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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01151410
First received: June 23, 2010
Last updated: February 8, 2016
Last verified: January 2016

June 23, 2010
February 8, 2016
August 2010
August 2015   (final data collection date for primary outcome measure)
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study [ Time Frame: Baseline - end of study (Week 52 or Last observation carried forward (LOCF) ] [ Designated as safety issue: No ]
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
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 ]
Complete list of historical versions of study NCT01151410 on ClinicalTrials.gov Archive Site
  • Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study [ Time Frame: Baseline - end of study (Week 52 or Last observation carried forward (LOCF) ] [ Designated as safety issue: No ]
    Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.
  • Change in Mean Arterial Pressure (MAP) (mmHg) From Baseline to End of Study [ Time Frame: Baseline to end of study (Week 52 or LOCF) ] [ Designated as safety issue: No ]
    MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of diastolic blood pressure (DBP) and one third of difference between systolic blood pressure (SBP) and DBP i.e. MAP = DBP+1/3*(SBP--DBP).
  • 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 ]
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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
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

  • Experimental: Aliskiren
    Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
    Intervention: Drug: Aliskiren
  • Active Comparator: Enalapril
    Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
    Intervention: Drug: Enalapril
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
208
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 information is only displayed when the study is recruiting subjects
United States,   Guatemala,   Hungary,   Poland,   Puerto Rico,   Slovakia,   Turkey
Belgium,   France,   Germany
 
NCT01151410
CSPP100A2365E1, 2009-017029-20
Not Provided
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Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2016

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