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

• Status: Terminated
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Sanofi
• Treatments: Enoxaparin; Enoxaparin sodium; Heparin, Low-Molecular-Weight; Semuloparin

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

• 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.