Trials / Completed
CompletedNCT02714062
A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents
A Randomized, Double-Blind, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study of VI-0521 in Obese Adolescents
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- VIVUS LLC · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in obese adolescents.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | po once daily |
| DRUG | VI-0521 Mid Dose | po once daily |
| DRUG | VI-0521 Top Dose | po once daily |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2016-10-01
- Completion
- 2016-11-01
- First posted
- 2016-03-21
- Last updated
- 2022-08-23
- Results posted
- 2018-02-05
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02714062. Inclusion in this directory is not an endorsement.