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

Phase 2WithdrawnNCT01666704

Bristol-Myers Squibb

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Atherosclerotic Cardiovascular Disease

Interventions

BMS-823778DRUG

Capsules, Oral, 2mg, Once daily, 1 year

BMS-823778DRUG

Capsules, Oral, 15mg, Once daily, 1 year

Placebo matching with BMS-823778DRUG

Capsules, Oral, 0mg, Once daily, 1 year

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

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

Time frame: Day 168

Secondary Outcomes

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)

Time frame: Day 364

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

Data from ClinicalTrials.gov

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