Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
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|ClinicalTrials.gov Identifier: NCT01896297|
Recruitment Status : Completed
First Posted : July 11, 2013
Results First Posted : November 30, 2016
Last Update Posted : November 30, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: Pradaxa, dabigatran etexilate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
U.S. FDA Resources
75mg BID by oral
Drug: Pradaxa, dabigatran etexilate
75mg BID by oral
- 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 ]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 ]Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896297
Show 26 Study Locations
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|