A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age

An 8-day Open-label, Multiple-dose, Multicenter Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age

This first open-label study in a pediatric population was designed to evaluate aliskiren safety and pharmacokinetics after single and multiple dosing in 6-17 year old children with hypertension.

Inclusion Criteria:

• Male or female, 6-17 years of age
• Documented history of hypertension as defined in National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents (2004)
• Must be ≥ 21.0 kg and ≤ 100.0 kg at randomization
• Able to safely wash out previous antihypertensive therapy for 1-2 weeks

Exclusion Criteria:

• Body weight of < 21 kg (45 lbs) or > 100 kg (220 lbs)
• Inability to discontinue prior antihypertensive medication as required during the washout period
• Any clinically significant abnormalities or clinically noteworthy abnormal laboratory values
• Renal artery stenosis
• Current diagnosis of heart failure (NYHA Class II-IV)
• msSBP ≥ 25% above the 95th percentile for age, gender, and height at Visit 2
• Second or third degree heart block with or without a pacemaker
• Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening or any symptomatic arrhythmia during the 12 months prior to Visit 1
• Evidence of current symptomatic valvular disease

Other protocol-defined inclusion/exclusion criteria applied to the study.