At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 300 enrolled
Drug / intervention
Valsartan +1 moredrug
Likely dose
Valsartan 320 mgfrom 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 Multicenter, Randomized, Double-blind, Parallel-group, Evaluation of 12 Weeks of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children 6 to 17 Years of Age With Hypertension
In Brief
A Phase 3 clinical trial evaluating Valsartan and Enalapril for Hypertension. Completed, enrolled 300 participants across 11 sites in 11 countries.
Detailed Summary
The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with hypertension (SSBP ≥ 95th percentile for age gender and height).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesBelgium, France, Germany, Hungary, India, Italy, Poland, Slovakia, Sweden, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
First PostedFeb 2007
Primary CompletionFeb 2009
TodayJul 2026
First PostedFeb 12, 2007
Enrollment StartJan 1, 2007
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.4 years ago
Interventions
Valsartandrug
Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
Enalaprildrug
Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.