NCT00518921撤回2 期
Phase IIa Efficacy and Safety Trial of Capadenoson in Patients With Chronic Stable Angina
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
- Bayer
- 主要终点
- Total exercise time
研究概览
简要总结
This is a multi-center and multi-national,randomized, double blind, placebo-controlled, 28-day treatment study with BAY 68-4986 taken orally or a matching placebo.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The primary diagnosis is chronic stable angina of mild-moderate intensity as defined by the Canadian Cardiovascular Society Functional Class II-III, in the presence of definitive coronary artery disease.
- •Male or female subjects aged 35 to 75 years (if female, only if postmenopausal or permanently sterilized)
- •Stable angina of mild-moderate intensity (Canadian class II-III) with anti-anginal medication not changed for the last 5 weeks
排除标准
- •Inability to withdraw current anti-anginal therapy
- •Inability to withdraw any concomitant therapy that would interfere with interpretation of study results
研究组 & 干预措施
Arm 1
Experimental
干预措施: Capadenoson (BAY 68-4986) (Drug)
Arm 2
Experimental
干预措施: Capadenoson (BAY 68-4986) (Drug)
Arm 3
Experimental
干预措施: Capadenoson (BAY 68-4986) (Drug)
Arm 4
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Total exercise time
时间窗: 28 days for ETT and 42 days for safety
次要结局
- Time to angina onset(28 days)
研究者
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