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NCT00554216 · ClinicalTrials.gov registry record · Phase 3

Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults

A Phase 3 study of Obesity, sponsored by VIVUS.

Completed
Registry status
Phase 3
Development phase
1,267
Enrollment target
5
Study locations

NCT00554216 is a Phase 3 study of Obesity that has completed, run by VIVUS. The registered enrollment target is 1,267 participants, above the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (55% higher). The trial reports 5 study locations across 5 states.

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The verdict

NCT00554216, a Phase 3 study of Obesity, has completed, sponsored by VIVUS.

COMPLETED
Registry status
Phase 3
Development phase
1,267 participants
Enrollment target
5
Study locations

Study Summary

The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.

Conditions Studied

Interventions

  • DRUG VI-0521
  • DRUG Placebo matched phentermine/topiramate

Study Locations (5)

California

  • Research Site - San Diego

Connecticut

  • Research - Ridgefield

North Carolina

  • Research Site - Durham

Ohio

  • Research Site - Toledo

Texas

  • Research Site - Austin

Trial Details

FieldValue
Enrollment Target 1,267 participants
Start Date 2007-11
Est. Completion 2009-05
Phase Phase 3

Sponsor

VIVUS

35 total trials

What the Registry Record Tells You About NCT00554216

The ClinicalTrials.gov registry entry for NCT00554216 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,267 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (55% higher). The listed sponsor is VIVUS, which has 35 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which VI-0521 is the first listed.

NCT00554216 reports 5 study locations spanning 5 distinct geographic areas - top geographies include California, Connecticut, North Carolina.

Frequently Asked Questions

What is clinical trial NCT00554216 about?

NCT00554216 is a clinical study titled "Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults". The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.

What is the current status of trial NCT00554216?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,267 participants. The study started on 2007-11. Estimated completion is 2009-05.

What conditions does trial NCT00554216 study?

This clinical trial studies the following conditions: Obesity.

What interventions are being tested in trial NCT00554216?

The interventions under investigation include: VI-0521 (DRUG), Placebo matched phentermine/topiramate (DRUG).

Who is sponsoring clinical trial NCT00554216?

This trial is sponsored by VIVUS, which has 35 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00554216 being conducted?

This trial has 5 study locations across California, Connecticut, North Carolina, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.