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Sponsors and Collaborators: |
Bristol-Myers Squibb Sanofi-Aventis |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00110422 |
The purpose of this clinical research study is to learn if irbesartan is superior to hydrochlorothiazide relative to effects on insulin sensitivity and glucose metabolism in hypertensive patients with metabolic syndrome.
Condition | Intervention | Phase |
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Metabolic Syndrome Hypertension |
Drug: Irbesartan Drug: Hydrochlorothiazide |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome |
Estimated Enrollment: | 400 |
Study Start Date: | November 2005 |
Arms | Assigned Interventions |
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A1: Experimental |
Drug: Irbesartan
Tablets, Oral, 150 mg. titrated to 300 mg, once daily, 28 weeks.
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B1: Active Comparator |
Drug: Hydrochlorothiazide
Tablets, Oral, 12.5 mg. titrated to 25 mg, once daily, 28 weeks.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Presenting at least 2 of the following:
Exclusion Criteria:
France | |
Local Institution | |
Angers, France | |
Local Institution | |
Nantes, France | |
Local Institution | |
Tierce, France | |
Germany | |
Local Institution | |
Muenchen, Germany | |
Local Institution | |
Hannover, Germany | |
Local Institution | |
Villingen-Schwenningen, Germany | |
Local Institution | |
Ornbau, Germany | |
Local Institution | |
Tuebingen, Germany | |
Local Institution | |
Rotenburg An De Fluda, Germany | |
Italy | |
Local Institution | |
Ancona, Italy | |
Local Institution | |
Chieti Scalo, Italy | |
Local Institution | |
Pisa, Italy | |
Local Institution | |
Ravenna, Italy | |
Local Institution | |
Sassari, Italy | |
Norway | |
Local Institution | |
Oslo, Norway | |
Local Institution | |
Snaroya, Norway | |
Russian Federation | |
Local Institution | |
St. Petersburg, Russian Federation | |
Local Institution | |
Saratov, Russian Federation | |
Local Institution | |
Moscow, Russian Federation | |
Local Institution | |
Yaroslavl, Russian Federation | |
Spain | |
Local Institution | |
Zaragoza, Spain | |
Local Institution | |
Barcelona, Spain | |
Local Institution | |
Sevilla, Spain | |
Local Institution | |
A Coruna, Spain | |
Local Institution | |
Granada, Spain |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Study ID Numbers: | CV131-186 |
Study First Received: | May 9, 2005 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00110422 |
Health Authority: | United States: Food and Drug Administration; France: Ministry of Health |
Metabolic Syndrome |
Irbesartan Vascular Diseases Angiotensin II Hydrochlorothiazide Hypertension |
Disease Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Pathologic Processes Natriuretic Agents Therapeutic Uses Syndrome Cardiovascular Diseases |