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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | statin+ezetimibe compound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Statin+Ezetimibe compound | Drug | Crezet Tablet, Litorvazet Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate and amount of change in LDL-C (measured LDL-C and calculated LDL-C) | Rate and amount of change in LDL-C (measured LDL-C and calculated LDL-C) at 24 weeks compared to baseline | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C change rate and amount | LDL-C change rate and amount at 12 weeks compared to baseline | 12 weeks |
| Rate and amount of change in lipid variables (Non-HDL-C, HDL-C, TG, TC) | Rate and amount of change in lipid variables (Non-HDL-C, HDL-C, TG, TC) at 12 weeks compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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In order to assume the amount of LDL-C change at 24 weeks compared to the base value, the clinical trial results of the test subjects with similar underlying diseases that can be currently referred to were used.
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| Name | Affiliation | Role |
|---|---|---|
| JinWon Kim | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 12 weeks |
| Rate and amount of change in lipid variables (Non-HDL-C, HDL-C, TG, TC) | Rate and amount of change in lipid variables (Non-HDL-C, HDL-C, TG, TC) at 24 weeks compared to baseline | 24 weeks |
| Changes in ALT (Alanine Transaminase), AST (Aspartate Transaminase), and e-GFR (Estimated Glomerular Filtration Rate) | Changes in ALT (Alanine Transaminase), AST (Aspartate Transaminase), and e-GFR (Estimated Glomerular Filtration Rate) at 12 weeks compared to baseline | 12 weeks |
| Changes in ALT (Alanine Transaminase), AST (Aspartate Transaminase), and e-GFR (Estimated Glomerular Filtration Rate) | Changes in ALT (Alanine Transaminase), AST (Aspartate Transaminase), and e-GFR (Estimated Glomerular Filtration Rate) at 24 weeks compared to baseline | 24 weeks |