A Study to Evaluate the Efficacy and Safety of CREZET Tablet

Last updated: January 21, 2025
Sponsor: Daewoong Pharmaceutical Co. LTD.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Ezetimibe/Rosuvastatin

Clinical Study ID

NCT05889143
DWCRZ_OS_01
  • Ages > 19
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. an adult male and female over 19 years of age

  2. A patient with dyslipidemia who is scheduled to administer Crezet tablets accordingto the medical judgment of the investigator based on permission

  3. A person who voluntarily participates in the observational study and agrees inwriting to comply with the subject's precautions during the study period afterhearing and understanding the detailed explanation of the characteristics of theobservational study and the drug to be studied

Exclusion

Exclusion Criteria:

  1. A person who is prohibited from administering according to the permission of theCrezet definition

  • Patients who overreact to the principal or component of the Crezet definition

  • Patients with active liver disease or patients with persistent high symptoms ofserum 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 lactasedeficiency, or glucose-galactose malabsorption

  1. A person who has a history of taking Crezet tablets within three months of the dateof registration

  2. A person who is deemed inappropriate to participate in this observational studybased on the judgment of investigator.

Study Design

Total Participants: 15000
Treatment Group(s): 1
Primary Treatment: Ezetimibe/Rosuvastatin
Phase:
Study Start date:
May 24, 2023
Estimated Completion Date:
June 30, 2025

Study Description

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.

  1. Visit 1 (baseline, day 0)

  2. Visit 2 (at 12 weeks)

  3. Visit 3 (at 24 weeks)

Connect with a study center

  • Kimyounggi Clinic

    Busan,
    Korea, Republic of

    Site Not Available

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