A Study to Evaluate the Efficacy and Safety of CREZET Tablet

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dyslipidemias
• Intervention / Treatment: Drug: Ezetimibe/Rosuvastatin

Detailed 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)

• Study Type: Observational
• Enrollment (Estimated): 15000

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Kimyounggi Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The number of test subjects was calculated using the confidence interval of the rate of change, noting that the primary purpose of this observation study was to evaluate the rate of change in a single group.

Recruitment of 14,151 people, which is 1.5%, was expected by referring to the minimum number of subjects required and the estimated patients taking two components of single drug and ezetimib compound.

However, this study was a non-intervention observation study conducted under daily treatment, and it was confirmed that the number of subjects who applied 10% of the dropout rate was about 15,000 Therefore, this study will be conducted with study population of 15,000 subjects.

Description

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 according to the medical judgment of the investigator based on permission
3. 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:

1. 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
2. A person who has a history of taking Crezet tablets within three months of the date of registration
3. A person who is deemed inappropriate to participate in this observational study based on the judgment of investigator.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mucotra® SR Tab	Drug: Ezetimibe/Rosuvastatin; Patient treated with Crezet Tablet; Other Names: Crezet Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Rate of change in LDL-C	The Rate of change in LDL-C at 24 weeks from baseline	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Rate of change in LDL-C	The Rate of change in LDL-C at 12 weeks from baseline	12 weeks
The change in HbA1c	The change in HbA1c at 12 weeks from baseline	12 weeks
The change in HbA1c	The change in HbA1c at 24 weeks from baseline	24 weeks
The change in FPG	The change in FPG at 12 weeks from baseline	12 weeks
The change in FPG	The change in FPG at 24 weeks from baseline	24 weeks
The chanage in lipid variable	The chanage in lipid variable at 12 weeks from baseline	12 weeks
The chanage in lipid variable	The chanage in lipid variable at 24 weeks from baseline	24 weeks
The change in AST	The change in AST at 12 weeks from baseline	12 weeks
The change in AST	The change in AST at 24 weeks from baseline	24 weeks
The change in ALT	The change in ALT at 12 weeks from baseline	12 weeks
The change in ALT	The change in ALT at 24 weeks from baseline	24 weeks
Percentage of subjects who reached LDL-C target	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	12 weeks
Percentage of subjects who reached LDL-C target	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	24 weeks

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Study Director: JunYoung Park, Daewoong Pharma

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium; Ezetimibe
• Other Study ID Numbers: DWCRZ_OS_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided at this point

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No