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

Completed · Phase 3

Conditions studied: Hypertension

In brief

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).

Key facts

Study ID

NCT01151410

Run by

Novartis Pharmaceuticals

People needed

208

Starts

2010-08-01

Expected to finish

2015-08-01

Last updated by the study team

2016-03-07

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• 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
• 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
• Novartis Investigative Site — Columbus, Ohio, United States
• Novartis Investigative Site — Toledo, Ohio, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Charleston, South Carolina, United States
• Novartis Investigative Site — Amarillo, Texas, United States
• Novartis Investigative Site — Charleston, West Virginia, United States
• Novartis Investigative Site — Guatemala City, Departamento de Guatemala, Guatemala
• Novartis Investigative Site — Nyíregyháza, Hungary, Hungary
• Novartis Investigative Site — Szeged, Hungary, Hungary
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Debrecen, Hungary
• Novartis Investigative Site — Miskolc, Hungary
• Novartis Investigative Site — Veszprém, Hungary

Full record on ClinicalTrials.gov

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