JPRN-jRCT2080222082已完成2 期
Phase II Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder -Long Term Extension Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
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 53weeks. 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
- •Patients who hope to continue treatment with S-877489 after the preceding study. etc.
排除标准
- •Patients who have complications such as serious hepatic disorder, renal disorder, heart disease, lung disease, hematological disease, and metabolic disease. etc.
研究者
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