跳至主要内容
临床试验/NCT01170091
NCT01170091已完成不适用

Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS

Boehringer Ingelheim36 个研究点 分布在 1 个国家目标入组 651 人开始时间: 2007年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
651
试验地点
36
主要终点
Number of Reported Adverse Events

研究概览

简要总结

Safety and Effect of Mirapex(Pramipexole) tablet among Korean Restless Legs Syndrome Patients: An Open-Label, Postmarketing Surveillance Study

详细描述

Study Design:

研究设计

研究类型
Observational
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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of Reported Adverse Events

时间窗: Up to 4 weeks

If there is a dose titration, another 4 weeks should be followed up

次要结局

  • International Restless Legs Syndrome Rating Scale (IRLS) Change After 4 Weeks of Mirapex Treatment(before and after the treatment with Mirapex (at least 4 weeks after the end of titration))
  • Patient-Global Impressions (PGI-I)(before and after the treatment with Mirapex (at least 4 weeks after the end of titration))
  • Clinical Global Impressions-Global Improvement (CGI-I)(before and after the treatment with Mirapex (at least 4 weeks after the end of titration))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (36)

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