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
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
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.
Inclusion criteria:
Exclusion criteria:
Rio de Janeiro - RJ, Brazil
Ostrava-Vitkovice, Czechia
Tamil Nadu, India
DN Lower Galillee, Israel
KfarSaba, Israel
Tel Hashomer, Ramat Gan, Israel
Kelantan Kota Bahru, Malaysia
Grafton Auckland, New Zealand
Otahuhu Auckland, New Zealand
Takapuna Auckland, New Zealand
Kyunggi-do, South Korea
Cartagena. Murcia, Spain
Sabadell - Barcelona, Spain
Muang Nakhonratchasima, Thailand
Nakhonratchasima, Thailand
Nokorn Nayok, Thailand
Phayathai, Thailand
Headington, Oxford, United Kingdom