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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01896297
First Posted: July 11, 2013
Last Update Posted: November 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose

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: Intervention Model: Single Group Assignment
Masking: None (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: Immediately before the last drug administration, on day 8 ]
    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).

  • Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose [ Time Frame: 2 hours after the last drug administration, on day 8 ]
    Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss)


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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896297


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

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01896297     History of Changes
Other Study ID Numbers: 1160.173
First Submitted: July 8, 2013
First Posted: July 11, 2013
Results First Submitted: October 7, 2016
Results First Posted: November 30, 2016
Last Update Posted: November 30, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Atrial Fibrillation
Renal Insufficiency
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Kidney Diseases
Urologic Diseases
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants