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Decided by Sponsor
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The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1: Olmesartan+Chlorthalidone | Experimental | The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 12,5 mg) a day, in the morning. |
|
| Test 2: Olmesartan+Chlorthalidone | Experimental | The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 25 mg) a day, in the morning. |
|
| Comparator 1: Benicar HCT® | Active Comparator | The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 12,5 mg) a day, in the morning. |
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| Comparator 2: Benicar HCT® | Active Comparator | The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 25 mg) a day, in the morning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olmesartan medoxomil 40mg + chlorthalidone 12,5mg | Drug | 1 tablet a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study. | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be evaluated by the adverse events occurrences | Adverse events will be collected and followed in order to evaluate safety and tolerability | 9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Olmesartan medoxomil 40mg + chlorthalidone 25mg | Drug | 1 tablet a day |
|
| Olmesartan 40mg + Hydrochlorothiazide 12,5mg | Drug | 1 tablet a day |
|
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| Olmesartan 40mg + Hydrochlorothiazide 25mg | Drug | 1 tablet a day |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068557 | Olmesartan Medoxomil |
| D002752 | Chlorthalidone |
| C437965 | olmesartan |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001577 | Benzophenones |
| D010797 | Phthalimides |
| D007094 | Imides |
| D007659 | Ketones |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D049971 | Thiazides |
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