Multiple-dose Study to Evaluate the Efficacy, Safety and Pharmacokinetics of BMS-646256 in Obese Subjects
NCT ID: NCT00388609
Last Updated: 2010-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
705 participants
INTERVENTIONAL
2006-11-30
2009-04-30
Brief Summary
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* overweight with high blood pressure or high cholesterol or
* obese
The safety of this treatment will also be studied
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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T
5 mg (ST) to 50 mg (LT)
BMS-646256
Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
U
10 mg (ST) to 50 mg (LT)
BMS-646256
Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
V
25 mg (ST) to 50 mg (LT)
BMS-646256
Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
W
50 mg (ST and LT)
BMS-646256
Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
X
25 mg/d (X1 wk), 5 mg/d (X11 wks) (ST) to 50 mg (LT)
BMS-646256
Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
Z
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)
BMS-646256
Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
Y
0 mg (ST and LT)
Placebo
Tablet, Oral, Once daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
Interventions
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BMS-646256
Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
Placebo
Tablet, Oral, Once daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
Eligibility Criteria
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Inclusion Criteria
* Hypertension defined as treatment with an antihypertensive agent or mean systolic blood pressure ≥140 and ≤160 mmHg and/or diastolic blood pressure ≥ 90 and ≤ 105 mmHg
* Dyslipidemia defined as stable dose treatment with a statin, fibrate or ezetimibe for ≥ 6 weeks and/or triglycerides ≥ 150 and ≤ 600 mg/dL, LDL ≥ 130 and ≤ 300 mg/dL, or HDL \< 40 mg/dL
Exclusion Criteria
* history of MI in the prior 6 months
* history of heart failure
* history of symptomatic arrhythmia
* active hepatic disease
* any documented muscle disease
* history of neurological symptoms or disease (including but not limited to tremor, ataxia, dizziness, neuropathy, or episodes of confusion, history of seizures, stroke or TIA)
* known history of major psychiatric conditions (e.g. schizophrenia anxiety disorder, dementia or bipolar disorder as defined by DSM IV criteria)
* history of depression or suicide attempt or ideation
* previous history of surgical procedures for weight loss (e.g., stomach stapling, bypass)
* uncontrolled blood pressure
18 Years
70 Years
ALL
No
Sponsors
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Solvay Pharmaceuticals
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Ucla Center For Human Nutrition
Los Angeles, California, United States
Domenica M. Rubino, Md
Washington D.C., District of Columbia, United States
Csra Partners In Health, Inc
Augusta, Georgia, United States
Springfield Diabetes And Endocrine Center
Springfield, Illinois, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
The Center For Nutrition & Preventive Medicine, Pllc
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Medical University Of South Carolina
Charleston, South Carolina, United States
Hampton Roads Center For Clinical Research Inc.
Norfolk, Virginia, United States
National Clinical Research, Inc.
Richmond, Virginia, United States
Countries
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Other Identifiers
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MB109-007
Identifier Type: -
Identifier Source: org_study_id