At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 39 enrolled
Drug / intervention
Aliskiren 3.125 mini-tabletsdrug
Likely dose
Aliskiren 3.125 mini-tablets 3.125 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.
An 8-day Open-label, Multiple-dose, Multicenter Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age
In Brief
A Phase 2 clinical trial evaluating Aliskiren 3.125 mini-tablets for Hypertension. Completed, enrolled 39 participants across 5 sites in 5 countries.
Detailed Summary
This first open-label study in a pediatric population was designed to evaluate aliskiren safety and pharmacokinetics after single and multiple dosing in 6-17 year old children with hypertension.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesBelgium, Brazil, Hungary, Poland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2009
Enrollment StartApr 2009
Primary CompletionJan 2010
TodayJul 2026
First PostedFeb 3, 2009
Enrollment StartApr 1, 2009
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.4 years ago
Interventions
Aliskiren 3.125 mini-tabletsdrug
Oral mini-tablets (3.125 mg) of aliskiren once each morning