A Study to Evaluate the Efficacy and Safety of CREZET Tablet

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05889143
• Other study ID #: DWCRZ_OS_01
• Status: Recruiting
• Start date: May 24, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: SaeKyung Hong
• Phone: 82-02-550-8563
• Email: skhong129[@]daewoong.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• Ezetimibe/Rosuvastatin
Patient treated with Crezet Tablet

Locations

Country	Name	City	State
Korea, Republic of	Kimyounggi Clinic	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Rate of change	The Rate of change in LDL-C	at 24 weeks from baseline