Back to resultsProof of Concept Study of BMS-823778 to Assess the Effects on Atherosclerosis
Primary Purpose
Atherosclerotic Cardiovascular Disease
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
BMS-823778
BMS-823778
Placebo matching with BMS-823778
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerotic Cardiovascular Disease
Eligibility Criteria
Inclusion Criteria:
- Documented atherosclerotic cardiovascular disease or at high risk of cardiovascular event
- On stable statin dose
- Clinically stable at time of screening and randomization
Exclusion Criteria:
- Women of child bearing potential
- Medical conditions that would impact the absorption of the study drug
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Treatment A: BMS-823778 (2mg)
Treatment B: BMS-823778 (15mg)
Treatment C: Placebo
Arm Description
Outcomes
Primary Outcome Measures
The effect of BMS-823778 versus placebo on carotids and/or ascending aortic will be measured by fluorodeoxyglucose (FDG) uptake in the index vessel as by positron emission tomography (PET) imaging
Secondary Outcome Measures
Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices)
Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices): total vessel area, wall area, wall thickness, and wall area/total vessel area ratio (normalized wall index), based on the average of the right and left carotids, measured by Magnetic Resonance Imaging (MRI)
Safety will be measured by adverse event, vital signs, electrocardiogram, physical examinations, clinical laboratory tests and Ferriman- Gallwey scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01666704
Brief Title
Proof of Concept Study of BMS-823778 to Assess the Effects on Atherosclerosis
Official Title
A Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Effects of BMS-823778 on Atherosclerotic Plaque Inflammation as Measured by Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET) in Patients With Atherosclerotic Cardiovascular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Withdrawn
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
May 2016 (Anticipated)
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 the study is to assess the effect of BMS-823778 on reducing atherosclerotic plaque inflammation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerotic Cardiovascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A: BMS-823778 (2mg)
Arm Type
Experimental
Arm Title
Treatment B: BMS-823778 (15mg)
Arm Type
Experimental
Arm Title
Treatment C: Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-823778
Intervention Description
Capsules, Oral, 2mg, Once daily, 1 year
Intervention Type
Drug
Intervention Name(s)
BMS-823778
Intervention Description
Capsules, Oral, 15mg, Once daily, 1 year
Intervention Type
Drug
Intervention Name(s)
Placebo matching with BMS-823778
Intervention Description
Capsules, Oral, 0mg, Once daily, 1 year
Primary Outcome Measure Information:
Title
The effect of BMS-823778 versus placebo on carotids and/or ascending aortic will be measured by fluorodeoxyglucose (FDG) uptake in the index vessel as by positron emission tomography (PET) imaging
Time Frame
Day 168
Secondary Outcome Measure Information:
Title
Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices)
Description
Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices): total vessel area, wall area, wall thickness, and wall area/total vessel area ratio (normalized wall index), based on the average of the right and left carotids, measured by Magnetic Resonance Imaging (MRI)
Time Frame
Day 364
Title
Safety will be measured by adverse event, vital signs, electrocardiogram, physical examinations, clinical laboratory tests and Ferriman- Gallwey scores
Time Frame
Approximately up to 60 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented atherosclerotic cardiovascular disease or at high risk of cardiovascular event
On stable statin dose
Clinically stable at time of screening and randomization
Exclusion Criteria:
Women of child bearing potential
Medical conditions that would impact the absorption of the study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
Learn more about this trial
Proof of Concept Study of BMS-823778 to Assess the Effects on Atherosclerosis
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