NCT01376284已完成不适用
Drug Use Investigation for AVOLVE(BPH)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 主要终点
- The number of adverse events in Japanese subjects with BPH treated with dutasteride capsules
研究概览
简要总结
The study is designed to investigate the safety and efficacy of dutasteride capsules 0.5 mg collected from the required number of Japanese subjects with benign prostatic hyperplasia (BPH) in order to identify concerns or problems, if any, about the efficacy and safety of its use at post-marketing clinical settings.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Must be male subjects
- •Use dutasteride capsules for the first time
排除标准
- •Subjects who is hypersensitivity to dutasteride or 5α reductase inhibitor
- •Subjects with severe hepatic function disorder
- •Dutasteride capsules shall not be used to female or child
研究组 & 干预措施
Subjects prescribed dutasteride capsules
Subjects with BPH prescribed dutasteride capsules during study period
干预措施: Dutasteride (Drug)
结局指标
主要结局
The number of adverse events in Japanese subjects with BPH treated with dutasteride capsules
时间窗: 1 year
次要结局
未报告次要终点
研究者
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