Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
CV185-079 is a multiple dose Apixaban Pharmacokinetics/Pharmacodynamics (PK/PD) study in pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric subjects with a central venous catheter.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 5A - Apixaban (Low Dose) | Experimental | Group 5: 12 years to <18 years; 0.66 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days |
|
| Group 5B - Apixaban (High Dose) | Experimental | Group 5: 12 years to <18 years; 1.32 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK): Model-derived population & individual PK parameters (e.g., CL/F, Vc/F, KA) used to estimate steady state Cmax & AUC(TAU), Cmin & Tmax in each subject. Population PK model will be developed using plasma concentration vs time data | Days 1, 2, Day 5, 6 or 7 and Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of anti-Factor Xa confirmed by analysis of anti-Factor Xa PD analysis | Days 1, 2, Day 5, 6 or 7 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children'S Hospital Of Orange County | Orange | California | 92868 | United States | ||
| Saint Peter'S University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| New Brunswick |
| New Jersey |
| 08901 |
| United States |
| The Toledo Children'S Hospital | Toledo | Ohio | 43606 | United States |
| Penn State Hershey Children'S Hospital | Hershey | Pennsylvania | 17033 | United States |
| Local Institution | Brussels | 1020 | Belgium |
| Local Institution | Leuven | 3000 | Belgium |
| Local Institution | Edmonton | Alberta | T6G 2B7 | Canada |
| Local Institution | Ottawa | Ontario | K1H 8L1 | Canada |
| Local Institution | Guadalajara | Jalisco | 44340 | Mexico |
| Local Institution | Mexico City | Mexico City | 04530 | Mexico |
| Local Institution | Mexico City | Mexico City | 14080 | Mexico |
| Local Institution | Mexico, D. F. | Mexico City | 11000 | Mexico |
| Local Institution | Puebla City | Puebla | 72190 | Mexico |
| Local Institution | Amsterdam | 1105 AZ | Netherlands |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C522181 | apixaban |
Not provided
Not provided
Not provided