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临床试验/EUCTR2007-002160-10-FR
EUCTR2007-002160-10-FR进行中(未招募)1 期

A prospective, open-label, single arm, multinational, multi-centre, flexible dose, extension study of the SCoP 99824 with sertindole for patients suffering from schizophrenia

H. Lundbeck A/S0 个研究点目标入组 50 人开始时间: 2007年10月19日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
50

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

  • 1.The patient and/or legally acceptable representative is able to read and understand the Patient Information Sheet for Study 12009A.
  • 2.The patient has signed the Informed Consent Form for Study 12009A.
  • 3.The patient has taken part in SCoP Study 99824 study.
  • 4.The patient still fulfils the EU SPC requirements for sertindole, including pregnancy exclusion and ECG parameters warnings.
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1.The patient has withdrawn before the end of SCoP 99824 study.
  • The patient has become homeless.
  • 3.The patient is going to participate in another clinical trial at the same time.
  • 4.The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.

研究者

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