Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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).

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: 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) ]

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.


Original Primary Outcome: 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 ]

Current Secondary Outcome:

  • 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) ]
    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) ]
    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).


Original Secondary Outcome:

  • 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 ]
  • 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 ]
  • 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 ]


Information By: Novartis

Dates:
Date Received: June 23, 2010
Date Started: August 2010
Date Completion:
Last Updated: February 8, 2016
Last Verified: January 2016