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The purpose of this study is to evaluate the efficacy and safety of combination therapy of omega-3-acids ethylesters 90/Atorvastatin calcium in type â…¡b hyperlipidemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin 20mg, Omega-3-acids ethylesters 90 4g | Experimental | Atorvastatin calcium 20mg, Omega-3-acids ethylesters 90 4g: po, q.d |
|
| Atorvastatin 20mg, Placebo | Placebo Comparator | Atorvastatin calcium 20mg, Placebo for Omega-3-acids ethylesters 90 4g: po, q.d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 20mg | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The mean percent change of Triglyceride(TG) | from baseline at week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| The mean percent change of Triglyceride(TG) | from baseline at week 4 | |
| The mean percent change of Total Cholesterol(TC), LDL-C, HDL-C | from baseline at week 4,8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kuhnil Clinical Research Team | Contact | +82-2-2175-9760 | jmhong@kuhnil.com |
| Name | Affiliation | Role |
|---|---|---|
| Hong Seog Seo, Ph.D. | Korea University Guro Hospital | Principal Investigator |
| Hee Kyoung Cheon, Ph.D. | Uijongbu St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Active, not recruiting | Anyang, Gyeonggi | 431-070 | South Korea | ||
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| Omega-3-acids ethylesters 90 4g | Drug |
|
|
| Placebo(Omega-3-acids ethylesters 90) | Other |
|
| Sang-Ho Jo, Ph.d. |
| Hallym University Medical Center |
| Principal Investigator |
| Mi-Seung Shin, Ph.D | Gachon University Gil Medical Center | Principal Investigator |
| Gachon University Gil Hospital |
| Not yet recruiting |
| Incheon |
| 405-760 |
| South Korea |
| Korea University Guro Hospital | Recruiting | Seoul | 152-703 | South Korea |
| Uijongbu St. Mary's Hospital | Active, not recruiting | Uijongbu, Gyeonggi | 480-717 | South Korea |
| ID | Term |
|---|---|
| D006950 | Hyperlipidemia, Familial Combined |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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