EUCTR2011-000106-22-GB进行中（未招募）不适用
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
GE Healthcare Ltd. and its affiliates0 个研究点目标入组 250 人开始时间: 2011年6月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •(1)The subject is over 18 years old.
- •(2)Subjects are referred to undergo a peripheral arteriography as part of their routine clinical care.
- •(3)The subject has provided signed and dated informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 125
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 125
排除标准
- •(1)The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM.
- •(2)The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within 24 hours follow-up period.
- •(3)The subject is pregnant or lactating.
- •(4)The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to discontinue at the time of the study procedure.
- •Note: Metformin must not be taken at least 24 hours prior to the study procedures, withheld for at least 48 hours post-procedure, and restarted only after the subjects renal function has been evaluated and it is deemed safe to resume metformin.
- •(5)The subject manifests thyrotoxicosis or is on dialysis.
- •(6)The subject was previously included in this study.
- •(7)The subject has unstable clinical condition where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study.
研究者
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