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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 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.
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 4,413 participants |
| Start Date | 2008-04 |
| Est. Completion | 2010-08 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 4,413 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,202-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (29% 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.
NCT00679588 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.
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