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NCT00768404 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Pharmacokinetics of VI-0521 Subjects With Renal Impairment
A Phase 1 study, sponsored by VIVUS.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT00768404: Completed Phase 1 study, sponsored by VIVUS.
NCT00768404 is a Phase 1 study that has completed, run by VIVUS. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00768404, a Phase 1 study, has completed, sponsored by VIVUS.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
VI-0521, a fixed dose combination of immediate-release (IR) phentermine and controlled-release (CR) topiramate, is in Phase III clinical development as a potential therapy for obesity. In human, both phentermine and topiramate are primarily cleared by renal excretion. The contribution of hepatic metabolism to elimination of phentermine and topiramate is not significant. Obese patients, the proposed indicated population for future treatment with VI-0521, are likely to have renal impairment. Therefore, this study is important in understanding the effect of renal impairment on the pharmacokinetics of topiramate and phentermine in subjects with renal impairment compared to subjects with normal renal function.
Interventions
- DRUG Topirmate and Phentermine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2008-10 |
| Est. Completion | 2009-07 |
| Phase | Phase 1 |
What the finished NCT00768404 record still lists
NCT00768404 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which Topirmate and Phentermine is the first listed.
NCT00768404 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00768404 about?
NCT00768404 is a clinical study titled "A Study to Evaluate the Pharmacokinetics of VI-0521 Subjects With Renal Impairment". VI-0521, a fixed dose combination of immediate-release (IR) phentermine and controlled-release (CR) topiramate, is in Phase III clinical development as a potential therapy for obesity. In human, both phentermine and topiramate are primarily cleared by renal excretion. The contribution of hepatic met...
What is the current status of trial NCT00768404?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2008-10. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00768404?
The interventions under investigation include: Topirmate and Phentermine (DRUG).
Who is sponsoring clinical trial NCT00768404?
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 NCT00768404's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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