NCT00997984已完成3 期
A Phase 3, Double-blind, Randomized, Multicenter, Placebo-controlled, Dose Optimization Study Evaluating the Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children Aged 6-12 With 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
- 340
- 试验地点
- 43
- 主要终点
- Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)
研究概览
简要总结
The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1, 2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.
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
- •6-12 years old
- •ADHD diagnosis
- •ADHD-RS-IV minimum score of 28
- •CGI-S score > or = 4
排除标准
- •Current, controlled or uncontrolled, comorbid psychiatric diagnosis
- •Condition or illness which represent inappropriate risk to subject
- •Known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems, exercise-related cardiac events, or clinically significant bradycardia; orthostatic hypotension or controlled or uncontrolled hypertension
- •Use of prohibited medication that have CNS effects or affect cognitive performance
- •History of alcohol or substance abuse within 6 months
- •Current use of medication that affect BP or heart rate
- •Significantly overweight
- •Weight of less than 55 lbs
- •Known allergy to SPD503
- •Abnormal urine drug and alcohol screen
研究组 & 干预措施
Extended-release Guanfacine Hydrochloride (SPD503) AM
Experimental
干预措施: extended-release guanfacine hydrochloride (SPD503) (Drug)
placebo
Experimental
干预措施: placebo (Drug)
SPD503 PM
Experimental
干预措施: extended-release guanfacine hydrochloride (Drug)
结局指标
主要结局
Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)
时间窗: Baseline and up to 8 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.
次要结局
- Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF(Baseline and up to 8 weeks)
- Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF(up to 8 weeks)
- Change From Baseline in Conner's Parent Rating Scale - Revised Short Version (CPRS-R:S) Score at Week 8 - LOCF(Baseline and up to 8 weeks)
- Change From Baseline in Mean Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 8 - LOCF(Baseline and up to 8 weeks)
- Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF(Baseline and up to 8 weeks)
- Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF(Baseline and up to 8 weeks)
- Change From Baseline in Pulse Rate at Week 8 - LOCF(Baseline and up to 8 weeks)
- Change From Baseline in Height at Week 8 - LOCF(Baseline and up to 8 weeks)
- Change From Baseline in Weight at Week 8 - LOCF(Baseline and up to 8 weeks)
- Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF(Baseline and up to 8 weeks)
- Change From Baseline in Health Utilities Index-2/3 (HUI 2/3) Scores at Week 8 - LOCF(Baseline and up to 8 weeks)
- Change From Baseline in the Bedtime Resistance Subscale of Child's Sleep Habits Questionnaire (CSHQ) at Week 8 - LOCF(Baseline and up to 8 weeks)
- Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF(up to 8 weeks)
- Change From Baseline in Oral Temperature at Week 8 - LOCF(Baseline and up to 8 weeks)
研究者
研究点 (43)
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