CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 793 enrolled
Drug / intervention
Naltrexone SR 32 mg/ bupropion SR 360 mg/ day +2 moredrug
Likely dose
Naltrexone SR 32 mg/ bupropion SR 360 mg/ dayfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00456521
NCT00456521Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Naltrexone Sustained Release (SR)/Bupropion SR and Placebo in Subjects With Obesity Participating in a Behavior Modification Program

Orexigen Therapeutics, Inc·interventional·Posted Apr 5, 2007·Updated Dec 17, 2014

In Brief

A Phase 3 clinical trial evaluating Naltrexone SR 32 mg/ bupropion SR 360 mg/ day, Placebo, and 1 other intervention for Obesity and Overweight. Completed, enrolled 793 participants across 9 sites.

Detailed Summary

The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in treating obesity and leads to greater weight loss when given with a group lifestyle modification program than with group lifestyle modification alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Overweight
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 5, 2007
Enrollment StartMar 1, 2007
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.2 years ago

Interventions

Naltrexone SR 32 mg/ bupropion SR 360 mg/ daydrug

Placebodrug

Intensive group lifestyle modification counselingbehavioral