Conditions: Obesity Overweight
Keywords: Obesity Antiobesity agents Antiobesity drugs Overweight drug therapy Obese drug therapy Weight loss drug effects Bupropion administration and dosage Naltrexone administration and dosage Double blind method Combination drug therapy Delayed action preparations
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1742
Healthy volunteers: no

Brief 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.

Detailed description:
Two Phase II clinical trials demonstrated that a combination of bupropion SR and naltrexone is associated with greater weight loss than bupropion SR alone, naltrexone alone, or placebo in subjects with uncomplicated obesity. The current study investigated the safety and efficacy of 2 doses of the combination of naltrexone SR and bupropion SR compared to placebo in obese subjects with uncomplicated obesity and in those with overweight/obesity and hypertension and/or dyslipidemia.

Arms:
arm 1: Naltrexone SR 16 mg/Bupropion SR 360 mg /day with ancillary therapy arm 2: Naltrexone SR 32 mg/Bupropion SR 360 mg /day with ancillary therapy arm 3: Placebo with ancillary therapy

Interventions: intervention 1: Naltrexone SR 16 mg/Bupropion SR 360 mg /day intervention 2: Naltrexone SR 32 mg/Bupropion SR 360 mg /day intervention 3: Placebo intervention 4: Ancillary therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling

Protocol document: