Clinical Trials Detalhe
Clinical Study Assessing Idrabiotaparinux Sodium Injections Once-weekly in Pulmonary Embolism Therapeutic Approach
Visão Geral
Gender
ALL
Idade
N/A
Fase
PHASE3
Tipo de Estudo
INTERVENTIONAL
Localização
Sanofi-Aventis Administrative Office (Porto Salvo, Portugal)
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT00345618Sumário
Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.
Condições
Embolism
Thrombosis
Elegibilidade
Inclusion Criteria: * Symptomatic pulmonary embolism with or without symptomatic deep vein thrombosis Exclusion Criteria: * End stage renal failure, hepatic failure, uncontrolled hypertension; * Active bleeding or high risk for bleeding; * Pregnancy or childbearing potential without proper contraceptive measures, threatened abortion. * Breastfeeding. * Known allergy to idraparinux or idrabiotaparinux, avidin or egg proteins; * hypersensitivity to warfarin, enoxaparin, heparin or pork product; or any other contraindication listed in the labelling of warfarin or enoxaparin; * Indication of prolonged anticoagulation therapy for other reason than PE; * Life expectancy \< 6 months;