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Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery

NCT00331838 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 705

Last updated 2013-01-15

No results posted yet for this study

Summary

The primary objective was to demonstrate the dose-response of Semuloparin sodium (AVE5026) for the prevention of Venous Thromboembolism \[VTE\] in patients undergoing total knee replacement \[TKR\] surgery.

Secondary objectives were to evaluate the safety (incidence of major bleeding) of AVE5026, to document the efficacy and safety of AVE5026 post-operative regimens, and to assess the pharmacokinetic parameters of AVE5026.

Conditions

  • Venous Thromboembolism

Interventions

DRUG

Semuloparin sodium

0.8 mL solution in Type I amber glass vials Subcutaneous injection

DRUG

Placebo (for Enoxaparin sodium)

0.4 mL solution in ready-to-use prefilled syringe strictly identical in appearance containing the same volume but without active component Subcutaneous injection

DRUG

Enoxaparin sodium

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

DRUG

Placebo (for Semuloparin sodium)

0.8 ml solution in type I amber glass vials strictly identical in appearance containing the same volume but without active component Subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Michael LASSEN, MD · Hoersholm Hospital (Denmark)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-06-30
Completion
2007-06-30

Countries

  • Argentina
  • Bulgaria
  • Chile
  • Colombia
  • Denmark
  • Finland
  • Greece
  • Malaysia
  • Mexico
  • Norway
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • Sweden
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

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 NCT00331838 on ClinicalTrials.gov