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A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy and safety of Olmesartan/Amlodipine/Rosuvastatin combination treatment in patients with concomitant hypertension and hyperlipidemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amlodpine, Olmesartan, Rosuvastatin | Experimental | co-administration of Olmesartan, Amlodipine and Rosuvastatin |
|
| Olmesartan, Rosuvastatin | Placebo Comparator | co-administration of Olmesartan and Rosuvastatin |
|
| Amlodipine, Olmesartan | Placebo Comparator | co-administration of Amlodipine and and Olmesartan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg | Drug | co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg), Crestor Tab. 20mg(Rosuvastatin 20mg) and placebo of Olmesartan 40mg |
| Measure | Description | Time Frame |
|---|---|---|
| the change of sitSBP based on baseline between Treatment arm and control 1 arm | 8 weeks | |
| the change of LDL-C based on baseline between Treatment arm and control2 arm | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul national university bundang hospital | Seoul | South Korea |
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| Olmesartan 40 mg, Rosuvastatin 20mg | Drug | co-administration of Olmetec tab. 40mg(Olmesartan 40mg), Crestor tab. 20mg(Rosuvastatin 20mg) and placebo of Sevikar Tab 10/40mg(Amlodipine/Olmesartan 10/40mg). |
|
| Amlodipine/Olmesartan 10/40mg (Combination drug) | Drug | co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg) 10/40mg, Placebo of Olmesartan Tab. 40mg and Placebo of Rosuvastatin 20mg |
|
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| C437965 | olmesartan |
| D004338 | Drug Combinations |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004364 | Pharmaceutical Preparations |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
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