Safety Study of BMS-770767 in Subjects With Hypercholesterolemia
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-770767
BMS-770767
BMS-770767
BMS-770767
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia
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
Sites / Locations
- Harrell, Robert
- Cetero Research - San Antonio
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
BMS-770767 (Treatment A)
BMS-770767 (Treatment B)
BMS-770767 (Treatment C)
BMS-770767 (Treatment D)
Placebo (Treatment E)
Arm Description
Outcomes
Primary Outcome Measures
Lowering of LDL-C
Secondary Outcome Measures
Pharmacokinetics (Blood Level) of BMS-770767
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01058083
Brief Title
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
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMS-770767 (Treatment A)
Arm Type
Experimental
Arm Title
BMS-770767 (Treatment B)
Arm Type
Experimental
Arm Title
BMS-770767 (Treatment C)
Arm Type
Experimental
Arm Title
BMS-770767 (Treatment D)
Arm Type
Experimental
Arm Title
Placebo (Treatment E)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-770767
Intervention Description
Active, Oral, 15 mg, Daily, 28 days
Intervention Type
Drug
Intervention Name(s)
BMS-770767
Intervention Description
Active, Oral, 50 mg, Daily, 28 days
Intervention Type
Drug
Intervention Name(s)
BMS-770767
Intervention Description
Active, Oral, 150 mg, Daily, 28 days
Intervention Type
Drug
Intervention Name(s)
BMS-770767
Intervention Description
Active, Oral, 50 mg BID, Daily, 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, Oral, 0 mg, daily, 28 days
Primary Outcome Measure Information:
Title
Lowering of LDL-C
Time Frame
Within 28 days following dosing
Secondary Outcome Measure Information:
Title
Pharmacokinetics (Blood Level) of BMS-770767
Time Frame
Within 28 days following dosing
Title
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)
Time Frame
Within 28 days following dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Harrell, Robert
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
Facility Name
Cetero Research - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Local Institution
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
Local Institution
City
Hornsby
State/Province
New South Wales
ZIP/Postal Code
2077
Country
Australia
Facility Name
Local Institution
City
Caboolture
State/Province
Queensland
ZIP/Postal Code
4510
Country
Australia
Facility Name
Local Institution
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Local Institution
City
Daw Park
State/Province
South Australia
ZIP/Postal Code
5041
Country
Australia
Facility Name
Local Institution
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6004
Country
Australia
Facility Name
Local Institution
City
Bathurst
State/Province
New Brunswick
ZIP/Postal Code
E2A 4X7
Country
Canada
Facility Name
Local Institution
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 3J1
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M8V 3X8
Country
Canada
Facility Name
Local Institution
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 5Y9
Country
Canada
Facility Name
Local Institution
City
Mirabel
State/Province
Quebec
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3J 2V5
Country
Canada
12. IPD Sharing Statement
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Safety Study of BMS-770767 in Subjects With Hypercholesterolemia
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