Studies
| Study First Submitted Date | 2021-11-16 |
| Study First Posted Date | 2022-01-11 |
| Last Update Posted Date | 2022-03-18 |
| Verification Month Year | March 2022 |
| Verification Date | 2022-03-31 |
| Last Update Posted Date | 2022-03-18 |
Facilities
| Sequence: | 201060440 |
| Status | Available |
| Name | Childrens Hospital Of Philadelphia |
| City | Philadelphia |
| State | Pennsylvania |
| Zip | 19104 |
| Country | United States |
Facility Contacts
| Sequence: | 28253369 |
| Facility Id | 201060440 |
| Contact Type | primary |
| Name | Andrew Glatz, Site 0001 |
Browse Interventions
| Sequence: | 96472880 | Sequence: | 96472881 | Sequence: | 96472882 | Sequence: | 96472883 | Sequence: | 96472884 | Sequence: | 96472885 | Sequence: | 96472886 | Sequence: | 96472887 |
| Mesh Term | Apixaban | Mesh Term | Factor Xa Inhibitors | Mesh Term | Antithrombins | Mesh Term | Serine Proteinase Inhibitors | Mesh Term | Protease Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Anticoagulants |
| Downcase Mesh Term | apixaban | Downcase Mesh Term | factor xa inhibitors | Downcase Mesh Term | antithrombins | Downcase Mesh Term | serine proteinase inhibitors | Downcase Mesh Term | protease inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | anticoagulants |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Id Information
| Sequence: | 40347778 |
| Id Source | org_study_id |
| Id Value | CV185-826 |
Countries
| Sequence: | 42780815 |
| Name | United States |
| Removed | False |
Interventions
| Sequence: | 52746122 |
| Intervention Type | Drug |
| Name | Apixaban |
| Description | Administered as directed by treating physician |
Sponsors
| Sequence: | 48565090 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Bristol-Myers Squibb |
Overall Officials
| Sequence: | 29423367 |
| Role | Study Director |
| Name | Bristol-Myers Squibb |
| Affiliation | Bristol-Myers Squibb |
Central Contacts
| Sequence: | 12078323 | Sequence: | 12078324 |
| Contact Type | primary | Contact Type | backup |
| Name | Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, | Name | First line of the email MUST contain NCT # and Site #. |
| Phone | please email: | ||
| Clinical.Trials@bms.com | |||
| Role | Contact | Role | Contact |
Eligibilities
| Sequence: | 30917404 |
| Gender | All |
| Minimum Age | 28 Days |
| Maximum Age | 17 Years |
| Criteria | Inclusion Criteria: Pediatric patients with Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention Previously participated in the CV185-362 study and was on apixaban for 1 year or until treatment was no longer required Exclusion Criteria: Weight less than 5 kg or greater than 35 kg Other inclusion/exclusion criteria apply |
| Adult | False |
| Child | True |
| Older Adult | False |
Calculated Values
| Sequence: | 254184542 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | True |
| Minimum Age Num | 28 |
| Maximum Age Num | 17 |
| Minimum Age Unit | Days |
| Maximum Age Unit | Years |
Intervention Other Names
| Sequence: | 26805230 |
| Intervention Id | 52746122 |
| Name | Eliquis |
Links
| Sequence: | 4408329 | Sequence: | 4408330 | Sequence: | 4408331 | Sequence: | 4408332 |
| Url | https://www.bms.com/healthcare-providers/early-patient-access-to-investigational-medicine/investigational-drugs-available.html | Url | https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html | Url | https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm | Url | https://www.bmsstudyconnect.com/s/US/English/USenHome |
| Description | Pre-Approval Access (PAA) Healthcare Practitioner Requests | Description | BMS Clinical Trial Information | Description | FDA Safety Alerts and Recalls | Description | BMS Clinical Trial Patient Recruiting |
Responsible Parties
| Sequence: | 29029773 |
| Responsible Party Type | Sponsor |