Myrbetriq granules
儿科标签批准日期
2021/3/25 0:00:00
特定指示/秒
Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older
标签更改摘要
- Safety and effectiveness in pediatric patients aged 3 years and older have been established for the treatment of neurogenic detrusor overactivity (NDO)
- Use is supported by evidence from a 52-week, open-label, baseline-controlled, multicenter, dose titration trial in pediatric patients 3 years of age and older with NDO. Results showed an improvement from baseline in maximum cystometric (bladder) capacity (MCC)
- The most commonly reported adverse reactions in study 9 were UTI, nasopharyngitis, constipation, and headache. Increased mean systolic and diastolic blood pressures occurred in patients less than 12 years of age with larger increases in patients younger than 8 years of age.
- Myrbetriq should be taken with food to reduce potential exposure-related risks, such as increased heart rate, as predicted by modeling of vital signs data in Study 9.
- Information on dosing, PK parameters, adverse reactions, and clinical trials.
研究年龄
4 YEARS - 10 YEARS
7 YEARS - 17 YEARS
3 YEARS - 17 YEARS
学习类型
Safety,Pharmacokinetic,Tolerability
Safety,Pharmacokinetic,Tolerability
Efficacy,Safety,Pharmacokinetic,Tolerability
研究设计
Multicenter,Open-Label,Single-dose,Phase 1
Multicenter,Open-Label,Single-dose,Phase 1
Multicenter,Open-Label,Phase 3,Baseline Controlled
国家
Denmark,Poland
Belgium,Denmark,Norway,Poland
Australia,Belgium,Croatia (Hrvatska),Denmark,Israel,Jordan,Korea, Republic of,Latvia,Lithuania,Malaysia,Mexico,Norway,Philippines,Poland,Romania,Serbia,Slovakia,Taiwan,Turkey