NCT02570035已完成不适用
Protocol for Specified Drug Use-results Survey of Betanis Tablets (for Patients With Coexisting Cardiovascular Disease)
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
- 316
- 试验地点
- 28
- 主要终点
- Incidence rate of cardiovascular system adverse reactions
研究概览
简要总结
This purpose of this study is to investigate the effects of mirabegron on the cardiovascular system in patients with overactive bladder with current or a history of cardiovascular disease.
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
- •having coexisting cardiovascular disease or a history of cardiovascular diseases
- •having electrocardiogram record conducted within seven days before the start of the mirabegron treatment (including the first day of administration)
排除标准
- •having serious cardiovascular disease
- •having significant long QT (QTc > 500 msec)
研究组 & 干预措施
Mirabegron group
Subjects with overactive bladder and cardiovascular disease prescribed mirabegron
干预措施: Mirabegron (Drug)
结局指标
主要结局
Incidence rate of cardiovascular system adverse reactions
时间窗: Up to four weeks
Safety assessed by biochemistry laboratory tests
时间窗: Up to four weeks
Changes in electrocardiogram parameters pre- and post- administration of mirabegron
时间窗: Baseline and up to four weeks
Safety assessed by incidence of adverse events
时间窗: Up to four weeks
次要结局
- Changes in overactive bladder (OAB) symptoms(Baseline and up to four weeks)
研究者
研究点 (28)
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