临床试验/NCT01061567

NCT01061567已完成不适用

Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice

Boehringer Ingelheim284 个研究点分布在 1 个国家目标入组 1,814 人开始时间: 2009年11月最近更新: 2014年7月8日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Boehringer Ingelheim
入组人数: 1,814
试验地点: 284
主要终点: Proportion of Patients With Withdrawals Due to Adverse Events.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The general aim of this non-interventional study is to assess the safety and efficacy of pramipexole extended release in patients with Parkinson's disease in routine clinical practice.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（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

结局指标

主要结局

Proportion of Patients With Withdrawals Due to Adverse Events.

时间窗: 16 weeks

Patients who discontinued treatment due to adverse events including deaths.

Incidence of Adverse Events

时间窗: From the treatment initiation to the end of study, on average 92.9 days

The number of patients with any adverse events (AEs), patients with drug-related AEs.

次要结局

Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score(Baseline and the end of study (up to 16 weeks))
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score(Baseline and the end of study (up to 16 weeks))
Clinical Global Impression of Improvement (CGI-I) Responder Rate(Baseline and the end of study (up to 16 weeks))
Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction(Baseline and the end of study (up to 16 weeks))

研究者

发起方

Boehringer Ingelheim

申办方类型

Industry

责任方

Sponsor

研究点 (284)

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