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

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: None (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 ]

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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 ]

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  Serious Adverse Events

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  Other Adverse Events

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  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: 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. 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. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.

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
First Submitted:	July 8, 2013
First Posted:	July 11, 2013
Results First Submitted:	October 7, 2016
Results First Posted:	November 30, 2016
Last Update Posted:	November 30, 2016