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Safety Study of BMS-770767 in Subjects With Hypercholesterolemia

Phase 2
Completed
Conditions
Dyslipidemia
Interventions
Drug: BMS-770767
Drug: 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

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
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
NameTimeMethod
Lowering of LDL-CWithin 28 days following dosing
Secondary Outcome Measures
NameTimeMethod
Pharmacokinetics (Blood Level) of BMS-770767Within 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

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