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The objective of this trial is to assess the efficacy of reducing plasma low-density lipoprotein(LDL) cholesterol and safety in two different brand drugs, Roty F.C. Tablets 10mg and Crestor 10mg F.C. Tablets in hypercholesterolemia population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin | Experimental | One Rosuvastatin tablet 10mg taken once daily. |
|
| Crestor® | Active Comparator | One Crestor® tablet 10mg taken once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | 10mg,once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy variable will be defined as the percent mean change in LDL-C from baseline to 12 weeks. | baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary efficacy variable will be described as the change of plasma AGE, sRAGE, Gas6 and sAx1. | baseline to week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu-Hsin Lu, M.S. | Contact | 886-2-26270255 | 206 | flora@twtungda.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| Yi-Jen Hung, M.D. | Tri-Service General Hospital (TSGH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-Service General Hospital | Recruiting | Taipei | 11490 | Taiwan |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | 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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| Crestor® | Drug | 10mg,once daily |
|
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |