5 results
To provide single dose PK/PD dataTo investigate tolerability and safety of dabigatran etexilate solution in children1 to <12 years of age
To asses the comparability of the estimated dabigatran concentration in plasma via calibrated Hemoclot and the measured dabigatran concentrations assessed in a central lab in patients with moderate renal impairment undergoing primary unilateral…
The goal of this trial is to collect long-term observational data on the tolerability, safety and efficacy of dabigatran etexilate in a spectrum of patients receiving bileaflet mechanical heart valves. All patients that have completed study 1160.113…
The purpose of this study is to confirm/validate predicted dabigatran trough plasma levels gained after individual dose assignment based on simulations by means of PK data from the RE-LY trial. Based on this validation a final appropriate dosing…
The aim of this phase I study is to assess the extent of intestinal absorption of rivaroxaban and dabigatran etexilate in adult patients with short bowel syndrome and treated with long-term TPN.