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A 6 Week, Randomized, Multicenter, Double-blind, Double-dummy Study to Evaluate the Dose Response of Valsartan on Blood Pressure Reduction in Children 1-5 Years Old With Hypertension, With or Without Chronic Kidney Disease, Followed by a 20 Week Open-label Titration Phase
To assess efficacy, safety and tolerability of valsartan when comparing two doses of valsartan in reducing and controlling blood pressure in children with hypertension with or without CKD.
Age
1 - 5 years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Antwerp, Belgium
Novartis Investigative Site
Liège, Belgium
Novartis Investigative Site
Curitibia, Paraná, Brazil
Novartis Investigative Site
Campinas, Brazil
Novartis Investigative Site
Caxias do Sul, Brazil
Novartis Investigative Site
Porto Alegre, Brazil
Novartis Investigative Site
Montpellier, France
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Marburg, Germany
Novartis Investigative Site
Guatemala City, Guatemala
Start Date
November 8, 2012
Primary Completion Date
January 24, 2017
Completion Date
January 24, 2017
Last Updated
September 27, 2017
127
ACTUAL participants
VAL489
DRUG
VAL489 matching placebo
DRUG
Lead Sponsor
Novartis Pharmaceuticals
Data Source & Attribution
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