Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
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.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Open Label Study to Evaluate the Pharmacokinetics of Dabigatran in Non-valvular Atrial Fibrillation (NVAF) Patients With Severely Impaired Renal Function on Dabigatran Etexilate 75 mg BID Therapy|
- Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose [ Time Frame: Immediately before the last drug administration, on day 8 ] [ Designated as safety issue: No ]Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) taken at approximately 12 hours after the last dose (trough).
- Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose [ Time Frame: 2 hours after the last drug administration, on day 8 ] [ Designated as safety issue: No ]Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss)
|Study Start Date:||July 2013|
|Study Completion Date:||October 2015|
|Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
75mg BID by oral
Drug: Pradaxa, dabigatran etexilate
75mg BID by oral
Please refer to this study by its ClinicalTrials.gov identifier: NCT01896297
Show 26 Study Locations
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|