NCT00735371已完成3 期
A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Forced-dose Titration, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Adolescents Aged 13-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
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
- Shire
- 入组人数
- 314
- 试验地点
- 44
- 主要终点
- Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks
研究概览
简要总结
The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet DSM-IV-TR criteria for a primary diagnosis of ADHD
- •Baseline ADHD-RS-IV score >=28
- •BP w/in 95th percentile for age, gender, and height
排除标准
- •Subject has controlled or uncontrolled comorbid psychiatric diagnosis
- •Subject has conduct disorder
- •Under or overweight
- •Concurrent chronic or acute illness that might confound results.
研究组 & 干预措施
Lisdexamfetamine Dimesylate (LDX) 30 mg
Active Comparator
干预措施: LDX 30 mg (Drug)
LDX 50 mg
Active Comparator
干预措施: LDX 50 mg (Drug)
LDX 70 mg
Active Comparator
干预措施: LDX 70 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks
时间窗: Baseline and 1, 2, 3 and 4 weeks
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
- Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores(1, 2, 3 and 4 Weeks)
- Youth Quality of Life-Research Version (YQOL-R) Total Score(Baseline and 4 weeks)
研究者
研究点 (44)
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