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

NCT02368314 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2016-10-24

Study results available
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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.

Conditions

  • Deep Vein Thrombosis

Interventions

DRUG

Sodium Enoxaparine

30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Ashot Agahanyan, MD · Railroad Clinical Hospital at the station Chelyabinsk, Chelyabinsk, Russia

  • Pavel Andreev, MD, PhD · Railroad Clinical Hospital at the station Samara, Samara, Russia

  • Ildar Ahtyamov, Professor · State budget institution of further education "Kazan State Medical Academy" the Ministry of Health of the Russian Federation

  • Valery Zagrekov, MD, PhD · Nizhny Novgorod Research Institute of Traumatology and Orthopedics of Public Health Ministry of Russian Federation

  • Maxim Lucenko, MD · Treatment and rehabilitation center of Public Health Ministry of Russian Federation, Moscow

  • Alexander Sitnik, MD, PhD · State Institution "Republican Scientific and Practical Centre for Traumatology and Orthopedics" of the Ministry of Health of the Republic of Belarus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02368314 on ClinicalTrials.gov