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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01151410
First received: June 23, 2010
Last updated: July 18, 2014
Last verified: July 2014

June 23, 2010
July 18, 2014
August 2010
August 2015   (final data collection date for primary outcome measure)
Evaluate the safety and tolerability (by measuring vital signs, AE, SAEs and safety laboratories) of long term administration of aliskiren compared to enalapril in hypertensive children aged 6-17 years old. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01151410 on ClinicalTrials.gov Archive Site
  • Mean sitting systolic blood pressure reduction of long-term administration of aliskiren compared to enalapril in hypertensive children aged 6-17 years old [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Evaluate the efficacy as assessed by calculated mean arterial pressure (MAP), of long-term administration of aliskiren compared to enalapril in hypertensive children 6 to 17 years old [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Mean sitting diastolic blood pressure reduction of long-term administration of aliskiren compared to enalapril in hypertensive children aged 6-17 years old [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
A Multicenter, Double-blind, Randomized, 52-week, 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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: Aliskiren

    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

  • Drug: Enalapril

    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

  • Active Comparator: Enalapril

    Patients will receive one of the following doses based on the their weight:

    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: Drug: Enalapril
  • Experimental: Aliskiren

    Patients will receive one of the following doses based on the their weight:

    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

    Intervention: Drug: Aliskiren
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
August 2015
August 2015   (final data collection date for primary outcome measure)

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
Both
6 Years to 17 Years
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States,   Belgium,   Germany,   Guatemala,   Hungary,   Poland,   Puerto Rico,   Slovakia,   Turkey
 
NCT01151410
CSPP100A2365E1, 2009-017029-20
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP