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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pradaxa, dabigatran etexilate
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • 1160.173.002 Boehringer Ingelheim Investigational Site
  • 1160.173.023 Boehringer Ingelheim Investigational Site
  • 1160.173.032 Boehringer Ingelheim Investigational Site
  • 1160.173.034 Boehringer Ingelheim Investigational Site
  • 1160.173.025 Boehringer Ingelheim Investigational Site
  • 1160.173.033 Boehringer Ingelheim Investigational Site
  • 1160.173.024 Boehringer Ingelheim Investigational Site
  • 1160.173.010 Boehringer Ingelheim Investigational Site
  • 1160.173.020 Boehringer Ingelheim Investigational Site
  • 1160.173.036 Boehringer Ingelheim Investigational Site
  • 1160.173.012 Boehringer Ingelheim Investigational Site
  • 1160.173.013 Boehringer Ingelheim Investigational Site
  • 1160.173.005 Boehringer Ingelheim Investigational Site
  • 1160.173.018 Boehringer Ingelheim Investigational Site
  • 1160.173.019 Boehringer Ingelheim Investigational Site
  • 1160.173.026 Boehringer Ingelheim Investigational Site
  • 1160.173.027 Boehringer Ingelheim Investigational Site
  • 1160.173.014 Boehringer Ingelheim Investigational Site
  • 1160.173.001 Boehringer Ingelheim Investigational Site
  • 1160.173.008 Boehringer Ingelheim Investigational Site
  • 1160.173.037 Boehringer Ingelheim Investigational Site
  • 1160.173.030 Boehringer Ingelheim Investigational Site
  • 1160.173.011 Boehringer Ingelheim Investigational Site
  • 1160.173.006 Boehringer Ingelheim Investigational Site
  • 1160.173.021 Boehringer Ingelheim Investigational Site
  • 1160.173.035 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

dabigatran etexilate

Arm Description

75mg BID by oral

Outcomes

Primary Outcome Measures

Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose
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
Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss)

Secondary Outcome Measures

Full Information

First Posted
July 8, 2013
Last Updated
October 7, 2016
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01896297
Brief Title
Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dabigatran etexilate
Arm Type
Other
Arm Description
75mg BID by oral
Intervention Type
Drug
Intervention Name(s)
Pradaxa, dabigatran etexilate
Intervention Description
75mg BID by oral
Primary Outcome Measure Information:
Title
Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose
Description
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).
Time Frame
Immediately before the last drug administration, on day 8
Title
Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose
Description
Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss)
Time Frame
2 hours after the last drug administration, on day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1160.173.002 Boehringer Ingelheim Investigational Site
City
Hot Springs
State/Province
Arkansas
Country
United States
Facility Name
1160.173.023 Boehringer Ingelheim Investigational Site
City
Fremont
State/Province
California
Country
United States
Facility Name
1160.173.032 Boehringer Ingelheim Investigational Site
City
Moreno Valley
State/Province
California
Country
United States
Facility Name
1160.173.034 Boehringer Ingelheim Investigational Site
City
Oceanside
State/Province
California
Country
United States
Facility Name
1160.173.025 Boehringer Ingelheim Investigational Site
City
Salinas
State/Province
California
Country
United States
Facility Name
1160.173.033 Boehringer Ingelheim Investigational Site
City
San Pedro
State/Province
California
Country
United States
Facility Name
1160.173.024 Boehringer Ingelheim Investigational Site
City
Wilmington
State/Province
Delaware
Country
United States
Facility Name
1160.173.010 Boehringer Ingelheim Investigational Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
1160.173.020 Boehringer Ingelheim Investigational Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
1160.173.036 Boehringer Ingelheim Investigational Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
1160.173.012 Boehringer Ingelheim Investigational Site
City
Largo
State/Province
Florida
Country
United States
Facility Name
1160.173.013 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
1160.173.005 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
1160.173.018 Boehringer Ingelheim Investigational Site
City
Springfield
State/Province
Missouri
Country
United States
Facility Name
1160.173.019 Boehringer Ingelheim Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
1160.173.026 Boehringer Ingelheim Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
1160.173.027 Boehringer Ingelheim Investigational Site
City
Neptune
State/Province
New Jersey
Country
United States
Facility Name
1160.173.014 Boehringer Ingelheim Investigational Site
City
Wilmington
State/Province
North Carolina
Country
United States
Facility Name
1160.173.001 Boehringer Ingelheim Investigational Site
City
Altoona
State/Province
Pennsylvania
Country
United States
Facility Name
1160.173.008 Boehringer Ingelheim Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
1160.173.037 Boehringer Ingelheim Investigational Site
City
Lancaster
State/Province
South Carolina
Country
United States
Facility Name
1160.173.030 Boehringer Ingelheim Investigational Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
1160.173.011 Boehringer Ingelheim Investigational Site
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
1160.173.006 Boehringer Ingelheim Investigational Site
City
Live Oak
State/Province
Texas
Country
United States
Facility Name
1160.173.021 Boehringer Ingelheim Investigational Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
1160.173.035 Boehringer Ingelheim Investigational Site
City
Waukesha
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29695165
Citation
Martin JL, Esmaeili H, Manuel RC, Petrini M, Wiebe S, Maas H. Pharmacokinetics/Pharmacodynamics of Dabigatran 75 mg Twice Daily in Patients With Nonvalvular Atrial Fibrillation and Severely Impaired Renal Function. J Cardiovasc Pharmacol Ther. 2018 Sep;23(5):399-406. doi: 10.1177/1074248418769167. Epub 2018 Apr 25.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
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Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function

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