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NCT00718224 · ClinicalTrials.gov registry record · Phase 3

Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Elective Knee Replacement Surgery

A Phase 3 study of Venous Thromboembolism, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
1,150
Enrollment target
17
Study locations

NCT00718224 is a Phase 3 study of Venous Thromboembolism that has completed, run by Sanofi. The registered enrollment target is 1,150 participants, below the 6,271-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (82% lower). The trial reports 17 study locations across 3 states.

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The verdict

NCT00718224, a Phase 3 study of Venous Thromboembolism, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
1,150 participants
Enrollment target
17
Study locations

Study Summary

The primary objective was to compare the efficacy of Semuloparin sodium (AVE5026) with Enoxaparin for the prevention of Venous Thromboembolic Events \[VTE\] in patients undergoing elective knee replacement surgery. The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing elective knee replacement surgery, and to document AVE5026 exposure in this population.

Conditions Studied

Venous Thromboembolism

Interventions

  • DRUG Placebo
  • DRUG Enoxaparin
  • DRUG Semuloparin sodium

Study Locations (17)

Other

  • Sanofi-Aventis Administrative Office - Buenos Aires
  • Sanofi-Aventis Administrative Office - Minsk
  • Sanofi-Aventis Administrative Office - Laval
  • Sanofi-Aventis Administrative Office - Bogotá
  • Sanofi-Aventis Administrative Office - Prague
  • Sanofi-Aventis Administrative Office - Hørsholm
  • Sanofi-Aventis Administrative Office - Tallinn
  • Sanofi-Aventis Administrative Office - Athens
  • Sanofi-Aventis Administrative Office - Vilnius
  • Sanofi-Aventis Administrative Office - México
  • Sanofi-Aventis Administrative Office - Warsaw
  • Sanofi-Aventis Administrative Office - Bucharest
  • Sanofi-Aventis Administrative Office - Moscow
  • Sanofi-Aventis Administrative Office - Midrand
  • Sanofi-Aventis Administrative Office - Kiev

New Jersey

  • Sanofi-Aventis Administrative Office - Bridgewater

New South Wales

  • sanofi-aventis Australia & New Zealand administrative office - Macquarie Park

Trial Details

FieldValue
Enrollment Target 1,150 participants
Start Date 2008-07
Est. Completion 2009-05
Phase Phase 3

Sponsor

Sanofi

713 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00718224

The ClinicalTrials.gov registry entry for NCT00718224 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,271-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (82% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Venous Thromboembolism appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00718224 reports 17 study locations spanning 3 distinct geographic areas - top geographies include Other, New Jersey, New South Wales.

Frequently Asked Questions

What is clinical trial NCT00718224 about?

NCT00718224 is a clinical study titled "Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Elective Knee Replacement Surgery". The primary objective was to compare the efficacy of Semuloparin sodium (AVE5026) with Enoxaparin for the prevention of Venous Thromboembolic Events \[VTE\] in patients undergoing elective knee replacement surgery. The secondary objectives were to evaluate the safety of AVE5026 in patients undergoi...

What is the current status of trial NCT00718224?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,150 participants. The study started on 2008-07. Estimated completion is 2009-05.

What conditions does trial NCT00718224 study?

This clinical trial studies the following conditions: Venous Thromboembolism.

What interventions are being tested in trial NCT00718224?

The interventions under investigation include: Placebo (DRUG), Enoxaparin (DRUG), Semuloparin sodium (DRUG).

Who is sponsoring clinical trial NCT00718224?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00718224 being conducted?

This trial has 17 study locations across New Jersey, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.