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Clinical trial

A Safety and Efficacy Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects

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Last updated:1st Dec 2007

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 Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Enrollment: 1496
Study Start Date: December 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

- Experimental:
Naltrexone SR 32 mg/bupropion SR 360 mg/day with ancillary therapy
- Placebo Comparator: Placebo
Placebo with ancillary therapy

Category Value
Study start date 2007-12-01

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