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临床试验/NCT07382778
NCT07382778已完成不适用

A Multi-center, Open-label, Observational Study to Compare and Evaluate the Efficacy and Safety of Livalozet® According to the Presence or Absence of Diabetes Mellitus in Hypercholesterolemia Patients

JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 1,538 人开始时间: 2022年10月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,538
试验地点
1
主要终点
Percent change from baseline in LDL-C level at Week 24

研究概览

简要总结

A Multi-center, Open-label, Observational Study to Compare and Evaluate the Efficacy and Safety of Livalozet® according to the Presence or Absence of Diabetes Mellitus in Hypercholesterolemia Patients

详细描述

A Multi-center, Open-label, Observational Study

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women aged ≥19 years
  • Diagnosed with hypercholesterolemia
  • LDL-C level meets cardiovascular/cerebrovascular risk group classification
  • Willing to participate for 12 months
  • Provided written informed consent

排除标准

  • - Contraindications to Livalozet®

研究组 & 干预措施

Hypercholesterolemia with Diabetes Mellitus

Observational study; LDL-C and lipid parameters will be followed; no intervention assigned.

Hypercholesterolemia without Diabetes Mellitus

Observational study; LDL-C and lipid parameters will be followed; no intervention assigned.

结局指标

主要结局

Percent change from baseline in LDL-C level at Week 24

时间窗: From enrollment to the end of treatment at 24 weeks

次要结局

未报告次要终点

研究者

发起方
JW Pharmaceutical
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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