Safety of Pramipexole Monotherapy or Combination Therapy in Chinese Patients With Parkinson¿s Disease: a 12 Week Post Marketing Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,017
- 试验地点
- 103
- 主要终点
- Incidence of AE/SAE
研究概览
简要总结
This is an open-label, multicenter, non-interventional, prospective observational study. we collect the safety information of pramipexole over 12w treatment. Parkinson disease patients with different severity who have already used pramipexole could be observed in this study. In the whole observation period, treatment decision was determined by physician and patient completely. The safety endpoint is AE(Adverse Event), SAE(Serious Adverse Event), patient withdraw, laboratory test.
详细描述
Purpose:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
pramipexole group
It's a open-label, non-intervention,observation post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
干预措施: pramipexole (Drug)
结局指标
主要结局
Incidence of AE/SAE
时间窗: 12 weeks
The percentage of adverse events or serious adverse events occurring under Pramipexole mono- or combination therapy with other medication in this study.
次要结局
- The Dosage Related Information of Pramipexole at Baseline(baseline)
- Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study)(Baseline (Visit 1) and 12 weeks (Visit 3))
- The Dosage Related Information of Pramipexole at the End of Study(12 weeks)