通用名称

sacubitril/valsartan

儿科标签批准日期

2019/10/1 0:00:00

特定指示/秒

Treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older

标签更改摘要

- Safety and effectiveness in pediatric heart failure patients 1 to <18 years old are supported by the reduction from baseline to 12 weeks in NT-proBNP in a randomized, double-blind clinical study [see Clinical Studies (14.2)]. The analysis of NT-proBNP included 90 patients age 6 to 18 years and 20 patients age 1 to 6 years. - Safety and effectiveness have not been established in pediatric patients less than 1 year of age. - Adverse reactions were similar to those observed in adults. - Information on dosing, PK parameters, clinical trial, and preparation of oral solution. - New indication.

治疗类别

N/A

立法类型

PREA + BPCA

产品说明书链接

书号

2.0 1.0

研究年龄

1 MONTHS - 17 YEARS 1 MONTHS - 17 YEARS

学习类型

Efficacy,Safety Safety,Pharmacokinetic,Pharmacodynamic,Tolerability

研究设计

Multicenter,Randomized,Active Comparator,Double-Blind,Parallel Group,Population PK Multicenter,Open-Label

登记的患者

110 18

患者分析

110 N/A

中心的数量

60 60

国家数量

19 19

西班牙裔拉美裔/拉丁裔总计

17 N/A

非西班牙裔/非拉丁裔总人数

62 N/A

总数#种族不明

31 N/A

亚裔学生总数

15 N/A

黑人总数

18 N/A

白人总数

63 N/A

夏威夷或太平洋岛民总数

0 N/A

美洲印第安人/阿拉斯加本地人总数

2 N/A

其他种族总计

10 N/A

未知种族总数

2 N/A

国家

United States N/A