NCT01666704撤回2 期
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
Bristol-Myers Squibb0 个研究点开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- 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
研究概览
简要总结
The purpose of the study is to assess the effect of BMS-823778 on reducing atherosclerotic plaque inflammation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented atherosclerotic cardiovascular disease or at high risk of cardiovascular event
- •On stable statin dose
- •Clinically stable at time of screening and randomization
排除标准
- •Women of child bearing potential
- •Medical conditions that would impact the absorption of the study drug
研究组 & 干预措施
Treatment A: BMS-823778 (2mg)
Experimental
干预措施: BMS-823778 (Drug)
Treatment B: BMS-823778 (15mg)
Experimental
干预措施: BMS-823778 (Drug)
Treatment C: Placebo
Placebo Comparator
干预措施: Placebo matching with BMS-823778 (Drug)
结局指标
主要结局
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
时间窗: Day 168
次要结局
- Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices)(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)
研究者
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