Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age

Inclusion Criteria:

- Documented diagnosis of hypertension as defined in the NHLBI 4th Report, 2004

- msSBP (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height,
at Visit 2 (randomization) measurement as defined by the NHLBI 4th Report, 2004

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

Other protocol-defined inclusion/exclusion criteria may apply