Evaluation of Dyslipidemia Management After Statin and Ezetimibe Complex Treatment

NCT05614765 | Active Not Recruiting

• 1 other identifier: DWLC_RWE02
• Study Type: observational
• Target: 18,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

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

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

  24 weeks

Secondary Outcomes (5)

• LDL-C change rate and amount

  12 weeks

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

  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)

  12 weeks

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

  24 weeks

Study Arms (1)

Treatment group

statin+ezetimibe compound

Drug: Statin+Ezetimibe compound

Interventions

Statin+Ezetimibe compound DRUG

Crezet Tablet, Litorvazet Tablet

Treatment group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In order to assume the amount of LDL-C change at 24 weeks compared to the base value, the clinical trial results of the test subjects with similar underlying diseases that can be currently referred to were used.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• JinWon Kim

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: July 8, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

KR (1)