At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 42 enrolled
Drug / intervention
Placebo +2 moredrug
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.
A Randomized, Double-Blind, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study of VI-0521 in Obese Adolescents
In Brief
A Phase 4 clinical trial evaluating Placebo, VI-0521 Mid Dose, and 1 other intervention for Pediatric Obesity and Childhood Obesity. Completed, enrolled 42 participants across 4 sites.
Detailed Summary
The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in obese adolescents.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPediatric Obesity, Childhood Obesity
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMar 2016
First PostedMar 2016
Primary CompletionOct 2016
Study CompletionNov 2016
TodayJul 2026
First PostedMar 21, 2016
Enrollment StartMar 1, 2016
Primary CompletionOct 1, 2016
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.3 years ago
Interventions
Placebodrug
po once daily
VI-0521 Mid Dosedrug
po once daily
VI-0521 Top Dosedrug
po once daily