NCT00311753

Efficacy and Safety of Low-molecular Weight Heparin for Thromboprophylaxis in Acutely Ill Medical Patients

An Open-label Comparison of the Efficacy and Safety of the Low-molecular-weight Heparin (3000 U Anti-Xa Once Daily) With Unfractionated Heparin for the Prevention of Thromboembolic Complications in Acutely Ill Non-surgical Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: —

Summary

Acutely ill immobilized patients are at a high risk for thromboembolic events including deep venous thrombosis or pulmonary embolism. Unfractionated heparin (UFH) and low molecular weight heparins (LMWH) are thought to be effective in preventing thromboembolic events. This study is designed to provide efficacy and safety data for thromboprophylaxis with the LMWH certoparin in comparison to thromboprophylaxis with UFH in acutely ill non-surgical patients.

Conditions

• Embolism

Interventions

Type	Name	Description
DRUG	Certoparin	Low-molecular-weight heparin, Certoparin (3000 U anti-Xa once daily) treatment period of 10 ± 2 days
DRUG	Heparin	7500 IU of unfractionated heparin administered twice daily during the treatment period of 10 ± 2 days

Timeline

• Start date: 2006-02-01
• Primary completion: 2007-12-01
• First posted: 2006-04-06
• Last updated: 2017-02-24

Locations

2 sites across 2 countries: Germany, Switzerland