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

Completed · Phase 3 · Has a placebo group

Conditions studied: Embolism, Thrombosis

In brief

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.

Key facts

Study ID

NCT00345618

Run by

Sanofi

People needed

3202

Starts

2006-06-01

Expected to finish

2010-10-01

Last updated by the study team

2016-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Symptomatic pulmonary embolism with or without symptomatic deep vein thrombosis

You may not qualify if…

• 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;

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Buenos Aires, Argentina
• sanofi-aventis Australia & New Zealand administrative office — Macquarie Park, New South Wales, Australia
• Sanofi-Aventis Administrative Office — Vienna, Austria
• Sanofi-Aventis Administrative Office — Minsk, Belarus
• Sanofi-Aventis Administrative Office — Diegem, Belgium
• Sanofi-Aventis Administrative Office — São Paulo, Brazil
• Sanofi-Aventis Administrative Office — Sofia, Bulgaria
• Sanofi-Aventis Administrative Office — Laval, Canada
• Sanofi-Aventis Administrative Office — Santiago, Chile
• Sanofi-Aventis Administrative Office — Shanghai, China
• Sanofi-Aventis Administrative Office — Bogotá, Colombia
• Sanofi-Aventis Administrative Office — Zagreb, Croatia
• Sanofi-Aventis Administrative Office — Prague, Czechia
• Sanofi-Aventis Administrative Office — Hørsholm, Denmark
• Sanofi-Aventis Administrative Office — Cairo, Egypt
• Sanofi-Aventis Administrative Office — Tallinn, Estonia
• Sanofi-Aventis Administrative Office — Paris, France
• Sanofi-Aventis Administrative Office — Athens, Greece
• Sanofi-Aventis Administrative Office — Mumbai, India
• Sanofi-Aventis Administrative Office — Netanya, Israel
• Sanofi-Aventis Administrative Office — Milan, Italy
• Sanofi-Aventis Administrative Office — México, Mexico
• Sanofi-Aventis Administrative Office — Gouda, Netherlands
• Sanofi-Aventis Administrative Office — Lysaker, Norway

Full record on ClinicalTrials.gov

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