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Active, Not Recruiting

NCT Number: NCT05889143

A Study to Evaluate the Efficacy and Safety of CREZET Tablet

This observation study is to evaluate blood lipid-lowering effects and liver/renal safety, changes in HbA1c and FPG in patients with dyslipidemia who administered CREZET tablets for 24 weeks.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kimyounggi Clinic

Busan, South Korea

About this study

A subject who is diagnosed with dyslipidemia and scheduled to administer CREZET tablets, will be enrolled in this study based on the doctor's medical decision.

The CREZET Tablet will be administered for 24 weeks, and the data including demographic information, body measurement, vital signs and etc will be collected during the study period.

The data collection point is as follows.

  • Visit 1 (baseline, day 0)
  • Visit 2 (at 12 weeks)
  • Visit 3 (at 24 weeks)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • an adult male and female over 19 years of age
  • A patient with dyslipidemia who is scheduled to administer Crezet tablets according to the medical judgment of the investigator based on permission
  • A person who voluntarily participates in the observational study and agrees in writing to comply with the subject's precautions during the study period after hearing and understanding the detailed explanation of the characteristics of the observational study and the drug to be studied

Exclusion criteria

  • A person who is prohibited from administering according to the permission of the Crezet definition
  • Patients who overreact to the principal or component of the Crezet definition
  • Patients with active liver disease or patients with persistent high symptoms of serum aminotransferase levels
  • a patient with a muscle disease
  • a patient administered in combination with a cyclosporine-med
  • Patients with severe renal failure (Creatinine Clearance (CLcr) < 30 mL/min)
  • Women and lactating women who may be pregnant or pregnant
  • Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  • A person who has a history of taking Crezet tablets within three months of the date of registration
  • A person who is deemed inappropriate to participate in this observational study based on the judgment of investigator.

Treatment and study plan

Ezetimibe/Rosuvastatin

Drug

Patient treated with Crezet Tablet

Other names: Crezet Tablet

Primary outcomes

  1. The Rate of change in LDL-C

    Time frame: 24 weeks

    The Rate of change in LDL-C at 24 weeks from baseline

Secondary outcomes

  1. The Rate of change in LDL-C

    Time frame: 12 weeks

    The Rate of change in LDL-C at 12 weeks from baseline

  2. The change in HbA1c

    Time frame: 12 weeks

    The change in HbA1c at 12 weeks from baseline

  3. The change in HbA1c

    Time frame: 24 weeks

    The change in HbA1c at 24 weeks from baseline

  4. The change in FPG

    Time frame: 12 weeks

    The change in FPG at 12 weeks from baseline

  5. The change in FPG

    Time frame: 24 weeks

    The change in FPG at 24 weeks from baseline

  6. The chanage in lipid variable

    Time frame: 12 weeks

    The chanage in lipid variable at 12 weeks from baseline

  7. The chanage in lipid variable

    Time frame: 24 weeks

    The chanage in lipid variable at 24 weeks from baseline

  8. The change in AST

    Time frame: 12 weeks

    The change in AST at 12 weeks from baseline

  9. The change in AST

    Time frame: 24 weeks

    The change in AST at 24 weeks from baseline

  10. The change in ALT

    Time frame: 12 weeks

    The change in ALT at 12 weeks from baseline

  11. The change in ALT

    Time frame: 24 weeks

    The change in ALT at 24 weeks from baseline

  12. Percentage of subjects who reached LDL-C target

    Time frame: 12 weeks

    Percentage of subjects who reached LDL-C target according to Korean Society of Lipid Arteriosclerosis's risk classification of treatment guidelines for dyslipidemia at 12 weeks from baseline

  13. Percentage of subjects who reached LDL-C target

    Time frame: 24 weeks

    Percentage of subjects who reached LDL-C target according to Korean Society of Lipid Arteriosclerosis's risk classification of treatment guidelines for dyslipidemia at 24 weeks from baseline

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Prospective, Non-Intervention, Multi-Center Observational Study to Evaluate the Efficacy and Safety of CREZET Tablet in Patients With Dyslipidemia

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jun 5, 2023
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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