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The purpose of this study is to evaluate the efficacy and safety of Atorvastatin and Fenofibrate compared with atorvastatin monotherapy in mixed hypercholesterolemic patients.
Multi center, randomized, double-blind, parallel-group, therapeutic confirmatory study
Primary Outcome Measure:
The mean percent change of Non-HDL Cholesterol [Time Frame: from baseline at week 8]
Secondary Outcome Measures:
The achievement rate of LDL-C<100mg/dl, Non-HDL-C<130mg/dl [Time Frame: from baseline at week 8] The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B [Time Frame: from baseline at week 4, 8] The mean percent change of Non-LDL-C/HDL-C, TC/HDL-C, LDL-C/HDL-C, Apo-B/Apo-AI [Time Frame: from baseline at week 4, 8] The mean percent change of Fibrinogen, hs-CRP [Time Frame: from baseline at week 4, 8] Safety evaluation [Time Frame: Treatment period and Extension period]
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin 20mg, Fenofibrate 160mg | Experimental | Atorvastatin 20mg, Fenofibrate 160mg: po, q.d. |
|
| Atorvastatin 20mg, Placebo | Active Comparator | Atorvastatin 20mg, Placebo for Fenofibrate 160mg po, q.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 20mg | Drug | [Atorvastatin Run-in Period] Take Atorvastatin 20mg 1 tablet once a day (after breakfast) [Treatment Period] Take Atrovastatin 20mg/Fenofibrate 160mg or Atorvastiatin 20mg/Placebo of Finofibrate 160mg 2 tablet once a day (after breakfast) [Extension Period] Take Atrovastatin 20mg, Fenofibrate 160mg 2 tablet once a day (after breakfast) |
| Measure | Description | Time Frame |
|---|---|---|
| The mean percent change of Non-HDL Cholesterol | from baseline at week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| The achievement rate of LDL-C<100mg/dl, Non-HDL-C<130mg/dl | from baseline at week 8 | |
| The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B | from baseline at week 4, 8 | |
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Inclusion Criteria:
>19 years old
High risk patient to Coronary Heart Disease (applied to 1 or more CHD risk factor listed below)
At Visit 1(Screening)
100mg/dl≥LDL-C, 150mg/dl≤TG≤500mg/dl
LDL-C<100mg/dl, 150mg/dl≤TG≤500mg/dl
At Visit 2(After 4weeks of Atorvastatin monotherapy run-in period)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyun-Kyung Oh | Contact | 82-2-2194-0469 | hkoh@ckdpharm.com |
| Name | Affiliation | Role |
|---|---|---|
| MoonKyu Lee, M.D., Ph.D. | Samsung Medical Center - Seoul | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Recruiting | Busan | South Korea |
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|
|
| Fenofibrate 160mg | Drug | Refer to Intervention Description of Atorvastatin 20mg |
|
| Placebo (Fenofibrate 160 mg) | Other | Refer to Intervention Description of Atorvastatin 20mg |
|
|
| The mean percent change of Non-LDL-C/HDL-C, TC/HDL-C, LDL-C/HDL-C, Apo-B/Apo-AI |
| from baseline at week 4, 8 |
| The mean percent change of Fibrinogen, hs-CRP | from baseline at week 4, 8 |
| Safety evaluation (Physical examination, Vital sign, Laboratory, AE etc.) | Treatment period (8 weeks) and Extension period (16 weeks) |
| Pusan National University Hospital | Recruiting | Busan | South Korea |
|
| Kangwon University Hospital | Recruiting | Chuncheon | South Korea |
|
| Daegu Catholic University Medical Center | Recruiting | Daegu | South Korea |
|
| Keimyung University Dongsan Medical Center | Recruiting | Daegu | South Korea |
|
| Konyang University Hospital | Recruiting | Daejeon | South Korea |
|
| Chonnam National University Hospital | Recruiting | Gwangju | South Korea |
|
| Dongguk University Ilsan Hospital | Recruiting | Ilsan | South Korea |
|
| Inje University Ilsan Paik Hospital | Recruiting | Ilsan | South Korea |
|
| Chonbuk National University Hospital | Recruiting | Jeonju | South Korea |
|
| Hanyang University Guri Hospital | Recruiting | Kyunggi | South Korea |
|
| Seoul National University Hospital, Bundang | Recruiting | Seongnam | South Korea |
|
| Asan Medical Center | Recruiting | Seoul | South Korea |
|
| Eulji General Hospital | Recruiting | Seoul | South Korea |
|
| Gangnam Severance Hospital | Recruiting | Seoul | South Korea |
|
| Kangbuk Samsung Medical Center | Recruiting | Seoul | South Korea |
|
| Kangdong Sacred Heart Hospital | Recruiting | Seoul | South Korea |
|
| Korea University Anam Hospital | Recruiting | Seoul | South Korea |
|
| Korea University Huro Hospital | Recruiting | Seoul | South Korea |
|
| Kyunghee University Hospital at Gangdong | Recruiting | Seoul | South Korea |
|
| Kyunghee University Medical center | Recruiting | Seoul | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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| Severance Hospital | Recruiting | Seoul | South Korea |
|
| SMG-SNU Boramae Medical Center | Recruiting | Seoul | South Korea |
|
| The Catholic University of Korea, St. Mary's Hospital | Recruiting | Seoul | South Korea |
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| The Catholic University of Korea, Uijeongbu St. Mary's Hospital | Recruiting | Seoul | South Korea |
|
| The Catholic University of korea, Yeouido St. Mary's Hospital | Recruiting | Seoul | South Korea |
|
| Ajou University hospital | Recruiting | Suwon | South Korea |
|
| Wonju Severance Christian Hospital | Recruiting | Wŏnju | South Korea |
|
| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |
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