Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe
renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by
Cockcroft-Gault formula.
The dabigatran etexilate dose of 75 mg BID was approved by the FDA for NVAF patients with
severe renal impairment (CrCl 15-30 mL/min) , based on pharmacokinetic modeling and
simulation.