NCT00141050已完成3 期
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in attention and deportment measured at 2 hours post-dose
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo in children ages 6-12 diagnosed with ADHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double
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
- •DSM-IV diagnosis of ADHD
- •Males and females aged 6-12
排除标准
- •Inability to understand or follow instructions
- •Is pregnant
- •Diagnosis of tic disorder
- •History of seizure disorder
结局指标
主要结局
Change in attention and deportment measured at 2 hours post-dose
次要结局
- Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose
- Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline
- Safety and tolerability of two doses of dexmethylphenidate compared to two doses of an approved, long-acting, marketed medication for ADHD and placebo in children ages 6-12 diagnosed with ADHD.
研究者
研究点 (2)
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