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The purpose of this study is to evaluate the safety and efficacy of fixed combination of amlodipine(5mg or 10mg) and losartan (50 mg or 100 mg), amlodipine and losartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine plus Losartan | Drug | amlodipine/losartan 5/50mg, 5/100mg, 10/50mg, 10/100mg |
| |
| Amlodipine | Drug | amlodipine 5mg, 10mg | ||
| Losartan | Drug | Losartan 50mg, 100mg |
| Measure | Description | Time Frame |
|---|---|---|
| Average changes from baseline in sitDBP | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Average changes from baseline in sitDBP | Week 4 | |
| Average changes from baseline in sitSBP | Week 4, 8 | |
| Blood pressure 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 |
|---|---|---|---|---|---|---|
| 14 sites in Korea | Seoul, Busan, Etc. | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22217192 | Derived | Park CG, Youn HJ, Chae SC, Yang JY, Kim MH, Hong TJ, Kim CH, Kim JJ, Hong BK, Jeong JW, Park SH, Kwan J, Choi YJ, Cho SY. Evaluation of the dose-response relationship of amlodipine and losartan combination in patients with essential hypertension: an 8-week, randomized, double-blind, factorial, phase II, multicenter study. Am J Cardiovasc Drugs. 2012 Feb 1;12(1):35-47. doi: 10.2165/11597170-000000000-00000. |
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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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| 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 |