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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Biotin; Enoxaparin; Idrabiotaparinux; Idraparinux; Warfarin

Criteria

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;