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
- 14,012명
- 시작일
- 2023-03-09
- 완료(예정)
- 2029-04-16
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