Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00423319 · ClinicalTrials.gov registry record · Phase 3
Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 5,407
- Enrollment target
NCT00423319: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00423319 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 5,407 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (600% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00423319, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 5,407 participants
- Enrollment target
Study Summary
The purpose of this study is to learn whether apixaban can prevent the blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip replacement surgery and to learn how apixaban compares with enoxaparin in preventing these clots. The safety of apixaban will also be studied
Primary Outcome
Event rate=Number of events divided by the number of patients evaluated. A mandatory bilateral ascending contrast venogram was to be obtained on Day 35 (± 3). Patients with confirmed symptomatic DVT at any time, or asymptomatic DVT upon venography, were to receive treatment for DVT according to the investigator's standard of care. Signs and symptoms suggestive of VTE included, but were not limited to: 1) lower extremity DVT: erythema, warmth, pain, swelling, tenderness; and 2) PE: pleuritic ches
Interventions
- DRUG Apixaban
- DRUG Enoxaparin
- DRUG Enoxaparin-matching placebo
- DRUG Apixaban-matching placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,407 participants |
| Start Date | 2007-03 |
| Est. Completion | 2009-09 |
| Phase | Phase 3 |
What the finished NCT00423319 record still lists
NCT00423319 is an interventional study that assigns participants to a tested intervention. Its 5,407 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 (600% higher).
The record links to 0 conditions, and to 4 interventions - of which Apixaban is the first listed.
NCT00423319 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00423319 about?
NCT00423319 is a clinical study titled "Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)". The purpose of this study is to learn whether apixaban can prevent the blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip replacement surgery and to learn how apixaban compares with enoxaparin in preventing these clots. The safety of apixaban w...
What is the current status of trial NCT00423319?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 5,407 participants. The study started on 2007-03. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00423319?
The interventions under investigation include: Apixaban (DRUG), Enoxaparin (DRUG), Enoxaparin-matching placebo (DRUG), Apixaban-matching placebo (DRUG).
Who is sponsoring clinical trial NCT00423319?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00423319's enrollment target sits among peer trials
5,407 45th of 2000 higher than 1,956 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05722769 · 5,408 participants · NA
CSTOP Now! Child Sex Trafficking Stops With You
- NCT05836987 · 5,350 participants · Phase 3
The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
- NCT04295486 · 5,478 participants · Phase 2
Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For VTE Following Total Joint Arthroplasty
- NCT05373771 · 5,328 participants · NA
Sickle Cell Improvement: Enhancing Care in the Emergency Department
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia