通用名称

varenicline

儿科标签批准日期

2019/2/22 0:00:00

特定指示/秒

Aid to smoking cessation treatment

标签更改摘要

- Chantix is not recommended for use in pediatric patients 16 years or younger because its efficacy in this population was not demonstrated. - Efficacy and safety of varenicline were evaluated in a randomized, double-blind, placebo-controlled study of 312 patients aged 12 to 19 years. Results from this study showed that varenicline, at either dose studied, did not improve continuous abstinence rates at weeks 9 through 12 of treatment compared with placebo in patients 12 to 19 years. - Varenicline safety profile in this study was consistent with that observed in adult studies. - Information on pharmacokinetics.

治疗类别

N/A

立法类型

PREA + BPCA

产品说明书链接

书号

3.0 2.0 1.0

研究年龄

12 YEARS - 17 YEARS 12 YEARS - 16 YEARS 12 YEARS - 19 YEARS

学习类型

Safety,Pharmacokinetic,Tolerability Safety,Pharmacokinetic,Tolerability Efficacy,Safety

研究设计

Randomized,Double-Blind,Parallel Group,Placebo Control,Single Dose Randomized,Double-Blind,Phase 1,Placebo Control Randomized,Double-Blind,Parallel Group,Placebo Control

登记的患者

27 73 312

患者分析

27 72 307

中心的数量

1 16 74

国家数量

1 2 6

西班牙裔拉美裔/拉丁裔总计

N/A N/A N/A

非西班牙裔/非拉丁裔总人数

N/A 51 N/A

总数#种族不明

0 21 0

亚裔学生总数

0 1 53

黑人总数

24 1 23

白人总数

3 45 228

夏威夷或太平洋岛民总数

0 0 0

美洲印第安人/阿拉斯加本地人总数

0 1 0

其他种族总计

0 3 3

未知种族总数

N/A N/A N/A

国家

N/A N/A N/A