Secondary Prevention of Venous Thrombo Embolism (VTE).
Completed · Phase 3
Conditions studied: Thromboembolism
In brief
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.
Key facts
- Study ID
- NCT00329238
- Run by
- Boehringer Ingelheim
- People needed
- 2867
- Starts
- 2006-05-01
- Last updated by the study team
- 2014-05-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Inclusion_Criteria
- Acute symptomatic deep vein thrombosis (DVT)
- Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing
You may not qualify if…
- Exclusion_Criteria
- Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-12 months of treatment for the prior VTE.
- Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) > 2x ULN
- Severe renal impairment (estimated creatinine clearance <= 30 ml/min)
Where it is running
- 1160.47.01056 Boehringer Ingelheim Investigational Site — Hartford, Connecticut, United States
- 1160.47.01044 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
- 1160.47.01019 Boehringer Ingelheim Investigational Site — Augusta, Georgia, United States
- 1160.47.01008 Boehringer Ingelheim Investigational Site — Decatur, Georgia, United States
- 1160.47.01014 Boehringer Ingelheim Investigational Site — Baltimore, Maryland, United States
- 1160.47.01018 Boehringer Ingelheim Investigational Site — Roxbury Crossing, Massachusetts, United States
- 1160.47.01023 Boehringer Ingelheim Investigational Site — Detroit, Michigan, United States
- 1160.47.01009 Boehringer Ingelheim Investigational Site — Saint Louis Park, Minnesota, United States
- 1160.47.01031 Boehringer Ingelheim Investigational Site — Lebanon, New Hampshire, United States
- 1160.47.01036 Boehringer Ingelheim Investigational Site — Albuquerque, New Mexico, United States
- 1160.47.01027 Boehringer Ingelheim Investigational Site — Chapel Hill, North Carolina, United States
- 1160.47.01039 Boehringer Ingelheim Investigational Site — Winston-Salem, North Carolina, United States
- 1160.47.01030 Boehringer Ingelheim Investigational Site — Grand Forks, North Dakota, United States
- 1160.47.01013 Boehringer Ingelheim Investigational Site — Toledo, Ohio, United States
- 1160.47.01052 Boehringer Ingelheim Investigational Site — Altoona, Pennsylvania, United States
- 1160.47.01055 Boehringer Ingelheim Investigational Site — Summerville, South Carolina, United States
- 1160.47.01017 Boehringer Ingelheim Investigational Site — Richmond, Virginia, United States
- 1160.47.54017 Boehringer Ingelheim Investigational Site — Adrogué, Argentina
- 1160.47.54015 Boehringer Ingelheim Investigational Site — Bahía Blanca, Argentina
- 1160.47.54001 Boehringer Ingelheim Investigational Site — Capital Federal, Argentina
- 1160.47.54003 Boehringer Ingelheim Investigational Site — Capital Federal, Argentina
- 1160.47.54005 Boehringer Ingelheim Investigational Site — Capital Federal, Argentina
- 1160.47.54006 Boehringer Ingelheim Investigational Site — Capital Federal, Argentina
- 1160.47.54007 Boehringer Ingelheim Investigational Site — Capital Federal, Argentina
- 1160.47.01035 Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.