A Study to Evaluate the Efficacy and Safety of CREZET Tablet

NCT ID: NCT05889143

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 15000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-24
• Study Completion Date: 2026-03-01

Brief 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.

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)

Conditions

Dyslipidemias

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Mucotra® SR Tab

Ezetimibe/Rosuvastatin

Intervention Type: DRUG

Patient treated with Crezet Tablet

Interventions

Ezetimibe/Rosuvastatin

Patient treated with Crezet Tablet

Intervention Type: DRUG

Other Intervention Names

Crezet Tablet

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JunYoung Park

Role: STUDY_DIRECTOR

Daewoong Pharma

Locations

Kimyounggi Clinic

Busan, , South Korea

Countries

South Korea

Other Identifiers

DWCRZ_OS_01

Identifier Type: -

Identifier Source: org_study_id