An 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

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