NCT01919047已完成不适用
Drug Use-Results Survey of Betanis Tablets 25 and 50 mg
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.
- The occurrence of adverse drug reactions in clinical settings.
- 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):
- The occurrence of adverse drug reactions in clinical settings.
- 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
- 否
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
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