Status:
COMPLETED
Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 for...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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,
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01896297
Start Date
July 1 2013
End Date
October 1 2015
Last Update
November 30 2016
Active Locations (26)
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1
1160.173.002 Boehringer Ingelheim Investigational Site
Hot Springs, Arkansas, United States
2
1160.173.023 Boehringer Ingelheim Investigational Site
Fremont, California, United States
3
1160.173.032 Boehringer Ingelheim Investigational Site
Moreno Valley, California, United States
4
1160.173.034 Boehringer Ingelheim Investigational Site
Oceanside, California, United States