Safety Study of BMS-823778 in Subjects With Hypercholesterolemia

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112423
• Other study ID #: MB121-003
• Status: Completed
• Phase: Phase 2
• First received: April 23, 2010
• Last updated: September 23, 2015
• Start date: June 2010
• Est. completion date: December 2010

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health CanadaUnited States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypercholesterolemia

Intervention

Drug:
• BMS-823778
Capsules, Oral, 2 mg, once daily, 28 days
• BMS-823778
Capsules, Oral, 10 mg, once daily, 28 days
• BMS-823778
Capsules, Oral, 20 mg, once daily, 28 days
• Placebo
Capsules, Oral, 0 mg, once daily, 28 days

Locations

Country	Name	City	State
Australia	Local Institution	Brisbane	Queensland
Canada	Local Institution	Drummondville	Quebec
Canada	Local Institution	London	Ontario
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Mount Pearl	Newfoundland and Labrador
Canada	Local Institution	Winnipeg	Manitoba
United States	Sterling Research Grp, Ltd.	Cincinnati	Ohio
United States	Pra International	Lenexa	Kansas
United States	Osborne Research Center	Little Rock	Arkansas
United States	National Clinical Research - Norfolk, Inc.	Norfolk	Virginia
United States	National Clinical Research - Richmond, Inc.	Richmond	Virginia
United States	Cetero Research - San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lowering of LDL-C		Within 28 days following dosing	No
Secondary	Pharmacokinetics (measuring trough concentrations)		On days 7, 14, and 28	No
Secondary	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)		Within 28 days following dosing	No

External Links

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