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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00558259

Public ClinicalTrials.gov record NCT00558259. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 12:34 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long-term Prevention of Recurrent Symptomatic Proximal Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT00558259
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
1,353 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 2007 (Type not available)
Primary completion
Feb 2011 (Actual)
Completion
Not listed
Last update posted
Jun 27, 2014

Started 2007

United States locations

U.S. sites
21
U.S. states
16
U.S. cities
20
Facility City State ZIP Site status
1160.63.01025 Boehringer Ingelheim Investigational Site Birmingham Alabama — —
1160.63.01023 Boehringer Ingelheim Investigational Site Huntsville Alabama — —
1160.63.01002 Boehringer Ingelheim Investigational Site Laguna Hills California — —
1160.63.01014 Boehringer Ingelheim Investigational Site Colorado Springs Colorado — —
1160.63.01003 Boehringer Ingelheim Investigational Site Jacksonville Florida — —
1160.63.01030 Boehringer Ingelheim Investigational Site Key West Florida — —
1160.63.01022 Boehringer Ingelheim Investigational Site Lafayette Louisiana — —
1160.63.01044 Boehringer Ingelheim Investigational Site New Iberia Louisiana — —
1160.63.01017 Boehringer Ingelheim Investigational Site Biddeford Maine — —
1160.63.01004 Boehringer Ingelheim Investigational Site Salisbury Maryland — —
1160.63.01016 Boehringer Ingelheim Investigational Site Worcester Massachusetts — —
1160.63.01037 Boehringer Ingelheim Investigational Site St Louis Missouri — —
1160.63.01019 Boehringer Ingelheim Investigational Site Missoula Montana — —
1160.63.01032 Boehringer Ingelheim Investigational Site Columbus Ohio — —
1160.63.01001 Boehringer Ingelheim Investigational Site Uniontown Pennsylvania — —
1160.63.01024 Boehringer Ingelheim Investigational Site Uniontown Pennsylvania — —
1160.63.01005 Boehringer Ingelheim Investigational Site Charleston South Carolina — —
1160.63.01020 Boehringer Ingelheim Investigational Site Spartanburg South Carolina — —
1160.63.01011 Boehringer Ingelheim Investigational Site Salt Lake City Utah — —
1160.63.01007 Boehringer Ingelheim Investigational Site Richmond Virginia — —
1160.63.01035 Boehringer Ingelheim Investigational Site Bellevue Washington — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 126 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00558259, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 27, 2014 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00558259 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →