NCT00613301已完成不适用
Pramipexole Special Survey on Patients Without Concomitant Use of L-Dopa
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 119
- 主要终点
- Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
研究概览
简要总结
The survey is conducted to collect safety and effectiveness information in Parkinson's Disease patients treated with Pramipexole without concomitant L-Dopa supplementation in the daily clinical settings in Japan.
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
- •Patients with Parkinson's disease who do not receive L-Dopa supplementation
排除标准
- •Patients should have been treated according to the Japanese insert slip
结局指标
主要结局
Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
时间窗: during 36 months
The aim of this Post Marketing Surveillance (PMS) was to obtain safety data in Parkinson's disease (PD) patients without concomitant use of levodopa for 3 years.
次要结局
- Clinical Global Impression of Improvement(after 36 months treatment)
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score(Baseline and at 36 months (or at the time of discontinuation))
- Change From Baseline in Modified Hoehn & Yahr Rating Scale(Baseline and at 36 months (or at the time of discontinuation))
研究者
研究点 (119)
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