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Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)

NCT00839163 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 613

Last updated 2023-09-07

No results posted yet for this study

Summary

The purpose of this study is to compare the safety and efficacy of BAY59-7939 with the safety and efficacy of the licensed drug enoxaparin and a licensed oral vitamin K-antagonist and to find the optimal dose of BAY59-7939 for the anticipated phase III trials and for the future clinical use.

Conditions

  • Venous Thrombosis
  • Deep Vein Thrombosis

Interventions

DRUG

Xarelto (Rivaroxaban, BAY59-7939)

10 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).

DRUG

Xarelto (Rivaroxaban, BAY59-7939)

20 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).

DRUG

Xarelto (Rivaroxaban, BAY59-7939)

30 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).

DRUG

Xarelto (Rivaroxaban, BAY59-7939)

40 mg od main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).

DRUG

Enoxaparin/Vitamin K-Antagonist

Enoxaparin/Vitamin K-Antagonist main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84). Enoxaparin was to be administered 1mg/kg bid sc for about 5-7 days. It was to be discontinued when INR was within the therapeutic range 2-3 for 2 consecutive days

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2005-10-31
Completion
2005-10-31

Countries

  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Colombia
  • Czechia
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • New Zealand
  • Peru
  • Poland
  • South Africa
  • Spain
  • Sweden
  • Switzerland

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 NCT00839163 on ClinicalTrials.gov