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

Completed · Phase 4

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01896297

Run by

Boehringer Ingelheim

People needed

63

Starts

2013-07-01

Expected to finish

2015-10-01

Last updated by the study team

2016-11-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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,

Where it is running

• 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

Full record on ClinicalTrials.gov

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