Expired Study
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Bridgewater, New Jersey 08807


Purpose:

The primary objective was to evaluate the efficacy of AVE5026 versus placebo for 3 weeks following an initial open-label treatment period with AVE5026 of 7 to 10 days in patients having undergone hip fracture surgery. The secondary objective was to evaluate the safety of AVE5026.


Study summary:

The total duration of observation per patient was 56 - 63 days from surgery, and included: - a run-in phase with open-label AVE5026 treatment of 7 - 10 days, - a double-blind treatment period with AVE5026 or placebo of 19 - 23 days (randomization ratio 2:1), - a follow-up period of 30 days. Mandatory bilateral venography of the lower limbs was to be performed between Day 19 and Day 24 after randomization.


Criteria:

Inclusion Criteria: - Hip fracture surgery Exclusion Criteria: - Any major orthopedic surgery within 3 months prior to enrolment - Deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome - Patient at high risk of bleeding - Known hypersensitivity to heparins - Any contraindication to the performance of venography - Permanent discontinuation of AVE5026 during the run-in phase The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


NCT ID:

NCT00709904


Primary Contact:

Principal Investigator
William D. Fisher, MD
McGill University Health Centre, Montreal, Quebec, Canada


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: October 09, 2019

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