Safety Study of BMS-770767 in Subjects With Hypercholesterolemia

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058083
• Other study ID #: MB117-004
• Secondary ID: 2009-014306-33
• Status: Completed
• Phase: Phase 2
• First received: January 26, 2010
• Last updated: April 18, 2012
• Start date: May 2010
• Est. completion date: March 2011

Study information

• Verified date: April 2012
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health Canada
• 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: 81
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• 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, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypercholesterolemia

Intervention

Drug:
• BMS-770767
Active, Oral, 15 mg, Daily, 28 days
• BMS-770767
Active, Oral, 50 mg, Daily, 28 days
• BMS-770767
Active, Oral, 150 mg, Daily, 28 days
• BMS-770767
Active, Oral, 50 mg BID, Daily, 28 days
• Placebo
Placebo, Oral, 0 mg, daily, 28 days

Locations

Country	Name	City	State
Australia	Local Institution	Blacktown	New South Wales
Australia	Local Institution	Caboolture	Queensland
Australia	Local Institution	Daw Park	South Australia
Australia	Local Institution	Hornsby	New South Wales
Australia	Local Institution	Nedlands	Western Australia
Australia	Local Institution	South Brisbane	Queensland
Canada	Local Institution	Bathurst	New Brunswick
Canada	Local Institution	Brampton	Ontario
Canada	Local Institution	Charlottetown	Prince Edward Island
Canada	Local Institution	Mirabel	Quebec
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Toronto	Ontario
United States	Harrell, Robert	Little Rock	Arkansas
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 (Blood Level) of BMS-770767		Within 28 days following dosing	No
Secondary	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)		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