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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 - Trial NCT00843492

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.

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NCT00843492
Phase 3
Completed
drug
Trial Details
ClinicalTrials.gov • NCT00843492
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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

Study Focus

Thrombosis, Venous

Fondaparinux sodium

Interventional

drug

Sponsor & Location

GlaxoSmithKline

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 3

Dec 01, 2008

Jun 01, 2010

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 thrombosis
Embolism and thrombosis of unspecified vein
Embolism and thrombosis of other specified veins
Perianal venous thrombosis
Arterial embolism and thrombosis

Data Source

ClinicalTrials.gov

NCT00843492

Non-Device Trial