CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,148 enrolled
Drug / intervention
Rivaroxaban (Xarelto, BAY59-7939) +3 moredrug
Likely dose
Rivaroxaban (Xarelto, BAY59-7939) 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/NCT00362232
NCT00362232Phase 3Completed
CompareCT.gov

RECORD 4 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled, Double-blind, Randomized Study of BAY59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement

Bayer·interventional·Posted Aug 9, 2006·Updated Nov 4, 2014

In Brief

A Phase 3 clinical trial evaluating Rivaroxaban (Xarelto, BAY59-7939), Enoxaparin, and 2 other interventions for Venous Thromboembolism. Completed, enrolled 3,148 participants across 124 sites in 13 countries.

Detailed Summary

The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thromboembolism
CountriesBulgaria, Canada, Denmark, India, Israel, Lithuania, Mexico, Norway, Pakistan, Poland, Sri Lanka, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 9, 2006
Enrollment StartJun 1, 2006
Primary CompletionJan 1, 2007
Study CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 19.9 years ago

Interventions

Rivaroxaban (Xarelto, BAY59-7939)drug

Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening.

Enoxaparindrug

Syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Placebo: tablet of Rivaroxabandrug

Placebo tablet of rivaroxaban administered once daily in the evening.

Placebo: syringes of Enoxaparindrug

Placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.