Expired Study
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Bridgewater, New Jersey 08807


Purpose:

The primary objective of the study is to compare the efficacy of AVE5026 with Enoxaparin for the primary prevention of Venous Thromboembolic Events (VTE) in patients hospitalized for acute medical illness. The secondary objectives of this study are to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.


Study summary:

The total duration of observation per patient is 35 - 42 days from randomization, and includes: - a treatment period of 10 - 14 days, - a follow-up period of 25 - 32 days. Mandatory compression ultrasound (CUS) is performed 10 to 15 days after randomization.


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*. *Patients with 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. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


NCT ID:

NCT00714597


Primary Contact:

Principal Investigator
Patrick Mismetti, MD
University Hospital of Saint-Etienne, France


Backup Contact:

N/A


Location Contact:

Bridgewater, New Jersey 08807
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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