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Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01734772
First Posted: November 28, 2012
Last Update Posted: May 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
Results First Submitted: April 2, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Healthy
Interventions: Drug: dabigatran etexilate
Drug: ticagrelor

  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
Part 1 In part 1, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, ticagrelor treatment was added starting with the concomitant administration of a 180 mg ticagrelor loading dose followed by 90 mg ticagrelor twice daily. Dabigatran PK profiles were taken on day 1 of the test treatment and day 4 of the test treatment.
Part 2 In part 2, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, 180 mg ticagrelor were given 2 hours after the morning dose of 110 mg dabigatran etexilate and dabigatran PK profile were taken on this day 1 of the test treatment.

Participant Flow:   Overall Study
    Part 1   Part 2
STARTED   24   24 
COMPLETED   23   21 
NOT COMPLETED   1   3 
Adverse Event                1                2 
Withdrawal by Subject                0                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 which includes all subjects who were documented to have received at least 1 dose of trial medication.

Reporting Groups
  Description
Part 1 In part 1, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, ticagrelor treatment was added starting with the concomitant administration of a 180 mg ticagrelor loading dose followed by 90 mg ticagrelor twice daily. Dabigatran PK profiles were taken on day 1 of the test treatment and day 4 of the test treatment.
Part 2 In part 2, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, 180 mg ticagrelor were given 2 hours after the morning dose of 110 mg dabigatran etexilate and dabigatran PK profile were taken on this day 1 of the test treatment.
Total Total of all reporting groups

Baseline Measures
   Part 1   Part 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   24   48 
Age 
[Units: Years]
Mean (Standard Deviation)
 28.0  (7.2)   28.6  (7.1)   28.3  (7.15) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   24   24   48 


  Outcome Measures
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1.  Primary:   Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)   [ Time Frame: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours ]

2.  Primary:   Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss)   [ Time Frame: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01734772     History of Changes
Other Study ID Numbers: 1160.142
2012-002656-16 ( EudraCT Number: EudraCT )
First Submitted: November 15, 2012
First Posted: November 28, 2012
Results First Submitted: April 2, 2014
Results First Posted: May 5, 2014
Last Update Posted: May 5, 2014