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

NCT01666704 — Phase 2, Withdrawn, Bristol-Myers Squibb

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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

Registry	NCT01666704
Status	Withdrawn
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Sponsor	Bristol-Myers Squibb (Industry)
Conditions	Atherosclerotic Cardiovascular Disease
Interventions	BMS-823778, Placebo matching with BMS-823778 (Drug)
Dates	start 2014-04-01, primary completion 2015-10-01 (estimated), completion 2016-05-01 (estimated), first posted 2012-08-16, last updated 2013-06-21

-Summary

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

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+Arms and interventions

Arm	Type	Interventions
Treatment A: BMS-823778 (2mg)	Experimental	Drug: BMS-823778
Treatment B: BMS-823778 (15mg)	Experimental	Drug: BMS-823778
Treatment C: Placebo	Placebo comparator	Drug: Placebo matching with BMS-823778

BMS-823778 (Drug): Capsules, Oral, 2mg, Once daily, 1 year
BMS-823778 (Drug): Capsules, Oral, 15mg, Once daily, 1 year
Placebo matching with BMS-823778 (Drug): Capsules, Oral, 0mg, Once daily, 1 year

+Outcome measures

Primary outcomes

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 outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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

+Investigators

Bristol-Myers Squibb, Study director, Bristol-Myers Squibb