A Study to Evaluate the Efficacy and Safety of CREZET Tablet

Daewoong Pharmaceutical

Status: Active, not recruiting

Conditions: Dyslipidemias

Treatments: Drug: Ezetimibe/Rosuvastatin

Study type: Observational

Funder types: Industry

Identifiers

NCT05889143

DWCRZ_OS_01

Details and patient eligibility

About

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.

Full 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)

Enrollment: 15,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

15,000 participants in 1 patient group

Mucotra® SR Tab

Treatment:

Drug: Ezetimibe/Rosuvastatin