A Study to Evaluate the Efficacy and Safety of CREZET Tablet

Active, not recruiting

• Conditions: Dyslipidemias
• Interventions: Drug: Ezetimibe/Rosuvastatin

• Registration Number: NCT05889143
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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)

Study Timeline

• Study Start: 2023-05-24
• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-05-25
• Study First Posted: 2023-06-05
• Primary Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-22
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mucotra® SR Tab	Ezetimibe/Rosuvastatin	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kimyounggi Clinic; 🇰🇷 Busan, Korea, Republic of