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The objective of this clinical study is to evaluate the efficacy and safety by comparing the fimasartan/atorvastatin treatment group to the fimasartan/placebo treatment group and the placebo/atorvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Co-administration of a fixed dose combination of Fimasartan 120mg and Atorvastatin 40mg |
|
| Active Comparator 1 | Active Comparator | Co-administration of Fimasartan 120mg and Placebo for Atorvastatin 40mg |
|
| Active Comparator 2 | Active Comparator | Co-administration of Atorvastatin 40mg and Placebo for Fimasartan 120mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan 120mg | Drug | Fimasartan 120mg will be administrated once daily for 8 weeks treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| SiSBP | The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 2(Atorvastatin 40mg) | 8weeks from Baseline Visit |
| LDL-C | The change in LDL-C from baseline in the test group at Week 8 compared to the active comparator group 1(fimasartan 120 mg) | 8weeks from Baseline Visit |
| Measure | Description | Time Frame |
|---|---|---|
| SiSBP | The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 1(Fimasartan 120mg) | 8weeks from Baseline Visit |
| LDL-C |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | South Korea |
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| Atorvastatin 40mg | Drug | Atorvastatin 40mg will be administrated once daily for 8 weeks treatment period |
|
| Placebo for Fimasartan 120mg | Drug | Placebo for Fimasartan 120mg will be administrated once daily for 8 weeks treatment period |
|
| Placebo for Atorvastatin 40mg | Drug | Placebo for Atorvastatin 40mg will be administrated once daily for 8 weeks treatment period |
|
The change in LDL-C from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 2(Atorvastatin 40mg)
| 8weeks from Baseline Visit |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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