PER-103-06已完成未知
26-Week Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Adolescent Subjects With Schizophrenia
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- PFIZER S.A.,
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
- •1. The subject and the authorized legal representative must understand the nature of the study and must be able to obey the protocol requirements. The representative must sign an Informed Consent Document and the subject must provide the Written Consent.
- •2. Subjects must have received the study medication in study A1281134.
- •3. In the opinion of the investigator, the subject should be likely to benefit from antipsychotic therapy and should not represent any concern about clinically significant safety during the preceding double-blind study.
- •4. Women with potential for maternity may be included, provided they are not pregnant, or breastfeeding, and are practicing effective contraception.
排除标准
- •1. The subjects who experienced a serious adverse event.
- •2. Subjects who experienced cardiac arrhythmias, conduction abnormalities, or QTc prolongation during the preceding study.
- •3. Subjects that require some medication not allowed.
- •4. Subjects that require treatment with drugs that are known to prolong QT consistently.
- •5. Subjects with a grade of 7 in the individual section of Suicidal Idea of the CDRS-R.
- •6. Subjects who may be at imminent risk of suicide
- •during the study.
研究者
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