Clinical Trials Detalhe
Secondary Prevention of Venous Thrombo Embolism (VTE).
General Information
Gender
ALL
Age
N/A
Phase
PHASE3
Study Type
INTERVENTIONAL
Location
1160.47.35104 Boehringer Ingelheim Investigational Site (Almada, Portugal)
1160.47.35109 Boehringer Ingelheim Investigational Site (Coimbra, Portugal)
1160.47.35107 Boehringer Ingelheim Investigational Site (Covilha, Portugal)
1160.47.35101 Boehringer Ingelheim Investigational Site (Lisbon, Portugal)
1160.47.35102 Boehringer Ingelheim Investigational Site (Lisbon, Portugal)
1160.47.35105 Boehringer Ingelheim Investigational Site (Lisbon, Portugal)
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT00329238Summary
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.
Conditions
Thromboembolism
Eligibility
Inclusion criteria: Inclusion\_Criteria * Acute symptomatic deep vein thrombosis (DVT) * Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing Exclusion criteria: Exclusion\_Criteria * Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-12 months of treatment for the prior VTE. * Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) \> 2x ULN * Severe renal impairment (estimated creatinine clearance \<= 30 ml/min)