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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 is a Phase 1 study that has completed, run by VIVUS. The registered enrollment target is 32 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00768404
The ClinicalTrials.gov registry entry for NCT00768404 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VIVUS, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Topirmate and Phentermine is the first listed.
NCT00768404 reports 0 study locations.
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.
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