NCT00763971已完成3 期
A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) 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
- 336
- 试验地点
- 49
- 主要终点
- Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks
研究概览
简要总结
The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subject is a male or female aged 6-17 years inclusive at the time of consent.
- •Subject must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
- •Subject must have a Baseline ADHD-RS-IV total score ≥
- •Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline.
- •Subject is able to swallow a capsule.
排除标准
- •Subject has failed to respond to more than one adequate course (dose and duration) of stimulant therapy. One course must have been a long-acting formulation.
- •Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.
- •Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently, demonstrating active suicidal ideation.
- •Subject has glaucoma.
- •Subject weighs less than 22.7kg (50lbs).
- •Subject is significantly overweight based on Centre for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts at Screening. Significantly overweight is defined as a BMI >97th percentile for this study.
- •Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or methylphenidate.
- •Subject has a documented allergy, hypersensitivity, or intolerance to any excipients in the test or reference products.
- •Subject has a history of seizures (other than infantile febrile seizures), a tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.
- •Subject has a known history of symptomatic cardiovascular disease, advance arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
- •Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
- •Subject is well controlled on their current ADHD medication with acceptable tolerability.
- •Subject has a pre-existing severe gastrointestinal tract narrowing (pathologic or iatrogenic).
研究组 & 干预措施
Lisdexamfetamine Dimesylate (LDX)
Experimental
Overencapsulated LDX 30, 50, or 70mg
干预措施: Lisdexamfetamine Dimesylate (LDX) (Drug)
Methylphenidate Hydrochloride
Active Comparator
Overencapsulated Concerta 18, 36, or 54mg
干预措施: Methylphenidate Hydrochloride (Drug)
Placebo
Placebo Comparator
Overencapsulated Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks
时间窗: Baseline and up to 7 weeks
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. A decrease in score indicates an improvement in ADHD symptomology.
次要结局
- Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 Weeks(Baseline and up to 7 weeks)
- Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to 7 weeks)
- Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks(Baseline and up to 7 weeks)
- Change From Baseline in the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks(Baseline and up to 7 weeks)
- Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores(Up to 7 weeks)
- Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks(Baseline and up to 7 weeks)
- Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 Weeks(Baseline and up to 7 weeks)
研究者
研究点 (49)
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