Boehringer Ends Phase 2 Trial Of Dabigatran In Mechanical Valve Patients
Boehringer Ingelheim today announced that it had discontinued a phase 2 trial of its anticoagulant drug dabigatran (Pradaxa) in patients with mechanical heart valves. As reported here in October, the company had previously terminated one arm of the study after an interim review of the data by the trial's Data Safety Monitoring Board
The RE-ALIGN trial was an open-label, 12-week randomized comparison of warfarin and dabigatran in 400 patients who received a mechanical valve.
Disappointing results here for novel anticoagulants in patients with mechanical heart valves
