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Sponsors and Collaborators: |
Bristol-Myers Squibb Solvay Pharmaceuticals |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00388609 |
The purpose of this study is to learn if BMS-646256 can cause weight loss in men and women who are:
The safety of this treatment will also be studied
Condition | Intervention | Phase |
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Obesity |
Drug: BMS-646256 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multiple-Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BMS-646256 in Obese and High Risk Overweight Subjects |
Enrollment: | 705 |
Study Start Date: | November 2006 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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T: Experimental
5 mg (ST) to 50 mg (LT)
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Drug: BMS-646256
Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
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U: Experimental
10 mg (ST) to 50 mg (LT)
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Drug: BMS-646256
Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
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V: Experimental
25 mg (ST) to 50 mg (LT)
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Drug: BMS-646256
Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
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W: Experimental
50 mg (ST and LT)
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Drug: BMS-646256
Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
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X: Experimental
25 mg/d (X1 wk), 5 mg/d (X11 wks) (ST) to 50 mg (LT)
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Drug: BMS-646256
Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
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Z: Experimental
Open label: 50 mg/d (X 4 wks) 100 mg/wk (X8 wks) (ST) to 50 mg (LT) Once daily (x 4 weeks), once daily (x 8 weeks) |
Drug: BMS-646256
Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
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Y: Placebo Comparator
0 mg (ST and LT)
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Drug: Placebo
Tablet, Oral, Once daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Ucla Center For Human Nutrition | |
Los Angeles, California, United States, 90095 | |
United States, District of Columbia | |
Domenica M. Rubino, Md | |
Washington, District of Columbia, United States, 20037 | |
United States, Georgia | |
Csra Partners In Health, Inc | |
Augusta, Georgia, United States, 30909 | |
United States, Illinois | |
Springfield Diabetes And Endocrine Center | |
Springfield, Illinois, United States, 62704 | |
United States, Louisiana | |
Pennington Biomedical Research Center | |
Baton Rouge, Louisiana, United States, 70808 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
The Center For Nutrition & Preventive Medicine, Pllc | |
Charlotte, North Carolina, United States, 28211 | |
United States, South Carolina | |
Medical University Of South Carolina | |
Charleston, South Carolina, United States, 29425 | |
United States, Virginia | |
National Clinical Research, Inc. | |
Richmond, Virginia, United States, 23294 | |
Hampton Roads Center For Clinical Research Inc. | |
Norfolk, Virginia, United States, 23502 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | MB109-007 |
Study First Received: | October 5, 2006 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00388609 |
Health Authority: | United States: Food and Drug Administration |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overnutrition Overweight |