Proof of Concept Study of BMS-823778 to Assess the Effects on Atherosclerosis

Phase 2

Withdrawn

• Conditions: Atherosclerotic Cardiovascular Disease
• Interventions: Drug: BMS-823778; Drug: Placebo matching with BMS-823778

• Registration Number: NCT01666704
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of the study is to assess the effect of BMS-823778 on reducing atherosclerotic plaque inflammation

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-16
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-21
• Study Start: 2014-04
• Primary Completion: 2015-10
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

• Women of child bearing potential
• Medical conditions that would impact the absorption of the study drug

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment A: BMS-823778 (2mg)	BMS-823778	-
Treatment B: BMS-823778 (15mg)	BMS-823778	-
Treatment C: Placebo	Placebo matching with BMS-823778	-

Primary Outcome Measures

Name	Time	Method
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	Day 168

Secondary Outcome Measures

Name	Time	Method
Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices)	Day 364	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	Approximately up to 60 weeks