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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00500604 |
The primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (SBP) as measured by home blood pressure monitoring (HBPM) after 24 weeks compared with baseline.
The secondary objectives are:
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: Irbesartan/hydrochlorothiazide Drug: Valsartan/hydrochlorothiazide Drug: Hydrochlorothiazide |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Comparative Study of the Efficacy of Irbesartan/Hydrochlorothiazide 300/25 mg Versus Valsartan/Hydrochlorothiazide 160/25 mg Using Home Blood Pressure Monitoring in the Treatment of Mild to Moderate Hypertension |
Estimated Enrollment: | 1040 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
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Drug: Irbesartan/hydrochlorothiazide
150/12.5mg tablet and 300/12.5mg tablet
Drug: Hydrochlorothiazide
12.5 mg administered orally, once daily in the morning
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B: Active Comparator
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Drug: Valsartan/hydrochlorothiazide
80/12.5mg tablet and 160/12.5mg tablet
Drug: Hydrochlorothiazide
12.5 mg administered orally, once daily in the morning
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Established essential hypertension, untreated or treated but uncontrolled with treatment:
Previous antihypertensive therapy must have been implemented for a minimum of 4 weeks and must be either monotherapy or one of the following permitted combination drugs:
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 |
Egypt | |
Sanofi-Aventis | Recruiting |
Cairo, Egypt | |
Hong Kong | |
Sanofi-Aventis | Recruiting |
Hong Kong, Hong Kong | |
India | |
Sanofi-Aventis | Recruiting |
Mumbai, India | |
Indonesia | |
Sanofi-Aventis | Recruiting |
Jakarta, Indonesia | |
Korea, Republic of | |
Sanofi-Aventis | Recruiting |
Seoul, Korea, Republic of | |
Malaysia | |
Sanofi-Aventis | Recruiting |
Kuala Lumpur, Malaysia | |
Morocco | |
Sanofi-Aventis | Recruiting |
Casablanca, Morocco | |
Pakistan | |
Sanofi-Aventis | Recruiting |
Karachi, Pakistan | |
Philippines | |
Sanofi-Aventis | Recruiting |
Manila, Philippines | |
Singapore | |
Sanofi-Aventis | Recruiting |
Singapore, Singapore | |
Taiwan | |
Sanofi-Aventis | Recruiting |
Taipei, Taiwan | |
Thailand | |
Sanofi-Aventis | Recruiting |
Bangkok, Thailand | |
Tunisia | |
Sanofi-Aventis | Recruiting |
Megrine, Tunisia | |
Vietnam | |
Sanofi-Aventis | Recruiting |
Ho Chi Minh City, Vietnam |
Study Director: | Benedict Blayney | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | IRBEH_R_02584 |
Study First Received: | July 11, 2007 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00500604 |
Health Authority: | Taiwan: Institutional Review Board |
Irbesartan Vascular Diseases Angiotensin II |
Hydrochlorothiazide Valsartan 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 |