Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
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
1 other identifier
interventional
63
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 atrial-fibrillation
Started Jul 2013
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 8, 2013
CompletedFirst Posted
Study publicly available on registry
July 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
November 30, 2016
CompletedNovember 30, 2016
September 1, 2016
2.3 years
July 8, 2013
October 7, 2016
October 7, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose
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).
Immediately before the last drug administration, on day 8
Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose
Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss)
2 hours after the last drug administration, on day 8
Study Arms (1)
dabigatran etexilate
OTHER75mg BID by oral
Interventions
Eligibility Criteria
You may qualify if:
- Subjects diagnosed with non-valvular atrial fibrillation with an indication for the anticoagulation therapy,
- Subjects with severe renal function impairment defined as creatinine clearance between 15 and 30 mL/min by Cockcroft-Gault formula,
- Male and female patients, age =18 years at entry
You may not qualify if:
- Contraindications to Pradaxa (history of a serious hypersensitivity reaction to Pradaxa, active pathological bleeding, patients with mechanical prosthetic heart valve),
- Creatinine clearance \<15ml/min or patients with End Stage Renal Disease on dialysis,
- Creatinine clearance \>30 ml/min,
- Pre-menopausal women (last menstruation less than one year prior to informed consent) who are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include abstinence, tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, double barrier method and vasectomised partner,
- Patients who are participating in another drug study,
- Patients who have participated in another drug study within 6 weeks,
- Patients considered unreliable by the investigator concerning the requirements for participating in the study, including a follow-up interview,
- Any condition the investigator believes would not allow safe participation in the study,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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 D.C., 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
1160.173.012 Boehringer Ingelheim Investigational Site
Largo, Florida, United States
1160.173.013 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
1160.173.005 Boehringer Ingelheim Investigational Site
Columbus, Georgia, United States
1160.173.018 Boehringer Ingelheim Investigational Site
Springfield, Missouri, United States
1160.173.019 Boehringer Ingelheim Investigational Site
St Louis, Missouri, United States
1160.173.026 Boehringer Ingelheim Investigational Site
St Louis, Missouri, United States
1160.173.027 Boehringer Ingelheim Investigational Site
Neptune City, New Jersey, 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
1160.173.037 Boehringer Ingelheim Investigational Site
Lancaster, South Carolina, United States
1160.173.030 Boehringer Ingelheim Investigational Site
Memphis, Tennessee, United States
1160.173.011 Boehringer Ingelheim Investigational Site
Fort Worth, Texas, United States
1160.173.006 Boehringer Ingelheim Investigational Site
Live Oak, Texas, United States
1160.173.021 Boehringer Ingelheim Investigational Site
Norfolk, Virginia, United States
1160.173.035 Boehringer Ingelheim Investigational Site
Waukesha, Wisconsin, United States
Related Publications (1)
Martin JL, Esmaeili H, Manuel RC, Petrini M, Wiebe S, Maas H. Pharmacokinetics/Pharmacodynamics of Dabigatran 75 mg Twice Daily in Patients With Nonvalvular Atrial Fibrillation and Severely Impaired Renal Function. J Cardiovasc Pharmacol Ther. 2018 Sep;23(5):399-406. doi: 10.1177/1074248418769167. Epub 2018 Apr 25.
PMID: 29695165DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2013
First Posted
July 11, 2013
Study Start
July 1, 2013
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
November 30, 2016
Results First Posted
November 30, 2016
Record last verified: 2016-09