Status:
COMPLETED
Clinical Study Assessing Idrabiotaparinux Sodium Injections Once-weekly in Pulmonary Embolism Therapeutic Approach
Lead Sponsor:
Sanofi
Conditions:
Embolism
Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patient...
Detailed Description
Treatment with a therapeutic dose of any low molecular weight heparin (LMWH) or unfractioned heparin (UFH) or fondaparinux is allowed only within the 36 hours immediately preceding randomization. Rand...
Eligibility Criteria
Inclusion
- Symptomatic pulmonary embolism with or without symptomatic deep vein thrombosis
Exclusion
- End stage renal failure, hepatic failure, uncontrolled hypertension;
- Active bleeding or high risk for bleeding;
- Pregnancy or childbearing potential without proper contraceptive measures, threatened abortion.
- Breastfeeding.
- Known allergy to idraparinux or idrabiotaparinux, avidin or egg proteins;
- hypersensitivity to warfarin, enoxaparin, heparin or pork product; or any other contraindication listed in the labelling of warfarin or enoxaparin;
- Indication of prolonged anticoagulation therapy for other reason than PE;
- Life expectancy \< 6 months;
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
3202 Patients enrolled
Trial Details
Trial ID
NCT00345618
Start Date
June 1 2006
End Date
October 1 2010
Last Update
March 21 2016
Active Locations (38)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
3
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales, Australia
4
Sanofi-Aventis Administrative Office
Vienna, Austria