CompletedPhase 3

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

United States, Argentina, Australia757 participantsStarted 2006-04

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Confirmed acute symptomatic DVT of the lower limbs Exclusion Criteria: * 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.

What they're measuring

Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters

Timeframe: Day 183

Avidin neutralizing effect substudy: decrease in anti-Xa activity between the start and end of the avidin infusion

Timeframe: Day 183 to Day 188

Trial details

NCT IDNCT00311090

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-01

View on ClinicalTrials.gov More Deep Venous Thrombosis trials