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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

NCT00439725 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1197

Last updated 2014-11-04

Study results available
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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).

Conditions

  • Venous Thromboembolism

Interventions

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-08-31
Completion
2009-09-30

Countries

  • United States
  • Australia
  • 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

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00439725 on ClinicalTrials.gov