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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 is a Phase 3 study that has completed, run by VIVUS. The registered enrollment target is 756 participants.

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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.

Interventions

  • DRUG VI-0521
  • DRUG topiramate
  • DRUG phentermine

Trial Details

FieldValue
Enrollment Target 756 participants
Start Date 2007-12
Est. Completion 2008-09
Phase Phase 3

Sponsor

VIVUS

35 total trials

What the Registry Record Tells You About NCT00563368

The ClinicalTrials.gov registry entry for NCT00563368 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 756 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 3 interventions - of which VI-0521 is the first listed.

NCT00563368 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.