A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication
- NCT00680186
- PHASE3
- INTERVENTIONAL
Last updated: 2014-05-19
Purpose of Trial
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.
This study is for people with
Thromboembolism
Interventions being studied
Warfarin
Dabigatran etexilate
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
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
10 Locations
Little Rock
1160.46.01073 Boehringer Ingelheim Investigational Site
Arkansas, United States
Clearwater
1160.46.01044 Boehringer Ingelheim Investigational Site
Florida, United States
Normal
1160.46.01068 Boehringer Ingelheim Investigational Site
Illinois, United States
Shreveport
1160.46.01071 Boehringer Ingelheim Investigational Site
Louisiana, United States
Stony Brook
1160.46.01060 Boehringer Ingelheim Investigational Site
New York, United States
Columbus
1160.46.01061 Boehringer Ingelheim Investigational Site
Ohio, United States
Bend
1160.46.01059 Boehringer Ingelheim Investigational Site
Oregon, United States
Corvallis
1160.46.01063 Boehringer Ingelheim Investigational Site
Oregon, United States
Summerville
1160.46.01055 Boehringer Ingelheim Investigational Site
South Carolina, United States
Bellevue
1160.46.01062 Boehringer Ingelheim Investigational Site
Washington, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov