Clinical trial NCT01058083: Safety Study of BMS-770767 in Subjects With Hypercholesterolemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-01-28
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

This list is not inclusive additional information is provided in the protocol

Primary outcomes:
measure: Lowering of LDL-C
timeFrame: Within 28 days following dosing
Secondary outcomes:
measure: Pharmacokinetics (Blood Level) of BMS-770767
timeFrame: Within 28 days following dosing
measure: 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)
timeFrame: Within 28 days following dosing
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Harrell, Robert
state: Arkansas
city: San Antonio
country: United States
facility: Cetero Research - San Antonio
state: Texas
city: Blacktown
country: Australia
facility: Local Institution
state: New South Wales
city: Hornsby
country: Australia
facility: Local Institution
state: New South Wales
city: Caboolture
country: Australia
facility: Local Institution
state: Queensland
city: South Brisbane
country: Australia
facility: Local Institution
state: Queensland
city: Daw Park
country: Australia
facility: Local Institution
state: South Australia
city: Nedlands
country: Australia
facility: Local Institution
state: Western Australia
city: Bathurst
country: Canada
facility: Local Institution
state: New Brunswick
city: Brampton
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Charlottetown
country: Canada
facility: Local Institution
state: Prince Edward Island
city: Mirabel
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: