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临床试验/NCT01919047
NCT01919047已完成不适用

Drug Use-Results Survey of Betanis Tablets 25 and 50 mg

Astellas Pharma Inc0 个研究点目标入组 10,711 人开始时间: 2012年4月最近更新:
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
10,711
主要终点
Occurrence of adverse events and adverse drug reactions

研究概览

简要总结

This study is to determine the following information.

  1. The occurrence of adverse drug reactions in clinical settings.
  2. Factors potentially impacting safety, effectiveness, and other aspects.

详细描述

This survey aims to determine the following information and the need for conducting specified drug use-results surveys and post-marketing clinical studies in patients using Betanis (generic name: mirabegron):

  1. The occurrence of adverse drug reactions in clinical settings.
  2. Factors potentially impacting safety, effectiveness, and other aspects.

Items of Particular Interest:

  • Safety and effectiveness in patients with hepatic impairment and patients with renal impairment.
  • Safety and effectiveness when mirabegron is used concomitantly with other drugs (α1 blockers, anticholinergic agents, 5α reductase inhibitors, drugs with a potent CYP3A4-inhibiting effect, drugs with a CYP3A4-inducing effect, drugs metabolized primarily by CYP2D6, and other frequently used drugs).
  • The occurrence of cardiovascular adverse events.
  • The occurrence of adverse events related to increased intraocular pressure.
  • The occurrence of urinary retention

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
All
接受健康志愿者

入选标准

  • Patients who received mirabegron for the first time for the treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder.

排除标准

  • 未提供

研究组 & 干预措施

Betanis group

Patients receiving Betanis for Overactive Bladder

干预措施: Betanis (Drug)

结局指标

主要结局

Occurrence of adverse events and adverse drug reactions

时间窗: For 12 weeks

次要结局

  • Items of particular interest(baseline and at 12 weeks (or last observation period))
  • Changes in OABSS (overactive bladder symptom score)(baseline and at 12 weeks (or last observation period))

研究者

申办方类型
Industry
责任方
Sponsor

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