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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00708344 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Irbesartan - Hydrochlorothiazide |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Comparison of Active and Usual Titration Regimen in the Treatment of Hypertensive Patients Insufficiently Controlled by Monotherapy. A Randomised, Open-label, Multicentre, Phase IIIb/IV Study |
| Enrollment: | 832 |
| Study Start Date: | June 2008 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group 1: Active Comparator
Usual elective titration regimen
|
Drug: Irbesartan - Hydrochlorothiazide
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
|
|
Group 2: Active Comparator
Active elective titration regimen
|
Drug: Irbesartan - Hydrochlorothiazide
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Algeria | |
| Sanofi-aventis Administrative Office | |
| Alger, Algeria | |
| Argentina | |
| Sanofi-aventis Administrative Office | |
| Buenos Aires, Argentina | |
| Brazil | |
| Sanofi-aventis Administrative Office | |
| Sao Paulo, Brazil | |
| Colombia | |
| Sanofi-aventis Administrative Office | |
| Bogota, Colombia | |
| Ecuador | |
| Sanofi-aventis Administrative Office | |
| Quito, Ecuador | |
| Egypt | |
| Sanofi-aventis Administrative Office | |
| Cairo, Egypt | |
| Guatemala | |
| Sanofi-aventis Administrative Office | |
| Guatemala City, Guatemala | |
| Lebanon | |
| Sanofi-aventis Administrative Office | |
| Beirut, Lebanon | |
| Mexico | |
| Sanofi-aventis Administrative Office | |
| Col. Coyoacan, Mexico | |
| Morocco | |
| Sanofi-aventis Administrative Office | |
| Casablanca, Morocco | |
| Panama | |
| Sanofi-aventis Administrative Office | |
| Panama, Panama | |
| Peru | |
| Sanofi-aventis Administrative Office | |
| Lima, Peru | |
| Saudi Arabia | |
| Sanofi-aventis Administrative Office | |
| Jeddah, Saudi Arabia | |
| Tunisia | |
| Sanofi-aventis Administrative Office | |
| Megrine, Tunisia | |
| United Arab Emirates | |
| Sanofi-aventis Administrative Office | |
| Dubaï, United Arab Emirates | |
| Venezuela | |
| Sanofi-aventis Administrative Office | |
| Caracas, Venezuela | |
| Study Director: | Nathalie - GENES, MD | Sanofi-Aventis |
More Information
| Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
| Study ID Numbers: | IRBEH_R_02931 |
| Study First Received: | June 27, 2008 |
| Last Updated: | September 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00708344 History of Changes |
| Health Authority: | Colombia: Institutional Review Board |
|
Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Vascular Diseases Irbesartan Cardiovascular Agents Antihypertensive Agents |
Hydrochlorothiazide Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Cardiovascular Diseases Hypertension |