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NCT00679588 · ClinicalTrials.gov registry record · Phase 3

Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

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

Completed
Registry status
Phase 3
Development phase
4,413
Enrollment target
20
Study locations

NCT00679588: Completed Phase 3 study of Venous Thromboembolism, sponsored by Sanofi.

NCT00679588 is a Phase 3 study of Venous Thromboembolism that has completed, run by Sanofi. The registered enrollment target is 4,413 participants, below the 6,202-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00679588, a Phase 3 study of Venous Thromboembolism, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
4,413 participants
Enrollment target
20
Study locations

Study Summary

The primary objective is to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the prevention of Venous Thromboembolic Events (VTE) in patients undergoing major abdominal surgery. The secondary objectives are to evaluate the safety of Semuloparin sodium (AVE5026) and to document Semuloparin sodium (AVE5026) exposure in this population.

Primary Outcome

VTE includes any proximal or distal Deep Vein Thrombosis (DVT) (symptomatic or not) and non-fatal Pulmonary Embolism (PE) as confirmed by a Central Independent Adjudication Committee (CIAC) after review of mandatory bilateral venograms and diagnostic tests for VTE. All-cause deaths includes fatal PE and deaths for other reason than PE.

Conditions Studied

Venous Thromboembolism

Interventions

  • DRUG Placebo
  • DRUG Semuloparin Sodium
  • DRUG Enoxaparin sodium

Study Locations (20)

Alabama

  • Investigational Site Number 840026 - Birmingham
  • Investigational Site Number 840035 - Birmingham
  • Investigational Site Number 840042 - Birmingham
  • Investigational Site Number 840002 - Birmingham

California

  • Investigational Site Number 840031 - Corlton
  • Investigational Site Number 840007 - Huntingdon Beach
  • Investigational Site Number 840014 - Los Angeles
  • Investigational Site Number 840011 - Sant Barbara

Florida

  • Investigational Site Number 840029 - Clearwater
  • Investigational Site Number 840017 - Jacksonville
  • Investigational Site Number 840044 - Miami
  • Investigational Site Number 840015 - Orlando

Illinois

  • Investigational Site Number 840019 - Maywood
  • Investigational Site Number 840036 - Springfield

Colorado

  • Investigational Site Number 840021 - Denver

Georgia

  • Investigational Site Number 840009 - Columbus

Kentucky

  • Investigational Site Number 840037 - Hazard

Missouri

  • Investigational Site Number 840008 - St Louis

Trial Details

FieldValue
Enrollment Target 4,413 participants
Start Date 2008-04
Est. Completion 2010-08
Phase Phase 3
Sanofi

713 total trials

What the finished NCT00679588 record still lists

NCT00679588 is an interventional study that assigns participants to a tested intervention. Its 4,413 participants enrollment target places it among the larger protocols in the corpus, below the 6,202-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (29% lower).

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.

NCT00679588 names 20 study sites across 10 states, led by Alabama, California, Florida.

Frequently Asked Questions

What is clinical trial NCT00679588 about?

NCT00679588 is a clinical study titled "Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery". The primary objective is to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the prevention of Venous Thromboembolic Events (VTE) in patients undergoing major abdominal surgery. The second...

What is the current status of trial NCT00679588?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,413 participants. The study started on 2008-04. Estimated completion is 2010-08.

What conditions does trial NCT00679588 study?

This clinical trial studies the following conditions: Venous Thromboembolism.

What interventions are being tested in trial NCT00679588?

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

Who is sponsoring clinical trial NCT00679588?

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

Where is trial NCT00679588 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Venous Thromboembolism

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00679588's enrollment target sits among peer trials

4,413 13th of 47 higher than 35 of 47 other Venous Thromboembolism trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Venous Thromboembolism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00679588, the US trial registry maintained by the National Library of Medicine. NCT00679588 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.