Status:
COMPLETED
Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (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 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an Interna...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Acute symptomatic uni- or bilateral Deep Vein Thrombosis (DVT) of the leg involving proximal veins, and/or Pulmonary Embolism (PE)
- Male or female, being 18 years of age or older
- Written informed consent for study participation
- Exclusion criteria:
- Persistent symptoms of VTE
- PE requiring urgent intervention
- Use of vena cava filter
- Contraindications to anticoagulant therapy
- Allergy to study medications
- Elevated Aspartate-aminotransferase (AST) or Alanine-aminotransferase (ALT) \> 3x Upper Limit of Normal (ULN) or known liver disease expected to have an impact on survival
- Severe renal impairment
- Patients considered unsuitable for inclusion
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
2589 Patients enrolled
Trial Details
Trial ID
NCT00680186
Start Date
April 1 2008
Last Update
May 19 2014
Active Locations (220)
Enter a location and click search to find clinical trials sorted by distance.
1
1160.46.01073 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas, United States
2
1160.46.01044 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
3
1160.46.01068 Boehringer Ingelheim Investigational Site
Normal, Illinois, United States
4
1160.46.01071 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana, United States