NCT00556296已完成3 期
A Phase 3, Randomized, Multi-Center, Double-Blind, Parallel-Group, Placebo-Controlled Study of NRP104 in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder
New River Pharmaceuticals0 个研究点目标入组 297 人开始时间: 2004年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 297
- 主要终点
- Change score from baseline of the ADHD-RS
研究概览
简要总结
This study is designed to assess efficacy and safety of NRP-104 administered as a daily dose of 30mg, 50mg or 70mg compared to placebo in the treatment of children aged 6-12 years with ADHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •primary diagnosis of ADHD combined subtype or the predominantly hyperactive-impulsive subtype based on a psychiatric evaluation that reviews DSM-IV criteria
- •functioning at age appropriate levels intellectually
- •blood pressure measurements within the 95th percentile for their gender, height and age
- •ECG results are within the normal range
排除标准
- •comorbid psychiatric diagnosis (such as psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder) or other symptomatic manifestations
- •history of seizures (exclusive of febrile seizure), a tic disorder, or a family history of Tourette's disorder
- •weighs less than 55 lbs (25 kg)or is significantly overweight or obese
- •clinically significant ECG abnormality
- •documented allergy or intolerance to amphetamines
研究组 & 干预措施
1
Experimental
干预措施: NRp104 (Drug)
2
Experimental
干预措施: NRp104 (Drug)
3
Experimental
干预措施: NRp104 (Drug)
4
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change score from baseline of the ADHD-RS
时间窗: 4 weeks
次要结局
- Duration of therapeutic responses using the CPRS ADHD Index(At treatment endpoint, separately for morning, afternoon and evening responses)
- Clinical global impression of severity(CGI-S) and improvement (CGI-I)(Treatment endpoint)
- Treatment emergent AEs(4 weeks)
研究者
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