NCT03536390撤回4 期
A Phase 4, Double-blind, Randomized, Parallel Group, Placebo-controlled Study Of The Efficacy And Safety Of Methylphenidate Hydrochloride (Hcl) Extended Release Chewable Tablet (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
- Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version
研究概览
简要总结
This 6-week study is to determine if the study drug, Methylphenidate Hydrochloride (HCl) Extended-Release Chewable Tablets (ERCT), is safe, tolerable and effective when compared to a sugar pill or placebo in children 4 to 5 years of age with ADHD.
详细描述
Phase 4 Double-blind, Randomized, Parallel Group, Placebo-controlled Study of the Efficacy And Safety of Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablets (ERCT) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (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)
盲法说明
Double-blind
入排标准
- 年龄范围
- 48 Months 至 69 Months（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 screening.
- •Signed and dated informed consent provided by the subject's parent/legal and assent of the child (as applicable).
- •Meets DSM-5 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 (PPVT-4)Standard Score >/=
- •Child Global Assessment Scale (CGAS) score </=
- •Participation in a school type program (day care, preschool, kindergarten, transitional kindergarten, or elementary school) for at least >/=2 half days of the week for at least 3 months and that is anticipated to continue during the study.
- •History of an adequate course of non medication treatment for ADHD based on investigator judgment or, where such treatments are not available, the severity of the subject's ADHD symptoms are such that medication treatment is deemed necessary by the investigator
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 methylphenidate or other stimulant. If a known allergy to D&C red #30, he/she should not be enrolled in the study.
- •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
Placebo
Placebo Comparator
one chewable tablet once daily in morning.
干预措施: Placebo (Drug)
Methylphenidate Hydrochloride Extended Release Chewable Tablet
Experimental
one chewable tablet once daily in morning.
干预措施: Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT) (Drug)
结局指标
主要结局
Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version
时间窗: Basline, 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
- Change from Baseline in Clinical Global Impression - Severity (CGI-S) score(Baseline, Weeks 1 through 6)
- ADHD RS-IV Preschool-School Version Total score(Weeks 3 and 6)
- Safety-incidence of treatment emergent adverse events(6 Weeks)
- Change from Baseline in Clinical Global Impression of Improvement (CGI-I) Scale Score(Baseline, Weeks 1 through 6)
- ADHD RS-IV Preschool-Home Version hyperactivity and inattention subscales scores(Weeks 1 through 6)
- ADHD RS-IV Preschool-School Version hyperactivity and inattention subscales scores(Weeks 3 and 6)
- ADHD RS-IV Preschool-Home Version Total score(Weeks 1 through 5)
研究者
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