At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,496 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.
A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) and Placebo in Obese Subjects
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 1,496 participants across 36 sites.
Detailed Summary
The purpose of this study is to determine whether the combination of naltrexone SR and bupropion SR is 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
Enrollment StartDec 2007
First PostedDec 2007
Primary CompletionJun 2009
TodayJul 2026
First PostedDec 4, 2007
Enrollment StartDec 1, 2007
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.6 years ago
Interventions
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