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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

A Multicentre, Randomized, Open-label Study to Evaluate the Efficacy andSafety of Fondaparinux Versus Low Molecular Weight Heparin(Nadroparin) in Patients Requiring Rigid or Semi-rigid Immobilization for at Least 21 Days and up to 45 Days Because of Isolated Non-surgical Below-Knee Injury
GlaxoSmithKline·Phase 3·ClinicalTrials.gov·drugCompleted
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Thrombosis, Venous
Drug/Device/Intervention
Fondaparinux sodium
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
GlaxoSmithKline
Location
Agen Cedex 9,Angers,Antony Cedex,Argenteuil Cedex,Beauvais Cedex,Bobigny,Brest Cedex,Cergy Pontoise,Clermont Ferrand,Colmar Cedex,Créteil Cedex,Grenoble Cedex 9,Lille Cedex,Lyon Cedex 03,Lyon Cedex 07, France,Germany,Italy,Netherlands,Russian Federation,Spain
Timeline & enrollment
Phase
Phase 3
Start date
Dec 01, 2008
End date
Jun 01, 2010
Enrollment
1351 participants
Primary outcome

Number of Participants With Venous Thromboembolism (VTE) or Death up to the Time of Complete Mobilization

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.

ICD-10 classifications
Other venous embolism and thrombosisEmbolism and thrombosis of unspecified veinEmbolism and thrombosis of other specified veinsPerianal venous thrombosisArterial embolism and thrombosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT00843492
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT00843492 through Pure Global AI's free database. This Phase 3 trial is sponsored by GlaxoSmithKline and is currently Completed. The study focuses on Thrombosis, Venous. Target enrollment is 1351 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.