Status:
COMPLETED
Safety and Efficacy of Aliskiren 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
This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight...
Eligibility Criteria
Inclusion
- Documented diagnosis of hypertension as defined in the NHLBI 4th Report, 2004
- msSBP (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization) measurement as defined by the NHLBI 4th Report, 2004
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
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT01150357
Start Date
June 1 2010
End Date
August 1 2014
Last Update
October 15 2015
Active Locations (48)
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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
San Diego, California, United States, 92123