NCT00507065已完成3 期
A Phase III, Randomized, Multicenter, Double-blind, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of ADDERALL XR With an Open Label Extension, in the Treatment of Adolescents Aged 13-17 With 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
- 329
- 试验地点
- 1
- 主要终点
- Change from baseline to final visit of the double-blind phase of the study in the ADHD-RS-IV score in the cohort weighing less than or equal to 75 kg.
研究概览
简要总结
Assess the safety and efficacy of ADDERALL XR compared to placebo in the treatment of adolescents (aged 13-17) with ADHD. Subjects were assigned to one of two cohorts based on weight (<= 75 kg or > 75 kg).
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males/females 13-17 years of age meeting DSM-IV criteria for a primary diagnosis of ADHD
排除标准
- •Controlled or uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms such as PTSD, psychosis, bipolar disease, severe OCD
- •Known non-responder to stimulant medication
- •Documented allergy or intolerance to ADDERALL, ADDERALL XR or amphetamines
- •Conduct Disorder, hypertension, history of seizure
- •Tic disorder or Tourette's disorder
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: Placebo (Drug)
Adderall XR (10 mg)
Experimental
干预措施: Mixed salts of a single-entity amphetamine (ADDERALL XR) (Drug)
Adderall XR (20 mg)
Experimental
干预措施: Mixed salts of a single-entity amphetamine (ADDERALL XR) (Drug)
Adderall XR (30 mg)
Experimental
干预措施: Mixed salts of a single-entity amphetamine (ADDERALL XR) (Drug)
Adderall XR (40 mg)
Experimental
干预措施: Mixed salts of a single-entity amphetamine (ADDERALL XR) (Drug)
结局指标
主要结局
Change from baseline to final visit of the double-blind phase of the study in the ADHD-RS-IV score in the cohort weighing less than or equal to 75 kg.
时间窗: approximately 4 weeks
次要结局
- Change from baseline to final visit of double-blind phase of the study in ADHD-RS-IV score in the cohort weighing >75 kg and the CGI for ADHD in both cohorts.(Approximately 4 weeks)
- Adverse events, labs, physical exam, ECG(approximately 4 weeks)
研究者
研究点 (1)
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