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This study is to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension patient with Dyslipidemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuampin 10/5mg | Experimental | Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks |
|
| Rosuampin 20/5mg | Experimental | Rosuvastatin 20mg/Amlodipine 5mg qd for 8 weeks |
|
| Amlodipine/Atorvastatin 5/20mg | Active Comparator | Atorvastatin 20mg/Amlodipine 5mg qd for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuampin 10/5mg | Drug | Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of change from baseline to week 8 in LDL-Cholesterol | Baseline/Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of change from baseline to week 4 in LDL-Cholesterol | Baseline/Week 4 | |
| Proportion of subjects who reached the therapeutic goal to week 8 | * Group I: < 160 mg/dL, Group II: < 130 mg/dL, Group III: < 100 mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daegu Catholic Univ. Medical Center | Daegu | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40429358 | Derived | Park CM, Jung HW. Predictors of Significant High-Sensitivity C-Reactive Protein Reduction After Use of Rosuvastatin/Amlodipine and Atorvastatin/Amlodipine-Subgroup Analysis in Randomized Controlled Trials. J Clin Med. 2025 May 12;14(10):3363. doi: 10.3390/jcm14103363. | |
| 37584254 | Derived | Jung HW, Kim CY, Hong SP, Bae HJ, Choi JY, Ryu JK, Lee JB, Lee KH, Han KR, Yang DH, Park CG, Yu GW, Rhee MY, Park SJ, Hyon MS, Shin JH, Hong BK, Jin HY, Lee SY, Seol SH, Lee SR, Kim SY, Lee KJ, Cho EJ, Nam CW, Park TH, Kim U, Kim KS. Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia. J Clin Hypertens (Greenwich). 2023 Sep;25(9):828-844. doi: 10.1111/jch.14715. Epub 2023 Aug 16. |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Rosuampin 20/5mg |
| Drug |
Rosuampin 20/5mg qd for 8 weeks |
|
| Amlodipine/Atorvastatin 5/20mg | Drug | Amlodipine/Atorvastatin 5/20mg qd for 8 weeks |
|
| Week 8 |
| Rate of change from baseline to week 4, 8 in lipid profile(without LDL-C) | Total cholesterol, HDL-C, Triglyceride, Apo A-1, Apo B, Apo B/Apo A-1, Lipoprotein(a) | Baseline/Week 4, 8 |
| Rate of change from baseline to week 4, 8 in hs-CRP | Baseline/Week 4, 8 |
| Rate of change from baseline to week 4, 8 in glucose index | Fasting Blood Glucose, HbA1C, HOMA-IR | Baseline/Week 4, 8 |
| Rate of change from baseline to week 4, 8 in msSBP & msDBP in both arm | Baseline/Week 4, 8 |
| Rate of change from baseline to week 4, 8 in difference of msSBP & msDBP in both arm | Baseline/Week 4, 8 |
| The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) | Week 8 |
| D002318 | Cardiovascular Diseases |
| D011758 |
| Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |