NCT00265382终止3 期
26-Week Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Adolescent Subjects With Schizophrenia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 221 人开始时间: 2006年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in adolescents (ages 13-17) with schizophrenia.
详细描述
On March 24, 2009, Pfizer Inc. stopped late stage Geodon pediatric clinical trials in schizophrenia (A1281134 - placebo controlled; A1281135 - open label). As recommended by the DSMB, these studies were stopped due to lack of efficacy. No safety concerns were identified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in double-blind treatment study A1281134, meeting specific criteria of duration and safety
排除标准
- •Imminent risk of suicide or homicide, as judged by the site investigator
- •Serious adverse event related to study medication in study A1281134
- •Significant prolongation of QT interval in study A1281134
研究组 & 干预措施
Open
Other
干预措施: Ziprasidone oral capsules (Drug)
结局指标
主要结局
Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: 26 weeks
All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.
次要结局
- Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment(Baseline, Week 26, Early Termination (ET))
- Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score(Baseline, Weeks 2, 6, 18, 26, ET)
- Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score(Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET)
- Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales(Baseline, Weeks 6 and 26, ET)
- Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index(Baseline, Weeks 6 and 26, ET)
- Change From Baseline in Simpson-Angus Rating Scale (SARS)(Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET)
- Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item(Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET)
- Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score(Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET)
- Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score(Baseline, Weeks 2, 6, 18, 26, ET)
- Change From Baseline in Children's Global Assessment Scale (CGAS)(Baseline, Weeks 2, 6, 18, 26, ET)
- Change From Baseline in Child Health Questionnaire (CHQ)(Baseline, Weeks 6 and 26, ET)
- Number of Subjects Per Response on the School Placement Questionnaire: School Situation(Baseline, Weeks 6 and 26, ET)
- Number of Subjects Per Response on the School Placement Questionnaire: School Attendance(Baseline, Weeks 6 and 26, ET)
- Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance(Baseline, Weeks 6 and 26, ET)
研究者
研究点 (1)
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