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NCT00643201 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism
A Phase 3 study of Venous Thrombosis, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 5,614
- Enrollment target
- 20
- Study locations
NCT00643201: Completed Phase 3 study of Venous Thrombosis, sponsored by Bristol-Myers Squibb.
NCT00643201 is a Phase 3 study of Venous Thrombosis that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 5,614 participants, above the 501-participant average among 9 other Venous Thrombosis trials with a reported enrollment target (1021% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00643201, a Phase 3 study of Venous Thrombosis, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 5,614 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)
Primary Outcome
VTE: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants): n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing
Conditions Studied
Interventions
- DRUG Enoxaparin
- DRUG warfarin
- DRUG Placebo for apixaban
- DRUG Placebo for enoxaparin
- DRUG Placebo for warfarin
Study Locations (20)
California
- Beaver Medical Group - Banning
- University Of California San Francisco-Fresno - Fresno
- University Of California, Davis Medical Center - Sacramento
- Chest Medicine & Critical Care Medical Gr. Inc. - San Diego
- Stanford University Medical Center - Stanford
- Harbor Ucla Medical Center - Torrance
Florida
- Bay Pines Va Healthcare Systems - Bay Pines
- Daniel G. Lorch, Jr, Md, Cpi - Brandon
- Research Alliance, Inc. - Clearwater
- River City Clinical Research - Jacksonville
- Pasadena Center For Medical Research - St. Petersburg
Alabama
- Alabama Clinical Therapeutics, Llc - Birmingham
- Horizon Research Group, Inc. - Mobile
Arkansas
- Fort Smith Lung Center - Fort Smith
- University Of Arkansas For Medical Sciences - Little Rock
Colorado
- New West Physicians - Golden
- Drogue Medical, Llc - Wheat Ridge
Connecticut
- Bridgeport Hospital - Bridgeport
- Dept Of Internal Med, Sect Of Pulmonary & Critical Care Med - New Haven
District of Columbia
- George Washington University Medical Faculty Associates - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,614 participants |
| Start Date | 2008-07 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
What the finished NCT00643201 record still lists
NCT00643201 is an interventional study that assigns participants to a tested intervention. Its 5,614 participants enrollment target places it among the larger protocols in the corpus, above the 501-participant average among 9 other Venous Thrombosis trials with a reported enrollment target (1021% higher).
The record links to 1 condition, with Venous Thrombosis appearing as the primary indexed condition, and to 5 interventions - of which Enoxaparin is the first listed.
NCT00643201 names 20 study sites across 7 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT00643201 about?
NCT00643201 is a clinical study titled "Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism". The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)
What is the current status of trial NCT00643201?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 5,614 participants. The study started on 2008-07. Estimated completion is 2013-03.
What conditions does trial NCT00643201 study?
This clinical trial studies the following conditions: Venous Thrombosis.
What interventions are being tested in trial NCT00643201?
The interventions under investigation include: Enoxaparin (DRUG), warfarin (DRUG), Placebo for apixaban (DRUG), Placebo for enoxaparin (DRUG), Placebo for warfarin (DRUG).
Who is sponsoring clinical trial NCT00643201?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00643201 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. 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 NCT00643201's enrollment target sits among peer trials
5,614 1st of 9 higher than 9 of 9 other Venous Thrombosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Venous Thrombosis 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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