Safety Study of BMS-823778 in Subjects With Hypercholesterolemia
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01112423
First received: April 23, 2010
Last updated: January 24, 2011
Last verified: January 2011
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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-823778 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
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 (measuring trough concentrations) [ Time Frame: On days 7, 14, and 28 ] [ Designated as safety issue: No ]
- 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) [ Time Frame: Within 28 days following dosing ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | June 2010 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: BMS-823778 (2 mg) |
Drug: BMS-823778
Capsules, Oral, 2 mg, once daily, 28 days
|
| Experimental: BMS-823778 (10 mg) |
Drug: BMS-823778
Capsules, Oral, 10 mg, once daily, 28 days
|
| Experimental: BMS-823778 (20 mg) |
Drug: BMS-823778
Capsules, Oral, 20 mg, once daily, 28 days
|
| Placebo Comparator: Placebo |
Drug: Placebo
Capsules, Oral, 0 mg, once 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: NCT01112423
Locations
| United States, Arkansas | |
| Osborne Research Center | |
| Little Rock, Arkansas, United States, 72201 | |
| United States, Kansas | |
| Pra International | |
| Lenexa, Kansas, United States, 66219 | |
| United States, Ohio | |
| Sterling Research Grp, Ltd. | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Texas | |
| Cetero Research - San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| National Clinical Research - Norfolk, Inc. | |
| Norfolk, Virginia, United States, 23502 | |
| National Clinical Research - Richmond, Inc. | |
| Richmond, Virginia, United States, 23294 | |
| Australia, Queensland | |
| Local Institution | |
| Brisbane, Queensland, Australia, 4021 | |
| Canada, Manitoba | |
| Local Institution | |
| Winnipeg, Manitoba, Canada, R2V 4W3 | |
| Canada, Newfoundland and Labrador | |
| Local Institution | |
| Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7 | |
| Canada, Ontario | |
| Local Institution | |
| London, Ontario, Canada, N6A 5R8 | |
| Canada, Quebec | |
| Local Institution | |
| Drummondville, Quebec, Canada, J2B 7T1 | |
| 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: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01112423 History of Changes |
| Other Study ID Numbers: | MB121-003 |
| Study First Received: | April 23, 2010 |
| Last Updated: | January 24, 2011 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada United States: Institutional Review Board United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013