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Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis

NCT00395772 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 543

Last updated 2014-10-28

No results posted yet for this study

Summary

The purpose of this study is to determine the optimal dose of BAY 59-7939 and to compare the safety and effectiveness of this new drug with the standard way of treatment of deep vein thrombosis (heparin infusion plus one of the vitamin K antagonists), taking into account new events of thrombosis and pulmonary embolism and bleeding risk.

Conditions

  • Venous Thromboembolism

Interventions

DRUG

Xarelto (Rivaroxaban, BAY59-7939)

BAY59-7939 20 mg once daily (od) for 12 weeks

DRUG

Xarelto (Rivaroxaban, BAY59-7939)

BAY59-7939 30 mg od for 12 weeks

DRUG

Xarelto (Rivaroxaban, BAY59-7939)

BAY59-7939 40 mg od for 12 weeks

DRUG

(LMW) Heparin + Vitamin K Antagonist

Low Molecular Weight (LMW) Heparin + Vitamin K Antagonist (VKA) for 5 days, then VKA only for the rest of 12 weeks

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
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Completion
2005-12-31

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • France
  • Israel
  • Italy
  • Netherlands
  • Poland
  • South Africa
  • Sweden

Study Locations

More Related Trials

Entities

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 NCT00395772 on ClinicalTrials.gov