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| Name | Class |
|---|---|
| Linical Korea | INDUSTRY |
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A Study to Compare Rosuvastatin/Ezetimibe Combination and Monotherapy in Patients with Diabetes Mellitus and Hypercholesterolemia.
This trial is conducted to compare the efficacy and safety between Rosuvastatin/Ezetimibe combination and Rosuvastatin monotherapy in patients with Diabetes Mellitus and Hypercholesterolemia for 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin+Ezetimibe | Experimental | Rosuvastatin 5mg+Ezetimibe 10mg Rosuvamibe ® Tablet, 1T, Once a day/8week |
|
| Rosuvastatin | Active Comparator | Rosuvastatin 5mg Monorova ® Tablet, 1T, Once a day/8week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin+Ezetimibe | Drug | Rosuvastatin 5mg+Ezetimibe 10mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Low density lipoprotein cholesterol (LDL-C) (%) | The rate of change(%) of LDL-C at Week 8 compared to the baseline | baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Low density lipoprotein cholesterol (LDL-C) (100mg/dL) | The ratio of patients who reached the treatment target (100mg/dL) of LDL-C at Week 8 compared to the baseline | baseline, Week 8 |
| HbA1C, Glycated albumin, Homeostasis model assessment Insulin resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soon Chun Hyang University Hospital Cheonan | Cheonan | South Korea | ||||
| Soon Chun Hyang University Hospital Gumi |
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| Rosuvastatin | Drug | Rosuvastatin 5Mg Tablet |
|
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Variation of HbA1C, Glycated albumin, Homeostasis model assessment Insulin resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) at Week 8 compared to the baseline resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) change form the baseline at Week 8 |
| baseline, Week 8 |
| LDL-C, Non HDL-C, HDL-C, Triglyceride(TG), Total cholesterol(TC), Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) | Variation of LDL-C, Non HDL-C, HDL-C, Triglyceride(TG), Total cholesterol(TC), Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) at Week 8 compared to the baseline Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) change form the base line at Week 8 | baseline, Week 8 |
| Thiobarbituric acid reactive substances(TBARs) | Absolute value change of Thiobarbituric acid reactive substances(TBARs) at Week 8 compared to baseline to baseline. | baseline, Week 8 |
| Fibroblast Growth Factor 21 | Absolute value change of Fibroblast Growth Factor 21 at Week 8 compared to baseline. | baseline, Week 8 |
| Gumi |
| South Korea |
| Soon Chun Hyang University Hospital Bucheon | Gyeonggi-do | South Korea |
| Soon Chun Hyang University Hospital Seoul | Seoul | South Korea |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| 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 |
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