CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Rivaroxaban (Xarelto, BAY59-7939)drug
Likely dose
Rivaroxaban (Xarelto, BAY59-7939) 30 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/NCT00786422
NCT00786422Phase 2Completed
CompareCT.gov

The EINSTEIN CYP Cohort Study Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-vein Thrombosis or Pulmonary Embolism Using a Strong CYP 3A4 Inducer

Bayer·interventional·Posted Nov 6, 2008·Updated Nov 18, 2015

In Brief

A Phase 2 clinical trial evaluating Rivaroxaban (Xarelto, BAY59-7939) for Venous Thrombosis and Deep Vein Thrombosis. Completed, enrolled 25 participants across 16 sites in 9 countries.

Detailed Summary

This is a multicenter, cohort study evaluating an adapted rivaroxaban dose regimen in patients with acute, proximal deep-vein thrombosis (DVT) or acute pulmonary embolism (PE) who concomitantly use a strong cytochrome P450 isoenzyme 3A4 (CYP 3A4) inducer for the entire 3-month study duration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thrombosis, Deep Vein Thrombosis
CountriesAustralia, Austria, Brazil, Germany, Hungary, Israel, Italy, Netherlands, South Africa
CollaboratorsJohnson & Johnson Pharmaceutical Research & Development, L.L.C.

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 6, 2008
Enrollment StartMay 1, 2009
Primary CompletionMay 1, 2011
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 17.7 years ago

Interventions

Rivaroxaban (Xarelto, BAY59-7939)drug

Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.