JPRN-jRCT2080222718已完成2 期
Phase II/III 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
- 76
研究概览
简要总结
The superiority of 4 week-administration of S-877489 at the doses of 30, 50, and 70 mg versus the placebo was verified from the above results, and thus the efficacy of S-877489 in pediatric patients with ADHD was demonstrated. It was considered that there might be no great safety concerns, because neither serious nor severe adverse events and no adverse events specific to Japanese subjects occurred.
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 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 has psychiatric disease such as schizophrenia spectrum, or bipolar disorder.
- •3) Patient has personality disorder or mental retardation.
- •4) Patient considered a suicide risk.
研究者
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