Thromboembolism Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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