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临床试验/EUCTR2013-004936-31-NL
EUCTR2013-004936-31-NL进行中(未招募)1 期

Establish limits for fitness to drive with prolonged use of ICADTS class III medication

Ministry of Infrastructure and the Environment0 个研究点开始时间: 2014年1月20日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Patients: chronic use of ICADTS class III medication (> 6 months)
  • - age between 21 and 75 (inclusive)
  • - BMI between 19 an 29 m2/kg (inclusive)
  • - in posession of a valid drivers license for at least 3 years
  • - driving experience of at least 3000 km/yeat on average
  • - sufficient vision
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 140
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 140

排除标准

  • - a neurological disorder
  • - use of drugs
  • - excessive alcohol consumption (> 21 glasses of alcohol/week)
  • - smoking (> 10 cigarettes/day)
  • - pregnancy

研究者

发起方
Ministry of Infrastructure and the Environment

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