Status:
COMPLETED
Secondary Prevention of Venous Thrombo Embolism (VTE).
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 lon...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Inclusion\_Criteria
- Acute symptomatic deep vein thrombosis (DVT)
- Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing
- Exclusion criteria:
- 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)
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
2867 Patients enrolled
Trial Details
Trial ID
NCT00329238
Start Date
May 1 2006
Last Update
May 19 2014
Active Locations (275)
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1
1160.47.01035 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
2
1160.47.01056 Boehringer Ingelheim Investigational Site
Hartford, Connecticut, United States
3
1160.47.01044 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
4
1160.47.01019 Boehringer Ingelheim Investigational Site
Augusta, Georgia, United States