NCT06283641已完成不适用
Multicentre, Single-arm, Non-interventional Regulatory Post- Marketing Surveillance (rPMS) Study to Evaluate the Safety and Effectiveness of Saxenda® for Weight Management in Routine Clinical Practice in Taiwan.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 17
- 主要终点
- Incidence of adverse events (AEs) by preferred term (PT)
研究概览
简要总结
This is a non-interventional study to evaluate the safety and effectiveness of Saxenda® in obese adults and adolescents in Taiwan. The participants will recieve Saxenda® treatment which is a medicine that doctors can already prescribe.
The study will last for about 26 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female of Taiwanese patients, age above or equal to 12 years who are under Saxenda® treatment or are scheduled to treat with Saxenda® according to approved label in Taiwan based on the clinical judgment of their treating physician.
- •Patients should have baseline (pre-dosing) values, including body height, weight and initial dosage of Saxenda® .
- •The decision to initiate treatment or to have started with commercially available Saxenda® has been made by the patient/Legally Acceptable Representative (LAR) and the physician independently from the decision to join this study.
- •Informed consent obtained before collection of clinical data for this study. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
排除标准
- •Known or suspected hypersensitivity to Saxenda® , the active substance or any of the excipients
- •Previous participation in this study. Participation is defined as having given informed consent in this study.
- •Treatment with any investigational drug within 30 days prior to initiation of Saxenda® treatment.
- •Female patient who is pregnant, breast-feeding, or intends to become pregnant.
- •Patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- •Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation
研究组 & 干预措施
Saxenda®
Patients with obesity treated with Saxenda® for weight management in routine clinical practice in Taiwan
干预措施: Liraglutide (Drug)
结局指标
主要结局
Incidence of adverse events (AEs) by preferred term (PT)
时间窗: From baseline (week 0) to week 26
Percent(%)
次要结局
- Change in body mass index (BMI) (%) (Adolescent)(From baseline (week 0) to week 26)
- Number of adverse drug reaction (ADRs)(From baseline (week 0) to week 26)
- Body weight loss Kilogram(Kg) (Adult)(From baseline (week 0) to week 13)
- Number of unexpected SAEs and unexpected SADRs(From baseline (week 0) to week 26)
- Body weight loss Percent (%) (Adult)(From baseline (week 0) to week 13)
- Body weight loss (kg) (Adolescent)(From baseline (week 0) to week 26)
- Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs)(From baseline (week 0) to week 26)
- Number of unexpected AEs and unexpected ADRs(From baseline (week 0) to week 26)
- Dose and exposure of liraglutide after initiation and reasons if not escalate to liraglutide 3.0 miligram (mg) for maintenance as specified in the product label(From baseline (week 0) to week 26)
- Body weight loss (%) (Adult)(From baseline (week 0) to week 26)
- The proportion of adult subjects losing more than 10% of baseline body weight(At Week 26)
- Change in body mass index (BMI) (kg/m^2) (Adolescent)(From baseline (week 0) to week 26)
- The proportion of adolescent subjects losing at least 4% of baseline BMI(At Week 26)
- Change in body mass index standard deviation score (BMI SDS) (Adolescent)(From baseline (week 0) to week 26)
- Body weight loss (%) (Adolescent)(From baseline (week 0) to week 26)
- Body weight loss (kg) (Adult)(From baseline (week 0) to week 26)
- The proportion of losing at least 5% of baseline body weight from adult subjects whose maintenance dose of 3 mg, 12- week Saxenda®(At Week 26)
- The proportion of losing at least 4% of baseline BMI from adolescent subjects whose maintenance dose of 3 mg or maximum tolerated dose, 12- week Saxenda®(At Week 26)
- The proportion of adult subjects losing at least 5% of baseline body weight(At Week 26)
- The proportion of adolescent subjects losing at least 10% of baseline BMI(At Week 26)
- The proportion of adult subjects losing at least 5% of baseline body weight(At Week 13)
- The proportion of adult subjects losing more than 10% of baseline body weight(At Week 13)
- Change in body mass index (BMI) (kg/m^2) (Adolescent)(From baseline (week 0) to week 13)
- Change in body mass index (BMI) (%) (Adolescent)(From baseline (week 0) to week 13)
- Change in body mass index standard deviation score (BMI SDS) (Adolescent)(From baseline (week 0) to week 13)
- Body weight loss (%) (Adolescent)(From baseline (week 0) to week 13)
- Body weight loss (kg) (Adolescent)(From baseline (week 0) to week 13)
- The proportion of adolescent subjects losing at least 4% of baseline BMI(At Week 13)
- The proportion of adolescent subjects losing at least 10% of baseline BMI(At Week 13)
研究者
研究点 (17)
Loading locations...
相似试验
已完成
不适用
A Regulatory Post-marketing Surveillance (rPMS) Study to Evaluate the Safety and Effectiveness of Saxenda®(Liraglutide 3.0 mg) in Obese Patients and Overweight Patients With Obesity-related Comorbidities in Routine Clinical Practice in Korea.OverweightObesityNCT03560336Novo Nordisk A/S758
撤回
不适用
INSPIRE Turkey :A Research Study Looking at the Clinical Parameters Associated With Use and Discontinuation of Saxenda® in Local Clinical Practice in Turkey by Analysing Past Patient Medical RecordsObesityNCT05438186Novo Nordisk A/S
已完成
不适用
A Research Study About Weight Loss and Treatment Patterns With the Use of Saxenda® in Adults in Real-life Settings in SwitzerlandObesity or OverweightNCT05153590Novo Nordisk A/S269
尚未招募
不适用
Effect of Sadabhadradyam churna and Vrehddhatrayadi kwath in BPH.CTRI/2022/03/040919MMM GovtAyurved CollegeUdaipurRajasthan
招募中
Unknown
A multicenter, single-arm study to evaluate the safety and feasibility of PMA System for chronic total occlusion of coronary arteriesIschemic Heart DiseaseJPRN-jRCT2042230026asu Kenya20