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NCT00806260 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects.
A Phase 2 study, sponsored by VIVUS.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT00806260: Completed Phase 2 study, sponsored by VIVUS.
NCT00806260 is a Phase 2 study that has completed, run by VIVUS. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00806260, a Phase 2 study, has completed, sponsored by VIVUS.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
The purpose of this study is to determine how VI-0521 affect speed and reaction time on specific tasks that require eye and hand coordination, compared to placebo.
Primary Outcome
CogScreen-Psychomotor Edition (CogScreen-PM) consists of a series of computerized cognitive tasks, each self-contained and presented with instructions and a practice segment. The test battery takes about 20-25 minutes to perform. Performance on the test will be measured as the median reaction time for correct responses (PFNRTC) and coordination errors (PFNCOOR) before and after treatment. The measures of the tests are: (a) response speed, the median response time to complete each sequential ste
Interventions
- DRUG Placebo
- OTHER Alcohol
- DRUG VI-0521
- OTHER alcohol placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2008-12 |
| Est. Completion | 2009-05 |
| Phase | Phase 2 |
What the finished NCT00806260 record still lists
NCT00806260 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00806260 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00806260 about?
NCT00806260 is a clinical study titled "A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects.". The purpose of this study is to determine how VI-0521 affect speed and reaction time on specific tasks that require eye and hand coordination, compared to placebo.
What is the current status of trial NCT00806260?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2008-12. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00806260?
The interventions under investigation include: Placebo (DRUG), Alcohol (OTHER), VI-0521 (DRUG), alcohol placebo (OTHER).
Who is sponsoring clinical trial NCT00806260?
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 NCT00806260's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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