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临床试验/CTRI/2012/02/002403
CTRI/2012/02/002403已完成3 期

A 26-week, Multi-center, Open-label, Flexible Dose, Long-term SafetyTrial of Asenapine in Adolescent Subjects With Schizophrenia - ADDRESS-97

Merck Sharp and Dohme Corp0 个研究点目标入组 150 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
150
研究概览入排标准研究者记录与标识符相似试验

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

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 trial (P05896) 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) and, according to the investigators 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), 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

发起方
Merck Sharp and Dohme Corp

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