NCT00367835已完成3 期
A Double-Blind, Randomized, Multi-Center, Flexible Dose Study Evaluating the Efficacy and Safety of SPD503 (Guanfacine Hydrochloride) in Children Aged 6-12 With Symptoms of Oppositionality and a Diagnosis of Attention Deficit/Hyperactivity Disorder
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
- 217
- 试验地点
- 32
- 主要终点
- Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks
研究概览
简要总结
To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.
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
- •Healthy subjects with ADHD and oppositional symptoms
- •ADHD-RS>=24
- •T-score of Opp subscale CPRS-R:L >=65
- •Normal ECG and BP
- •>= 55 lbs
排除标准
- 未提供
研究组 & 干预措施
SPD503 (Guanfacine hydrochloride)
Experimental
干预措施: SPD503 (Guanfacine hydrochloride) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks
时间窗: Baseline and up to 8 weeks
The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.
次要结局
- Assessment of Clinical Global Impression-Severity of Illness (CGI-S)(up to 8 weeks)
- Change From Baseline in Electrocardiogram Results (QTcF Interval) at Up to 8 Weeks(Baseline and up to 8 weeks)
- Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)(up to 8 weeks)
- Change From Baseline in the Parent Stress Index-Short Form (PSI/SF) Score at Up to 8 Weeks(Baseline and up to 8 weeks)
- Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at Up to 8 Weeks(Baseline and up to 8 weeks)
- Change From Baseline in the 40-Item Conduct Problem Scale of the New York Parent's Rating Scale-School-aged (NYPRS-S) Score at Up to 8 Weeks(Baseline and up to 8 weeks)
- Number of Participants With Overall Satisfaction on the Medication Satisfaction Survey (MSS)(up to 8 weeks)
- Change From Baseline in Pulse Rate at Up to 8 Weeks(Baseline and up to 8 weeks)
- Change From Baseline in Systolic Blood Pressure at Up to 8 Weeks(Baseline and up to 8 weeks)
- Change From Baseline in Diastolic Blood Pressure at Up to 8 Weeks(Baseline and up to 8 weeks)
研究者
研究点 (32)
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