drugset / Trial / NCT02368314
A Safety and Efficacy Study of BCD-080 Compared to Clexan for Deep Vein Thrombosis Prophylaxis at Orthopedic Surgeries
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Enoxaparine | Unknown | 30 mg | Subcutaneous |