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The purpose of this study is to compare the effect and safety of the antihypertensive combination therapies between losartan/amlodipine and fixed dose drug of losartan/hydrochlorothiazide.
The combination therapy with multiple antihypertensive drugs is recommended in the patients who are uncontrolled with monotherapy. Diuretics increase the activities of renin-angiotensin-aldosterone system (RAS), and angiotensin receptor blockers (ARB) depress blood pressure potently in the state of increased RAS activities. Thus, the combination therapy with ARB and diuretics is expected to lower the blood pressure synergistically. This combination therapy is also expected to reduce the side effects of each drug. In this study, we will compare the effect and safety of the combination therapies between losartan/amlodipine and fixed dose drug of losartan/hydrochlorothiazide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Losartan/hydrochlorothiazide | Experimental | Combination drug with losartan 50mg and hydrochlorothiazide 12.5mg |
|
| Losartan/amlodipine | Active Comparator | Combination therapy with losartan 50mg and amlodopine 5mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan/amlodipine or losartan/hydrochlorothiazide | Drug | Losartan 50mg/amlodipine 5mg and the fixed dose combination drug of losartan 50mg/hydrochlorothiazide 12.5mg once a day during 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| The change of systolic blood pressure | three months |
| Measure | Description | Time Frame |
|---|---|---|
| The achievement rate of target blood pressure | three months | |
| The change of diastolic blood pressure | three months | |
| The change of blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Satoshi Umemura, MD, PhD | Yokohama City University Graduate School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yokohama City University Graduate School of Medicine | Yokohama | Kanagawa | 236-0004 | Japan |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| D017311 | Amlodipine |
| C505809 | hydrochlorothiazide, losartan drug combination |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| six months, nine months and one year |
| The achievement rate of target blood pressure | six months, nine months and one year |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |