NCT00924586已完成3 期
Study of ONO-1101 in Patients Scheduled for Multi-Slice Computed Tomography (CT), 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
- 3 期
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 2
- 主要终点
- 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 multi-slice CT, 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 old
- •Heart rate ≥ 70beats/min and ≤ 90beats/min at entering the CT room and just before dosing organic nitrates.
排除标准
- •Previous allergic reactions to contrast agent
- •Renal failure
研究组 & 干预措施
P
Placebo Comparator
干预措施: ONO-1101 (Drug)
E
Experimental
干预措施: ONO-1101 (Drug)
结局指标
主要结局
Image quality
时间窗: one day
次要结局
- Heart rate(5 days maximum)
研究者
研究点 (2)
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