NCT01525641已完成不适用
Special Survey on Long-term Drug Use of Mirapex®-LA Tablets in Patients With Parkinson's 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
- 615
- 试验地点
- 118
- 主要终点
- Percentage of Adverse Drug Reactions
研究概览
简要总结
Post-marketing surveillance (PMS) to investigate the safety and efficacy of long-term daily use of Mirapex®-LA Tablets in patients with Parkinson's disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 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
Patient with Parkinson's Disease
干预措施: Mirapex LA (Drug)
结局指标
主要结局
Percentage of Adverse Drug Reactions
时间窗: From baseline up to week 52
Percentage of subjects with adverse drug reactions
次要结局
- Change From Baseline in the Modified Hoehn & Yahr to Last Observation(Baseline and week 52)
- Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA(Week 52)
- Clinical Global Impression of Effect(Week 52)
- Change From Baseline in Total Score of the UPDRS Part III to Last Observation(Baseline and week 52)
- Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA(Week 52)
研究者
研究点 (118)
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