NCT01795105已完成不适用
Post-Marketing Surveillance of Safety and Efficacy of Abilify® Tablets in Korean Patients With Tourette's Disorder Under the "New Drug Re-Examination"
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 692
- 试验地点
- 4
- 主要终点
- Frequency (n) of Subjects With Adverse Event
研究概览
简要总结
This is a Post-Marketing Surveillance study of Abilify® tablets in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: KFDA Notification No. 2010-94 dated 27 December 2010).
详细描述
This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the patient's follow-up is not prescriptive in nature and must be left up to the judgment of the physician (investigator), within the period of observation set forth in the protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients 6 to 18 years of age with Tourette's Disorder
- •Patients who are prescribed Abilify® treatment as per investigator's medical judgment.
- •Patients who gave written authorization to use their personal and health data
- •Patients starting Abilify® treatment after agreement is in place
排除标准
- •Patients with known hypersensitivity to Aripiprazole or any excipients of Abilify®
- •Patients who have been treated with Abilify®
- •Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactose malabsorption
- •Patients with score 0(Not assessed) or 1(Normal, not at all ill) in the TS-CGI-S
- •Patients participating in other clinical trial
结局指标
主要结局
Frequency (n) of Subjects With Adverse Event
时间窗: Follow-up at least once from baseline to 6 weeks and at least 12weeks
Frequency (n) and Percentage(%) of subjects with Adverse event
次要结局
- Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement)(at least 6, 12 weeks interval from baseline)
研究者
研究点 (4)
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