CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,365 enrolled
Drug / intervention
BAY 59-7939 +2 moredrug
Likely dose
BAY 59-7939 10 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/NCT02064439
NCT02064439Phase 3Completed
CompareCT.gov

Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or Pulmonary Embolism

Bayer·interventional·Posted Feb 17, 2014·Updated Dec 19, 2017

In Brief

A Phase 3 clinical trial evaluating BAY 59-7939 and ASA for Pulmonary Embolism and 4 related conditions. Completed, enrolled 3,365 participants across 266 sites in 31 countries.

Detailed Summary

This is a multicenter, randomized, double-blind, 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 of anticoagulation are eligible for this trial

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Embolism, Thromboembolism, Thrombosis, Venous Thrombosis, Venous Thromboembolism
CountriesAustralia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States, Vietnam
CollaboratorsJanssen Scientific Affairs, LLC

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 17, 2014
Enrollment StartMar 5, 2014
Primary CompletionSep 22, 2016
Study CompletionNov 4, 2016
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 12.4 years ago

Interventions

BAY 59-7939drug

10 mg tablet once daily for 12 months

BAY 59-7939drug

20 mg tablet once daily for 12 months

ASAdrug

100 mg tablet once daily for 12 months