跳至主要内容
临床试验/NCT06314919
NCT06314919招募中不适用

A Multicenter, Prospective, Cohort Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimibe Under the Real-World Condition

Boryung Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 8,606 人开始时间: 2024年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
8,606
试验地点
1
主要终点
Rate of reaching the target LDL Cholesterol level

研究概览

简要总结

The purpose of this study is to evaluate the efficacy and safety of fixed-Dose combination of Pitavastatin/Ezetimibe under the real-world condition

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

  • Those who taking statins or statins and ezetimibe in addition to dietary and exercise therapy for primary hypercholesterolemia or mixed hyperlipidemia
  • Those who are judged to need administration of a fixed-dose combination of pitavastatin/ezetimibe for change of statin's formulation or change of statin's dose, addition of ezetimibe

排除标准

  • Those who are taking a fixed-dose combination of pitavastatin/ezetimibe at study enrollment
  • Those with hypersensitivity reactions or relevant medical history to pitavastatin or ezetimibe
  • Those who have been administered an investigational product within 12 weeks of the enrollment date or are planning to participate in another clinical trial during this study participation period.

结局指标

主要结局

Rate of reaching the target LDL Cholesterol level

时间窗: 12 weeks after administration

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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