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The objective of this clinical study is to evaluate the efficacy and safety by comparing the fimasartan/amlodipine/rosuvastatin treatment group to the fimasartan/amlodipine treatment group and the fimasartan/rosuvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia who fail to respond to the fimasartan monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fimasartan/Amlodipine, Rosuvastatin | Experimental | Co-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin |
|
| Fimasartan/Amlodipine | Active Comparator | a fixed dose combination of Fimasartan/Amlodipine |
|
| Fimasartan, Rosuvastatin | Active Comparator | Co-administration of Fimasartan and Rosuvastatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan/Amlodipine, Rosuvastatin | Drug | "A fixed dose combination tablet of Fimasartan and Amlodipine" and "Rosuvastatin" will be administrated once daily on treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C | The percent change in LDL-C from baseline in the test group at Week 8 compared to the fimasartan 60 mg/amlodipine 10 mg combination treatment group | 8weeks from Baseline Visit |
| Sitting systolic blood pressure(SiSBP) | The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group at Week 8 compared to the fimasartan 60 mg and rosuvastatin 20 mg concomitant treatment group | 8weeks from Baseline Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Sitting systolic blood pressure(SiSBP) | The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group at Week 8 compared to the fimasartan 60 mg/amlodipine 10 mg combination treatment group | 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 |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36451242 | Derived | Jeon ES, Lim SW, Kim SY, Yang HM, Kim MH, Rhee MY, Han SH, Shin J, Kim KI, Jeong JO, Sung KC, Hong GR, Kim HS, Kwon K, Kang TS, Lee HY, Han SE. A randomized, double-blind, multicenter, phase III study on the efficacy and safety of a combination treatment involving fimasartan, amlodipine, rosuvastatin in patients with essential hypertension and dyslipidemia who fail to respond adequately to fimasartan monotherapy. Clin Hypertens. 2022 Dec 1;28(1):40. doi: 10.1186/s40885-022-00223-4. |
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| Fimasartan/Amlodipine | Drug | "A fixed dose combination tablet of Fimasartan and Amlodipine" will be administrated once daily on treatment period. |
|
| Fimasartan, Rosuvastatin | Drug | "Fimasartan" and "Rosuvastatin" will be administrated once daily on treatment period. |
|
The percent change in LDL-C from baseline in the test group at Week 8 compared to the fimasartan 60 mg and rosuvastatin 20 mg concomitant treatment group
| 8weeks from Baseline Visit |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D050171 | Dyslipidemias |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| 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 |
| D017311 | Amlodipine |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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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