NCT02773355已完成不适用
Timely Detection of Treatment Emergent Serious and Non-serious Adverse Events for Saxenda® in Mexican Patients
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
- 27
- 试验地点
- 15
- 主要终点
- Frequency of pancreatitis
研究概览
简要总结
This trial is conducted in North America. The aim is to investigate timely detection of pancreatitis cases as well as cases of suspicion of serious and non-serious adverse reactions possibly or probably related to Saxenda® in Mexican patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
- •The decision to initiate the treatment with commercially available Saxenda® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
- •Obese patients (BMI equal to or above 30 kg/m^2) or overweight patients (BMI Equal to or above 27 kg/m^2) with at least one weight related comorbidity according to Saxenda® label text in Mexico
- •Age equal or above 18 years at the time of signing informed consent
排除标准
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- •Hypersensitivity to Saxenda® or to any of its excipients
- •Females of child-bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
- •Diagnosis of type 1 diabetes
研究组 & 干预措施
Saxenda®
干预措施: liraglutide 3.0 mg (Drug)
结局指标
主要结局
Frequency of pancreatitis
时间窗: Year 0-3
次要结局
- Adverse drug reactions (ADR)(Year 0-3)
研究者
研究点 (15)
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