drugset / Trial / NCT02368314

A Safety and Efficacy Study of BCD-080 Compared to Clexan for Deep Vein Thrombosis Prophylaxis at Orthopedic Surgeries

NCT02368314 ↗

Phase 3 Completed 124 enrolled Biocad
RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of the study is to prove equivalence of efficacy and safety of BCD-080 and Clexan for deep vein thrombosis and embolism prophylaxis at orthopedic surgeries.

Timeline

Start
2015-01
Primary completion
2015-12
Completion
2015-12

Outcome

Missed primary endpoint

registry analysis (superiority or other test); BCD-080 vs Clexane; p = 0.226; Fisher Exact NCT02368314 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Enoxaparine Unknown 30 mg Subcutaneous