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NCT02714062 · ClinicalTrials.gov registry record · Phase 4
A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents
A Phase 4 study of Pediatric Obesity and Childhood Obesity, sponsored by VIVUS.
- Completed
- Registry status
- Phase 4
- Development phase
- 42
- Enrollment target
- 4
- Study locations
NCT02714062: Completed Phase 4 study of Pediatric Obesity and Childhood Obesity, sponsored by VIVUS.
NCT02714062 is a Phase 4 study of Pediatric Obesity and Childhood Obesity that has completed, run by VIVUS. The registered enrollment target is 42 participants, below the 229-participant average among 45 other Pediatric Obesity trials with a reported enrollment target (82% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02714062, a Phase 4 study of Pediatric Obesity and Childhood Obesity, has completed, sponsored by VIVUS.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 42 participants
- Enrollment target
- 4
- Study locations
Study Summary
The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in obese adolescents.
Primary Outcome
A Bayesian analysis was performed to derive posterior Bayes individual pharmacokinetic (PK) parameters.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG VI-0521 Mid Dose
- DRUG VI-0521 Top Dose
Study Locations (4)
Louisiana
- Research Facility - Baton Rouge
- Research Facility - Marrero
Ohio
- Research Facility - Cincinnati
South Carolina
- Research Facility - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2016-03 |
| Est. Completion | 2016-11 |
| Phase | Phase 4 |
What the finished NCT02714062 record still lists
NCT02714062 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 229-participant average among 45 other Pediatric Obesity trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Pediatric Obesity appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02714062 reports a single indexed study location in Louisiana, Ohio, South Carolina.
Frequently Asked Questions
What is clinical trial NCT02714062 about?
NCT02714062 is a clinical study titled "A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents". The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in obese adolescents.
What is the current status of trial NCT02714062?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 42 participants. The study started on 2016-03. Estimated completion is 2016-11.
What conditions does trial NCT02714062 study?
This clinical trial studies the following conditions: Pediatric Obesity, Childhood Obesity.
What interventions are being tested in trial NCT02714062?
The interventions under investigation include: Placebo (DRUG), VI-0521 Mid Dose (DRUG), VI-0521 Top Dose (DRUG).
Who is sponsoring clinical trial NCT02714062?
This trial is sponsored by VIVUS, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02714062 being conducted?
This trial has 4 study locations across Louisiana, Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02714062's enrollment target sits among peer trials
42 34th of 45 higher than 12 of 45 other Pediatric Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pediatric Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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