFR \< 40 ml/min/1.73m2 as measured by the Modification of Diet in Renal Disease (MDRD) formula
* Serum albumin \< 2.0 mg/dL
* History of hypertensive encephalopathy or cerebrovascular accident in the last 12 months prior to Visit 1
* Transient ischemic cerebral attack during the 6 months prior to Visit 1
* Current diagnosis of heart failure (New York Heart Association \[NYHA\] Class II-IV)
* History of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 6 months prior to Visit 1
* Second or third degree heart block without a pacemaker
* Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia
* Clinically significant valvular heart disease
* Type 1 diabetes mellitus
* Uncontrolled type II diabetes mellitus; hemoglobin subtype A1C (HbA1C) \> 11%
* History of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
* Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
* Significant illness within the two weeks prior to dosing.
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs including, but not limited to, any of the following:

  * History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
  * Currently active or previously active inflammatory bowel disease during the 12 months prior to Visit 1
  * Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to Visit 1.
  * Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase
  * Evidence of hepatic disease, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portacaval shunt
  * Current treatment with cholestyramine or colestipol resins
* History of immunocompromise, including a positive test result.
* History of a positive hepatitis B surface antigen (HBsAg) or hepatitis C test result.
* History of drug or alcohol abuse within the 12 months prior to dosing.
* Persons directly involved in the execution of this protocol.
* Any condition that, in the opinion of the investigator or the Novartis medical monitor, would jeopardize the evaluation of efficacy or safety
* History of noncompliance to medical regimens or unwillingness to comply with the study protocol
* Known or suspected contraindications to the study medications, including history of allergy to ACE inhibitors and/or to thiazide diuretics or other sulfonamide derived drug
* Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
* Use of any prescription drug or over-the-counter (OTC) medication which is prohibited by the protocol.
* Patients who previously participated in any aliskiren study.

Other protocol-defined inclusion/exclusion criteria may apply.
D: Core Study Inclusion Criteria:

* Male or female patients 18 years and older.
* Patients within 7-42 days of an acute myocardial infarction associated with left ventricular systolic dysfunction.
* Documented left ventricular systolic dysfunction associated with the qualifying acute myocardial.
* 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) or Angiotensin Receptor Blocker (ARB) but not both.
* Qualifying Echocardiogram at Visit 1:

Core Study Exclusion Criteria:

* Patients requiring both Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin Receptor 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 2.
* Cardiogenic shock or systolic BP \< 100 mmHg or diastolic \< 60 mmHg within the 24 hours prior to Visits 1 or 2
* Estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73m2 using the MDRD formula at 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 on double-blind study drug
* Patients who were able to participate in the study, and who consented to do so after the purpose and nature of the study had been clearly explained to them (written informed consent)

Extension Study Exclusion Criteria:

* New York Heart Association (NYHA) class IV Congestive Heart Failure at Visit 1 (Core study Visit 10)
* Symptomatic hypotension or reported systolic blood pressure (BP) \< 90 mmHg within 24 hours prior to Visit 1 (Core study Visit 10)
* Known Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73m\^2 using the Modification 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 a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL)
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant Unless post-menopausal or using an acceptable method of contraception
* Any surgical or medical condition that in the opinion of the investigator may place the patient at higher risk from his/her participation in the study or was likely to prevent the patient from complying with the requirements or completing the study

Other protocol-defined inclusion/exclusion criteria applied

Answer: D