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| Sponsor: | Orexigen Therapeutics, Inc |
|---|---|
| Information provided by: | Orexigen Therapeutics, Inc |
| ClinicalTrials.gov Identifier: | NCT00532779 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: naltrexone SR/bupropion SR |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3 Study Comparing the Safety and Efficacy of Two Doses of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) and Placebo in Obese Subjects |
| Estimated Enrollment: | 1650 |
| Study Start Date: | September 2007 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group 1
Naltrexone SR 16 mg/Bupropion SR 360 mg /day
|
Drug: naltrexone SR/bupropion SR
naltrexone 16 mg/bupropion SR 360 mg/day naltrexone 32 mg/bupropion SR 360 mg/day
|
|
Active Comparator: Group 2
Naltrexone SR 32 mg/Bupropion SR 360 mg /day
|
Drug: naltrexone SR/bupropion SR
naltrexone 16 mg/bupropion SR 360 mg/day naltrexone 32 mg/bupropion SR 360 mg/day
|
|
Placebo Comparator: Group 3
Placebo
|
Drug: naltrexone SR/bupropion SR
naltrexone 16 mg/bupropion SR 360 mg/day naltrexone 32 mg/bupropion SR 360 mg/day
|
Two Phase II clinical trials have 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 will investigate 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 obesity and hypertension and/or dyslipidemia.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 34 Study Locations| Principal Investigator: | Frank Greenway, MD | Pennington Biomedical Research Center, Baton Rouge, Louisiana |
More Information
| Responsible Party: | Eduardo Dunayevich, MD, Orexigen Therapeutics, Inc |
| ClinicalTrials.gov Identifier: | NCT00532779 History of Changes |
| Other Study ID Numbers: | NB-301 |
| Study First Received: | September 19, 2007 |
| Last Updated: | February 4, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Obesity |
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Naltrexone Bupropion Narcotic Antagonists Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents |
Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors |