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NCT00694382 · ClinicalTrials.gov registry record · Phase 3
Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy
A Phase 3 study of Cancer and Venous Thromboembolism, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,212
- Enrollment target
- 20
- Study locations
NCT00694382: Completed Phase 3 study of Cancer and Venous Thromboembolism, sponsored by Sanofi.
NCT00694382 is a Phase 3 study of Cancer and Venous Thromboembolism that has completed, run by Sanofi. The registered enrollment target is 3,212 participants, roughly in line with the 3,486-participant average among 615 other Cancer trials with a reported enrollment target. The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00694382, a Phase 3 study of Cancer and Venous Thromboembolism, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,212 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism \[VTE\] in cancer patients at high risk for VTE and who were undergoing chemotherapy. The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.
Primary Outcome
VTE included any symptomatic Deep Vein Thrombosis \[DVT\] of lower or upper limbs and any non-fatal Pulmonary Embolism \[PE\] as confirmed by a Central Independent Adjudication Committee \[CIAC\] after review of compression ultrasound or venography for DVT, ventilation/perfusion lung scan, pulmonary angiogram or spiral computer tomography lung scan for PE. VTE-related death included fatal PE and unexplained deaths without confirmatory autopsy. Any sudden death could be classified as fatal PE by
Conditions Studied
Interventions
- DRUG Semuloparin sodium
- DRUG Placebo (for semuloparin)
Study Locations (20)
California
- Investigational Site Number 840050 - Fountain Valley
- Investigational Site Number 840072 - Fullerton
- Investigational Site Number 840037 - Indian Wells
- Investigational Site Number 840069 - La Verne
- Investigational Site Number 840009 - Long Beach
- Investigational Site Number 840001 - Oceanside
- Investigational Site Number 840011 - Rancho Mirage
- Investigational Site Number 840029 - West Covina
Florida
- Investigational Site Number 840074 - Clearwater
- Investigational Site Number 840019 - Jacksonville
- Investigational Site Number 840051 - Rockledge
- Investigational Site Number 840073 - Sarasota
Connecticut
- Investigational Site Number 840005 - Norwich
- Investigational Site Number 840064 - Torrington
- Investigational Site Number 840038 - Woodbridge
Arizona
- Investigational Site Number 840007 - Casa Grande
- Investigational Site Number 840060 - Tucson
District of Columbia
- Investigational Site Number 840052 - Washington D.C.
- Investigational Site Number 840025 - Washington D.C.
Alabama
- Investigational Site Number 840006 - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,212 participants |
| Start Date | 2008-06 |
| Est. Completion | 2010-11 |
| Phase | Phase 3 |
What the finished NCT00694382 record still lists
NCT00694382 is an interventional study that assigns participants to a tested intervention. Its 3,212 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 3,486-participant average among 615 other Cancer trials with a reported enrollment target.
The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 2 interventions - of which Semuloparin sodium is the first listed.
NCT00694382 names 20 study sites across 6 states, led by California, Florida, Connecticut.
Frequently Asked Questions
What is clinical trial NCT00694382 about?
NCT00694382 is a clinical study titled "Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy". The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism \[VTE\] in cancer patients at high risk for VTE and who were undergoing chemotherapy. The secondary objectives were to eva...
What is the current status of trial NCT00694382?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,212 participants. The study started on 2008-06. Estimated completion is 2010-11.
What conditions does trial NCT00694382 study?
This clinical trial studies the following conditions: Cancer, Venous Thromboembolism.
What interventions are being tested in trial NCT00694382?
The interventions under investigation include: Semuloparin sodium (DRUG), Placebo (for semuloparin) (DRUG).
Who is sponsoring clinical trial NCT00694382?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00694382 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00694382's enrollment target sits among peer trials
3,212 48th of 615 higher than 568 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer 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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