Status:
COMPLETED
Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an Internati...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Acute deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) iin patients for whom at least 6 months of anticoagulant therapy is considered appropriate
- Male or female, being 18 years of age or older
- Written informed consent for study participation
- Exclusion criteria
- Overt symptoms of VTE for longer than 2 weeks prior to enrolment
- PE satisfying at least one of the following criteria: Haemodynamic instability, embolectomy is indicated or performed, thrombolytic therapy is indicated or performed, or suspected source of PE is other than the legs
- Actual or anticipated use of vena cava filter
- Contraindications to anticoagulant therapy
- Patients who in the investigators opinion should not be treated with warfarin
- Allergy to heparins or other alternate approved therapy used for initial treatment, warfarin or dabigatran, or to one of the excipients included in these medications
- Patients who in the investigators judgement are perceived as having an excessive risk of bleeding
- Known anaemia
- Need of anticoagulant treatment for disorders other than VTE
- Recent unstable cardiovascular disease
- Elevated AST or ALT \> 2x ULN
- Liver disease expected to have any potential impact on survival
- Patients who have developed transaminase elevations upon exposure to ximelagatran
- Severe renal impairment
- Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception
- Participation in another clinical trial with an investigational drug during the last 30 days or previous participation in this study
- Patients considered unsuitable for inclusion by the investigator
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
2564 Patients enrolled
Trial Details
Trial ID
NCT00291330
Start Date
February 1 2006
Last Update
June 6 2014
Active Locations (250)
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1
1160.53.01035 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
2
1160.53.01056 Boehringer Ingelheim Investigational Site
Hartford, Connecticut, United States
3
1160.53.01044 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
4
1160.53.01033 Boehringer Ingelheim Investigational Site
Sarasota, Florida, United States