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Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy

NCT00694382 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3212

Last updated 2013-01-23

No results posted yet for this study

Summary

The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism \[VTE\] in cancer patients at high risk for VTE and who were undergoing chemotherapy.

The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.

Conditions

  • Venous Thromboembolism
  • Cancer

Interventions

DRUG

Semuloparin sodium

0.4 mL solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection

DRUG

Placebo (for semuloparin)

0.4 mL solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component Subcutaneous injection

Sponsors & Collaborators

Principal Investigators

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

  • Giancarlo Agnelli, MD · University Of Perugia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • India
  • Indonesia
  • Ireland
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Malaysia
  • Mexico
  • Netherlands
  • Norway
  • Peru
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • Slovenia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT00694382 on ClinicalTrials.gov