At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 124 enrolled
Drug / intervention
Sodium Enoxaparinedrug
Likely dose
Sodium Enoxaparine 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
International Multicenter Randomized Double-blind Comparative Clinical Trial of Safety and Efficacy of BCD-080 (JSC BIOCAD, Russia) and Clexan® (Sanofi Aventis France, France) for Deep Vein Thrombosis Prophylaxis at Orthopedic Surgeries
In Brief
A Phase 3 clinical trial evaluating Sodium Enoxaparine for Deep Vein Thrombosis. Completed, enrolled 124 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDeep Vein Thrombosis
CountriesRussia
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJan 2015
First PostedFeb 2015
Primary CompletionDec 2015
TodayJul 2026
First PostedFeb 23, 2015
Enrollment StartJan 1, 2015
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.4 years ago
Interventions
Sodium Enoxaparinedrug
30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).