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Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor and Assessment of Ticagrelor Interaction Potential With Dabigatran

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01595854
First Posted: May 10, 2012
Last Update Posted: August 22, 2013
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
May 9, 2012
May 10, 2012
June 18, 2013
August 22, 2013
August 22, 2013
May 2012
June 2012   (Final data collection date for primary outcome measure)
  • Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours ]
    Area under the concentration-time curve of the analyte in plasma, over the time interval from 0 extrapolated to infinity, of dabigatran.
  • Total Dabigatran: Maximum Measured Concentration (Cmax) [ Time Frame: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours ]
    Maximum measured concentration of total dabigatran in plasma, per period.
  • AUC of total dabigatran [Area under the concentration time curve] [ Time Frame: up to 48 hours ]
  • Cmax of total dabigatran [maximum measured concentration] [ Time Frame: up to 48 hours ]
Complete list of historical versions of study NCT01595854 on ClinicalTrials.gov Archive Site
Number of Participants With Drug Related Adverse Events [ Time Frame: From screening until the end-of-study examination ]
The number of participants with drug related adverse events
  • Number of participants with clinically relevant findings in vital signs [ Time Frame: up to 10 days ]
  • Number of participants with clinically relevant changes in electrocardiogram results [ Time Frame: up to 10 days ]
  • Number of participants with clinically relevant changes from baseline laboratory measurements [ Time Frame: up to 10 days ]
  • Number of participants with adverse events [ Time Frame: up to 10 days ]
Not Provided
Not Provided
 
Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor and Assessment of Ticagrelor Interaction Potential With Dabigatran
Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor (Part 1 and 2, Open, Non-randomised, 2 Parallel Groups) and Assessment of Ticagrelor Interaction Potential With Dabigatran (Part 3, Open, Randomised, Two-period Cross-over) in Healthy Male Subjects
Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new pharmacodynamic methods
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
  • Drug: dabigatran etexilate
    medium dose dabigatran
  • Drug: Ticagrelor
    high dose ticagrelor
  • Drug: dabigatran etexilate
    low dose dabigatran
  • Experimental: Test 2 (part 3)
    low dose dabigatran + high dose ticagrelor
    Interventions:
    • Drug: Ticagrelor
    • Drug: dabigatran etexilate
  • Active Comparator: Test 1 (part 1 + 2)
    high dose ticagrelor
    Intervention: Drug: Ticagrelor
  • Experimental: Reference 1 (part 1 + 2)
    medium dose dabigatran
    Intervention: Drug: dabigatran etexilate
  • Experimental: Reference 2 (part 3)
    low dose dabigatran
    Intervention: Drug: dabigatran etexilate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
June 2012
June 2012   (Final data collection date for primary outcome measure)

Inclusion criteria:

  1. Healthy male subjects

    Exclusion criteria:

  2. Any relevant deviation from healthy conditions
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01595854
1160.141
2012-000874-42 ( EudraCT Number: EudraCT )
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP