CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 6,758 enrolled
Drug / intervention
Apixaban +1 moredrug
Likely dose
Not stated in 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/NCT00457002
NCT00457002Phase 3Completed
CompareCT.gov

A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.

Bristol-Myers Squibb·interventional·Posted Apr 5, 2007·Updated Dec 8, 2015

In Brief

A Phase 3 clinical trial evaluating Apixaban and Enoxaparin for Venous Thrombosis and Pulmonary Embolism. Completed, enrolled 6,758 participants across 296 sites in 35 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 within patients hospitalized for acute medical illness, 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--
ConditionsVenous Thrombosis, Pulmonary Embolism
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 5, 2007
Enrollment StartJun 1, 2007
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 19.2 years ago

Interventions

Apixabandrug

Apixaban: Twice daily, 30 days Placebo: Once daily, 6-14 days

Enoxaparindrug

Enoxaparin: Once daily, 6-14 days Placebo: Twice daily, 30 days