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This study will evaluate the efficacy and aafety of rosuvastatin/ezetimibe combination therapy vs. rosuvastatin monotherapy in atherosclerotic cardiovascular disease patients with type 2 diabetes mellitus
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvamibe Tab | Experimental | Rosuvastatin 10mg/Ezetimibe 10mg qd for 24 weeks |
|
| Monorova Tab | Active Comparator | Rosuvastatin 20mg qd for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvamibe | Drug | Rosuvastatin 10mg/Ezetimibe 10mg |
| |
| Monorova |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 24 in LDL-C level | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 12 in LDL-C level | Baseline, Week 12 | |
| Change from baseline to week 12 and week 24 in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG) | Baseline, Week 12, Week 24 |
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Inclusion Criteria:
Aged 19 and above
Patient with type 2 diabetes taking oral diabetes medication for at least 3 months
Patient diagnosed with ASCVD
Written informed consent
Exclusion Criteria:
Type 1 diabetes
HbA1c > 8.5% at screening
Fasting triglyceride ≥ 400 mg/dL at screening
History of muscular disease or rhabdomyolysis due to use of statin
Hypersensitive to rosuvastatin or ezetemibe
Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following:
â‘ Severe renal disease (CrCL < 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) < 30mL/min/1.73m2)
â‘¡ ALT, AST > 3x ULN or history of active liver disease
â‘¢ CPK > 3x ULN
Those participating in clinical trials of other drugs
Other than the above who is deemed to be ineligible to participate in the trial by investigator
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangbuk Samsung Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Drug |
Rosuvastatin 20mg |
|
| Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP) | Baseline, Week 12, Week 24 |
| Change from baseline to week 12 and week 24 in Apolipoprotein A1, Apolipoprotein B, Apolipoprotein B48, and Apolipoprotein B/Apolipoprotein A1 | Baseline, Week 24 |
| Change from baseline to week 12 and week 24 in glycosylated hemoglobin (HbA1c) | Baseline, Week 12, Week 24 |
| Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG) | Baseline, Week 12, Week 24 |
| Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR) | Baseline, Week 12, Week 24 |
| Proportion of subjects achieving LDL-C < 70mg/dL | Baseline, Week 12, Week 24 |
| Proportion of subjects achieving LDL-C < 55mg/dL | Baseline, Week 12, Week 24 |
| Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event) | Up to 24 weeks |
| D003920 |
| Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |