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The purpose of the study is to assess the effect of BMS-823778 on reducing atherosclerotic plaque inflammation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: BMS-823778 (2mg) | Experimental |
| |
| Treatment B: BMS-823778 (15mg) | Experimental |
| |
| Treatment C: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-823778 | Drug | Capsules, Oral, 2mg, Once daily, 1 year |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000624964 | BMS-823778 |
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| BMS-823778 |
| Drug |
Capsules, Oral, 15mg, Once daily, 1 year |
|
| Placebo matching with BMS-823778 | Drug | Capsules, Oral, 0mg, Once daily, 1 year |
|
| Day 364 |
| Safety will be measured by adverse event, vital signs, electrocardiogram, physical examinations, clinical laboratory tests and Ferriman- Gallwey scores | Approximately up to 60 weeks |