CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 7,513 enrolled
Drug / intervention
Betrixaban +1 moredrug
Likely dose
Betrixaban 80 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/NCT01583218
NCT01583218Phase 3Completed
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(Apex) Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients

Portola Pharmaceuticals·interventional·Posted Apr 23, 2012·Updated Aug 7, 2023

In Brief

A Phase 3 clinical trial evaluating Betrixaban and Enoxaparin for Venous Thromboembolism (VTE). Completed, enrolled 7,513 participants across 462 sites in 34 countries.

Detailed Summary

The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thromboembolism (VTE)
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Czechia, Denmark, Estonia, Finland, France, Georgia, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Montserrat, Peru, Poland, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 23, 2012
Enrollment StartMar 1, 2012
Primary CompletionDec 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.2 years ago

Interventions

Betrixabandrug

Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days. Enoxaparin Placebo: Once daily, 6-14 days

Enoxaparindrug

Enoxaparin 40 mg subcutaneous (SC) QD for 10 ± 4 days. Betrixaban Placebo: once daily, 35 days