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The purpose of this study is to evaluate the efficacy and safety of combination of Fimasartan/Rosuvastatin in comparison to each component administered alone in patients with essential hypertension and dyslipidemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fimasartan and Rosuvastatin | Experimental | Combination of Fimasartan and Rosuvastatin |
|
| Fimasartan | Active Comparator | Fimasartan monotherapy |
|
| Rosuvastatin | Active Comparator | Rosuvastatin monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan and Rosuvastatin | Drug |
| ||
| Fimasartan |
| Measure | Description | Time Frame |
|---|---|---|
| Change rate of LDL-C at week 8 of Fimasartan/Rosuvastatin combination administration from the Baseline to compare the one of Fimasartan 120mg single administration | 8 weeks from Baseline Visit | |
| Change of SiSBP at week 8 of Fimasartan/Rosuvastatin combination administration from the Baseline to compare the one of Rosuvastatin 20mg single administration | 8 weeks from Baseline Visit |
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Inclusion Criteria:
Patients who voluntarily signed informed consent for participating in this clinical trial
Male and female between 20 and 75 years old
Patients must have been confirmed essential hypertension and dyslipidemia at Screening visit (Visit1)
Patients who meet the following criteria of fasting LDL-C and blood pressure at Baseline visit (Visit3) assessment after undergoing the therapeutic lifestyle change.
Low risk group: the case that does not have any other risk factor apart from hypertension / LDL-C (mg/dL): ≥160, ≤250, Mean SiSBP(mmHg): ≥140, <180
Moderate risk group: the case that has more than or equal to one risk factor apart from hypertension and has the 10-year risk of less than 10% / LDL-C (mg/dL): ≥160, ≤250, Mean SiSBP(mmHg): ≥140, <180
Moderate high risk group: the case that has more than or equal to one risk factor apart from hypertension and has the 10-year risk between 10% and 20% / LDL-C (mg/dL): ≥130, ≤250, Mean SiSBP(mmHg): ≥140, <180
High risk group: the case of CHD (Coronary heart disease) or CHD risk equivalents
Subject must be able to understand the trial procedures and be willing to cooperate and complete the trial.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dongjoo Oh | Korea University Guro Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul university Bundang hospital | Bundang | South Korea | ||||
| Dong-A university hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28057081 | Derived | Rhee MY, Ahn T, Chang K, Chae SC, Yang TH, Shim WJ, Kang TS, Ryu JK, Nah DY, Park TH, Chae IH, Park SW, Lee HY, Tahk SJ, Yoon YW, Shim CY, Shin DG, Seo HS, Lee SY, Kim DI, Kwan J, Joo SJ, Jeong MH, Jeong JO, Sung KC, Kim SY, Kim SH, Chun KJ, Oh DJ. The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia. BMC Pharmacol Toxicol. 2017 Jan 5;18(1):2. doi: 10.1186/s40360-016-0112-7. |
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|
| Rosuvastatin | Drug |
|
| Busan |
| South Korea |
| Inje Heaundai Paik hospital | Busan | South Korea |
| Inje university Busan Paik hospital | Busan | South Korea |
| The Catholic university of Korea Daegu hospital | Daegu | South Korea |
| DongGuk university Gyeongju hospital | Gyeongju | South Korea |
| DongGuk university Ilsan hospital | Ilsan | South Korea |
| Inje university Ilsan Paik hospital | Ilsan | South Korea |
| Gachon university Gil medical center | Incheon | South Korea |
| Inha university hospital | Incheon | South Korea |
| Jeju national university hospital | Jeju City | South Korea |
| JeonNam university hospital | JeonNam | South Korea |
| ChungNam university hospital | Jungnam | South Korea |
| DanGuk university hospital | Jungnam | South Korea |
| Kyungbook National university hospital | Kyungbook | South Korea |
| Gangnam Severance hospital | Seoul | South Korea |
| Jeil hospital | Seoul | South Korea |
| Korea university Anam hospital | Seoul | South Korea |
| Korea university Guro hospital | Seoul | South Korea |
| Kyunghee university hospital | Seoul | South Korea |
| Samsung Seoul hospital | Seoul | South Korea |
| Seoul national university hospital | Seoul | South Korea |
| Severance hospital | Seoul | South Korea |
| The Catholic university St. Mary hospital | Seoul | South Korea |
| Aju university hospital | Suwon | South Korea |
| YoungNam university hospital | YoungNam | South Korea |
| 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 |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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