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Trial record 65 of 333 for:    DABIGATRAN

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

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ClinicalTrials.gov Identifier: NCT01595854
Recruitment Status : Completed
First Posted : May 10, 2012
Results First Posted : August 22, 2013
Last Update Posted : August 22, 2013
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: dabigatran etexilate
Drug: Ticagrelor
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dabigatran Etexilate 220 mg - Part 1 Ticagrelor 180 mg - Part 1 Dabigatran Etexilate 220 mg - Part 2 Ticagrelor 180 mg - Part 2 Dabigatran Etexilate/Multiple Dose Ticagrelor Crossover-Part 3
Hide Arm/Group Description A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test. A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test. A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test. A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test

A randomised, two-period, cross-over trial, the two treatments administered were

  • A single dose of dabigatran etexilate 75 mg
  • Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4.

Between treatment periods there was a washout period of at least 4 days.

Period Title: Overall Study
Started 8 4 8 4 12
Completed 8 4 8 4 12
Not Completed 0 0 0 0 0
Arm/Group Title Dabigatran Etexilate 220 mg - Part 1 Ticagrelor 180 mg - Part 1 Dabigatran Etexilate 220 mg - Part 2 Ticagrelor 180 mg - Part 2 Dabigatran Etexilate / Multiple Dose Ticagrelor - Part 3 Total
Hide Arm/Group Description A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test. A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test. A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test. A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test

A randomised two-period cross-over trial, the two treatments administered were

  • A single dose of dabigatran etexilate 75 mg
  • Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered with a single dose of 75 mg Dabigatran etexilate on days 1 and 4.

Between treatment periods there was a washout period of at least 4 days.

Total of all reporting groups
Overall Number of Baseline Participants 8 4 8 4 12 36
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 4 participants 8 participants 4 participants 12 participants 36 participants
30.6  (7.7) 29.8  (11.4) 33.6  (9.1) 33.3  (6.3) 30.2  (7.2) 31.3  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 8 participants 4 participants 12 participants 36 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
8
 100.0%
4
 100.0%
8
 100.0%
4
 100.0%
12
 100.0%
36
 100.0%
1.Primary Outcome
Title Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞)
Hide Description Area under the concentration-time curve of the analyte in plasma, over the time interval from 0 extrapolated to infinity, of dabigatran.
Time Frame -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set defined as all subjects of Part 3 who received at least 1 dose of trial medication and provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability.
Arm/Group Title Dabi 75 mg Dabi + Ticagrelor LD Dabi + Ticagrelor MD
Hide Arm/Group Description:
A single dose of Dabigatran etexilate (Dabi) 75 mg.
A single dose of 75 mg Dabigatran coadministered with a loading dose (LD) of 180 mg ticagrelor coated tablets (T).
A single dose of 75 mg Dabigatran coadministered with a morning dose of multiple dose (MD) ticagrelor.
Overall Number of Participants Analyzed 12 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
281.05
(104%)
485.48
(40.5%)
410.46
(53.1%)
2.Primary Outcome
Title Total Dabigatran: Maximum Measured Concentration (Cmax)
Hide Description Maximum measured concentration of total dabigatran in plasma, per period.
Time Frame -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set defined as all subjects of Part 3 who received at least 1 dose of trial medication and provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability.
Arm/Group Title Dabi 75 mg Dabi + Ticagrelor LD Dabi + Ticagrelor MD
Hide Arm/Group Description:
A single dose of Dabigatran etexilate (Dabi) 75 mg.
A single dose of 75 mg Dabigatran coadministered with a loading dose (LD) of 180 mg ticagrelor coated tablets (T).
A single dose of 75 mg Dabigatran coadministered with a morning dose of multiple dose (LD) ticagrelor.
Overall Number of Participants Analyzed 12 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
31.47
(130%)
61.30
(42.9%)
49.11
(64.8%)
3.Secondary Outcome
Title Number of Participants With Drug Related Adverse Events
Hide Description The number of participants with drug related adverse events
Time Frame From screening until the end-of-study examination
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set
Arm/Group Title Dabigatran 220 mg - Part 1 Ticagrelor 180 mg - Part 1 Dabigatran 220 mg - Part 2 Ticagrelor 180 mg - Part 2 Dabigatran 75 mg - Part 3 Dabigatran + Ticagrelor - Part 3
Hide Arm/Group Description:
A single dose of Dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
A single dose of Ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
A single dose of Dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
A single dose of Ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test.
A single dose of Dabigatran etexilate 75 mg
Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4.
Overall Number of Participants Analyzed 8 4 8 4 12 12
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0 1
Time Frame 3 to 10 days after last dosing
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dabigatran Etexilate 220 mg - Part 1 Ticagrelor 180 mg - Part 1 Dabigatran Etexilate 220 mg - Part 2 Ticagrelor 180 mg - Part 2 Dabi 75 mg - Part 3 Multiple Dose Ticagrelor - Part 3
Hide Arm/Group Description A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test. A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test. A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test. A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test A single dose of dabigatran etexilate (Dabi) 75 mg Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4.
All-Cause Mortality
Dabigatran Etexilate 220 mg - Part 1 Ticagrelor 180 mg - Part 1 Dabigatran Etexilate 220 mg - Part 2 Ticagrelor 180 mg - Part 2 Dabi 75 mg - Part 3 Multiple Dose Ticagrelor - Part 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran Etexilate 220 mg - Part 1 Ticagrelor 180 mg - Part 1 Dabigatran Etexilate 220 mg - Part 2 Ticagrelor 180 mg - Part 2 Dabi 75 mg - Part 3 Multiple Dose Ticagrelor - Part 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/4 (0.00%)   0/8 (0.00%)   0/4 (0.00%)   0/12 (0.00%)   0/12 (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 Etexilate 220 mg - Part 1 Ticagrelor 180 mg - Part 1 Dabigatran Etexilate 220 mg - Part 2 Ticagrelor 180 mg - Part 2 Dabi 75 mg - Part 3 Multiple Dose Ticagrelor - Part 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/8 (12.50%)   0/4 (0.00%)   0/8 (0.00%)   0/4 (0.00%)   2/12 (16.67%)   3/12 (25.00%) 
Gastrointestinal disorders             
Nausea  1  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Infections and infestations             
Gastrointestinal infection  1  1/8 (12.50%)  0/4 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Musculoskeletal and connective tissue disorders             
Neck pain  1  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%)  1/12 (8.33%) 
Skin and subcutaneous tissue disorders             
Erythema  1  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Rash  1  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 15.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
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: NCT01595854     History of Changes
Other Study ID Numbers: 1160.141
2012-000874-42 ( EudraCT Number: EudraCT )
First Submitted: May 9, 2012
First Posted: May 10, 2012
Results First Submitted: June 18, 2013
Results First Posted: August 22, 2013
Last Update Posted: August 22, 2013