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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001581-15 | EudraCT Number |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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CV185118 is a single dose Apixaban PK/PD study in pediatric participants. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric participants at risk for thrombosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Apixaban (low dose) | Experimental |
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| Group 2A: Apixaban (low dose) | Experimental |
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| Group 2B: Apixaban (low dose) | Experimental |
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| Group 3: Apixaban (low dose) | Experimental |
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| Group 4: Apixaban (low dose) | Experimental |
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| Group 5: Apixaban (low dose) | Experimental |
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| Group 2A (higher dose): Apixaban (low dose) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban | Up to 26 hours, post dose (from Day 1 to Day 2) | |
| Maximum estimated plasma concentration (Cmax) of Apixaban | Up to 26 hours, post dose (from Day 1 to Day 2) | |
| Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban | Up to 26 hours, post dose (from Day 1 to Day 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing |
| Number of participants with Serious Adverse Events (SAEs) |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Participants with any stable disease that are at risk for a venous or arterial thrombotic disorder
Neonates ≥ 34 weeks gestational or ≥ 37 weeks post conceptual age (corrected gestational age) to <18 years of age
Participants with any functional CVAD (Central Venous Access Device) in the upper or lower venous system
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children'S Hospital | Little Rock | Arkansas | 72202-3591 | United States | ||
| Children'S Hospital Of Orange County |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36861188 | Derived | Merali SJ, Byon W, Patel YT, Elsrougy A, Marchisin D, Perera V, Chen W, He B, Murthy B. Evaluation of safety, pharmacokinetics, and pharmacodynamics of apixaban in pediatric subjects at risk of venous or arterial thrombotic disorder. CPT Pharmacometrics Syst Pharmacol. 2023 Apr;12(4):500-512. doi: 10.1002/psp4.12935. Epub 2023 Mar 5. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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|
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
| Up to 30 Days after last dosing |
| Change from baseline in Vital Signs of body temperature | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing |
| Change from baseline in Vital Signs of respiratory rate | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing |
| Change from baseline in Vital Signs of blood pressure | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing |
| Change from baseline in Vital Signs of heart rate | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing |
| Number of participants with abnormalities in Physical Examinations | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing |
| Change from baseline in Clinical Laboratory Tests of blood | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing |
| Change from baseline in Clinical Laboratory Tests of blood serum | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing |
| Change from baseline in Activated partial thromboplastin time (aPTT) clotting activity during treatment | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing |
| Change from baseline in International Normalized Ratio (INR) clotting activity during treatment | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing |
| Change from baseline in Prothrombin Time (PT) clotting activity during treatment | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing |
| Change from baseline in Clinical Laboratory Tests of urine | Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing | Up to 30 Days after last dosing |
| Pharmacodynamics will be analyzed using anti-Factor Xa activity | Up to 26 hours, post dose (from Day 1 to Day 2) |
| Orange |
| California |
| 92868 |
| United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Childrens National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Children's Healthcare Of Atlanta | Atlanta | Georgia | 30322 | United States |
| Blank Childrens Hospital | Des Moines | Iowa | 50309 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Kosair Charities Pediatric Clinical Research Unit | Louisville | Kentucky | 40202 | United States |
| Children'S Mercy Hospital And Clinics | Kansas City | Missouri | 64108 | United States |
| Saint Peter'S University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| ProMedica Toledo Children's Hospital | Toledo | Ohio | 43606 | United States |
| Penn State Hershey Children'S Hospital | Hershey | Pennsylvania | 17033 | United States |
| Childrens Hospital Of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hopsital Of Pittsburgh Of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Children's Hospital Of Pittsburgh Of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Childrens Hospital Of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Local Institution | Parkville | Victoria | 3052 | Australia |
| University of Alberta - Edmonton Clinic Health Academy | Edmonton | Alberta | T6G 1C9 | Canada |
| Local Institution | Hamilton | Ontario | L8S 4K1 | Canada |
| The Hospital For Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Local Institution | Ramat Gan | 52621 | Israel |
| Local Institution | Guadalajara | Jalisco | 44260 | Mexico |
| Local Institution | Mexico City | Mexico City | 04530 | Mexico |
| Local Institution | Mexico City | Mexico City | 14080 | Mexico |
| Local Institution | Monterrey | Nuevo León | 64460 | Mexico |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C522181 | apixaban |
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