Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Pradaxa, dabigatran etexilate

• 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

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-08
• Study First Posted: 2013-07-11
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-09
• Results First Submitted: 2016-10-07
• Results First Submitted QC: 2016-10-07
• Last Update Submitted: 2016-10-07
• Results First Posted: 2016-11-30
• Last Update Posted: 2016-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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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)

Trial Locations

Locations (26)

1160.173.026 Boehringer Ingelheim Investigational Site; 🇺🇸 St. Louis, Missouri, United States

1160.173.011 Boehringer Ingelheim Investigational Site; 🇺🇸 Fort Worth, Texas, United States

1160.173.019 Boehringer Ingelheim Investigational Site; 🇺🇸 St. Louis, Missouri, United States

1160.173.021 Boehringer Ingelheim Investigational Site; 🇺🇸 Norfolk, Virginia, United States

1160.173.002 Boehringer Ingelheim Investigational Site; 🇺🇸 Hot Springs, Arkansas, United States

1160.173.036 Boehringer Ingelheim Investigational Site; 🇺🇸 Jacksonville, Florida, United States

1160.173.024 Boehringer Ingelheim Investigational Site; 🇺🇸 Wilmington, Delaware, United States

1160.173.032 Boehringer Ingelheim Investigational Site; 🇺🇸 Moreno Valley, California, United States

1160.173.033 Boehringer Ingelheim Investigational Site; 🇺🇸 San Pedro, 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

1160.173.020 Boehringer Ingelheim Investigational Site; 🇺🇸 Jacksonville, Florida, United States

1160.173.023 Boehringer Ingelheim Investigational Site; 🇺🇸 Fremont, California, United States

1160.173.013 Boehringer Ingelheim Investigational Site; 🇺🇸 Tampa, Florida, United States

1160.173.005 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbus, Georgia, United States

1160.173.010 Boehringer Ingelheim Investigational Site; 🇺🇸 Washington, District of Columbia, United States

1160.173.027 Boehringer Ingelheim Investigational Site; 🇺🇸 Neptune, New Jersey, United States

1160.173.012 Boehringer Ingelheim Investigational Site; 🇺🇸 Largo, Florida, United States

1160.173.037 Boehringer Ingelheim Investigational Site; 🇺🇸 Lancaster, South Carolina, United States

1160.173.018 Boehringer Ingelheim Investigational Site; 🇺🇸 Springfield, Missouri, United States

1160.173.030 Boehringer Ingelheim Investigational Site; 🇺🇸 Memphis, Tennessee, United States

1160.173.014 Boehringer Ingelheim Investigational Site; 🇺🇸 Wilmington, North Carolina, United States

1160.173.001 Boehringer Ingelheim Investigational Site; 🇺🇸 Altoona, Pennsylvania, United States

1160.173.008 Boehringer Ingelheim Investigational Site; 🇺🇸 Pittsburgh, Pennsylvania, United States

1160.173.006 Boehringer Ingelheim Investigational Site; 🇺🇸 Live Oak, Texas, United States

1160.173.035 Boehringer Ingelheim Investigational Site; 🇺🇸 Waukesha, Wisconsin, United States