![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | February 22, 2006 | ||||
Last Updated Date | June 23, 2008 | ||||
Start Date † | February 2006 | ||||
Current Primary Outcome Measures † |
comparison of the relative change from baseline in hsCRP at day 60 between the two treatment groups | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00296218 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
|
||||
Original Secondary Outcome Measures † |
|
||||
Descriptive Information | |||||
Brief Title † | ARCHIPELAGO: Irbesartan in Patients With Acute Coronary Syndrome Without ST Segment Elevation | ||||
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. | ||||
Brief Summary | Primary Objective
Secondary Objectives
|
||||
Detailed Description | |||||
Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study | ||||
Condition † |
|
||||
Intervention † | Drug: Irbesartan | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 440 | ||||
Completion Date | |||||
Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | 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
Exclusion Criteria
|
||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States, Belgium, Canada, France, Germany, Hungary, Italy, Netherlands, Spain, Switzerland, United Kingdom | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00296218 | ||||
Responsible Party | |||||
Secondary IDs †† | EudraCT #: 2005-002161-36 | ||||
Study Sponsor † | Sanofi-Aventis | ||||
Collaborators †† | Bristol-Myers Squibb | ||||
Investigators † |
|
||||
Information Provided By | Sanofi-Aventis | ||||
Verification Date | June 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |