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

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: July 8, 2013
Last updated: November 12, 2015
Last verified: November 2015

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.

Condition Intervention Phase
Atrial Fibrillation
Drug: Pradaxa, dabigatran etexilate
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: July 2013
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
dabigatran etexilate
75mg BID by oral
Drug: Pradaxa, dabigatran etexilate
75mg BID by oral


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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,
  Contacts and Locations
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Please refer to this study by its identifier: NCT01896297

  Show 26 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Identifier: NCT01896297     History of Changes
Other Study ID Numbers: 1160.173
Study First Received: July 8, 2013
Last Updated: November 12, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Renal Insufficiency
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Kidney Diseases
Pathologic Processes
Urologic Diseases
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Serine Proteinase Inhibitors
Therapeutic Uses processed this record on November 30, 2015