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

October 7, 2016 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States
        • 1160.173.002 Boehringer Ingelheim Investigational Site
    • California
      • Fremont, California, United States
        • 1160.173.023 Boehringer Ingelheim Investigational Site
      • Moreno Valley, California, United States
        • 1160.173.032 Boehringer Ingelheim Investigational Site
      • Oceanside, California, United States
        • 1160.173.034 Boehringer Ingelheim Investigational Site
      • Salinas, California, United States
        • 1160.173.025 Boehringer Ingelheim Investigational Site
      • San Pedro, California, United States
        • 1160.173.033 Boehringer Ingelheim Investigational Site
    • Delaware
      • Wilmington, Delaware, United States
        • 1160.173.024 Boehringer Ingelheim Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • 1160.173.010 Boehringer Ingelheim Investigational Site
    • Florida
      • Jacksonville, Florida, United States
        • 1160.173.020 Boehringer Ingelheim Investigational Site
      • Jacksonville, Florida, United States
        • 1160.173.036 Boehringer Ingelheim Investigational Site
      • Largo, Florida, United States
        • 1160.173.012 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, United States
        • 1160.173.013 Boehringer Ingelheim Investigational Site
    • Georgia
      • Columbus, Georgia, United States
        • 1160.173.005 Boehringer Ingelheim Investigational Site
    • Missouri
      • Springfield, Missouri, United States
        • 1160.173.018 Boehringer Ingelheim Investigational Site
      • St. Louis, Missouri, United States
        • 1160.173.019 Boehringer Ingelheim Investigational Site
      • St. Louis, Missouri, United States
        • 1160.173.026 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Neptune, New Jersey, United States
        • 1160.173.027 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Wilmington, North Carolina, United States
        • 1160.173.014 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States
        • 1160.173.001 Boehringer Ingelheim Investigational Site
      • Pittsburgh, Pennsylvania, United States
        • 1160.173.008 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Lancaster, South Carolina, United States
        • 1160.173.037 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States
        • 1160.173.030 Boehringer Ingelheim Investigational Site
    • Texas
      • Fort Worth, Texas, United States
        • 1160.173.011 Boehringer Ingelheim Investigational Site
      • Live Oak, Texas, United States
        • 1160.173.006 Boehringer Ingelheim Investigational Site
    • Virginia
      • Norfolk, Virginia, United States
        • 1160.173.021 Boehringer Ingelheim Investigational Site
    • Wisconsin
      • Waukesha, Wisconsin, United States
        • 1160.173.035 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: dabigatran etexilate
75mg BID by oral
Drug: Pradaxa, dabigatran etexilate
75mg BID by oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Immediately before the last drug administration, on day 8
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)
2 hours after the last drug administration, on day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

July 8, 2013

First Submitted That Met QC Criteria

July 8, 2013

First Posted (Estimate)

July 11, 2013

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

October 7, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1160.173

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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