Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01896297
First received: July 8, 2013
Last updated: October 7, 2016
Last verified: September 2016
Results First Received: October 7, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Atrial Fibrillation
Intervention: Drug: Pradaxa, dabigatran etexilate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Dabigatran Etexilate Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.

Participant Flow:   Overall Study
    Dabigatran Etexilate
STARTED   60 
COMPLETED   59 
NOT COMPLETED   1 
Died in post treatment phase                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set (TS) which included all enrolled patients who were eligible to enter the trial, who were dispensed trial medication and were documented to have taken at least one dose of trial drug.

Reporting Groups
  Description
Dabigatran Etexilate Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.

Baseline Measures
   Dabigatran Etexilate 
Overall Participants Analyzed 
[Units: Participants]
 60 
Age 
[Units: Years]
Mean (Standard Deviation)
 83.35  (7.55) 
Gender 
[Units: Participants]
 
Female   36 
Male   24 


  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01896297     History of Changes
Other Study ID Numbers: 1160.173
Study First Received: July 8, 2013
Results First Received: October 7, 2016
Last Updated: October 7, 2016
Health Authority: United States: Food and Drug Administration