A Phase 4, Open-label, Safety, Tolerability And Pharmacokinetic Study Of Methylphenidate Hydrochloride (Hcl) Extended Release Chewable Tablet (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- PK parameter-Tmax
研究概览
简要总结
2-week open-label safety, tolerability and pharmacokinetic study of methylphenidate HCl ERCT in 4-5 year old children with ADHD.
详细描述
Phase 4, Open-label, Safety, Tolerability And Pharmacokinetic Study 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
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 </=
- •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 subject has 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
methylphenidate HCl ERCT
methylphenidate HCl ERCT
干预措施: methylphenidate HCl ERCT (Drug)
结局指标
主要结局
PK parameter-Tmax
时间窗: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
PK parameter- AUClast
时间窗: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
PK parameter-AUC0-2
时间窗: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
PK parameter-AUC2-6
时间窗: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
PK parameter- Cmax
时间窗: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
PK parameter-AUC6-24
时间窗: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
PK parameter-AUCinf
时间窗: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
PK parameter- t1/2
时间窗: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
PK parameter-CL/F
时间窗: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
PK parameter-Vz/F
时间窗: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
次要结局
- incidence of treatment emergent adverse events (safety and tolerability)(2 weeks)