NCT00560209已完成2 期
Study of ONO-1101 in Patients Scheduled for Coronary Angiography, a Double-Blind, Randomized,Placebo-Controlled, Parallel Group, Multi-Center Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- CT image quality
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients scheduled for coronary angiography, in a double-blind, randomized, placebo-controlled, parallel group, multi-center study.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years of age or older
- •Heart rate less than 90 beats/min and more than 70 beats/min at entering the CT room
排除标准
- •Previous allergic reactions to contrast agent
- •Renal failure
- •Concomitant beta-receptor blocking agent
研究组 & 干预措施
P
Placebo Comparator
干预措施: ONO-1101 (Drug)
E2
Experimental
干预措施: ONO-1101 (Drug)
E1
Experimental
干预措施: ONO-1101 (Drug)
结局指标
主要结局
CT image quality
时间窗: one day
次要结局
- Heart rate(For less than one month)
- CT diagnostic accuracy(For less than one month)
研究者
研究点 (1)
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