Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility

Stopped early · Phase 3

Conditions studied: Venous Thromboembolism

In brief

The primary objective was to compare the efficacy of once daily \[q.d\] subcutaneous \[s.c.\] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the primary prevention of Venous Thromboembolic Events \[VTE\] in patients hospitalized for acute medical illness. The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.

Key facts

Study ID

NCT00714597

Run by

Sanofi

People needed

421

Starts

2008-07-01

Expected to finish

2009-03-01

Last updated by the study team

2013-01-23

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient with an acute medical condition requiring bed rest for at least 3 days, and hospitalized for at least one of the following medical conditions:
• Congestive heart failure (New York Heart Association [NYHA] class III/IV);
• Acute respiratory failure (not requiring mechanical ventilation);
• Acute infection (without septic shock)*;
• Acute rheumatic disorder*;
• Acute episode of inflammatory bowel disease*.
• Patient with one of these conditions should have at least one additional risk factor for venous thromboembolism (VTE) among the following:
• Age ≥ 75 years;
• Active cancer or myeloproliferative disorders (having received treatment for cancer within the last 6 months);
• Previous VTE;
• Obesity;
• Oral hormone therapy (antiandrogen or estrogen);
• Chronic heart failure;
• Chronic respiratory failure.

You may not qualify if…

• Previous surgery with general anesthesia within 30 days before inclusion in the study;
• Patient requiring a curative anticoagulant or thrombolytic treatment;
• Patient at risk of bleeding;
• Stroke;
• Known hypersensitivity to heparin or enoxaparin sodium;
• End stage renal disease or patient on dialysis.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• sanofi-aventis Australia & New Zealand administrative office — Macquarie Park, New South Wales, Australia
• Sanofi-Aventis Administrative Office — Vienna, Austria
• Sanofi-Aventis Administrative Office — Laval, Canada
• Sanofi-Aventis Administrative Office — Prague, Czechia
• Sanofi-Aventis Administrative Office — Tallinn, Estonia
• Sanofi-Aventis Administrative Office — Paris, France
• Sanofi-Aventis Administrative Office — Berlin, Germany
• Sanofi-Aventis Administrative Office — Budapest, Hungary
• Sanofi-Aventis Administrative Office — Mumbai, India
• Sanofi-Aventis Administrative Office — Milan, Italy
• Sanofi-Aventis Administrative Office — Riga, Latvia
• Sanofi-Aventis Administrative Office — Vilnius, Lithuania
• Sanofi-Aventis Administrative Office — México, Mexico
• Sanofi-Aventis Administrative Office — Gouda, Netherlands
• Sanofi-Aventis Administrative Office — Auckland, New Zealand
• Sanofi-Aventis Administrative Office — Bucharest, Romania
• Sanofi-Aventis Administrative Office — Moscow, Russia
• Sanofi-Aventis Administrative Office — Seoul, South Korea
• Sanofi-Aventis Administrative Office — Barcelona, Spain
• Sanofi-Aventis Administrative Office — Kiev, Ukraine
• Sanofi-Aventis Administrative Office — Guildford Surrey, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.