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Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE

NCT00558259 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1353

Last updated 2014-06-27

Study results available
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Summary

The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA).

Conditions

  • Venous Thromboembolism

Interventions

DRUG

dabigatran etexilate 150 mg twice daily (BID)

dabigatran etexilate capsules 150 mg BID

DRUG

matching placebo twice daily (BID)

Matching placebo BID

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2011-02-28

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Estonia
  • Germany
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • New Zealand
  • Poland
  • Russia
  • Singapore
  • South Africa
  • South Korea
  • Sweden
  • Switzerland
  • Thailand

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 NCT00558259 on ClinicalTrials.gov