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Safety Study of BMS-823778 in Subjects With Hypercholesterolemia

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ClinicalTrials.gov Identifier: NCT01112423
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: BMS-823778 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : June 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Lowering of LDL-C [ Time Frame: Within 28 days following dosing ]

Secondary Outcome Measures :
  1. Pharmacokinetics (measuring trough concentrations) [ Time Frame: On days 7, 14, and 28 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01112423     History of Changes
Other Study ID Numbers: MB121-003
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases