A Prospective, Open-Label, Multi-Center, Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) 20-70mg in Children Aged 6-12 Diagnosed With ADHD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 318
- 试验地点
- 39
- 主要终点
- Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks
研究概览
简要总结
Assess the efficacy & tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.
详细描述
Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (lisdexamfetamine dimesylate) in Children aged 6-12 Diagnosed with ADHD
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
干预措施: Vyvanse (lisdexamfetamine dimesylate) (Drug)
结局指标
主要结局
Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks
时间窗: Baseline and 7 weeks
Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
次要结局
- Weekly Change From Baseline in Total ADHD-RS-IV Score(Baseline and 1, 2, 3, 4, 5, 6, and 7 weeks)
- Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)(7 weeks)
- Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks(Baseline and 7 weeks)
- Number of Participants With Improvement onParent Global Assessment (PGA)(7 weeks)
- Change From Baseline in Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks(Baseline and 7 weeks)