ong-term Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder

Shionogi & Co., Ltd.0 个研究点目标入组 132 人开始时间: 2015年1月16日最近更新: 2023年10月17日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Shionogi & Co., Ltd.
入组人数: 132

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

There is no major safety concerns in Japanese pediatric patients with ADHD who received S-877489 30-70mg for up to 57weeks. The changes in ADHD-RS-IV total score at LOCF and all points from 1 to 53 weeks indicated a significant decrease from baseline. The other endpoints (ADHD-RS-IV subscale score, Conners 3 symptom scale score and the total score, CGI-I, CGI-S, PGA, QCD) also showed improvement at the final evaluation point, suggesting the long-term sustainable efficacy of S-877489.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 6age old 至 <= 17age old（—）
性别: All

入选标准

•Continuing participants from Phase 2/3 study:
•Patient has completed the preceding study (Phase II/III Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder). And et al.
•New participants:
•1) Patient aged from 6 to 17 years at the time of signing the informed consent form.
•2) Patient meets the DSM-5 criteria for a principal diagnosis of ADHD (combined presentation [314.01], predominantly inattentive presentation [314.00], or predominantly hyperactive-impulsive presentation [314.01]). etc.

排除标准

•1) Patient has complications such as serious hepatic disorder, renal disorder, heart disease, lung disease, hematological disease, and metabolic disease.
•2) Patient considered a suicide risk. etc.

研究者

发起方

Shionogi & Co., Ltd.

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