Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Aliskiren (6.25/12.5/25 mg); Aliskiren (37.5/75/150 mg); Aliskiren (150/300/600 mg)
Intervention description: Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the low dose arm, participants used one or more of the 6.25 mg capsule (containing 2 minitablets) once daily to reach the body-weight stratified dose of aliskiren.; Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the medium dose arm, participants used one or more of the 37.5 mg capsule (containing 12 minitablets) once daily to reach the body- weight stratified dose of aliskiren.; Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the high dose arm, participants used one or more of the 150 mg capsule (containing 48 minitablets) once daily to reach the body- weight stratified dose of aliskiren.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 267.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatric hypertension; primary hypertension; secondary hypertension

Summary:

      This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering
      effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid
      and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid
      dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600
      mg of aliskiren. This study is being conducted to support monotherapy registration of
      aliskiren for the treatment of hypertension in children 6-17 years of age.
    

Eligibility criteria:

        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