NCT01376193已完成不适用
Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet
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
- 500
- 主要终点
- The number of incidence of adverse events in subjects with migraine headache
研究概览
简要总结
The study is designed to investigate the information on safety and efficacy of naratriptan tablets on Japanese subjects with migraine headache during Japanese post-marketing surveillance period.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with migraine headache
- •Must use naratriptan tablets for the first time
排除标准
- •Subjects with hypersensitivity to naratriptan
- •Subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina
- •Subjects with history of peripheral vascular disorder
- •Subjects with history of cerebrovascular disorder or transient ischemic attacks
- •Subjects with uncontrolled high-blood pressure
- •Subjects with severe hepatic function disorder or renal function disorder
- •Subjects taking ergotamine, ergotamine derivative containing product, or 5-HT1B/1D agonist
研究组 & 干预措施
Subjects prescribed naratriptan tablets
Subjects with migraine headache prescribed naratriptan tablets during study period
干预措施: Naratriptan (Drug)
结局指标
主要结局
The number of incidence of adverse events in subjects with migraine headache
时间窗: 2 months
次要结局
- Occurrence of cardiovascular-related adverse events(2 months)
- Occurrence of cerebrovascular disorder(2 months)
- Occurrence of serotonin syndrome(2 months)
研究者
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