CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 841 enrolled
Drug / intervention
Rivaroxaban +1 moredrug
Likely dose
Rivaroxaban 10 milligramfrom 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/NCT02555878
NCT02555878Phase 3Completed

Efficacy and Safety of Rivaroxaban Prophylaxis Compared With Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism

Janssen Research & Development, LLC·interventional·Posted Sep 22, 2015·Updated Sep 12, 2019

In Brief

A Phase 3 clinical trial evaluating Rivaroxaban and Placebo for Neoplasms. Completed, enrolled 841 participants across 151 sites in 10 countries.

Detailed Summary

The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult participants with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesBelgium, Brazil, Bulgaria, Canada, Czechia, France, Germany, Russia, United Kingdom, United States
CollaboratorsBayer

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 22, 2015
Enrollment StartSep 11, 2015
Primary CompletionAug 24, 2018
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 10.8 years ago

Interventions

Rivaroxabandrug

Rivaroxaban 10 milligram (mg) tablet will be administered orally once daily for 180 days.

Placebodrug

Placebo tablet will be administered orally once daily for 180 days.