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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00580216 |
The objective of this study is to evaluate wether the new investigational, neutralizable blood thinner (anticoagulant) "biotinylated idraparinux", administered once weekly under the skin, is at least as efficient to prevent clots in brain and in the other organs than the standard of care with warfarin an oral anticoagulant whose doses are adjusted according to a regular monitoring of a blood coagulation test (INR) in patients with heart rhythm disorder called "atrial fibrillation".
Condition | Intervention | Phase |
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Atrial Fibrillation |
Drug: SSR126517E "biotinylated idraparinux" Drug: warfarin |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-blind, Assessor-blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Biotinylated Idraparinux (SSR126517E) With Oral Adjusted-dose Warfarin in the Prevention of Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation |
Estimated Enrollment: | 9600 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: SSR126517E "biotinylated idraparinux"
once-weekly subcutaneous injection
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2: Active Comparator |
Drug: warfarin
oral INR adjusted-dose
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Main exclusion Criteria:
Contact: For site information, send an email with site number to | GV-Contact-us@sanofi-aventis.com |
Study Director: | ICD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC10295, EudraCT 2007-004817-33 |
Study First Received: | December 21, 2007 |
Last Updated: | August 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00580216 History of Changes |
Health Authority: | United States: Food and Drug Administration; Russia: Pharmacological Committee, Ministry of Health; Netherlands: Medicines Evaluation Board (MEB) |
stroke systemic thromboembolic events |
Embolism and Thrombosis Anticoagulants Heart Diseases Cerebral Infarction Embolism Stroke |
Vascular Diseases Warfarin Atrial Fibrillation Thrombosis Arrhythmias, Cardiac |
Heart Diseases Anticoagulants Hematologic Agents Vascular Diseases Warfarin Pharmacologic Actions Embolism and Thrombosis |
Pathologic Processes Embolism Therapeutic Uses Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |