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

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ClinicalTrials.gov Identifier: NCT01896297
Recruitment Status : Completed
First Posted : July 11, 2013
Results First Posted : November 30, 2016
Last Update Posted : November 30, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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
Enrollment 63
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
Period Title: Overall Study
Started 60
Completed 59
Not Completed 1
Reason Not Completed
Died in post treatment phase             1
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
83.35  (7.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
36
  60.0%
Male
24
  40.0%
1.Primary Outcome
Title Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose
Hide Description Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) taken at approximately 12 hours after the last dose (trough).
Time Frame Immediately before the last drug administration, on day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set (PKS) which included all patients in the treated set with analyzable data in at least one observation for at least one primary endpoint without important protocol violations relevant to the evaluation of PK. Analysis includes patients with available data.
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description:
Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
Overall Number of Participants Analyzed 51
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
155
(76.9%)
2.Primary Outcome
Title Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose
Hide Description Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss)
Time Frame 2 hours after the last drug administration, on day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PKS. Analysis includes patients with available data.
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description:
Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
Overall Number of Participants Analyzed 59
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
202
(70.6%)
Time Frame From first drug administration until 3 days after last drug administration, up to 18 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
All-Cause Mortality
Dabigatran Etexilate
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran Etexilate
Affected / at Risk (%)
Total   2/60 (3.33%) 
Cardiac disorders   
Acute myocardial infarction  1  1/60 (1.67%) 
Metabolism and nutrition disorders   
Hyperkalaemia  1  1/60 (1.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dabigatran Etexilate
Affected / at Risk (%)
Total   0/60 (0.00%) 
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.
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
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