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Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility

NCT00714597 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 421

Last updated 2013-01-23

No results posted yet for this study

Summary

The primary objective was to compare the efficacy of once daily \[q.d\] subcutaneous \[s.c.\] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the primary prevention of Venous Thromboembolic Events \[VTE\] in patients hospitalized for acute medical illness.

The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.

Conditions

  • Venous Thromboembolism

Interventions

DRUG

Semuloparin sodium

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection

DRUG

Enoxaparin sodium

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Patrick Mismetti, MD · University Hospital of Saint-Etienne, France

  • Alexander Turpie, MD · HHS-General Hospital, Hamilton, Canada

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Czechia
  • Estonia
  • France
  • Germany
  • Hungary
  • India
  • Italy
  • Latvia
  • Lithuania
  • Mexico
  • Netherlands
  • New Zealand
  • Romania
  • Russia
  • South Korea
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Companies

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 NCT00714597 on ClinicalTrials.gov