Status:
COMPLETED
Bioequipotency Study of Idrabiotaparinux and Idraparinux in Patients With Deep Venous Thrombosis of the Lower Limbs
Lead Sponsor:
Sanofi
Conditions:
Deep Venous Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The three purposes of this study are the following: * To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux (SSR126517) with that of idraparinux (SR34006), taking int...
Detailed Description
The study consists in a 6-month treatment period followed by an observational period of 3 to 6 months with a month 9 visit and a phone/contact visit at month 12. All participants who complete the 6-m...
Eligibility Criteria
Inclusion
- Confirmed acute symptomatic DVT of the lower limbs
Exclusion
- Severe concomitant diseases (e.g. renal failure, hepatic failure, uncontrolled hypertension)
- Active bleeding or high risk for bleeding.
- Pregnancy or childbearing potential without proper contraceptive measures.
- Breastfeeding
- Known allergy to idraparinux, SSR126517E, or egg proteins
- Indication of prolonged anticoagulation for other reason than DVT of the lower limbs
- Symptomatic pulmonary embolism (PE)
- Life expectancy \< 6 months.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
757 Patients enrolled
Trial Details
Trial ID
NCT00311090
Start Date
April 1 2006
End Date
January 1 2008
Last Update
March 21 2016
Active Locations (20)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis
Buenos Aires, Argentina, 1642
3
Sanofi-Aventis
Macquarie Park, Australia, NSW 2113
4
Sanofi-Aventis
Vienna, Austria, 1220