At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 127 enrolled
Drug / intervention
VAL489 +1 moredrug
Likely dose
VAL489 3mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating VAL489 and VAL489 matching placebo for Pediatric Hypertension With or Without CKD. Completed, enrolled 127 participants across 27 sites in 9 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Brazil, France, Germany, Guatemala, Hungary, Italy, Lithuania, Poland
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartNov 2012
Primary CompletionJan 2017
TodayJul 2026
First PostedJun 12, 2012
Enrollment StartNov 8, 2012
Primary CompletionJan 24, 2017
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 14.1 years ago
Interventions
VAL489drug
Valsartan 3mg/kg oral solution
VAL489 matching placebodrug
Valsartan 3 mg/kg oral solution