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The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan and amlodipine alone in patients with essential hypertension inadequately controlled on amlodipine monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| amlodipine/losartan 5/50mg | Experimental |
| |
| amlodipine 5mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine plus Losartan | Drug | amlodipine/losartan 5/50mg 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 |
|---|---|---|---|---|---|---|
| 13 sites in Korea | Seoul, Busan, Etc. | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22136978 | Derived | Kang SM, Youn JC, Chae SC, Park CG, Yang JY, Kim MH, Hong TJ, Kim CH, Kim JJ, Shin DG, Jeong JW, Yoon JH, Park SH, Kwon J, Cho SY. Comparative efficacy and safety profile of amlodipine 5 mg/losartan 50 mg fixed-dose combination and amlodipine 10 mg monotherapy in hypertensive patients who respond poorly to amlodipine 5 mg monotherapy: an 8-week, multicenter, randomized, double-blind phase III noninferiority study. Clin Ther. 2011 Dec;33(12):1953-63. doi: 10.1016/j.clinthera.2011.11.007. Epub 2011 Dec 2. |
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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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| Amlodipine | Drug | amlodipine 5mg 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 |