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NCT00474630 · ClinicalTrials.gov registry record · Phase 3

A Safety and Efficacy Study Comparing Naltrexone SR/Bupropion SR and Placebo in Obese Subjects With Type 2 Diabetes

A Phase 3 study of Obesity and Diabetes Mellitus, Type 2, sponsored by Orexigen Therapeutics.

Completed
Registry status
Phase 3
Development phase
505
Enrollment target
20
Study locations

NCT00474630 is a Phase 3 study of Obesity and Diabetes Mellitus, Type 2 that has completed, run by Orexigen Therapeutics. The registered enrollment target is 505 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT00474630, a Phase 3 study of Obesity and Diabetes Mellitus, Type 2, has completed, sponsored by Orexigen Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
505 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is determine whether the combination of naltrexone SR and bupropion SR is safe and effective in treating obesity in subjects with type 2 diabetes.

Conditions Studied

Obesity Diabetes Mellitus, Type 2 Overweight

Interventions

  • DRUG Placebo
  • DRUG Naltrexone SR 32 mg/bupropion SR 360 mg/ day
  • BEHAVIORAL Ancillary therapy

Study Locations (20)

California

  • Impact Clinical Trials - Beverly Hills
  • Northern California Research - Carmichael
  • Sierra Medical Research - Fresno
  • Advance Clinical Research Institute - Orange
  • Affiliated Research Institute - San Diego
  • VA San Diego Healthcare System - San Diego
  • Apex Research Institue - Santa Ana

Florida

  • LCFP Inc. - Fort Myers
  • Miami Research Associates - Miami
  • Suncoast Clinical Research - Palm Harbor
  • University Clinical Research - Pembroke Pines

Arizona

  • Pivotal Research Centers - Peoria
  • HOPE Research Institute - Phoenix

Indiana

  • Deaconess Clinic - Evansville
  • Northwest Indiana Center for Clinical Research - Valparaiso

Alabama

  • SelfCenter, PC - Fairhope

Arkansas

  • HealthStar Research - Hot Springs

Connecticut

  • Chase Medical Research, LLC - Waterbury

Georgia

  • CSRA Partners in Health, Inc - Augusta

Trial Details

FieldValue
Enrollment Target 505 participants
Start Date 2007-05
Est. Completion 2009-06
Phase Phase 3

Sponsor

Orexigen Therapeutics

17 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00474630

The ClinicalTrials.gov registry entry for NCT00474630 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 505 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (38% lower). The listed sponsor is Orexigen Therapeutics, which has 17 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00474630 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT00474630 about?

NCT00474630 is a clinical study titled "A Safety and Efficacy Study Comparing Naltrexone SR/Bupropion SR and Placebo in Obese Subjects With Type 2 Diabetes". The purpose of this study is determine whether the combination of naltrexone SR and bupropion SR is safe and effective in treating obesity in subjects with type 2 diabetes.

What is the current status of trial NCT00474630?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 505 participants. The study started on 2007-05. Estimated completion is 2009-06.

What conditions does trial NCT00474630 study?

This clinical trial studies the following conditions: Obesity, Diabetes Mellitus, Type 2, Overweight.

What interventions are being tested in trial NCT00474630?

The interventions under investigation include: Placebo (DRUG), Naltrexone SR 32 mg/bupropion SR 360 mg/ day (DRUG), Ancillary therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT00474630?

This trial is sponsored by Orexigen Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00474630 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. 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.