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NCT00745251 · ClinicalTrials.gov registry record · Phase 1
A Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults
A Phase 1 study, sponsored by VIVUS.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT00745251: Completed Phase 1 study, sponsored by VIVUS.
NCT00745251 is a Phase 1 study that has completed, run by VIVUS. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00745251, a Phase 1 study, has completed, sponsored by VIVUS.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
The primary objectives of this study are to evaluate the safety and efficacy of VI-0521 compared to placebo in the treatment of obese adults with obstructive sleep apnea (OSA) and to assess the relative contributions of weight loss on parameters of OSA in these subjects.
Primary Outcome
AHI is calculated as the mean number of apnea or hypopnea episodes (each lasting a minimum of 10 second) observed per hour of sleep
Interventions
- DRUG placebo
- DRUG VI-0521
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2008-08 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
What the finished NCT00745251 record still lists
NCT00745251 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00745251 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00745251 about?
NCT00745251 is a clinical study titled "A Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults". The primary objectives of this study are to evaluate the safety and efficacy of VI-0521 compared to placebo in the treatment of obese adults with obstructive sleep apnea (OSA) and to assess the relative contributions of weight loss on parameters of OSA in these subjects.
What is the current status of trial NCT00745251?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2008-08. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00745251?
The interventions under investigation include: placebo (DRUG), VI-0521 (DRUG).
Who is sponsoring clinical trial NCT00745251?
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 NCT00745251's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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