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NCT00714597 · ClinicalTrials.gov registry record · Phase 3
Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 421
- Enrollment target
NCT00714597: Clinical Trial Phase 3 study, sponsored by Sanofi.
NCT00714597 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 421 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00714597, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 421 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 primary prevention of Venous Thromboembolic Events \[VTE\] in patients hospitalized for acute medical illness. The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.
Primary Outcome
VTE included: * asymptomatic proximal Deep Vein Thrombosis (DVT) detected by the mandatory CUS and confirmed by a Compression Ultrasound Adjudication Committee (CUSAC) after central and blind review of the mandatory CUS; * symptomatic DVT and non-fatal Pulmonary Embolism (PE) reported by the investigator and confirmed by a Central Independent Adjudication Committee (CIAC) after central and blind review of diagnosis tests. VTE-related Death included fatal PE and unexplained deaths.
Interventions
- DRUG Semuloparin sodium
- DRUG Enoxaparin sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 421 participants |
| Start Date | 2008-07 |
| Est. Completion | 2009-03 |
| Phase | Phase 3 |
Why NCT00714597 stopped before completion
NCT00714597 is an interventional study that assigns participants to a tested intervention. The registered 421 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 (45% lower).
The record links to 0 conditions, and to 2 interventions - of which Semuloparin sodium is the first listed.
NCT00714597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00714597 about?
NCT00714597 is a clinical study titled "Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility". 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 primary prevention of Venous Thromboembolic Events \[VTE\] in patients hospitalized for acute medical illness. The...
What is the current status of trial NCT00714597?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 421 participants. The study started on 2008-07. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00714597?
The interventions under investigation include: Semuloparin sodium (DRUG), Enoxaparin sodium (DRUG).
Who is sponsoring clinical trial NCT00714597?
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 NCT00714597's enrollment target sits among peer trials
421 890th of 2000 higher than 1,110 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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