drugset / Trial / NCT00843492

A Study to Evaluate the Efficacy and Safety of Fondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or Other Type of Immobilization for a Below-knee Injury Not Needing Surgery

NCT00843492

Phase 3 Completed 1351 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to evaluate the efficacy and safety of fondaparinux in comparison with a heparin (nadroparin) in preventing deep vein thrombosis (blood clots in the leg veins), whether symptomatic or detected by ultrasound, and pulmonary embolism (blood clots that migrate to the lungs) in patients with leg injuries below the knee that require a cast or other type of immobilization but not surgery.

Timeline

Start
2008-12
Primary completion
2010-01
Completion
2010-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Fondaparinux Other / unclassified 1.5 mg Subcutaneous
Subject Fondaparinux Other / unclassified 2.5 mg Subcutaneous
Comparator Nadroparin Calcium Other / unclassified 2850 iu Subcutaneous