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NCT00721760 · ClinicalTrials.gov registry record · Phase 3
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,003
- Enrollment target
NCT00721760: Completed Phase 3 study, sponsored by Sanofi.
NCT00721760 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,003 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00721760, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,003 participants
- Enrollment target
Study Summary
The primary objective was to compare the efficacy 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 hip fracture surgery. The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing hip fracture surgery, and to document AVE5026 exposure in this population.
Primary Outcome
VTE included any Deep Vein Thrombosis \[DVT\] (proximal or distal, 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 included fatal PE and deaths for other reason than PE.
Interventions
- DRUG Placebo
- DRUG Semuloparin sodium
- DRUG Enoxaparin sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,003 participants |
| Start Date | 2008-07 |
| Est. Completion | 2009-10 |
| Phase | Phase 3 |
What the finished NCT00721760 record still lists
NCT00721760 is an interventional study that assigns participants to a tested intervention. Its 1,003 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00721760 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00721760 about?
NCT00721760 is a clinical study titled "Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery". The primary objective was to compare the efficacy 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 hip fracture surgery. The secondary obje...
What is the current status of trial NCT00721760?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,003 participants. The study started on 2008-07. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00721760?
The interventions under investigation include: Placebo (DRUG), Semuloparin sodium (DRUG), Enoxaparin sodium (DRUG).
Who is sponsoring clinical trial NCT00721760?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00721760's enrollment target sits among peer trials
1,003 295th of 2000 higher than 1,706 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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