NCT02248168已完成不适用
Mirapex PMS Study Final Report
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
- 1,449
- 主要终点
- Assessment of Unified Parkinson's disease Rating Scale (UPDRS)
研究概览
简要总结
The objectives of this study are to investigate issues or questions about MIRAPEX Tablets as shown below through the Post Marketing Surveillance (PMS) study upon approval.
- Unexpected adverse events (especially, serious adverse events (SAEs))
- To find out the status of incidence of adverse events under actual practice
- Factors on the safety profile
- Factors on the efficacy profile
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
- •Among the patients with idiopathic Parkinson's disease, from those receiving MIRAPEX Tablets first after a contract of the study to the requested number of cases will be consecutively enrolled without skipping
排除标准
- •Following patients are contraindicated.
- •Patients who are hypersensitive to MIRAPEX or its ingredients
- •Refer to the insert paper for other contraindication.
- •Following patients should be carefully administered.
- •Patient with renal impairment
- •Refer to the insert paper for other precaution.
研究组 & 干预措施
Idiopathic Parkinson's disease patients
干预措施: Pramipexole (Drug)
结局指标
主要结局
Assessment of Unified Parkinson's disease Rating Scale (UPDRS)
时间窗: up to 4 weeks
Tremor at rest, Rigidity, Body bradykinesia and hypokinesia
次要结局
- Number of patients with adverse events(up to 4 weeks)
- Global Assessment of efficacy by investigator on 3-point scale(after 4 weeks)
研究者
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