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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:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01595854
First received: May 9, 2012
Last updated: June 18, 2013
Last verified: June 2013

May 9, 2012
June 18, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Cmax of total dabigatran [maximum measured concentration] [ Time Frame: up to 48 hours ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
  • Number of participants with clinically relevant changes in electrocardiogram results [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
  • Number of participants with clinically relevant changes from baseline laboratory measurements [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: 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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01595854
1160.141, 2012-000874-42
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