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 prevention of Venous Thromboembolic Events (VTE) in patients undergoing elective knee replacement surgery. The secondary objectives of this study are to evaluate the safety of AVE5026 in patients undergoing elective knee replacement surgery, and to document AVE5026 exposure in this population.


Study summary:

The total duration of observation per patient is 35 - 42 days from surgery, and includes: - a treatment period of 7 - 10 days, - a follow-up period of 28 - 35 days. Mandatory bilateral venography is performed 7 to 11 days after surgery.


Criteria:

Inclusion Criteria: - Knee replacement surgery or revision of at least one component of a knee prosthesis implanted ≥ 6 months prior to study entry. Exclusion Criteria: - Any major orthopedic surgeries in the 3 months prior to study. - Deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome. - Any contraindications to the performance of venography. - Patients at high risk of bleeding. - Know allergy to heparin, or enoxaparin, or pork products. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


NCT ID:

NCT00718224


Primary Contact:

Principal Investigator
Michael R. LASSEN, MD
Horsholm Hospital, Horsholm, Denmark


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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