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Safety Study of BMS-823778 in Subjects With Hypercholesterolemia

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-823778
BMS-823778
BMS-823778
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Osborne Research Center
  • Pra International
  • Sterling Research Grp, Ltd.
  • Cetero Research - San Antonio
  • National Clinical Research - Norfolk, Inc.
  • National Clinical Research - Richmond, Inc.
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

BMS-823778 (2 mg)

BMS-823778 (10 mg)

BMS-823778 (20 mg)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Lowering of LDL-C

Secondary Outcome Measures

Pharmacokinetics (measuring trough concentrations)
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)

Full Information

First Posted
April 23, 2010
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01112423
Brief Title
Safety Study of BMS-823778 in Subjects With Hypercholesterolemia
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 Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-823778 (2 mg)
Arm Type
Experimental
Arm Title
BMS-823778 (10 mg)
Arm Type
Experimental
Arm Title
BMS-823778 (20 mg)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-823778
Intervention Description
Capsules, Oral, 2 mg, once daily, 28 days
Intervention Type
Drug
Intervention Name(s)
BMS-823778
Intervention Description
Capsules, Oral, 10 mg, once daily, 28 days
Intervention Type
Drug
Intervention Name(s)
BMS-823778
Intervention Description
Capsules, Oral, 20 mg, once daily, 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules, Oral, 0 mg, once daily, 28 days
Primary Outcome Measure Information:
Title
Lowering of LDL-C
Time Frame
Within 28 days following dosing
Secondary Outcome Measure Information:
Title
Pharmacokinetics (measuring trough concentrations)
Time Frame
On days 7, 14, and 28
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Osborne Research Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
Facility Name
Pra International
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Sterling Research Grp, Ltd.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cetero Research - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
National Clinical Research - Norfolk, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
National Clinical Research - Richmond, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Local Institution
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
Facility Name
Local Institution
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2V 4W3
Country
Canada
Facility Name
Local Institution
City
Mount Pearl
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1N 1W7
Country
Canada
Facility Name
Local Institution
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5R8
Country
Canada
Facility Name
Local Institution
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 7T1
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3J 2V5
Country
Canada

12. IPD Sharing Statement

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Safety Study of BMS-823778 in Subjects With Hypercholesterolemia

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