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Study 14 of 18 for search of: | United Arab Emirates |
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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00708344 |
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 |
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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 |
Estimated Enrollment: | 834 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Active Comparator
Usual elective titration regimen
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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
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Group 2: Active Comparator
Active elective titration regimen
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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
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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.
Contact: Public Registry GMA | publicregistrygma@sanofi-aventis.com |
Study Director: | Nathalie - GENES, MD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | IRBEH_R_02931 |
Study First Received: | June 27, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00708344 |
Health Authority: | Colombia: Institutional Review Board |
Irbesartan Vascular Diseases Angiotensin II Hydrochlorothiazide Hypertension |
Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Natriuretic Agents Therapeutic Uses Sodium Chloride Symporter Inhibitors |
Physiological Effects of Drugs Diuretics Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |