通用名称

methylphenidate hydrochloride

儿科标签批准日期

2019/2/27 0:00:00

特定指示/秒

Attention Deficit Hyperactivity Disorder

标签更改摘要

- Safety and effectiveness have been established in one adequate and well-controlled 6-week study in pediatric patients ages 6 to 12 years, and in one adequate and well-controlled 4-week study in pediatric patients ages 12 to 17 years. - Safety and effectiveness in pediatric patients under the age of 6 years have not been established. - The long-term efficacy of methylphenidate in pediatric patients has not been established. - Information on dosing, adverse reactions, PK parameters, and clinical trials. - New dosage form

治疗类别

CNS Stimulants

立法类型

PREA Only

产品说明书链接

书号

3.0 2.0 1.0

研究年龄

6 YEARS - 12 YEARS 12 YEARS - 17 YEARS 12 YEARS - 17 YEARS

学习类型

Efficacy,Safety Efficacy,Safety Efficacy,Safety

研究设计

Placebo,Single-Blind,Parallel Group Open-Label Placebo,Single-Blind,Parallel Group

登记的患者

156 176 354

患者分析

N/A N/A N/A

中心的数量

6 34 42

国家数量

1 2 2

西班牙裔拉美裔/拉丁裔总计

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非西班牙裔/非拉丁裔总人数

N/A N/A N/A

总数#种族不明

N/A N/A N/A

亚裔学生总数

N/A N/A N/A

黑人总数

N/A N/A N/A

白人总数

N/A N/A N/A

夏威夷或太平洋岛民总数

N/A N/A N/A

美洲印第安人/阿拉斯加本地人总数

N/A N/A N/A

其他种族总计

N/A N/A N/A

未知种族总数

N/A N/A N/A

国家

N/A N/A N/A