Study will assess PK/PD parameters and safety and tolerability of the study medication in this age group
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
age \& weight adjusted equivalent of adult dose
1160.145.00010 Boehringer Ingelheim Investigational Site
Sacramento, California, United States
1160.145.00009 Boehringer Ingelheim Investigational Site
Louisville, Kentucky, United States
1160.145.00008 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
Ecarin clotting time (ECT)
Time frame: one day
Factor IIa inhibition
Time frame: one day
Incidence of all bleeding events
Time frame: 30 days
Incidence of all adverse events
Time frame: 30 days
Plasma concentrations of total dabigatran
Time frame: one day
Plasma concentrations of free dabigatran
Time frame: one day
Plasma concentrations of BIBR 1048 BS (Base)
Time frame: one day
Plasma concentrations of BIBR 951 BS
Time frame: one day
Plasma concentrations of BIBR 1087 SE (Acid)
Time frame: one day
Activated prothrombin time (aPTT)
Time frame: one day
Global assessment of tolerability will be summarized across all patients in the treated set
Time frame: 30 days
Patient assessment of taste will be summarized across all patients in the treated set
Time frame: one day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1160.145.00012 Boehringer Ingelheim Investigational Site
St Louis, Missouri, United States
1160.145.00007 Boehringer Ingelheim Investigational Site
Newark, New Jersey, United States
1160.145.0006 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
1160.145.00001 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1160.145.00011 Boehringer Ingelheim Investigational Site
Spokane, Washington, United States
Changes in laboratory and clinical parameters
Time frame: 30 days