CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,407 enrolled
Drug / intervention
Enoxaparin +3 moredrug
Likely dose
Enoxaparin 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00423319
NCT00423319Phase 3Completed
CompareCT.gov

A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery (The Advance-3 Study Apixaban Dosed Orally Versus Anticoagulation With Injectable Enoxaparin to Prevent Venous Thromboembolism)

Bristol-Myers Squibb·interventional·Posted Jan 18, 2007·Updated May 14, 2014

In Brief

A Phase 3 clinical trial evaluating Enoxaparin, Apixaban, and 2 other interventions for Deep Vein Thrombosis and Pulmonary Embolism. Completed, enrolled 5,407 participants across 143 sites in 21 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDeep Vein Thrombosis, Pulmonary Embolism
CountriesArgentina, Australia, Belgium, Canada, China, Denmark, France, Germany, Hungary, India, Israel, Mexico, Norway, Poland, Romania, Russia, Spain, Sweden, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 18, 2007
Enrollment StartMar 1, 2007
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 19.5 years ago

Interventions

Enoxaparindrug

Subcutaneous, 40 mg, once daily, 5 weeks

Apixabandrug

Oral tablets, 2.5 mg, twice daily, 5weeks

Enoxaparin-matching placebodrug

Administered as injection

Apixaban-matching placebodrug

Administered as oral tablets