Bioequipotency Study of Idrabiotaparinux and Idraparinux in Patients With Deep Venous Thrombosis of the Lower Limbs

Completed · Phase 3 · Has a placebo group

Conditions studied: Deep Venous Thrombosis

In brief

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 into account new events of deep venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk; * To compare the activities of idrabiotaparinux and idraparinux directly in blood during and after a 6-month treatment; * To check the ability of avidin (SSR29261) to reverse the blood thinning activity of idrabiotaparinux at the end of a 6-month treatment period.

Key facts

Study ID

NCT00311090

Run by

Sanofi

People needed

757

Starts

2006-04-01

Expected to finish

2008-01-01

Last updated by the study team

2016-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed acute symptomatic DVT of the lower limbs

You may not qualify if…

• 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.

Where it is running

• Sanofi-Aventis — Bridgewater, New Jersey, United States
• Sanofi-Aventis — Buenos Aires, Argentina
• Sanofi-Aventis — Macquarie Park, Australia
• Sanofi-Aventis — Vienna, Austria
• Sanofi-Aventis — Diegem, Belgium
• Sanofi-Aventis — São Paulo, Brazil
• Sanofi-Aventis — Laval, Canada
• Sanofi-Aventis — Prague, Czechia
• Sanofi-Aventis — Copenhagen, Denmark
• sanofi-aventis France — Paris, France
• sanofi-aventis Israel — Netanya, Israel
• Sanofi-aventis — Milan, Italy
• sanofi-aventis Mexico — México, Mexico
• sanofi-aventis, Netherlands — Gouda, Netherlands
• Sanofi-Aventis — New Zealand, New Zealand
• Sanofi-Aventis — Warsaw, Poland
• Sanofi-aventis — Moscow, Russia
• Sanofi-Aventis — Midrand, South Africa
• Sanofi-Aventis — Barcelona, Spain
• sanofi-aventis Turkey — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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