NCT00150618已完成3 期
A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of SPD503 in Children and Adolescents Aged 6-17 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
- 324
- 主要终点
- Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks
研究概览
简要总结
The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 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
- Double
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a primary diagnosis of ADHD
- •Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test
- •Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
排除标准
- •Subject has a current, uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as severe comorbid Axis II disorders or severe Axis I disorders
- •Subject weighs less than 55 lbs or is morbidly overweight with a BMI => 35
- •Subject has a history of seizure during the last 2 years or a serious tic disorder, including Tourette's Disorder
- •Subject is pregnant or lactating
研究组 & 干预措施
SPD503 (Guanfacine HCl) (1 mg)
Experimental
干预措施: SPD503 (1 mg) (Drug)
SPD503 (2 mg)
Experimental
干预措施: SPD503 (2 mg) (Drug)
SPD503 (3 mg)
Experimental
干预措施: SPD503 (3 mg) (Drug)
SPD503 (4 mg)
Experimental
干预措施: SPD503 (4 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 (ADHD-RS-IV) Score at 6 Weeks
时间窗: Baseline and 6 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
- Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks(Baseline and 6 weeks)
- Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)(6 weeks)
- Number of Participants With Improvement in Parent Global Assessment (PGA)(6 weeks)
- Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks(Baseline and 6 weeks)
研究者
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