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Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate in Patients With Stable Severe Renal Disease.

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ClinicalTrials.gov Identifier: NCT01711853
Recruitment Status : Completed
First Posted : October 22, 2012
Results First Posted : January 13, 2015
Last Update Posted : January 13, 2015
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 Renal Insufficiency, Chronic
Intervention Drug: Dabigatran Etexilate
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dabigatran 75 mg
Hide Arm/Group Description Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
Period Title: Overall Study
Started 19
Completed 16
Not Completed 3
Reason Not Completed
Not treated             3
Arm/Group Title Dabigatran 75 mg
Hide Arm/Group Description Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
Treated set (TS) which included all patients who had taken at least 1 dose of trial medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
72.7  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
3
  18.8%
Male
13
  81.3%
1.Primary Outcome
Title Cmax,ss
Hide Description

Maximum concentration of Dabigatran etexilate in plasma at steady state was measured.

The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration.

Time Frame -0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set (PKS) which included all treated subjects that provided at least 1 observation for at least 1 primary pharmacokinetic endpoint without important protocol violations with respect to the evaluation of the pharmacokinetic endpoints and with predose values not greater than 5% of Cmax.
Arm/Group Title Dabigatran 75 mg
Hide Arm/Group Description:
Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
207
(53.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 75 mg
Comments

Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median GFR (Glomerular filtration rate), 2: > median GFR).

Median is calculated based on trial data of treated set

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5186
Comments [Not Specified]
Method ANOVA
Comments ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran 75 mg
Comments

Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median age, 2: > median age).

Median is calculated based on trial data of treated set

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9883
Comments [Not Specified]
Method ANOVA
Comments ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dabigatran 75 mg
Comments Patients were classified based on the gender distribution.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7853
Comments [Not Specified]
Method ANOVA
Comments ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.
2.Primary Outcome
Title AUCtau,ss
Hide Description

Area under the plasma concentration-time curve of the total dabigatran at steady state over a uniform dosing interval tau was measured.

The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration.

Time Frame -0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Dabigatran 75 mg
Hide Arm/Group Description:
Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
2140
(51.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran 75 mg
Comments

Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median GFR, 2: > median GFR).

Median is calculated based on trial data of treated set

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4692
Comments [Not Specified]
Method ANOVA
Comments ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran 75 mg
Comments

Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median age, 2: > median age).

Median is calculated based on trial data of treated set

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9734
Comments [Not Specified]
Method ANOVA
Comments ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dabigatran 75 mg
Comments Patients were classified based on the gender distribution.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9201
Comments [Not Specified]
Method ANOVA
Comments ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.
Time Frame Up to Day 11
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dabigatran 75 mg
Hide Arm/Group Description Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
All-Cause Mortality
Dabigatran 75 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran 75 mg
Affected / at Risk (%)
Total   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dabigatran 75 mg
Affected / at Risk (%)
Total   6/16 (37.50%) 
Gastrointestinal disorders   
Diarrhoea  1  2/16 (12.50%) 
Gastrooesophageal reflux disease  1  1/16 (6.25%) 
Nausea  1  1/16 (6.25%) 
Vomiting  1  1/16 (6.25%) 
Injury, poisoning and procedural complications   
Nail injury  1  1/16 (6.25%) 
Wound  1  1/16 (6.25%) 
Vascular disorders   
Thrombophlebitis  1  1/16 (6.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 17.0
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
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01711853     History of Changes
Other Study ID Numbers: 1160.166
2011-003081-32 ( EudraCT Number: EudraCT )
First Submitted: October 19, 2012
First Posted: October 22, 2012
Results First Submitted: December 19, 2014
Results First Posted: January 13, 2015
Last Update Posted: January 13, 2015