临床试验/NCT05438069

NCT05438069招募中不适用

German Inclisiran Network: Retrospective Registry of Patients Being Treated With the siRNA Inclisiran in Germany

Jena University Hospital1 个研究点分布在 1 个国家目标入组 500 人开始时间: 2020年12月11日最近更新: 2022年7月7日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Jena University Hospital
入组人数: 500
试验地点: 1
主要终点: LDL-C change

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The German Inclisiran Network is a registry of patients with hypercholesterinemia on treatment with the siRNA inclisiran in Germany

详细描述

The aim of this retrospective, multi-center analysis is to use individual patient data to determine the extent of the variability in LDL-C reduction in response to inclisiran administration in a real-world setting.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Retrospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•patients with elevated LDL-C levels (hypercholesterolemia) on stable lipid-lowering drugs for at least one month prior to the application of the siRNA Inclisiran
•patients 18 years and older

排除标准

•patients who do not qualify for treatment with the siRNA inclisiran according to the G-BA (Gemeinsamer Bundesausschuß) in Germany.

结局指标

主要结局

LDL-C change

时间窗: 3 months, 6 months, 12 months, 24 months

LDL-C change in mg/dL / mmol/L

次要结局

未报告次要终点

研究者

发起方

Jena University Hospital

申办方类型

Other

责任方

Principal Investigator

主要研究者

Oliver Weingärtner

Clinical Professor

Jena University Hospital

研究点 (1)

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