EUCTR2013-001694-24-Outside-EU/EEA进行中（未招募）不适用
A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 295
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subjects must provide written informed assent and be willing to participate in the study.
- •Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects’ adherence to the study procedures.
- •2. Male or female subjects 13 to 17 years of age
- •3. Subject has completed Study D1050301 (Visit 9), inclusive and all required assessments.
- •4. Willing and able to adhere to protocol-specified meal requirements during dosing.
- •5. Willing and able to swallow the size and number of lurasidone tablets specified per protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 295
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject is considered by the investigator to be at imminent risk of suicide.
- •2. Subject has evidence of any chronic organic disease of the CNS.
研究者
相似试验
进行中（未招募）
1 期
A 104-WEEK, FLEXIBLE-DOSE, OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF LURASIDONE IN PEDIATRIC SUBJECTSEUCTR2013-001694-24-BESUNOVION PHARMACEUTICALS INC.701
进行中（未招募）
1 期
A 104-WEEK, FLEXIBLE-DOSE, OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF LURASIDONE IN PEDIATRIC SUBJECTSExtension study for the D1050301 Adolescent Schizophrenia study, the D1050325 Children and Adolescent autistic disorder and the D1050326 Children and Adolescent Bioplar I DepressionMedDRA version: 18.0Level: LLTClassification code 10004936Term: Bipolar depressionSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 18.0Level: HLGTClassification code 10039628Term: Schizophrenia and other psychotic disordersSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 18.0Level: LLTClassification code 10003808Term: Autistic disorderSystem Organ Class: 100000004852EUCTR2013-001694-24-FRSUNOVION PHARMACEUTICALS INC.574
进行中（未招募）
1 期
A 104-WEEK, FLEXIBLE-DOSE, OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF LURASIDONE IN PEDIATRIC SUBJECTS WITH SCHIZOPHRENIA AND SUBJECTS WITH IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDERSCHIZOPHRENIA AND IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDERMedDRA version: 14.1 Level: HLGT Classification code 10039628 Term: Schizophrenia and other psychotic disorders System Organ Class: 10037175 - Psychiatric disordersEUCTR2013-001694-24-ESSUNOVION PHARMACEUTICALS INC.701
进行中（未招募）
1 期
A 104-WEEK, FLEXIBLE-DOSE, OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF LURASIDONE IN PEDIATRIC SUBJECTSEUCTR2013-001694-24-HUSUNOVION PHARMACEUTICALS INC.574
进行中（未招募）
1 期
A 104-WEEK, FLEXIBLE-DOSE, OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF LURASIDONE IN PEDIATRIC SUBJECTSExtension study for the D1050301 Adolescent Schizophrenia study, the D1050325 Children and Adolescent autistic disorder and the D1050326 Children and Adolescent Bioplar I DepressionMedDRA version: 20.0Level: LLTClassification code 10004936Term: Bipolar depressionSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 20.0Level: HLGTClassification code 10039628Term: Schizophrenia and other psychotic disordersSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 20.0Level: LLTClassification code 10003808Term: Autistic disorderSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2013-001694-24-BGSUNOVION PHARMACEUTICALS INC.701