Phase 3
Completed N=208
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
Source: ClinicalTrials.gov NCT01151410 ↗Enrolled (actual)
208
Serious AEs
7.2%
Results posted
Mar 2016
Primary outcomePrimary: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study — -7.63; -7.94 millimeter(s) of mercury (mmHg) — p=0.0040
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study |
-7.63; -7.94 | 0.0040 sig |
| SECONDARY Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study |
-3.90; -4.94 | — |
| SECONDARY Change in Mean Arterial Pressure (MAP) (mmHg) From Baseline to End of Study |
-5.15; -5.95 | — |
Eligibility Criteria
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 5.2 mEq/L
- Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01151410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.