CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,742 enrolled
Drug / intervention
Naltrexone SR 16 mg/Bupropion SR 360 mg /day +3 moredrug
Likely dose
Naltrexone SR 16 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/NCT00532779
NCT00532779Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Two Doses of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) and Placebo in Obese Subjects

Orexigen Therapeutics, Inc·interventional·Posted Sep 20, 2007·Updated Nov 21, 2014

In Brief

A Phase 3 clinical trial evaluating Naltrexone SR 16 mg/Bupropion SR 360 mg /day, Naltrexone SR 32 mg/Bupropion SR 360 mg /day, and 2 other interventions for Obesity and Overweight. Completed, enrolled 1,742 participants across 34 sites.

Detailed Summary

The purpose of this study is to determine whether 2 doses of the combination of naltrexone SR and bupropion SR are safe and effective in the treatment of obesity.

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2007
Enrollment StartOct 1, 2007
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.8 years ago

Interventions

Naltrexone SR 16 mg/Bupropion SR 360 mg /daydrug

Naltrexone SR 32 mg/Bupropion SR 360 mg /daydrug

Placebodrug

Ancillary therapybehavioral

Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling