Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)

Completed · Phase 3

Conditions studied: Thromboembolism

In brief

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 International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE. The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.

Key facts

Study ID

NCT00680186

Run by

Boehringer Ingelheim

People needed

2589

Starts

2008-04-01

Last updated by the study team

2014-05-19

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 1160.46.01044 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
• 1160.46.01068 Boehringer Ingelheim Investigational Site — Normal, Illinois, United States
• 1160.46.01071 Boehringer Ingelheim Investigational Site — Shreveport, Louisiana, United States
• 1160.46.01060 Boehringer Ingelheim Investigational Site — Stony Brook, New York, United States
• 1160.46.01061 Boehringer Ingelheim Investigational Site — Columbus, Ohio, United States
• 1160.46.01059 Boehringer Ingelheim Investigational Site — Bend, Oregon, United States
• 1160.46.01063 Boehringer Ingelheim Investigational Site — Corvallis, Oregon, United States
• 1160.46.01055 Boehringer Ingelheim Investigational Site — Summerville, South Carolina, United States
• 1160.46.01062 Boehringer Ingelheim Investigational Site — Bellevue, Washington, United States
• 1160.46.61007 Boehringer Ingelheim Investigational Site — Concord, New South Wales, Australia
• 1160.46.61003 Boehringer Ingelheim Investigational Site — Box Hill, Victoria, Australia
• 1160.46.61001 Boehringer Ingelheim Investigational Site — Clayton, Victoria, Australia
• 1160.46.61006 Boehringer Ingelheim Investigational Site — Windsor, Victoria, Australia
• 1160.46.61005 Boehringer Ingelheim Investigational Site — Perth, Western Australia, Australia
• 1160.46.55010 Boehringer Ingelheim Investigational Site — Brasília, Brazil
• 1160.46.55007 Boehringer Ingelheim Investigational Site — Campinas, Brazil
• 1160.46.55014 Boehringer Ingelheim Investigational Site — Curitiba, Brazil
• 1160.46.55017 Boehringer Ingelheim Investigational Site — Curitiba, Brazil
• 1160.46.55019 Boehringer Ingelheim Investigational Site — Porto Alegre, Brazil
• 1160.46.55021 Boehringer Ingelheim Investigational Site — Recife, Brazil
• 1160.46.55016 Boehringer Ingelheim Investigational Site — Rio de Janeiro - RJ, Brazil
• 1160.46.55018 Boehringer Ingelheim Investigational Site — São Bernardo do Campo, Brazil
• 1160.46.55020 Boehringer Ingelheim Investigational Site — São Paulo, Brazil
• 1160.46.35901 Boehringer Ingelheim Investigational Site — Sofia, Bulgaria
• 1160.46.01073 Boehringer Ingelheim Investigational Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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