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To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients
To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R5 | Active Comparator | Rosuvastatin 5mg |
|
| R10 | Active Comparator | Rosuvastatin 10mg |
|
| R20 | Active Comparator | Rosuvastatin 20mg |
|
| R5/E10 | Experimental | Rosuvastatin 5mg/ezetimibe 10mg |
|
| R10/E10 | Experimental | Rosuvastatin 10mg/ezetimibe 10mg |
|
| R20/E10 | Experimental | Rosuvastatin 20mg/ezetimibe 10mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin/Ezetimibe | Drug | Rosuvastatin 5mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline to 8 week in LDL-Cholesterol | baseline and 8 week |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline to 4 week in LDL-Cholesterol | baseline and 4 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min-Hee Kwon | Contact | 02-526-3379 | minhee@ildong.com |
| Name | Affiliation | Role |
|---|---|---|
| Tae Hoon Ahn | Gachon University Gil Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gil Medical Center | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001384 | Azetidines |
| D001385 | Azetines |
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