Phase 3,Double Blind,Placebo-controlled,Multicentre,Randomised-withdrawal,Long-term Maintenance of Efficacy&Safety Study of Extended-release Guanfacine Hydrochloride in Children/Adolescents Aged 6-17 With ADHD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Attention Deficit Hyperactivity Disorder-Rating Scale -IV
研究概览
简要总结
A study to evaluate the long term maintenance of efficacy of using Guanfacine Hydrochloride (SPD-503) for the treatment of ADHD in Children aged 6-17 years in Europe, Australia, Canada and the US.
详细描述
The SPD503-315 clinical program has studied the efficacy, safety, and tolerability of this product in treating symptoms of ADHD in children and adolescents aged 6-17 through short-term, placebo-controlled studies and long-termn, open-label studies. This study will more rigorously assess the long-term maintenance of efficacy using a placebo-controlled, randomised-withdrawal design. To date, all of the completed studies conducted as part of the SPD503 proigram have enrolled subjects from the US. This study is designed to evaluate the long-term maintenance of efficacy of SPD503 for the treatment of ADHD in children aged 6-17 years in Europe, Australia, Canada and US.
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 (Participant, Investigator)
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
- •male or female, aged 6-17 years at the time of consent/assent at Screening/Visit 1
- •subject meets DSM-IV-TR criteria for primaru diagnosis of ADHD
- •subject has a minimum ADHD-RS-IV total score of 32 at enrolment/visit 2
- •subject has a minimum CGI-S score of 4 at Enrolment/Visit 2
- •subject is able to swallow intact tablets
排除标准
- •subject has a current controlled or uncontrolled, co-morbid psychiatric diagnosis.
- •subject has a know history or presence of structural cardiac abnormalities
- •subject with orthostatic hyupotension or a known history of controlled or uncontrolled hypertension
- •current use of any prohibited medication or other medications, including herbal supplements that affet blood pressure, or heart rate or that have CNS effects or affect cognitive performance
- •subject is significant overweight based on Centre for disease control and prevention BMI for age gender specific charts. Significantly overweight is defined as a BMI >95 th percentile Children aged 6-12 years with a body weight ,25,0kg, or adolescents aged 13-17 years with a body weight <43 kg or >91 kg at screening/visit 1
- •subject is currently considered a suicide risk in the opinion of the investigator
- •history of failure to respond to an adequate trial of an alfa2-agonist for the treatment of ADHD.
研究组 & 干预措施
Placebo
干预措施: Placebo oral capsule (Drug)
Extended-release Guanfacine Hydrochloride (SPD503)
干预措施: Extended-release Guanfacine Hydrochloride (SPD503) (Drug)
结局指标
主要结局
Attention Deficit Hyperactivity Disorder-Rating Scale -IV
时间窗: 13 weeks
次要结局
- Clinical Global Impressions-Severity score(13 weeks)