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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).
Age
6 - 17 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
August 1, 2010
Primary Completion Date
August 1, 2015
Completion Date
August 1, 2015
Last Updated
March 7, 2016
208
ACTUAL participants
Aliskiren
DRUG
Enalapril
DRUG
Lead Sponsor
Novartis Pharmaceuticals
NCT02417740
NCT07073820
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07480265