Status:
COMPLETED
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypertension
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
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 chil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT01151410
Start Date
August 1 2010
End Date
August 1 2015
Last Update
March 7 2016
Active Locations (36)
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1
Novartis Investigative Site
Birmingham, Alabama, United States, 35294-0006
2
Novartis Investigative Site
Little Rock, Arkansas, United States, 72202
3
Novartis Investigative Site
Los Angeles, California, United States, 90048
4
Novartis Investigative Site
Dalton, Georgia, United States, 30721