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The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan and losartan alone in patients with essential hypertension inadequately controlled on losartan monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| amlodipine/losartan 5/100mg | Experimental |
| |
| losartan 100mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine plus Losartan | Drug | amlodipine/losartan 5/100mg q.d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean sitting diastolic blood pressure | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean sitting diastolic blood pressure | Week 4 | |
| Change from baseline in mean sitting systolic blood pressure | Week 4, 8 | |
| Responder rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Yun Cho, M.D., Ph.D. | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 9 sites in Korea | Seoul, Daegu, Etc. | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22462558 | Derived | Hong BK, Park CG, Kim KS, Yoon MH, Yoon HJ, Yoon JH, Yang JY, Choi YJ, Cho SY. Comparison of the efficacy and safety of fixed-dose amlodipine/losartan and losartan in hypertensive patients inadequately controlled with losartan: a randomized, double-blind, multicenter study. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):189-95. doi: 10.2165/11597410-000000000-00000. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Losartan | Drug | losartan 100mg q.d. |
|
| Week 4, 8 |
| D001713 |
| Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D013777 | Tetrazoles |