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Study will assess PK/PD parameters and safety and tolerability of the study medication in this age group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dabigatran etexilate | Experimental | single dose treatment with dabigatran oral solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dabigatran etexilate | Drug | age & weight adjusted equivalent of adult dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ecarin clotting time (ECT) | one day | |
| Factor IIa inhibition | one day | |
| Incidence of all bleeding events | 30 days | |
| Incidence of all adverse events | 30 days | |
| Plasma concentrations of total dabigatran | one day | |
| Plasma concentrations of free dabigatran | one day | |
| Plasma concentrations of BIBR 1048 BS (Base) | one day | |
| Plasma concentrations of BIBR 951 BS | one day | |
| Plasma concentrations of BIBR 1087 SE (Acid) | one day | |
| Activated prothrombin time (aPTT) | one day |
| Measure | Description | Time Frame |
|---|---|---|
| Global assessment of tolerability will be summarized across all patients in the treated set | 30 days | |
| Patient assessment of taste will be summarized across all patients in the treated set | one day |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1160.145.00010 Boehringer Ingelheim Investigational Site | Sacramento | California | United States | |||
| 1160.145.00009 Boehringer Ingelheim Investigational Site |
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| Changes in laboratory and clinical parameters | 30 days |
| Louisville |
| Kentucky |
| United States |
| 1160.145.00008 Boehringer Ingelheim Investigational Site | Boston | Massachusetts | United States |
| 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 |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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