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To compare the antihypertensive efficacy of the combination irbesartan/hydrochlorothiazide (HCTZ) using either a usual or an active elective titration regimen. The main efficacy criteria will be the change in mean Systolic Blood Pressure (SBP), measured at doctor's office with an automatic device, after a 10-week treatment period in hypertensive patients insufficiently controlled by monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Usual elective titration regimen |
|
| Group 2 | Active Comparator | Active elective titration regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irbesartan - Hydrochlorothiazide | Drug | 150/12.5 mg (1 tablet once daily) or 300/25 mg (1 tablet once daily) depending on the control of the blood pressure. Duration of treatment : 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean Systolic Blood Pressure | between Visit 1 (Week 0) and Visit 4 (Week 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean Diastolic Blood Pressure | between Visit 1 (Week 0) and Visit 4 (Week 10) |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie - GENES, MD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Algiers | Algeria | ||||
| Sanofi-Aventis Administrative Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22352122 | Derived | Girerd X, Rosenbaum D, Aoun J; ACTUAL study Investigators. Efficacy and safety of early versus late titration of fixed-dose irbesartan/hydrochlorothiazide: ACTUAL study. Blood Press Suppl. 2011 Dec;2:22-9. doi: 10.3109/08037051.2011.633368. |
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| Irbesartan - Hydrochlorothiazide | Drug | 150/12.5 mg (1 tablet once daily) or 300/25 mg (1 tablet once daily) depending on the control of the blood pressure. Treatment duration : 10 weeks |
|
| Buenos Aires |
| Argentina |
| Sanofi-Aventis Administrative Office | São Paulo | Brazil |
| Sanofi-Aventis Administrative Office | Bogotá | Colombia |
| Sanofi-Aventis Administrative Office | Quito | Ecuador |
| Sanofi-Aventis Administrative Office | Cairo | Egypt |
| Sanofi-Aventis Administrative Office | Guatemala City | Guatemala |
| Sanofi-Aventis Administrative Office | Beirut | Lebanon |
| Sanofi-Aventis Administrative Office | Col. Coyoacan | Mexico |
| Sanofi-Aventis Administrative Office | Casablanca | Morocco |
| Sanofi-Aventis Administrative Office | Panama City | Panama |
| Sanofi-Aventis Administrative Office | Lima | Peru |
| Sanofi-Aventis Administrative Office | Jeddah | Saudi Arabia |
| Sanofi-Aventis Administrative Office | Mégrine | Tunisia |
| Sanofi-Aventis Administrative Office | Dubai | United Arab Emirates |
| Sanofi-Aventis Administrative Office | Caracas | Venezuela |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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