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临床试验/NCT05614765
NCT05614765进行中(未招募)不适用

Real World Data Observational Study to Evaluate the Management Status of Dyslipidemia Following Administration of Statin and Ezetimibe Complex Treatment Patient in the Medical Situation by Classification of Medical Institutions in KOREA

Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 18,000 人开始时间: 2022年7月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
18,000
试验地点
1
主要终点
Rate and amount of change in LDL-C (measured LDL-C and calculated LDL-C)

研究概览

简要总结

This study is a large-scale, prospective, multi-site, and non-interventional observational study to observe the change and safety of dyslipidemia management status when administering statin+etimib complex drugs in patients with dyslipidemia.

详细描述

All treatments, including drug administration and laboratory tests performed after administration of statin+etimib complex, are performed by the researcher's medical judgment regardless of the subject's participation in the study, and the information to be confirmed in this observational study is collected up to 24 weeks.

Data collection will begin after the date of signing the research contract, and the follow-up period for each study subject is from the registration date (Visit 1) to the 24th week (Visit 3).

To evaluate subjects' clinical performance in real world, we collect demographic information and medical treatment based on patient's medical records, previous dyslipidemia drug administration information, blood lipid tests and liver function tests conducted at the start date of statin+etimib compound administration and subsequent 24 weeks (± 8 weeks). In the case of safety-related information, such as abnormal cases, data shall be collected at any time during the 24-week follow-up period if there is a visit by the study subject according to daily treatment.

研究设计

研究类型
Observational
观察模型
Case Only
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
否

入选标准

  • •Adult men and women aged 19 or older as of the time of the registered visit (Visit 1)
  • •Patients with dyslipidemia who are planning to administer statin+ezetimib complex or who are administering dyslipidemia complex according to the researcher's medical judgment based on the permission of statin+ezetimib complex
  • •A person who can understand the information provided to him or her and voluntarily sign a written consent form

排除标准

  • •Patients who overreact to the main ingredients or components of the drug in the study
  • •Patients with active liver disease or patients with continuously high serum aminotransferase levels with unknown cause
  • •Patients with muscle disease.
  • •Pregnant women or pregnant women and nursing mothers
  • •Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabortion
  • •A person who is not permitted by administration of statin+etimib complex or who falls under prohibition of administration
  • •In addition to the above, a person who has determined that the researcher is not suitable for participation in this observation study

研究组 & 干预措施

Treatment group

statin+ezetimibe compound

干预措施: Statin+Ezetimibe compound (Drug)

结局指标

主要结局

Rate and amount of change in LDL-C (measured LDL-C and calculated LDL-C)

时间窗: 24 weeks

Rate and amount of change in LDL-C (measured LDL-C and calculated LDL-C) at 24 weeks compared to baseline

次要结局

  • LDL-C change rate and amount(12 weeks)
  • Rate and amount of change in lipid variables (Non-HDL-C, HDL-C, TG, TC)(24 weeks)
  • Changes in ALT (Alanine Transaminase), AST (Aspartate Transaminase), and e-GFR (Estimated Glomerular Filtration Rate)(24 weeks)

研究者

发起方
Daewoong Pharmaceutical Co. LTD.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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