3상모집 중단 (진행 중)

A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

연구 개요

CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.

스폰서
리드: 노바티스
적응증
Primary Prevention of Atherosclerotic Cardiovascular Disease
중재
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL, Placebo in 1.5ml
목표 등록
14,012
시작일
2023-03-09
완료(예정)
2029-04-16

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