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COMPLETED Phase 3

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

NCT00679588 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

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

Sponsor

Sanofi

275 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00679588

The ClinicalTrials.gov registry entry for NCT00679588 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4,413 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00679588 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Alabama, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00679588?

The interventions under investigation include: Placebo (DRUG), Semuloparin Sodium (DRUG), Enoxaparin sodium (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00679588?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial