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
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Aliskiren; Enalapril
Intervention description: Low weight patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg
Mid weight patients: Starting dose 75 mg with optional titration to 150 and then 300 mg
High weight patients: Starting dose 150 mg with optional titration to 300 and then 600 mg; Low weight patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg
Mid weight patients: Starting dose 5 mg with optional titration to 10 and then 20 mg
High weight patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
Intervention MeSH terms: Enalapril
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 208.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatric hypertension; primary hypertension; secondary; hypertension

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).
    

Eligibility criteria:

        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