CTRI/2009/091/000953已完成2 期
A Phase 2, Multicenter, Open-label Study to Assess the Safety and Tolerability of Oral OPC-34712 as Monotherapy in Adult Patients with Schizophrenia.
Otsuka Pharmaceutical Development Commercialization0 个研究点目标入组 300 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
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.Subjects who are able to provide written informed consent (as required by IRB/IEC) prior to the initiation of any protocol-required procedures.
- •2.Ability, in the opinion of the principal investigator, to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medication, and to be reliably rated on assessment scales.
- •3.Subjects who participated in 331-07-203 and who, in the opinion of the investigator, could potentially benefit from administration of OPC-34712 for the treatment of schizophrenia. Eligible subjects include those who completed participation in the Treatment Phase of Protocol 331-07-203 (ie, Week 6 visit), including subjects who initiated open-label OPC-34712 as rescue therapy at Week 4 or Week 5.
- •4.Outpatient status at last visit of Protocol 331-07-203.
排除标准
- •1.Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving open-label OPC-34712.
- •Target Disease, Medical History, and Concurrent Diseases
- •2.Subjects with a major protocol violation during the course of their participation in Protocol 331-07-203.
- •3.Subjects who do not continue to meet all applicable inclusion/ exclusion criteria for Protocol 331-07-203 at the last visit (ie, Week 6) of Protocol 331-07-203.
- •4.Subjects who represent a risk of committing suicide.
- •Prohibited Therapies or Medications
- •5.Subjects who would be likely to require prohibited concomitant therapy during the study
- •6.Any subject who, in the opinion of the investigator, should not participate in the study.
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