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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896297
• Other study ID #: 1160.173
• Status: Completed
• Phase: Phase 4
• First received: July 8, 2013
• Last updated: November 12, 2015
• Start date: July 2013
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Renal Insufficiency

Intervention

Drug:
• Pradaxa, dabigatran etexilate
75mg BID by oral

Locations

Country	Name	City	State
United States	1160.173.001 Boehringer Ingelheim Investigational Site	Altoona	Pennsylvania
United States	1160.173.005 Boehringer Ingelheim Investigational Site	Columbus	Georgia
United States	1160.173.011 Boehringer Ingelheim Investigational Site	Fort Worth	Texas
United States	1160.173.023 Boehringer Ingelheim Investigational Site	Fremont	California
United States	1160.173.002 Boehringer Ingelheim Investigational Site	Hot Springs	Arkansas
United States	1160.173.020 Boehringer Ingelheim Investigational Site	Jacksonville	Florida
United States	1160.173.036 Boehringer Ingelheim Investigational Site	Jacksonville	Florida
United States	1160.173.037 Boehringer Ingelheim Investigational Site	Lancaster	South Carolina
United States	1160.173.012 Boehringer Ingelheim Investigational Site	Largo	Florida
United States	1160.173.006 Boehringer Ingelheim Investigational Site	Live Oak	Texas
United States	1160.173.030 Boehringer Ingelheim Investigational Site	Memphis	Tennessee
United States	1160.173.032 Boehringer Ingelheim Investigational Site	Moreno Valley	California
United States	1160.173.027 Boehringer Ingelheim Investigational Site	Neptune	New Jersey
United States	1160.173.021 Boehringer Ingelheim Investigational Site	Norfolk	Virginia
United States	1160.173.034 Boehringer Ingelheim Investigational Site	Oceanside	California
United States	1160.173.008 Boehringer Ingelheim Investigational Site	Pittsburgh	Pennsylvania
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	1160.173.018 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	1160.173.013 Boehringer Ingelheim Investigational Site	Tampa	Florida
United States	1160.173.010 Boehringer Ingelheim Investigational Site	Washington	District of Columbia
United States	1160.173.035 Boehringer Ingelheim Investigational Site	Waukesha	Wisconsin
United States	1160.173.014 Boehringer Ingelheim Investigational Site	Wilmington	North Carolina
United States	1160.173.024 Boehringer Ingelheim Investigational Site	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose		12 hours	No
Primary	Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose		2 hours	No