NCT05614765

Evaluation of Dyslipidemia Management After Statin and Ezetimibe Complex Treatment

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 18,000 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Dyslipidemias

Interventions

Type	Name	Description
DRUG	Statin+Ezetimibe compound	Crezet Tablet, Litorvazet Tablet

Timeline

• Start date: 2022-07-08
• Primary completion: 2023-12-31
• Completion: 2025-12-31
• First posted: 2022-11-14
• Last updated: 2025-08-24

Locations

1 site across 1 country: South Korea