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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
208
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
Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Little Rock, Arkansas, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Dalton, Georgia, United States
Novartis Investigative Site
Lewiston, Idaho, United States
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study
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.
Time frame: Baseline - end of study (Week 52 or Last observation carried forward (LOCF)
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study
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.
Time frame: Baseline - end of study (Week 52 or Last observation carried forward (LOCF)
Change in Mean Arterial Pressure (MAP) (mmHg) From Baseline to End of Study
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).
Time frame: Baseline to end of study (Week 52 or LOCF)
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Novartis Investigative Site
Park Ridge, Illinois, United States
Novartis Investigative Site
Louisville, Kentucky, United States
Novartis Investigative Site
Hattiesburg, Mississippi, United States
Novartis Investigative Site
Jackson, Mississippi, United States
Novartis Investigative Site
New York, New York, United States
...and 26 more locations