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| Sponsor: | Sanofi-Aventis |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00296218 |
Purpose
Primary Objective
Secondary Objectives
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Ischemia Hypertension |
Drug: Irbesartan |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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) |
Eligibility| 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
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00296218 History of Changes |
| Other Study ID Numbers: | PM_C_0024, EudraCT #: 2005-002161-36 |
| Study First Received: | February 22, 2006 |
| Last Updated: | October 14, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Myocardial Ischemia Coronary Artery Disease Hypertension Ischemia Acute Coronary Syndrome Heart Diseases Cardiovascular Diseases Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Pathologic Processes |
Angina Pectoris Chest Pain Pain Signs and Symptoms Irbesartan Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |