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Comparison of the efficacy and safety of Cresnon® and Crestor® in patients with hyperlipidemia
- 8-week, active-controlled, open-label, randomized, parallelgroup, fixed-dose, noninferiority, multicenter, phase 4 design
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cresnon® | Experimental | Rosuvastatin 10mg, tablet, q.d. |
|
| Crestor® | Active Comparator | Rosuvastatin 10mg, tablet, q.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin(Cresnon®) | Drug | 10mg |
| |
| Rosuvastatin(Crestor®) |
| Measure | Description | Time Frame |
|---|---|---|
| The percent change in LDL-C | After taken medication for 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The percent change in total cholesterol, Triglyceride, HDL-C, non-HDL-C, and non-HDL-C/HDL-C | After taken medication for 8 weeks | |
| The proportion of subjects reaching LDL-C targeted level in accordance with the treatment guidelines for dyslipidemia released by Korean Society of Lipidology and Atherosclerosis |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Drug |
10mg |
|
| After taken medication for 8 weeks |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |