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临床试验/EUCTR2009-009215-22-DK
EUCTR2009-009215-22-DK进行中(未招募)1 期

Treating clozapine-induced sinustachycardia (BISCLOZ).” - BISCLOZ

Aalborg Psychiatric Hospital, Centre for Skizophrenia0 个研究点目标入组 36 人开始时间: 2009年2月23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)
发起方
入组人数
36

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

  • Both gender
  • Age 18-65 years
  • Treated with clozapine for minimum 3 months and minimum 100 mg/day
  • Fixed dose of antipsychotics and antidepressants during the last 14 days
  • Heart rate >100
  • Documentation that sinustachycardia was not present before clozapine
  • Pregnancy test negative
  • Sexual abstinence or birth control methods during the study and one month after
  • 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 36
  • F.1.3 Elderly (>=65 years)
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Significant substance misuse
  • Physical illness which demans precautions to treatment with clozapine and bisoprolol
  • Blood pressure <100/60 or dizziness causing fall
  • Administration of oral anticholinergics and carbamezapine
  • Treatment with betablocker 6 half-lives before inclusion or treatment with other cardiac medications (except acetylsalic acid or diuretics)
  • QT alterations (QTc>500 ms) SA or AV I and II
  • Retainment due to the mental health act.
  • Allergic to bisoprolol or clozapine.

研究者

发起方
Aalborg Psychiatric Hospital, Centre for Skizophrenia

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