NCT01299571已完成不适用
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVODART(Dutasteride) Administered in Korean BPH(Benign Prostatic Hyperplasia) Patients According to the Prescribing Information
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,977
- 试验地点
- 1
- 主要终点
- Number of Participants With an Adverse Event
研究概览
简要总结
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of AVODART administered in Korean BPH patients according to the prescribing information
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The Korean BPH Patients administrated dutasteride according to the prescribing information
排除标准
- •women and children and adolescents.
- •patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, or any of the excipients.
研究组 & 干预措施
Dutasteride
Patients administrated dutasteride at the site
干预措施: Dutasteride (Drug)
结局指标
主要结局
Number of Participants With an Adverse Event
时间窗: 6 months
An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, see the table entitled "Other (Non-Serious) Adverse Events" in the Adverse Event section of the results record.
次要结局
- Number of Participants With the Indicated Unexpected Adverse Events(6 months)
- Number of Participants With a Serious Adverse Event(6 months)
研究者
研究点 (1)
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