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Safety Study of BMS-823778 in Subjects With Hypercholesterolemia
This study has been completed.

First Received on April 23, 2010.   Last Updated on January 24, 2011   History of Changes
Sponsor: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01112423
  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 II

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:

Genetics Home Reference related topics: hypercholesterolemia
MedlinePlus related topics: Cholesterol
U.S. FDA Resources

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:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

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 February 09, 2012



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