NCT00593593已完成不适用
A Pharmacovigilance Study to Evaluate Safety of AVODART (Dutasteride) Administration 0,5 mg Once Daily, for 52 Weeks, in Subjects With Benign Prostate Hyperplasia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
研究概览
简要总结
This study has 4 phases: screening phase (visit 1), treatment phase (visit 2 - 6 mths after treatment initiation), and end of treatment phase (visit 3 - end of year 1). Only in the case a serious adverse event (SAE) arises, will there be a follow up phase (visit 4).
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject should fulfil criteria for the subscription of AVODART as these are mentioned in the SPC
- •Subject should be diagnosed with benign prostate hyperplasia
- •Subject's prostate volume should be equal or greater than 30 cm3
排除标准
- •Known hypersensitivity to any of the AVODART compounds
- •Suffers from a serious illness which either is not properly controlled or as per investigator´s judgment could interfere with the subject´s compliance into the trial
- •Receives treatment with enzyme inhibitors CYP3A4 and CYP3A
- •History of severe liver failure
研究者
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