A Phase III Randomised, Double-Blind, Parallel-Group Study to Assess the Effect of Fixed Dose Combination Laroprovstat/Rosuvastatin Compared With Rosuvastatin on Low-Density Lipoprotein Cholesterol in Patients With Hypercholesterolaemia

AstraZeneca0 个研究点目标入组 200 人开始时间: 2026年9月15日最近更新: 2026年6月1日

试验速览

阶段: 3 期
状态: 尚未招募
发起方: AstraZeneca
入组人数: 200

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the effect on low-density lipoprotein-cholesterol (LDL-C) and the safety and tolerability of a fixed dose combination (FDC) of laroprovstat/rosuvastatin versus rosuvastatin alone in patients with hypercholesterolaemia with either a history of a clinical atherosclerotic cardiovascular disease (ASCVD) event or at increased risk for a first clinical ASCVD event.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 130 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Participant must be ≥ 18 years of age
•Participants must be on a stable dose of all background LLTs
•The stable statin dose should be judged as their maximally tolerated dose
•Participants should have either history of a clinical ASCVD event or be at increased risk for a first clinical ASCVD event

排除标准

•Asian origin
•Uncontrolled severe hypertension
•Uncontrolled T2DM
•Inadequately treated hypothyroidism

研究者

发起方

AstraZeneca

申办方类型

Industry

责任方

Sponsor

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