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

Completed · Phase 3 · Has a placebo group

Conditions studied: Venous Thromboembolism

In brief

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).

Key facts

Study ID

NCT00558259

Run by

Boehringer Ingelheim

People needed

1353

Starts

2007-11-01

Last updated by the study team

2014-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with confirmed symptomatic PE or proximal DVT of the leg(s) who have been treated for 6 to 18 months with therapeutic dosages (intended INR between 2-3) of an oral VKA (e.g. warfarin, acenocoumarol, phenprocoumon, or fluindione) or RE-COVER study medication up to the moment of screening for the current study.
• Written informed consent

You may not qualify if…

• Younger then 18 years of age
• Indication for VKA other than DVT and/or PE
• Patients in whom anticoagulant treatment for their index PE or DVT should be continued
• Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN
• Creatinine clearance < 30 ml/min
• Acute bacterial endocarditis
• Active bleeding or high risk for bleeding.
• Uncontrolled hypertension (investigators judgement)
• Intake of another experimental drug within the 30 days prior to randomization into the study
• Life expectancy <6 months
• Childbearing potential without proper contraceptive measures*, pregnancy or breast feeding

Where it is running

• 1160.63.01023 Boehringer Ingelheim Investigational Site — Huntsville, Alabama, United States
• 1160.63.01002 Boehringer Ingelheim Investigational Site — Laguna Hills, California, United States
• 1160.63.01014 Boehringer Ingelheim Investigational Site — Colorado Springs, Colorado, United States
• 1160.63.01003 Boehringer Ingelheim Investigational Site — Jacksonville, Florida, United States
• 1160.63.01030 Boehringer Ingelheim Investigational Site — Key West, Florida, United States
• 1160.63.01022 Boehringer Ingelheim Investigational Site — Lafayette, Louisiana, United States
• 1160.63.01044 Boehringer Ingelheim Investigational Site — New Iberia, Louisiana, United States
• 1160.63.01017 Boehringer Ingelheim Investigational Site — Biddeford, Maine, United States
• 1160.63.01004 Boehringer Ingelheim Investigational Site — Salisbury, Maryland, United States
• 1160.63.01016 Boehringer Ingelheim Investigational Site — Worcester, Massachusetts, United States
• 1160.63.01037 Boehringer Ingelheim Investigational Site — St Louis, Missouri, United States
• 1160.63.01019 Boehringer Ingelheim Investigational Site — Missoula, Montana, United States
• 1160.63.01032 Boehringer Ingelheim Investigational Site — Columbus, Ohio, United States
• 1160.63.01001 Boehringer Ingelheim Investigational Site — Uniontown, Pennsylvania, United States
• 1160.63.01024 Boehringer Ingelheim Investigational Site — Uniontown, Pennsylvania, United States
• 1160.63.01005 Boehringer Ingelheim Investigational Site — Charleston, South Carolina, United States
• 1160.63.01020 Boehringer Ingelheim Investigational Site — Spartanburg, South Carolina, United States
• 1160.63.01011 Boehringer Ingelheim Investigational Site — Salt Lake City, Utah, United States
• 1160.63.01007 Boehringer Ingelheim Investigational Site — Richmond, Virginia, United States
• 1160.63.01035 Boehringer Ingelheim Investigational Site — Bellevue, Washington, United States
• 1160.63.61002 Boehringer Ingelheim Investigational Site — Greenslopes, Queensland, Australia
• 1160.63.61003 Boehringer Ingelheim Investigational Site — Elizabeth Vale, South Australia, Australia
• 1160.63.61001 Boehringer Ingelheim Investigational Site — Clayton, Victoria, Australia
• 1160.63.61004 Boehringer Ingelheim Investigational Site — Nedlands, Western Australia, Australia
• 1160.63.01025 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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