Safety Study of BMS-770767 in Subjects With Hypercholesterolemia
Phase 2
Completed
- Conditions
- Dyslipidemia
- Interventions
- Drug: BMS-770767Drug: Placebo
- Registration Number
- NCT01058083
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
Inclusion Criteria
- Hypercholesterolemia
- Currently taking a stable daily dose of statin therapy
- Serum triglyceride level < 500mg/dl
Exclusion Criteria
- History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study
- Congestive heart failure
- Diabetes mellitus
- Active liver disease
- Impaired renal function
- Hepatitis C, B and HIV
This list is not inclusive additional information is provided in the protocol
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-770767 (Treatment A) BMS-770767 - BMS-770767 (Treatment B) BMS-770767 - BMS-770767 (Treatment C) BMS-770767 - BMS-770767 (Treatment D) BMS-770767 - Placebo (Treatment E) Placebo -
- Primary Outcome Measures
Name Time Method Lowering of LDL-C Within 28 days following dosing
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (Blood Level) of BMS-770767 Within 28 days following dosing Pharmacodynamic effects of BMS-770767 on Total cholesterol, HDL-C, Triglycerides, non-HDL-C, non-esterified free fatty acids, Apolipoprotein fractions, HPA axis marker and free testosterone and sex hormone binding globulin (SHBG) Within 28 days following dosing
Trial Locations
- Locations (3)
Cetero Research - San Antonio
🇺🇸San Antonio, Texas, United States
Local Institution
🇨🇦Montreal, Quebec, Canada
Harrell, Robert
🇺🇸Little Rock, Arkansas, United States