Study to Evaluate the Management Status of Dyslipidemia Following Administration of Statin and Ezetimibe Complex Treatment Patient

Dyslipidemias Clinical Trial

Official title:

Real World Data Observational Study to Evaluate the Management Status of Dyslipidemia Following Administration of Statin and Ezetimibe Complex Treatment Patient in the Medical Situation by Classification of Medical Institutions in KOREA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05614765
• Other study ID #: DWLC_RWE02
• Status: Recruiting
• Start date: July 8, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2022
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: SeKyoung Hong
• Phone: 02-550-8563
• Email: skhong129[@]daewoong.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a large-scale, prospective, multi-site, and non-interventional observational study to observe the change and safety of dyslipidemia management status when administering statin+etimib complex drugs in patients with dyslipidemia.

Description:

All treatments, including drug administration and laboratory tests performed after administration of statin+etimib complex, are performed by the researcher's medical judgment regardless of the subject's participation in the study, and the information to be confirmed in this observational study is collected up to 24 weeks.

Data collection will begin after the date of signing the research contract, and the follow-up period for each study subject is from the registration date (Visit 1) to the 24th week (Visit 3).

To evaluate subjects' clinical performance in real world, we collect demographic information and medical treatment based on patient's medical records, previous dyslipidemia drug administration information, blood lipid tests and liver function tests conducted at the start date of statin+etimib compound administration and subsequent 24 weeks (± 8 weeks). In the case of safety-related information, such as abnormal cases, data shall be collected at any time during the 24-week follow-up period if there is a visit by the study subject according to daily treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18000
• Est. completion date: December 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Adult men and women aged 19 or older as of the time of the registered visit (Visit 1)

2. Patients with dyslipidemia who are planning to administer statin+ezetimib complex or who are administering dyslipidemia complex according to the researcher's medical judgment based on the permission of statin+ezetimib complex

3. A person who can understand the information provided to him or her and voluntarily sign a written consent form

Exclusion Criteria:

1. Patients who overreact to the main ingredients or components of the drug in the study

2. Patients with active liver disease or patients with continuously high serum aminotransferase levels with unknown cause

3. Patients with muscle disease

4. Pregnant women or pregnant women and nursing mothers

5. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabortion

6. A person who is not permitted by administration of statin+etimib complex or who falls under prohibition of administration

7. In addition to the above, a person who has determined that the researcher is not suitable for participation in this observation study

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• Statin+Ezetimibe compound
Crezet Tablet, Litorvazet Tablet

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

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	24 weeks from baseline