Bioequipotency Study of Idrabiotaparinux and Idraparinux in Patients With Deep Venous Thrombosis of the Lower Limbs
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2006 |
| End Date: | January 2008 |
International, Multicenter, Randomized, Parallel Group, Double-blind Study, in Patients With Acute Symptomatic Deep Vein Thrombosis of the Lower Limbs, Demonstrating the Bioequipotency at Steady State of Equimolar Doses of SSR126517E (3.0 mg) Once a Week and SR34006 (2.5 mg) Once a Week, Documenting the Safety and Efficacy of Both Compounds During a 6-month Treatment, and Demonstrating the Neutralizing Effect of SSR29261 on the SSR126517E-induced Anti-Xa Activity
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.
- 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.
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-month treatment period are re-randomized to either the
idrabiotaparinux/idraparinux bioequipotency sub-study or the avidin neutralizing effect
sub-study.
6 months with a month 9 visit and a phone/contact visit at month 12.
All participants who complete the 6-month treatment period are re-randomized to either the
idrabiotaparinux/idraparinux bioequipotency sub-study or the avidin neutralizing effect
sub-study.
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.
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