NCT02946450Unknown不适用
Multi-center, Prospective, Non-interventional, Observational Study to Assess the Safety of Omnipure® Inj.(Iohexol) Contrast Media in CT Scanning Patients
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2014年3月最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- adverse events, adverse drug reaction, serious adverse events, serious drug reaction, laboratory data, vital signs
研究概览
简要总结
The purpose of this study is to assess safety of Omnipure inj. (lohexol) contrast media in CT scanning patients
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects in need of CT scanning
- •subjects who signed up informed consent
排除标准
- •Known allergy or hypersensitivity to the study medication, ingredient of the medication, and Iodine type medication
- •severe renal insufficiency patients
- •severe hypothyroidism
- •severe local infection or bacteremia
结局指标
主要结局
adverse events, adverse drug reaction, serious adverse events, serious drug reaction, laboratory data, vital signs
时间窗: 14 days
次要结局
未报告次要终点
研究者
研究点 (1)
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