Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
- Registration Number
- NCT01896297
- Lead Sponsor
- Boehringer Ingelheim
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description dabigatran etexilate Pradaxa, dabigatran etexilate 75mg BID by oral
- Primary Outcome Measures
Name Time Method Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose 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 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
1160.173.002 Boehringer Ingelheim Investigational Site
🇺🇸Hot Springs, Arkansas, United States
1160.173.023 Boehringer Ingelheim Investigational Site
🇺🇸Fremont, California, United States
1160.173.032 Boehringer Ingelheim Investigational Site
🇺🇸Moreno Valley, California, United States
1160.173.034 Boehringer Ingelheim Investigational Site
🇺🇸Oceanside, California, United States
1160.173.025 Boehringer Ingelheim Investigational Site
🇺🇸Salinas, California, United States
1160.173.033 Boehringer Ingelheim Investigational Site
🇺🇸San Pedro, California, United States
1160.173.024 Boehringer Ingelheim Investigational Site
🇺🇸Wilmington, Delaware, United States
1160.173.010 Boehringer Ingelheim Investigational Site
🇺🇸Washington, District of Columbia, United States
1160.173.020 Boehringer Ingelheim Investigational Site
🇺🇸Jacksonville, Florida, United States
1160.173.036 Boehringer Ingelheim Investigational Site
🇺🇸Jacksonville, Florida, United States
Scroll for more (16 remaining)1160.173.002 Boehringer Ingelheim Investigational Site🇺🇸Hot Springs, Arkansas, United States