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NCT Number: NCT05614765

Evaluation of Dyslipidemia Management After Statin and Ezetimibe Complex Treatment

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Korea University Guro Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Statin+Ezetimibe compound

Drug

Crezet Tablet, Litorvazet Tablet

Primary outcomes

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

    Time frame: 24 weeks

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

Secondary outcomes

  1. LDL-C change rate and amount

    Time frame: 12 weeks

    LDL-C change rate and amount at 12 weeks compared to baseline

  2. Rate and amount of change in lipid variables (Non-HDL-C, HDL-C, TG, TC)

    Time frame: 12 weeks

    Rate and amount of change in lipid variables (Non-HDL-C, HDL-C, TG, TC) at 12 weeks compared to baseline

  3. Rate and amount of change in lipid variables (Non-HDL-C, HDL-C, TG, TC)

    Time frame: 24 weeks

    Rate and amount of change in lipid variables (Non-HDL-C, HDL-C, TG, TC) at 24 weeks compared to baseline

  4. Changes in ALT (Alanine Transaminase), AST (Aspartate Transaminase), and e-GFR (Estimated Glomerular Filtration Rate)

    Time frame: 12 weeks

    Changes in ALT (Alanine Transaminase), AST (Aspartate Transaminase), and e-GFR (Estimated Glomerular Filtration Rate) at 12 weeks compared to baseline

  5. Changes in ALT (Alanine Transaminase), AST (Aspartate Transaminase), and e-GFR (Estimated Glomerular Filtration Rate)

    Time frame: 24 weeks

    Changes in ALT (Alanine Transaminase), AST (Aspartate Transaminase), and e-GFR (Estimated Glomerular Filtration Rate) at 24 weeks compared to baseline

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Nov 14, 2022
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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