At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 66 enrolled
Drug / intervention
Valsartandrug
Likely dose
Not stated in 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.
An Open Label Extension Study to Evaluate Safety, Tolerability, and Efficacy of 18 Weeks of Valsartan Treatment in Children 6 Months-5 Years Old With Hypertension
In Brief
A Phase 3 clinical trial evaluating Valsartan for Hypertension. Completed, enrolled 66 participants across 36 sites in 10 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesBelgium, Brazil, France, Hungary, India, Italy, Poland, South Africa, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2007
Enrollment StartApr 2007
Primary CompletionMay 2009
TodayJul 2026
First PostedApr 6, 2007
Enrollment StartApr 9, 2007
Primary CompletionMay 25, 2009
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.2 years ago
Interventions
Valsartandrug
Extemporaneous suspension of valsartan, orally.