NCT00162084终止3 期
A Phase 3, Parallel, Double Blind, Multicenter Trial to Examine Inducible Myocardial Perfusion Abnormality Detection With BMS068645 and Adenosine Stress SPECT Compared to Coronary Angiography
Forest Laboratories78 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2005年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 2,000
- 试验地点
- 78
- 主要终点
- Sensitivity and specificity of BMS068645 vs. adenosine; to be determined at the end of the study after enrollment is complete
研究概览
简要总结
The purpose of the study is to determine whether BMS068645 is as effective as Adenosine SPECT at detecting blockages in heart arteries, and to determine if it will have fewer side effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referral for pharmacologic stress SPECT MPI
- •Have suspected Ischemic heart disease
排除标准
- •Acute myocardial Infarction, Coronary artery bypass graft, percutaneous coronary intervention within 30 days of enrollment
- •Severe asthma or COPD
结局指标
主要结局
Sensitivity and specificity of BMS068645 vs. adenosine; to be determined at the end of the study after enrollment is complete
次要结局
- Incidence of serious adverse events due to adenosine vs. BMS068645; incidence of adverse events due to adenosine vs. BMS068645; to be determined at the end of the study after enrollment, but with interim independent analysis by a safety monitoring board
研究者
研究点 (78)
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