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Prophylactic Use of Sodium Enoxaparin for Venous Thromboembolism in High-Risk Abdominal Surgery

Venous Thromboembolism Clinical Trial

Official title:
A Non-Inferiority Study of Enoxaparin Cristalia in Relation With Enoxaparin Sanofi-Aventis for Prophylaxis Against Venous Thromboembolism in Patients With High-Risk to Develop Thromboembolic Disease Undergoing Geral Abdominal Surgery

Clinical Trial Summary

The purpose of this study is to compare the safety and security and efficacy of sodium enoxaparin Cristália Produtos Químicos Farmaceuticos Ltda - Endocris with Clexane (Sanofi-Aventis) to prevent Venous Thromboembolism in Patients With High-Risk to Develop Thromboembolic Disease Undergoing Geral Abdominal Surgery.

Clinical Trial Description

This study is a requirement of Anvisa to add a new indication for off-label drug ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01308528
Study type Interventional
Source Cristália Produtos Químicos Farmacêuticos Ltda.
Contact
Status Completed
Phase Phase 3
Start date February 2015
Completion date April 2017
View Details
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