Clinical trial NCT01112423: Safety Study of BMS-823778 in Subjects With Hypercholesterolemia
Official title: A Double-Blind, Placebo-Controlled, Parallel-Group, Randomized, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of BMS-823778 in Non-Diabetic Subjects With Primary Hypercholesterolemia on a Stable Dose of Statin Therapy With or Without Ezetimibe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-04-28
Enrollment: 60
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 (measuring trough concentrations)
timeFrame: On days 7, 14, and 28
measure: Pharmacodynamic effects of BMS-823778 on Total cholesterol, HDL-C, Triglycerides, non-HDL-C, 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: Osborne Research Center
state: Arkansas
city: Lenexa
country: United States
facility: Pra International
state: Kansas
city: Cincinnati
country: United States
facility: Sterling Research Grp, Ltd.
state: Ohio
city: San Antonio
country: United States
facility: Cetero Research - San Antonio
state: Texas
city: Norfolk
country: United States
facility: National Clinical Research - Norfolk, Inc.
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research - Richmond, Inc.
state: Virginia
city: Brisbane
country: Australia
facility: Local Institution
state: Queensland
city: Winnipeg
country: Canada
facility: Local Institution
state: Manitoba
city: Mount Pearl
country: Canada
facility: Local Institution
state: Newfoundland and Labrador
city: London
country: Canada
facility: Local Institution
state: Ontario
city: Drummondville
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: