drugset / Trial / NCT01880216

Efficacy of Bemiparin Versus Enoxaparin in the Treatment of DVT

NCT01880216 ↗

Phase 3 Completed 312 enrolled Berlin-Chemie Menarini
RandomizedParallel-groupSingle-blindTreatment

Summary

Deep-vein thrombosis (DVT) is a common but under-diagnosed medical condition that occurs when a thrombus forms in one of the large veins, usually in the lower limbs, leading to either partial or complete blocked circulation. The condition may progress to severe health complications, such as pulmonary embolism (PE), if not diagnosed and treated in a timely and effective manner. The goal of the therapy for lower-extremity DVT is to prevent the extension of thrombus and pulmonary embolism in the short term and to prevent recurrent events in the long-term. Although anticoagulant therapy decreases the risk of recurrent thrombosis, the treatment also increases the risk for major hemorrhage. This trial aims to optimize the current medical knowledge on the effectiveness and safety of two low molecular weight heparins, bemiparin and enoxaparin in the treatment of deep vein thrombosis.

Timeline

Start
2013-06
Primary completion
2015-01
Completion
2015-05

Outcome

Met primary endpoint

paper CONCLUSIONS: The efficacy of bemiparin administered once daily is non-inferior to that of enoxaparin administered twice daily with a similar safety profile. PMID 29214507 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bemiparin Other / unclassified — Subcutaneous
Comparator Enoxaparin sodium Other / unclassified — Subcutaneous