drugset / Trial / NCT00345618

Clinical Study Assessing Idrabiotaparinux Sodium Injections Once-weekly in Pulmonary Embolism Therapeutic Approach

NCT00345618

Phase 3 Completed 3202 enrolled Sanofi
RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2006-06
Primary completion
2010-10
Completion
2010-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Idrabiotaparinux sodium Unknown 3 mg Subcutaneous
Subject Warfarin Small molecule 1 mg Oral
Subject Warfarin Small molecule 5 mg Oral
Background Avidin Unknown 100 mg Intravenous
Background Enoxaparin sodium Other / unclassified 1 mg/kg Subcutaneous