临床试验/NCT00905879

NCT00905879已完成不适用

Observational Study on the Safety and Tolerability of Gadobutrol (Gadovist) Among Filipino Patients

Bayer0 个研究点目标入组 30 人开始时间: 2009年6月最近更新: 2013年4月26日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Bayer
入组人数: 30
主要终点: The primary outcome measures would be safety and tolerability of Gadovist which would be measured by change in Vital signs before and after the procedure and the occurrence of serious or non-serious adverse events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Patients will be recruited from those who will undergo contrast enhanced MRI. Safety and tolerability will be assessed.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

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

•18 years old and above undergoing contrast enhanced cranial or spinal MRI with Gadobutrol (Gadovist)

排除标准

•History of hypersensitivity reaction to gadolinium containing contrast material
•Hypersensitivity to any of the ingredients of Gadobutrol (Gadovist)
•History of hypersensitivity to any other contrast agent
•Patients with uncorrected hypokalemia
•Pregnant and lactating women
•Patients with severe cardiovascular diseases
•Patients in whom MRI cannot be performed.

研究组 & 干预措施

Group 1

干预措施: Gadobutrol (Gadovist, BAY86-4875) (Drug)

结局指标

主要结局

The primary outcome measures would be safety and tolerability of Gadovist which would be measured by change in Vital signs before and after the procedure and the occurrence of serious or non-serious adverse events

时间窗: Up to 1 hour after MRI

次要结局

未报告次要终点

研究者

发起方

Bayer

申办方类型

Industry

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