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NCT00697099 · ClinicalTrials.gov registry record · Phase 3
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Total Hip Replacement Surgery
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,326
- Enrollment target
NCT00697099: Completed Phase 3 study, sponsored by Sanofi.
NCT00697099 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 2,326 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (201% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00697099, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,326 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 elective total hip replacement surgery. The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing elective total hip 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 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 | 2,326 participants |
| Start Date | 2008-06 |
| Est. Completion | 2009-06 |
| Phase | Phase 3 |
What the finished NCT00697099 record still lists
NCT00697099 is an interventional study that assigns participants to a tested intervention. Its 2,326 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 (201% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00697099 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00697099 about?
NCT00697099 is a clinical study titled "Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Total Hip Replacement 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 elective total hip replacement surgery. ...
What is the current status of trial NCT00697099?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,326 participants. The study started on 2008-06. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00697099?
The interventions under investigation include: Placebo (DRUG), Semuloparin sodium (DRUG), Enoxaparin sodium (DRUG).
Who is sponsoring clinical trial NCT00697099?
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 NCT00697099's enrollment target sits among peer trials
2,326 93rd of 2000 higher than 1,908 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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