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NCT00563368 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults
A Phase 3 study, sponsored by VIVUS.
- Completed
- Registry status
- Phase 3
- Development phase
- 756
- Enrollment target
NCT00563368: Completed Phase 3 study, sponsored by VIVUS.
NCT00563368 is a Phase 3 study that has completed, run by VIVUS. The registered enrollment target is 756 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00563368, a Phase 3 study, has completed, sponsored by VIVUS.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 756 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose.
Primary Outcome
Percent weight loss from baseline to Week 28 with last observation carried forward (LOCF)
Interventions
- DRUG VI-0521
- DRUG topiramate
- DRUG phentermine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 756 participants |
| Start Date | 2007-12 |
| Est. Completion | 2008-09 |
| Phase | Phase 3 |
What the finished NCT00563368 record still lists
NCT00563368 is an interventional study that assigns participants to a tested intervention. The registered 756 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which VI-0521 is the first listed.
NCT00563368 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00563368 about?
NCT00563368 is a clinical study titled "A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults". The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater t...
What is the current status of trial NCT00563368?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 756 participants. The study started on 2007-12. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00563368?
The interventions under investigation include: VI-0521 (DRUG), topiramate (DRUG), phentermine (DRUG).
Who is sponsoring clinical trial NCT00563368?
This trial is sponsored by VIVUS, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00563368's enrollment target sits among peer trials
756 457th of 2000 higher than 1,542 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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