A Double-blind, Placebo-Controlled, Parallel-Group, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Effects of BMS-770767 in Subjects With Primary Hypercholesterolemia

Bristol-Myers Squibb3 sites in 2 countries81 target enrollmentMay 2010

ConditionsDyslipidemia

InterventionsBMS-770767 Placebo

DrugsBMS-770767 Placebo

Overview

Phase: Phase 2
Intervention: BMS-770767
Conditions: Dyslipidemia
Sponsor: Bristol-Myers Squibb
Enrollment: 81
Locations: 3
Primary Endpoint: Lowering of LDL-C
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

March 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

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

Exclusion Criteria

Not provided

Arms & Interventions

BMS-770767 (Treatment A)

Intervention: BMS-770767

BMS-770767 (Treatment B)

Intervention: BMS-770767

BMS-770767 (Treatment C)

Intervention: BMS-770767

BMS-770767 (Treatment D)

Intervention: BMS-770767

Placebo (Treatment E)

Intervention: Placebo

Outcomes

Primary Outcomes

Lowering of LDL-C

Time Frame: Within 28 days following dosing

Secondary Outcomes

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)