NCT00615914已完成不适用
Pramipexole Special Survey on Long-Term Use
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,645
- 试验地点
- 1
- 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 on the use of Pramipexole for long time of period in 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
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 18 months
The aim of this Post Marketing Surveillance (PMS) was to obtain long-term safety data with treatment of pramipexole in Parkinson's disease (PD) patients. Therefore these items were considered as a safety evaluation.
次要结局
- Clinical Global Impression of Improvement(18 months)
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score(Baseline and at 18 months (or at the time of discontinuation))
- Change From Baseline in Modified Hoehn & Yahr Rating Scale(Baseline and at 18 months (or at the time of discontinuation))
研究者
研究点 (1)
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