NCT00151996已完成2 期
A Phase II, Open-Label Co-Administration Study of SPD503 and Psychostimulants 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
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 75
- 主要终点
- Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of administering SPD503 (Guanfacine hydrochloride) with psychostimulants (amphetamine or methylphenidate) for treatment of ADHD in children and adolescents aged 6-17
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject on a stable dose of a psychostimulant approved for the treatment of ADHD for at least 1 month, with sub-optimal control in the Investigator's opinion
- •Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
排除标准
- •Subject has current uncontrolled comorbid psychiatric diagnosis (except ODD and mild anxiety) with significant symptoms
- •History of seizure during the last 2 years
- •Subject has any specific cardiac condition or family history of significant cardiac condition
- •Subject is pregnant or lactating
研究组 & 干预措施
Methylphenidate + SPD503
Experimental
干预措施: Methylphenidate + SPD503 (Guanfacine hydrochloride) (Drug)
Amphetamine + SPD503
Experimental
干预措施: Amphetamine + SPD503 (Drug)
结局指标
主要结局
Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total 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 Child Health Questionnaire-Parent Form (CHQ-PF50) Scores at 6 Weeks(Baseline and 6 weeks)
- Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores(6 weeks)
- Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Total Score at 6 Weeks(Baseline and 6 weeks)
- Number of Participants With Improvement on Parent Global Assessment (PGA) Scores(6 weeks)
研究者
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