Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Randomized, 52-week, Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age
Brief Summary: The purpose of this study is to evaluate in a randomized, double-blind fashion, the long-term safety, tolerability and efficacy profile of aliskiren compared to the active comparator enalapril in children, 6 - 17 years old with hypertension (msSBP ≥ 95th percentile for age, gender and height, at baseline in study CSPP100A2365). Patients will be randomized to receive either aliskiren or enalapril. Weight-group based doses of aliskiren or enalapril will be administered once daily and children will receive study medication in a double-blind manner. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in pediatric patients 6-17 years of age (age at baseline in Study CSPP100A2365).


Options:
A: Inclusion Criteria

* Patients with essential severe hypertension Exclusion Criteria
* History or evidence of a secondary form of hypertension
* History of hypertensive encephalopathy or cerebrovascular accident.
* Diabetic patients requiring insulin Other protocol-defined inclusion/exclusion criteria also apply
B: Inclusion Criteria

* Patients with at least 65 years-old
* Patients with essential hypertension 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 also apply.
C: Inclusion Criteria:

* Male or female outpatients ≥ 65 years old.
* Patients with essential hypertension with an msSBP ≥ 140 mmHg and \< 180 mmHg, and msDBP \< 110 mmHg at Visits 2 and 3. (Visit 201 was deleted by the Administrative Changes document.)
* Patients must have had a difference in msSBP of ≤ 20 mmHg between Visit 3 and the visit immediately prior to Visit 3.
* Patients who were eligible and able to participate in the study, and who consented to do so after the purpose and nature of the investigation had been explained to them (written informed consent).

Exclusion Criteria:

* History of renal artery stenosis.
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
* History of hypertensive encephalopathy.
* Current diagnosis of heart failure (New York Heart Association Class III-IV).
* History of transient ischemic cerebral attack or cerebrovascular accident within 6 months.
* History of myocardial infarction, bypass surgery, or any percutaneous coronary intervention within 6 months.
* Current unstable angina pectoris. Patients on a stable dose of oral or topical nitrates or beta blockers for angina were acceptable.
* Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
* Clinically significant valvular heart disease.
* Concurrent use of any antihypersensitive medications except a stable dose 3 months prior to visit 1 of alpha adrenergic blockers for benign prostatic hypertrophy (e.g., Flomax for BPH), beta blockers for angina, or beta blockers ophthalmic preparations.
D: Inclusion Criteria:

* msSBP (mean of 3 systolic blood pressure measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization), in study CSPP100A2365
* Must be ≥ 20 kg and ≤ 150 kg at Visit 2 (randomization), in study CSPP100A2365
* Must be able to swallow minitablets (2mm in diameter) administered in soft food
* Successful completion of Phase 1 (dose response phase) and at least 1 week of Phase 2 (placebo withdrawal phase) of the CSPP100A2365 protocol, with no serious drug-related adverse event(s).

Exclusion Criteria:

* Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids, for any medical condition
* Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or obstructive valvular disease
* msSBP ≥ 25% above the 95th percentile
* Second or third degree heart block without a pacemaker
* AST/SGOT or ALT/SGPT \>3 times the upper limit of the reference range
* Total bilirubin \> 2 times the upper limit of the reference range
* Creatinine clearance \< 30 mL/min/1.73m² (calculated using Modified Schwartz formula to estimate glomerular filtration rate \[GFR\]), based on the serum creatinine concentration obtained at the screening visit)
* WBC count \< 3000/mm³
* Platelet count \< 100,000/mm³
* Serum potassium \> 5.2 mEq/L
* Other protocol-defined inclusion/exclusion criteria may apply

Answer: D