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NCT00709904 · ClinicalTrials.gov registry record · Phase 3
Evaluation of AVE5026 as Compared to Placebo for the Extended Prophylaxis of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 469
- Enrollment target
NCT00709904: Completed Phase 3 study, sponsored by Sanofi.
NCT00709904 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 469 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00709904, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 469 participants
- Enrollment target
Study Summary
The primary objective is to evaluate the efficacy of once daily (QD) subcutaneous (SC) injections of Semuloparin sodium (AVE5026) versus placebo for 3 additional weeks following an initial 7 to 10-day venous thromboprophylaxis with open-label AVE5026 in patients having undergone hip fracture surgery. The secondary objective is to evaluate the safety of extended AVE5026 administration.
Primary Outcome
VTE include any 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 suspected VTE. All-cause deaths include fatal PE and deaths for other reason than PE.
Interventions
- DRUG Semuloparin sodium
- DRUG Open-label Semuloparin sodium
- DRUG Placebo (for Semuloparin sodium)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 469 participants |
| Start Date | 2008-06 |
| Est. Completion | 2010-01 |
| Phase | Phase 3 |
What the finished NCT00709904 record still lists
NCT00709904 is an interventional study that assigns participants to a tested intervention. The registered 469 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 3 interventions - of which Semuloparin sodium is the first listed.
NCT00709904 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00709904 about?
NCT00709904 is a clinical study titled "Evaluation of AVE5026 as Compared to Placebo for the Extended Prophylaxis of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery". The primary objective is to evaluate the efficacy of once daily (QD) subcutaneous (SC) injections of Semuloparin sodium (AVE5026) versus placebo for 3 additional weeks following an initial 7 to 10-day venous thromboprophylaxis with open-label AVE5026 in patients having undergone hip fracture surgery...
What is the current status of trial NCT00709904?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 469 participants. The study started on 2008-06. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00709904?
The interventions under investigation include: Semuloparin sodium (DRUG), Open-label Semuloparin sodium (DRUG), Placebo (for Semuloparin sodium) (DRUG).
Who is sponsoring clinical trial NCT00709904?
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 NCT00709904's enrollment target sits among peer trials
469 815th of 2000 higher than 1,185 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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