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Efficacy of Bemiparin Versus Enoxaparin in the Treatment of DVT

NCT01880216 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2016-02-04

No results posted yet for this study

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.

Conditions

  • Deep Vein Thrombosis

Interventions

DRUG

Bemiparin sodium

subcutaneous application daily for 7±2 days

DRUG

Enoxaparin sodium

subcutaneous for 7±2 days

Sponsors & Collaborators

  • Berlin-Chemie AG Menarini Group

    lead INDUSTRY

Principal Investigators

  • Maria Th Kaltwasser, Dr. · Berlin-Chemie AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-01-31
Completion
2015-05-31

Countries

  • Georgia
  • 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 NCT01880216 on ClinicalTrials.gov