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.
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.
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.
Inclusion criteria
Exclusion criteria
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Cerqueira César - Sao Paulo, Brazil
Cerqueira César - São Paulo, Brazil
Cristo Rei - Curitiba, Brazil
Rio de Janeiro - RJ, Brazil
Saint Johns, New Brunswick, Canada
Ostrava-Vitkovice, Czechia
Toulon Naval, France
Toulon Naval, France
Toulon Naval, France
Toulon Naval, France
Toulon Naval, France
Kerala, India
KfarSaba, Israel
Otahuhu Auckland, New Zealand
Takapuna Auckland, New Zealand
Cartagena. Murcia, Spain
Torrelavega.Santander, Spain
Headington, Oxford, United Kingdom