NCT06770543招募中不适用
Regulatory Post-Marketing Surveillance (rPMS) Study for Leqvio® Pre-filled Syringe(Inclisiran Sodium)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Incidences of adverse events/adverse drug reactions (AEs/ADRs)
研究概览
简要总结
This non-interventional study is a mandatory regular Post Marketing Surveillance(rPMS) granted by the Korean health authorities, and is conducted to assess the effectiveness and safety of Leqvio® Pre-filled Syringe(inclisiran sodium) in routine clinical practice for the approved indications (primary hypercholesterolemia or mixed dyslipidemia).
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If a subject meets all of the following criteria, he/she can participate in this study:
- •Adult patients(18 years or older) who have hypercholesterolemia or mixed dyslipidemia and are prescribed Leqvio® Pre-filled Syringe(inclisiran sodium) according to domestically approved product information in real clinical practice
- •Patients who are unable to reach LDL-C target with maximum tolerated dose of statin, or patients with statin intolerance
- •Patients who provided consent to participate in the study(informed consent form)
排除标准
- •A subjects who meets any of the following criteria cannot participate in this study:
- •Contraindications in accordance with domestic prescribing information
- •Patients participating in clinical trials of other investigational drugs
- •Patients who do not provide consent to participate in the study
结局指标
主要结局
Incidences of adverse events/adverse drug reactions (AEs/ADRs)
时间窗: up to 15 months
Cumulative incidences of AEs, ADRs, SAEs, Serious ADR(SADRs), Unexpected AEs, and Unexpected ADRs due to Leqvio® Pre-filled Syringe(inclisiran sodium) during the observation period \["The term "unexpected" means that it is not listed in the domestic labeling(according to health authority regulations)\]
次要结局
- Change from baseline in low-density lipoprotein-cholesterol (LDL-C) and lipid profiles(Baseline, Months 3, 9 and 15)
- Impact of subjects' baseline characteristics and medication usage on cumulative incidence of AEs and SAEs(up to 15months)
- Impact of subjects' baseline characteristics and medication usage on changes from baseline in LDL-C and lipid profiles(up to 15 months)
研究者
研究点 (1)
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