CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,197 enrolled
Drug / intervention
Rivaroxaban (Xarelto, BAY59-7939) +1 moredrug
Likely dose
Rivaroxaban (Xarelto, BAY59-7939) 20 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/NCT00439725
NCT00439725Phase 3Completed
CompareCT.gov

Once-daily Oral Direct Factor Xa Inhibitor Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism. The Einstein-Extension Study

Bayer·interventional·Posted Feb 26, 2007·Updated Nov 4, 2014

In Brief

A Phase 3 clinical trial evaluating Rivaroxaban (Xarelto, BAY59-7939) and Placebo for Venous Thromboembolism. Completed, enrolled 1,197 participants across 322 sites in 33 countries.

Detailed Summary

This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension study).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thromboembolism
CountriesAustralia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Philippines, Poland, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States
CollaboratorsJohnson & Johnson Pharmaceutical Research & Development, L.L.C.

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 26, 2007
Enrollment StartFeb 1, 2007
Primary CompletionAug 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 19.3 years ago

Interventions

Rivaroxaban (Xarelto, BAY59-7939)drug

Patients randomized to rivaroxaban will receive rivaroxaban 20 mg once-daily.

Placebodrug

Patients allocated to placebo will receive a matching placebo tablet once daily.