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Evaluation of AVE5026 as Compared to Placebo for the Extended Prophylaxis of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery

NCT00709904 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 469

Last updated 2013-06-14

No results posted yet for this study

Summary

The primary objective is to evaluate the efficacy of once daily (QD) subcutaneous (SC) injections of Semuloparin sodium (AVE5026) versus placebo for 3 additional weeks following an initial 7 to 10-day venous thromboprophylaxis with open-label AVE5026 in patients having undergone hip fracture surgery.

The secondary objective is to evaluate the safety of extended AVE5026 administration.

Conditions

  • Venous Thromboembolism

Interventions

DRUG

Open-label Semuloparin sodium

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection once daily with an initial dose given 8 hours after surgery

DRUG

Placebo (for Semuloparin sodium)

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance containing the same volume but without active component Subcutaneous injection once daily

DRUG

Semuloparin sodium

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

Sponsors & Collaborators

Principal Investigators

  • William D. Fisher, MD · McGill University Health Centre, Montreal, Quebec, Canada

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

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
2010-01-31
Completion
2010-01-31

Countries

  • United States
  • Belarus
  • Canada
  • Chile
  • China
  • Colombia
  • Egypt
  • India
  • Lithuania
  • Mexico
  • Peru
  • Russia
  • South Africa
  • South Korea
  • Turkey (Türkiye)
  • Ukraine

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 NCT00709904 on ClinicalTrials.gov