JPRN-jRCT2080222081已完成2 期
Phase II Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
研究概览
简要总结
There is no new safety concerns in Japanese pediatric patients with ADHD who received S-877489 30-70mg for 4 weeks. The changes in ADHD-RS-IV total scoreat all evaluation points (Weeks 1-4) and the final evaluation point indicated a significant decrease from baseline(P<0.0001). 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.
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
- •1) Patient aged 6 years or older to less than 18 years at the time of signing the informed consent form.
- •2) Patient meets the DSM-IV-TR criteria for a primary diagnosis of ADHD (predominantly inattentive type [314.00], predominantly hyperactive-impulsive type [314.01], and combined type [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 has psychiatric disorder such as schizophrenia, bipolar disorder, and pervasive development disorder.
- •3) Patient has personality disorder or mental retardation.
- •4) Patient has a documented allergy, hypersensitivity or intolerance to amphetamine.
- •5) Patient considered a suicide risk. etc.
研究者
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