A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate 150 mg Twice Daily Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (VTE), Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication.
- NCT00291330
- PHASE3
- INTERVENTIONAL
Last updated: 2014-06-06
Purpose of Trial
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 International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.
This study is for people with
Thromboembolism
Interventions being studied
dabigatran etexilate 150 mg
warfarin (INR 2-3)
Inclusion criteria
1. 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
2. Male or female, being 18 years of age or older
3. Written informed consent for study participation
Exclusion criteria
1. Overt symptoms of VTE for longer than 2 weeks prior to enrolment
2. 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
3. Actual or anticipated use of vena cava filter
4. Contraindications to anticoagulant therapy
5. Patients who in the investigators opinion should not be treated with warfarin
6. 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
7. Patients who in the investigators judgement are perceived as having an excessive risk of bleeding
8. Known anaemia
9. Need of anticoagulant treatment for disorders other than VTE
10. Recent unstable cardiovascular disease
11. Elevated AST or ALT \> 2x ULN
12. Liver disease expected to have any potential impact on survival
13. Patients who have developed transaminase elevations upon exposure to ximelagatran
14. Severe renal impairment
15. Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception
16. Participation in another clinical trial with an investigational drug during the last 30 days or previous participation in this study
17. Patients considered unsuitable for inclusion by the investigator
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
23 Locations
Mobile
1160.53.01035 Boehringer Ingelheim Investigational Site
Alabama, United States
Hartford
1160.53.01056 Boehringer Ingelheim Investigational Site
Connecticut, United States
Clearwater
1160.53.01044 Boehringer Ingelheim Investigational Site
Florida, United States
Sarasota
1160.53.01033 Boehringer Ingelheim Investigational Site
Florida, United States
Sarasota
1160.53.01046 Boehringer Ingelheim Investigational Site
Florida, United States
Augusta
1160.53.01019 Boehringer Ingelheim Investigational Site
Georgia, United States
Decatur
1160.53.01008 Boehringer Ingelheim Investigational Site
Georgia, United States
Marietta
1160.53.01010 Boehringer Ingelheim Investigational Site
Georgia, United States
Baltimore
1160.53.01014 Boehringer Ingelheim Investigational Site
Maryland, United States
Detroit
1160.53.01023 Boehringer Ingelheim Investigational Site
Michigan, United States
Pontiac
1160.53.01029 Boehringer Ingelheim Investigational Site
Michigan, United States
St. Louis Park
1160.53.01009 Boehringer Ingelheim Investigational Site
Minnesota, United States
Lebanon
1160.53.01031 Boehringer Ingelheim Investigational Site
New Hampshire, United States
Albuquerque
1160.53.01036 Boehringer Ingelheim Investigational Site
New Mexico, United States
Valhalla
1160.53.01025 Boehringer Ingelheim Investigational Site
New York, United States
Chapel Hill
1160.53.01027 Boehringer Ingelheim Investigational Site
North Carolina, United States
Winston-Salem
1160.53.01039 Boehringer Ingelheim Investigational Site
North Carolina, United States
Grand Forks
1160.53.01030 Boehringer Ingelheim Investigational Site
North Dakota, United States
Toledo
1160.53.01013 Boehringer Ingelheim Investigational Site
Ohio, United States
Portland
1160.53.01028 Boehringer Ingelheim Investigational Site
Oregon, United States
Altoona
1160.53.01052 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Summerville
1160.53.01055 Boehringer Ingelheim Investigational Site
South Carolina, United States
Richmond
1160.53.01017 Boehringer Ingelheim Investigational Site
Virginia, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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