NCT01475097已完成4 期
A Phase 4 Randomized, Double-blind Study Comparing Patient Comfort and Safety Between Iodixanol 320 mg I/mL and Iopamidol 370 mg I/mL in Patients Undergoing Peripheral Arteriography
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography
研究概览
简要总结
The purpose of this study is to evaluate and compare overall patient comfort profile between an Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients undergoing arteriography of peripheral arteries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
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
- •The subject is over 18 years old.
- •Subjects are referred to undergo a peripheral arteriography as part of their routine clinical care.
排除标准
- •The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM.
- •The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within the 24 hour follow-up period.
- •The subject is pregnant or lactating.
- •The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to discontinue at the time of the study procedure.
- •The subject manifests thyrotoxicosis or is on dialysis.
研究组 & 干预措施
Active Arm
Active Comparator
干预措施: Iodixanol (Drug)
Comparator Arm
Active Comparator
干预措施: Iopamidol (Drug)
结局指标
主要结局
Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography
时间窗: Within 10 minutes post contrast administration.
The number of subjects experiencing overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.
次要结局
- Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography.(Within 10 minutes post contrast administration.)
研究者
研究点 (1)
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