NCT00557011已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Treatment, 3-Period, Crossover Study With One Week Per Treatment and Once-a-Day Dosing of Either NRP104, Adderall XR, or Placebo in Children Aged 6 to 12 Years With Attention-Deficit Hyperactivity Disorder (ADHD)
New River Pharmaceuticals0 个研究点目标入组 52 人开始时间: 2004年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 主要终点
- SKAMP-DS scores across a treatment assessment day
研究概览
简要总结
The purpose of this study is to assess, in a controlled environment, the efficacy and safety of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •males and non-pregnant females, aged 6-12 years DSM-IV-TR criteria for diagnosis of ADHD, combined or hyperactive-impulsive subtypes
- •on stable regimen of stimulants for at least one month in the last six months and has shown adequate response to stimulants without unacceptable side effects
排除标准
- •co-morbid psychiatric diagnosis such as psychosis, bipolar illness, severe OCD, severe depressive or anxiety disorder
- •history of seizure during the last 2 years, a tic disorder or Tourette's
- •clinically significant ECG or laboratory abnormalities at screening or baseline
- •taking clonidine or anticonvulsant drugs
- •taking medications that affect blood pressure or heart rate
研究组 & 干预措施
1
Experimental
NRP104
干预措施: NRP104 (Drug)
2
Active Comparator
Adderall XR
干预措施: Adderall XR (Drug)
3
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
SKAMP-DS scores across a treatment assessment day
时间窗: 1 week
次要结局
- SKAMP Attention Scale, PERMP attempted score, PERMP correct score, and CGI scores across the treatment assessment day(1 week)
- Treatment emergent adverse events(1 week)
- PK profile and PK/PD relationship of NRP104(After multiple doses)
研究者
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