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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01896297
First received: July 8, 2013
Last updated: September 4, 2014
Last verified: September 2014
  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: 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 ]

Estimated Enrollment: 75
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01896297

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Hide Study Locations
Locations
United States, Arkansas
1160.173.002 Boehringer Ingelheim Investigational Site Recruiting
Hot Springs, Arkansas, United States
United States, California
1160.173.023 Boehringer Ingelheim Investigational Site Recruiting
Fremont, California, United States
1160.173.032 Boehringer Ingelheim Investigational Site Recruiting
Moreno Valley, California, United States
1160.173.034 Boehringer Ingelheim Investigational Site Recruiting
Oceanside, California, United States
1160.173.025 Boehringer Ingelheim Investigational Site Recruiting
Salinas, California, United States
1160.173.033 Boehringer Ingelheim Investigational Site Recruiting
San Pedro, California, United States
United States, Delaware
1160.173.024 Boehringer Ingelheim Investigational Site Recruiting
Wilmington, Delaware, United States
United States, District of Columbia
1160.173.010 Boehringer Ingelheim Investigational Site Recruiting
Washington, District of Columbia, United States
United States, Florida
1160.173.020 Boehringer Ingelheim Investigational Site Recruiting
Jacksonville, Florida, United States
1160.173.036 Boehringer Ingelheim Investigational Site Recruiting
Jacksonville, Florida, United States
1160.173.012 Boehringer Ingelheim Investigational Site Recruiting
Largo, Florida, United States
1160.173.013 Boehringer Ingelheim Investigational Site Recruiting
Tampa, Florida, United States
United States, Georgia
1160.173.005 Boehringer Ingelheim Investigational Site Terminated
Columbus, Georgia, United States
United States, Missouri
1160.173.018 Boehringer Ingelheim Investigational Site Recruiting
Springfield, Missouri, United States
1160.173.019 Boehringer Ingelheim Investigational Site Recruiting
St. Louis, Missouri, United States
1160.173.026 Boehringer Ingelheim Investigational Site Recruiting
St. Louis, Missouri, United States
United States, New Jersey
1160.173.027 Boehringer Ingelheim Investigational Site Recruiting
Neptune, New Jersey, United States
United States, North Carolina
1160.173.014 Boehringer Ingelheim Investigational Site Recruiting
Wilmington, North Carolina, United States
United States, Pennsylvania
1160.173.001 Boehringer Ingelheim Investigational Site Completed
Altoona, Pennsylvania, United States
1160.173.008 Boehringer Ingelheim Investigational Site Recruiting
Pittsburgh, Pennsylvania, United States
United States, South Carolina
1160.173.037 Boehringer Ingelheim Investigational Site Recruiting
Lancaster, South Carolina, United States
United States, Tennessee
1160.173.028 Boehringer Ingelheim Investigational Site Recruiting
Chattanooga, Tennessee, United States
1160.173.030 Boehringer Ingelheim Investigational Site Recruiting
Memphis, Tennessee, United States
United States, Texas
1160.173.015 Boehringer Ingelheim Investigational Site Recruiting
Dallas, Texas, United States
1160.173.011 Boehringer Ingelheim Investigational Site Recruiting
Fort Worth, Texas, United States
1160.173.006 Boehringer Ingelheim Investigational Site Recruiting
Live Oak, Texas, United States
1160.173.009 Boehringer Ingelheim Investigational Site Recruiting
San Antonio, Texas, United States
United States, Virginia
1160.173.021 Boehringer Ingelheim Investigational Site Recruiting
Norfolk, Virginia, United States
United States, Wisconsin
1160.173.035 Boehringer Ingelheim Investigational Site Recruiting
Waukesha, Wisconsin, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01896297     History of Changes
Other Study ID Numbers: 1160.173
Study First Received: July 8, 2013
Last Updated: September 4, 2014
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014