Study to Evaluate a Single Dose of Apixaban in Pediatric Subjects at Risk for a Thrombotic Disorder
Overview[ - collapse ][ - ]
| Purpose | CV185118 is a single dose Apixaban PK/PD study in pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric subjects at risk for thrombosis |
|---|---|
| Condition | Thromboembolism |
| Intervention | Drug: Apixaban |
| Phase | Phase 1 |
| Sponsor | Bristol-Myers Squibb |
| Responsible Party | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier | NCT01707394 |
| First Received | October 12, 2012 |
| Last Updated | October 1, 2013 |
| Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 12, 2012 |
|---|---|
| Last Updated Date | October 1, 2013 |
| Start Date | February 2013 |
| Estimated Primary Completion Date | May 2015 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Study to Evaluate a Single Dose of Apixaban in Pediatric Subjects at Risk for a Thrombotic Disorder |
|---|---|
| Official Title | Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects at Risk for a Venous or Arterial Thrombotic Disorder |
| Brief Summary | CV185118 is a single dose Apixaban PK/PD study in pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric subjects at risk for thrombosis |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label |
| Condition | Thromboembolism |
| Intervention | Drug: Apixaban Other Names: BMS-562247 |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 40 |
| Estimated Completion Date | May 2015 |
| Estimated Primary Completion Date | May 2015 |
| Eligibility Criteria | Inclusion Criteria: - Subjects with stable disease that are at risk for a venous or arterial thrombotic Neonates > 37 weeks gestation at birth to < 18 years of age Exclusion Criteria: - Current or recent (within 3 months of study drug administration) gastrointestinal disease or gastrointestinal surgery that, in the opinion of the investigator and the BMS Medical Monitor, could impact the absorption of the study drug - Active bleeding or high risk of bleeding |
| Gender | Both |
| Ages | 37 Weeks |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com |
| Location Countries | United States, Canada, Israel, Mexico |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01707394 |
|---|---|
| Other Study ID Numbers | CV185-118 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Bristol-Myers Squibb |
| Study Sponsor | Bristol-Myers Squibb |
| Collaborators | Pfizer |
| Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
| Verification Date | October 2013 |
Locations[ + expand ][ + ]
| Arkansas Children'S Hospital | Little Rock, Arkansas, United States, 72202-3591 Contact: Parthak Prodhan, Site 0004 | 501-364-2596Recruiting |
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| Local Institution | Orange, California, United States, 92868 Contact: Site 0025Not yet recruiting |
| Local Institution | Hartford, Connecticut, United States, 06106 Contact: Site 0026Not yet recruiting |
| Local Institution | Washington, District of Columbia, United States, 20010 Contact: Site 0022Not yet recruiting |
| Local Institution | Washington, District of Columbia, United States, 20007 Contact: Site 0017Not yet recruiting |
| Local Institution | Atlanta, Georgia, United States, 30322 Contact: Site 0019Not yet recruiting |
| Kosair Charities Pediatric Clinical Research Unit | Louisville, Kentucky, United States, 40202 Contact: Janice Sullivan, Site 0001Recruiting |
| Children'S Mercy Hospital And Clinics | Kansas City, Missouri, United States, 64108 Contact: Keith August, Site 0013 | 816-234-3000Recruiting |
| Local Institution | New Brunswick, New Jersey, United States, 08901 Contact: Site 0006Not yet recruiting |
| Local Institution | New Brunswick, New Jersey, United States, 08903 Contact: Site 0023Not yet recruiting |
| Local Institution | Bronx, New York, United States, 10467 Contact: Site 0024Not yet recruiting |
| Local Institution | Durham, North Carolina, United States, 27710 Contact: Site 0015Not yet recruiting |
| Local Institution | Toledo, Ohio, United States, 43606 Contact: Site 0003Not yet recruiting |
| Local Institution | Hershey, Pennsylvania, United States, 17033 Contact: Site 0002Not yet recruiting |
| Local Institution | Pittsburgh, Pennsylvania, United States, 15224 Contact: Site 0016Not yet recruiting |
| Local Institution | San Antonio, Texas, United States, 78229-3900 Contact: Site 0018Not yet recruiting |
| Local Institution | Milwaukee, Wisconsin, United States, 53226 Contact: Site 0005Not yet recruiting |
| Local Institution | Edmonton, Alberta, Canada, T6G 1C9 Contact: Site 0014Recruiting |
| Local Institution | Toronto, Ontario, Canada, M5G 1X8 Contact: Site 0012Not yet recruiting |
| Local Institution | Ramat Gan, Israel, 52621 Contact: Site 0021Recruiting |
| Local Institution | Ramat Gan, Israel, 52621 Contact: Site 0027Recruiting |
| Local Institution | Mexico, Distrito Federal, Mexico, 04530 Contact: Site 0008Not yet recruiting |
| Local Institution | Mexico City, Distrito Federal, Mexico, 14080 Contact: Site 0007Recruiting |
| Local Institution | Guadalajara, Jalisco, Mexico, 44260 Contact: Site 0010Recruiting |
| Local Institution | Monterrey, Nuevo Leon, Mexico, 64460 Contact: Site 0009Recruiting |