Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE
Launched by BOEHRINGER INGELHEIM · Nov 13, 2007
Trial Information
Current as of April 29, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • 1. 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.
- • 2. Written informed consent
- Exclusion criteria:
- • 1. Younger then 18 years of age
- • 2. Indication for VKA other than DVT and/or PE
- • 3. Patients in whom anticoagulant treatment for their index PE or DVT should be continued
- • 4. Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT \> 3 x ULN
- • 5. Creatinine clearance \< 30 ml/min
- • 6. Acute bacterial endocarditis
- • 7. Active bleeding or high risk for bleeding.
- • 8. Uncontrolled hypertension (investigators judgement)
- • 9. Intake of another experimental drug within the 30 days prior to randomization into the study
- • 10. Life expectancy \<6 months
- • 11. Childbearing potential without proper contraceptive measures\*, pregnancy or breast feeding
About Boehringer Ingelheim
Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Laguna Hills, California, United States
Colorado Springs, Colorado, United States
Jacksonville, Florida, United States
Key West, Florida, United States
Lafayette, Louisiana, United States
New Iberia, Louisiana, United States
Biddeford, Maine, United States
Salisbury, Maryland, United States
Worcester, Massachusetts, United States
St. Louis, Missouri, United States
Missoula, Montana, United States
Columbus, Ohio, United States
Uniontown, Pennsylvania, United States
Uniontown, Pennsylvania, United States
Charleston, South Carolina, United States
Spartanburg, South Carolina, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Bellevue, Washington, United States
Greenslopes, Queensland, Australia
Elizabeth Vale, South Australia, Australia
Clayton, Victoria, Australia
Nedlands, Western Australia, Australia
Graz, , Austria
Innsbruck, , Austria
Wien, , Austria
Wien, , Austria
Wien, , Austria
Aalst, , Belgium
Duffel, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Lier, , Belgium
Edmonton, Alberta, Canada
Saint John, New Brunswick, Canada
Hamilton, Ontario, Canada
Quebec, , Canada
Ceske Budejovice, , Czech Republic
Jablonec Nad Nisou, , Czech Republic
Kladno, , Czech Republic
Liberec, , Czech Republic
Nymburk, , Czech Republic
Ostrava Vitkovice, , Czech Republic
Ostrava, , Czech Republic
Prague 4 Krc, , Czech Republic
Prague 4, , Czech Republic
Praha 4, , Czech Republic
Prostejov, , Czech Republic
Rakovnik, , Czech Republic
Slany, , Czech Republic
Tabor, , Czech Republic
Kohtla Järve, , Estonia
Tallin, , Estonia
Tartu, , Estonia
Darmstadt, , Germany
Dresden, , Germany
Dresden, , Germany
Gießen, , Germany
Ludwigshafen, , Germany
Mannheim, , Germany
Mannheim, , Germany
München, , Germany
Püttlingen, , Germany
Bergamo, , Italy
Castelfranco Veneto (Tv), , Italy
Chieti Scalo (Ch), , Italy
Cosenza, , Italy
Fidenza (Pr), , Italy
Firenze, , Italy
Genova, , Italy
Milano, , Italy
Milano, , Italy
Milano, , Italy
Napoli, , Italy
Palermo, , Italy
Pisa, , Italy
Rimini, , Italy
Roma, , Italy
Treviso, , Italy
Udine, , Italy
Vittorio Veneto (Tv), , Italy
Gwangju Si, , Korea, Republic Of
Incheon, , Korea, Republic Of
Kyeonggi Do, , Korea, Republic Of
Kyunggi Do, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Suwon, , Korea, Republic Of
Daugavpils, , Latvia
Riga, , Latvia
Kaunas, , Lithuania
Vilnius, , Lithuania
Assen, , Netherlands
Breda, , Netherlands
Den Haag, , Netherlands
Den Helder, , Netherlands
Dirksland, , Netherlands
Eindhoven, , Netherlands
Groningen, , Netherlands
Heerlen, , Netherlands
Oss, , Netherlands
Christchurch, , New Zealand
Kielce, , Poland
Poznan, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Ekaterinburg, , Russian Federation
Kursk, , Russian Federation
Ufa, , Russian Federation
Yaroslavl, , Russian Federation
Yaroslavl, , Russian Federation
Singapore, , Singapore
Cape Town, , South Africa
Centurion, , South Africa
Krugersdorp, , South Africa
Somerset West, , South Africa
Göteborg, , Sweden
Göteborg, , Sweden
Lund, , Sweden
Mölndal, , Sweden
Skövde, , Sweden
Stockholm, , Sweden
Värnamo, , Sweden
Basel, , Switzerland
Bruderholz, , Switzerland
Cham, , Switzerland
Glarus, , Switzerland
Luzern 16, , Switzerland
Luzern, , Switzerland
Schiers, , Switzerland
Thun, , Switzerland
Wetzikon, , Switzerland
Zug, , Switzerland
Zurich, , Switzerland
Bangkok, , Thailand
Bangkok, , Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
Patients applied
Trial Officials
Boehringer Ingelheim
Study Chair
Boehringer Ingelheim
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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