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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: Completed Phase 3 study of Venous Thromboembolism, sponsored by Sanofi.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
VTE included 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 central and blind review of mandatory bilateral venograms and diagnostic tests for VTE. All-cause deaths included fatal PE and deaths for other reason than PE.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,150 participants |
| Start Date | 2008-07 |
| Est. Completion | 2009-05 |
| Phase | Phase 3 |
What the finished NCT00718224 record still lists
NCT00718224 is an interventional study that assigns participants to a tested intervention. Its 1,150 participants enrollment target places it among the larger protocols in the corpus, below the 6,271-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (82% 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.
NCT00718224 lists 17 locations in 3 states (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.
Learn More About Clinical Trials
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Where NCT00718224's enrollment target sits among peer trials
1,150 18th of 47 higher than 30 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.
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