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临床试验/PER-055-10
PER-055-10已完成未知

A 26-WEEK, MULTI-CENTER, OPEN-LABEL, FLEXIBLE DOSE, LONG-TERM SAFETY TRIAL OF ASENAPINE IN ADOLESCENT SUBJECTS WITH SCHIZOPHRENIA

SCHERING PLOUGH RESEARCH INSTITUTE,0 个研究点目标入组 0 人开始时间: 2010年9月9日最近更新:
适应症

试验速览

阶段
未知
状态
已完成

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
14 至 18(—)
性别
All

入选标准

  • Each participant must be between 12 and 17 years of age at the time of entry on this study, however, participants in the 8-week base study (P05896 [NCT01190254]) who reach 18 years of age while on P05896 may be enrolled in this extension study provided all other inclusion/exclusion criteria are met.
  • Must have completed the 8-week efficacy and safety trial (P05896 [NCT01190254]) and, according to the investigator´s judgment, would benefit from long-term treatment.
  • Must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the 8-week trial (P05896 [NCT01190254]), in the opinion of the investigator.

排除标准

  • A female participant must not be pregnant and must not have the intention to become pregnant during the trial.
  • A participant must not be at imminent risk of self-harm or harm to others.
  • A participant must not currently be under involuntary inpatient commitment.

研究者

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A 26-WEEK, MULTI-CENTER, OPEN-LABEL, FLEXIBLE DOSE,... | 临床试验