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Sponsors and Collaborators: |
Sanofi-Aventis Bristol-Myers Squibb |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00296218 |
Primary Objective
Secondary Objectives
Condition | Intervention | Phase |
---|---|---|
Myocardial Ischemia Hypertension |
Drug: Irbesartan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study |
Official Title: | Randomized Comparison of a Two-Month Regimen of Irbesartan Versus Enalapril on Cardiovascular Markers in Patients With Acute Coronary Syndrome Without ST Segment Elevation. |
Estimated Enrollment: | 440 |
Study Start Date: | February 2006 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
Main criteria are listed hereafter:
Inclusion Criteria
Patient hospitalised with ischemic symptoms (last episode within the last 48 hours before randomization) and at least one of the following characteristics of NSTEACS (non-ST-segment-elevation acute coronary syndromes):
Exclusion Criteria
United States, New Jersey | |
Sanofi-Aventis | |
Bridgewater, New Jersey, United States | |
Belgium | |
Sanofi-Aventis | |
Brussels, Belgium | |
Canada | |
Sanofi-Aventis | |
Laval, Canada | |
France | |
Sanofi-Aventis | |
Paris, France | |
Germany | |
Sanofi-Aventis | |
Berlin, Germany | |
Hungary | |
Sanofi-Aventis | |
Budapest, Hungary | |
Italy | |
Sanofi-Aventis | |
Milan, Italy | |
Netherlands | |
Sanofi-Aventis | |
Gouda, Netherlands | |
Spain | |
Sanofi-Aventis | |
Barcelona, Spain | |
Switzerland | |
Sanofi-Aventis | |
Meyrin, Switzerland | |
United Kingdom | |
Sanofi-Aventis | |
Guildford, United Kingdom |
Study Director: | Catherine Domenger, MD | Sanofi-Aventis |
Study ID Numbers: | PM_C_0024, EudraCT #: 2005-002161-36 |
Study First Received: | February 22, 2006 |
Last Updated: | June 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00296218 |
Health Authority: | United States: Food and Drug Administration |
Enalapril Heart Diseases Enalaprilat Myocardial Ischemia Acute Coronary Syndrome |
Irbesartan Vascular Diseases Ischemia Angiotensin II Hypertension |
Angiotensin II Type 1 Receptor Blockers Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |