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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...

Update Il y a 4 ans
Reference: EUCTR2005-005326-30

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

Woman and Man

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Extract

Objetivo principal de la evaluación de bioequipotencia: Demostrar la bioequipotencia de idraparinux biotinilato (SSR126517E) e idraparinux (SR34006) en fase meseta, en pacientes con TVP sintomática aguda, evaluado a partir de la actividad anti-Xa. Objetivo principal de la evaluación del efecto neutralizador de avidina: Demostrar el efecto neutralizador de avidina (SSR29261) sobre la actividad anti-Xa inducida por idraparinux biotinilato (SSR126517E).

Inclusion criteria

  • pacientes con trombosis venosa profunda sintomática aguda de extremidades inferiores

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