NCT03580005撤回4 期
A Phase 4, Double-blind, Randomized, Parallel Group, Placebo-controlled Study Of The Efficacy And Safety Of Quillichew (Methylphenidate Hydrochloride (Hcl)) Extended Release Chewable Tablets (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Safety-incidence of treatment emergent adverse events
研究概览
简要总结
A 6-week double-blind study to evaluate the safety and efficacy of Quillichew extended release chewable tablets in 4-5 year old children with attention deficit hyperactivity disorder.
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
- 4 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female child 4-5 years of age at baseline.
- •Signed and dated informed consent document.
- •Meets DSM-V criteria for ADHD based on the K-SADS-PL.
- •ADHD RS-IV Preschool Home Version score at Screening and Baseline >/= 90th percentile for gender and age in >/=1 of the following: hyperactive-impulsive subscale, inattentive subscale, or total score.
- •Peabody Picture Vocabulary Test 4 (PPVT4)Standard Score >/=
- •Child Global Assessment Scale (CGAS) score </= 55.
排除标准
- •Treated with atomoxetine within 30 days prior to the Baseline.
- •Received any investigational products or devices within 30 days prior to the Baseline visit.
- •History of stimulant nonresponse, intolerability or hypersensitivity to any dose of Quillichew ERCT or other stimulant.
- •An intelligence quotient (IQ) <
- •History of acute or chronic medical or psychiatric condition or cardiac or laboratory abnormality.
- •Less than 5th percentile for height or weight at Screening.
- •History of recent clinically significant self-harming behaviors.
研究组 & 干预措施
Quillichew ERCT
Active Comparator
Quillichew ERCT
干预措施: methylphenidate HCl ERCT (Drug)
Placebo to match Quillichew ERCT
Placebo Comparator
Placebo to match Quillichew ERCT
干预措施: Placebo (Drug)
结局指标
主要结局
Safety-incidence of treatment emergent adverse events
时间窗: 6 months
incidence of treatment emergent adverse events
Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version
时间窗: 6 weeks
Change from Baseline to end of double-blind treatment in the total score of the Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version
次要结局
- incidence of adverse events(6 weeks)
- Clinical Global Impression of Improvement (CGI-I) Scale Score(weeks 1-6)
- Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18)(Weeks 1-6)
- Children's Global Assessment Scale (CGAS)(Week 6)
- Mean Clinical Global Impression - Severity (CGI-S) score(Weeks 1-6)
研究者
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