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The purpose of this study is to determine the efficiency of Olmesartan medoxomile (OLMETEC®) alone or in combination with hydrochlorothiazide (OLMETEC PLUS®) in the reduction of arterial blood pressure in patients with light to moderate hypertension, and to evaluate the percentage of patients that reach treatment goals using this antihypertensive regimen.
α= 0.05. α's Z=1.96 β= 80%. β's Z=0.84 Estimated proportion of subjects to achieve optimal control of arterial hypertension= 83.2%
450 subjects are expected to be enrolled in the study of which 40 subjects will be enrolled in Venezuela.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients with arterial hypertension Stade I or Stade II |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olmesartan medoxomile alone or combined with hydrochlorothiazide, | Drug | olmesartan medoxomile 20mg/daily or 40mg/daily; olmesartan medoxomile 20mg plus 12.5 mg of hydrochlorothiazide daily; olmesartan medoxomile 40mg plus 12.5 mg of hydrochlorothiazide daily |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the efficiency of Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) in decreasing diastolic pressure | basal registry and on follow-up visits in weeks 4, 8, 12, and 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the efficiency of Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) in decreasing systolic pressure | basal registry and on follow-up visits in weeks 4, 8, 12, and 16 | |
| Evaluation of the percentage of patients (including diabetics and those with renal disease) that achieve arterial blood pressure treatment goals with Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients in Venezuela with arterial hypertension Stade I or Stade II
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 19, 2009 | |
| Reset | Apr 28, 2009 |
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|
| basal registry and on follow-up visits in weeks 4, 8, 12, and 16 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 19, 2009 | Apr 28, 2009 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006852 | Hydrochlorothiazide |
| D000068557 | Olmesartan Medoxomil |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013777 | Tetrazoles |
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