Conditions: Atrial Fibrillation
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 63
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 75mg BID by oral

Interventions: intervention 1: Pradaxa, dabigatran etexilate
Intervention descriptions: intervention 1: 75mg BID by oral

Protocol document: