Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01896297
First received: July 8, 2013
Last updated: November 19, 2014
Last verified: November 2014

July 8, 2013
November 19, 2014
July 2013
April 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01896297 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
Drug: Pradaxa, dabigatran etexilate
75mg BID by oral
dabigatran etexilate
75mg BID by oral
Intervention: Drug: Pradaxa, dabigatran etexilate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
April 2015
April 2015   (final data collection date for primary outcome measure)

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,
Both
18 Years and older
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
United States
 
NCT01896297
1160.173
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP