Corlanor Oral Solution
通用名称
ivabradine
儿科标签批准日期
2019/4/22 0:00:00
特定指示/秒
Treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate
标签更改摘要
- Safety and effectiveness have been established in pediatric patients age 6 months to less than 18 years old and are supported by pharmacokinetic and pharmacodynamic trials and evidence from adequate and well-controlled trials of Corlanor in adult patients. - The pediatric study included 116 patients in the following age groups: 17 patients in the 6 months to less than 12 months age group, 36 patients in the 1 year to less than 3 years age group, and 63 patients in the 3 years to less than 18 years age group - Safety and efficacy have not been established in patients less than 6 months of age. - Bradycardia and first-degree heart block were observed in pediatric patients treated with Corlanor. - Asymptomatic and symptomatic bradycardia were observed in 6.8% and 4.1% of pediatric patients treated with Corlanor, respectively. - Phosphenes were observed in pediatric patients treated with Corlanor. - Information on dosing, adverse reactions, Pk parameters and clinical trial. - New dosage form
治疗类别
N/A
立法类型
BPCA Only
产品说明书链接
书号
2.0 1.0
研究年龄
2 YEARS - 17 YEARS 6 MONTHS - 17 YEARS
学习类型
Quality of Life Questionnaire Efficacy,Safety,Pharmacokinetic,Pharmacodynamic
研究设计
Quality of Life Questionnaire Multicenter,Randomized,Double-Blind,Phase 2,Placebo Control,3
登记的患者
N/A 116
患者分析
N/A 116
中心的数量
34 47
国家数量
13 16
西班牙裔拉美裔/拉丁裔总计
N/A N/A
非西班牙裔/非拉丁裔总人数
N/A N/A
总数#种族不明
N/A 0
亚裔学生总数
N/A 1
黑人总数
N/A 5
白人总数
N/A 102
夏威夷或太平洋岛民总数
N/A 0
美洲印第安人/阿拉斯加本地人总数
N/A 0
其他种族总计
N/A 8
未知种族总数
N/A N/A
国家
N/A N/A
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