CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,608 enrolled
Drug / intervention
Enoxaparin + Placebo +1 moredrug
Likely dose
Enoxaparin + Placebo 30mgfrom 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/NCT00371683
NCT00371683Phase 3Completed
CompareCT.gov

A Phase 3 Randomized, Double-Blind Active-Controlled (Enoxaparin), Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery

Bristol-Myers Squibb·interventional·Posted Sep 4, 2006·Updated Dec 30, 2015

In Brief

A Phase 3 clinical trial evaluating Enoxaparin + Placebo and Apixaban + Placebo for Deep Vein Thrombosis and Pulmonary Embolism. Completed, enrolled 3,608 participants across 107 sites in 13 countries.

Detailed Summary

The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis \[DVT\]) and lung (pulmonary embolism \[PE\]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for 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, Brazil, Canada, Denmark, Hungary, Israel, Mexico, Poland, Russia, Sweden, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 4, 2006
Enrollment StartNov 1, 2006
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.8 years ago

Interventions

Enoxaparin + Placebodrug

Syringes + tablets, Subcutaneous + Oral, 30mg, twice daily, 12 day treatment period

Apixaban + Placebodrug

Tablet + Syringes, Oral + subcutaneous, 2.5 mg, twice daily, 12 day treatment period