Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
NCT ID: NCT01896297
Last Updated: 2016-11-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
63 participants
INTERVENTIONAL
2013-07-31
2015-10-31
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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dabigatran etexilate
75mg BID by oral
Pradaxa, dabigatran etexilate
75mg BID by oral
Interventions
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Pradaxa, dabigatran etexilate
75mg BID by oral
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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,
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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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
Countries
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References
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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.
Other Identifiers
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1160.173
Identifier Type: -
Identifier Source: org_study_id