Status:
TERMINATED
Multiple-dose Study to Evaluate the Efficacy, Safety and Pharmacokinetics of BMS-646256 in Obese Subjects
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Solvay Pharmaceuticals
Conditions:
Obesity
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to learn if BMS-646256 can cause weight loss in men and women who are: * overweight with high blood pressure or high cholesterol or * obese The safety of this treatment ...
Eligibility Criteria
Inclusion
- Men and women, ages ≥18 to ≤70 years old with a Body Mass Index (BMI) ≥30 to ≤45 kg/m² OR BMI \>27 to \<30 kg/m² with hypertension and/or dyslipidemia defined as:
- 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
- Type 1 or 2 diabetes mellitus
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
705 Patients enrolled
Trial Details
Trial ID
NCT00388609
Start Date
November 1 2006
End Date
April 1 2009
Last Update
September 17 2010
Active Locations (10)
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1
Ucla Center For Human Nutrition
Los Angeles, California, United States, 90095
2
Domenica M. Rubino, Md
Washington D.C., District of Columbia, United States, 20037
3
Csra Partners In Health, Inc
Augusta, Georgia, United States, 30909
4
Springfield Diabetes And Endocrine Center
Springfield, Illinois, United States, 62704