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



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:6 - 17
Updated:4/21/2016
Start Date:August 2010
End Date:August 2015

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A Multicenter, Double-blind, Randomized, 52-week, 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

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).


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 < 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
We found this trial at
19
sites
Little Rock, Arkansas 72204
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Little Rock, AR
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Amarillo, Texas 79106
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Amarillo, TX
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Birmingham, Alabama 35209
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Birmingham, AL
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Charleston, South Carolina 29407
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Charleston, SC
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Charleston, West Virginia 25304
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Charleston, WV
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Columbus, Ohio 43205
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Columbus, OH
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Dalton, Georgia 30721
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Dalton, GA
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Guatemala City, 01010
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Guatemala City,
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Hattiesburg, Mississippi 39401
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Hattiesburg, MS
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Jackson, Mississippi 39209
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Jackson, MS
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Jackson, Mississippi 39209
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Jackson, MS
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Lewiston, Idaho 83501
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Lewiston, ID
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Los Angeles, California 90095
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Los Angeles, CA
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Louisville, Kentucky 40202
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Louisville, KY
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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New York, NY
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Park Ridge, Illinois 60068
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Park Ridge, IL
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Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Portland, OR
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Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Portland, OR
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Toledo, Ohio 43606
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Toledo, OH
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