Safety Study of BMS-770767 in Subjects With Hypercholesterolemia
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01058083
First received: January 26, 2010
Last updated: April 18, 2012
Last verified: April 2012
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Purpose
The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)
| Condition | Intervention | Phase |
|---|---|---|
|
Dyslipidemia |
Drug: BMS-770767 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Lowering of LDL-C [ Time Frame: Within 28 days following dosing ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacokinetics (Blood Level) of BMS-770767 [ Time Frame: Within 28 days following dosing ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 81 |
| Study Start Date: | May 2010 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: BMS-770767 (Treatment A) |
Drug: BMS-770767
Active, Oral, 15 mg, Daily, 28 days
|
| Experimental: BMS-770767 (Treatment B) |
Drug: BMS-770767
Active, Oral, 50 mg, Daily, 28 days
|
| Experimental: BMS-770767 (Treatment C) |
Drug: BMS-770767
Active, Oral, 150 mg, Daily, 28 days
|
| Experimental: BMS-770767 (Treatment D) |
Drug: BMS-770767
Active, Oral, 50 mg BID, Daily, 28 days
|
| Placebo Comparator: Placebo (Treatment E) |
Drug: Placebo
Placebo, Oral, 0 mg, daily, 28 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058083
Locations
| United States, Arkansas | |
| Harrell, Robert | |
| Little Rock, Arkansas, United States, 72201 | |
| United States, Texas | |
| Cetero Research - San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| Australia, New South Wales | |
| Local Institution | |
| Blacktown, New South Wales, Australia, 2148 | |
| Local Institution | |
| Hornsby, New South Wales, Australia, 2077 | |
| Australia, Queensland | |
| Local Institution | |
| Caboolture, Queensland, Australia, 4510 | |
| Local Institution | |
| South Brisbane, Queensland, Australia, 4101 | |
| Australia, South Australia | |
| Local Institution | |
| Daw Park, South Australia, Australia, 5041 | |
| Australia, Western Australia | |
| Local Institution | |
| Nedlands, Western Australia, Australia, 6004 | |
| Canada, New Brunswick | |
| Local Institution | |
| Bathurst, New Brunswick, Canada, E2A 4X7 | |
| Canada, Ontario | |
| Local Institution | |
| Brampton, Ontario, Canada, L6T 3J1 | |
| Local Institution | |
| Toronto, Ontario, Canada, M8V 3X8 | |
| Canada, Prince Edward Island | |
| Local Institution | |
| Charlottetown, Prince Edward Island, Canada, C1A 5Y9 | |
| Canada, Quebec | |
| Local Institution | |
| Mirabel, Quebec, Canada, J7J 2K8 | |
| Local Institution | |
| Montreal, Quebec, Canada, H3J 2V5 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01058083 History of Changes |
| Other Study ID Numbers: | MB117-004, 2009-014306-33 |
| Study First Received: | January 26, 2010 |
| Last Updated: | April 18, 2012 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada |
Additional relevant MeSH terms:
|
Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013