At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 74 enrolled
Drug / intervention
Valsartan 0.25 mg/kg +2 moredrug
Likely dose
Valsartan 0.25 mg/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 Randomized, Multicenter, Double-blind, 6 Week Study to Evaluate the Dose Response of Valsartan on Blood Pressure Reduction in Children 6 Months - 5 Years Old With Hypertension, Followed by a 2 Week Placebo Withdrawal Period.
In Brief
A Phase 3 clinical trial evaluating Valsartan 0.25 mg/kg, Valsartan 1.0 mg/kg, and 1 other intervention for Hypertension. Completed, enrolled 74 participants across 11 sites in 11 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure \[SSBP\] ≥ 95th percentile ).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesBelgium, Brazil, France, Hungary, India, Italy, Poland, South Africa, Sweden, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2007
Enrollment StartMar 2007
Primary CompletionJan 2009
TodayJul 2026
First PostedFeb 14, 2007
Enrollment StartMar 1, 2007
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.4 years ago
Interventions
Valsartan 0.25 mg/kgdrug
once daily
Valsartan 1.0 mg/kgdrug
once daily
Valsartan 4.0 mg/kgdrug
once daily