Belviq Tablet® Post Marketing Surveillance Protocol
试验速览
- 阶段
- 不适用
- 入组人数
- 3,000
- 主要终点
- Incidence of adverse event after this drug administration in general medical
研究概览
简要总结
Post-marketing surveillance of Lorcaserin
详细描述
Lorcaserin(Belviq) is a selective 5-hydroxytryptamine receptor agonist, witch is used long term for weight loss in those who are obese. Lorcaserin was approved in 2015 the Republic of Korea for weigh loss in those who are obese. A post-marketing surveillance was conducted following the approval to obtain data on the safety and efficacy of lorcaserin for weigh loss in real-world practice.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who use the drug as an adjuvant therapy of diet therapy and kinesitherapy for weight control are selected.
- •Obese patients whose body mass index (BMI) is ≧30 kg/m
- •Overweight patients whose body mass index(BMI) is ≧27 kg/m2 and who have other risk factors(e.g. hypertension, dyslipidemia, type II diabetes mellitus)
排除标准
- •Patients with a hypersensitivity reaction to the drug or the ingredient of the drug
- •Female patients of childbearing potential and pregnant or lactating women
- •Patients taking another weight control drug
- •Patients with the medical history of drug abuse
结局指标
主要结局
Incidence of adverse event after this drug administration in general medical
时间窗: 12 weeks
Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events.
次要结局
- The change from baseline to week 12 in the Body Mass Index(BMI)(12 weeks)