Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism

Completed · Phase 3

Conditions studied: Thromboembolism

In brief

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.

Key facts

Study ID

NCT00291330

Run by

Boehringer Ingelheim

People needed

2564

Starts

2006-02-01

Last updated by the study team

2014-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 1160.53.01056 Boehringer Ingelheim Investigational Site — Hartford, Connecticut, United States
• 1160.53.01044 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
• 1160.53.01033 Boehringer Ingelheim Investigational Site — Sarasota, Florida, United States
• 1160.53.01046 Boehringer Ingelheim Investigational Site — Sarasota, Florida, United States
• 1160.53.01019 Boehringer Ingelheim Investigational Site — Augusta, Georgia, United States
• 1160.53.01008 Boehringer Ingelheim Investigational Site — Decatur, Georgia, United States
• 1160.53.01010 Boehringer Ingelheim Investigational Site — Marietta, Georgia, United States
• 1160.53.01014 Boehringer Ingelheim Investigational Site — Baltimore, Maryland, United States
• 1160.53.01023 Boehringer Ingelheim Investigational Site — Detroit, Michigan, United States
• 1160.53.01029 Boehringer Ingelheim Investigational Site — Pontiac, Michigan, United States
• 1160.53.01009 Boehringer Ingelheim Investigational Site — Saint Louis Park, Minnesota, United States
• 1160.53.01031 Boehringer Ingelheim Investigational Site — Lebanon, New Hampshire, United States
• 1160.53.01036 Boehringer Ingelheim Investigational Site — Albuquerque, New Mexico, United States
• 1160.53.01025 Boehringer Ingelheim Investigational Site — Valhalla, New York, United States
• 1160.53.01027 Boehringer Ingelheim Investigational Site — Chapel Hill, North Carolina, United States
• 1160.53.01039 Boehringer Ingelheim Investigational Site — Winston-Salem, North Carolina, United States
• 1160.53.01030 Boehringer Ingelheim Investigational Site — Grand Forks, North Dakota, United States
• 1160.53.01013 Boehringer Ingelheim Investigational Site — Toledo, Ohio, United States
• 1160.53.01028 Boehringer Ingelheim Investigational Site — Portland, Oregon, United States
• 1160.53.01052 Boehringer Ingelheim Investigational Site — Altoona, Pennsylvania, United States
• 1160.53.01055 Boehringer Ingelheim Investigational Site — Summerville, South Carolina, United States
• 1160.53.01017 Boehringer Ingelheim Investigational Site — Richmond, Virginia, United States
• 1160.53.54017 Boehringer Ingelheim Investigational Site — Adrogué, Argentina
• 1160.53.54003 Boehringer Ingelheim Investigational Site — Capital Federal, Argentina
• 1160.53.01035 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.