check_circleStudy Completed
Venous Thrombosis, Pediatrics
Bayer Identifier:
12892
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Rivaroxaban pharmacokinetics/pharmacodynamics (PK/PD) study in Pediatric subjects
Trial purpose
The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism (VTE) treatment.
Key Participants Requirements
Sex
BothAge
6 - 18 YearsTrial summary
Enrollment Goal
59Trial Dates
November 2010 - July 2015Phase
Phase 1Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | Lübeck, 23538, Germany | |
Completed | Los Angeles, 90027-6089, United States | |
Completed | Genova, 16147, Italy | |
Completed | Torino, 10126, Italy | |
Completed | Hamilton, L8N 3Z5, Canada | |
Completed | Edmonton, T6G 1C9, Canada | |
Completed | Ramat Gan, 5262000, Israel | |
Completed | Parkville, 3052, Australia | |
Completed | Wien, 1090, Austria | |
Completed | Chicago, 60611, United States | |
Terminated | Detroit, 48201-2196, United States | |
Completed | Jerusalem, 9112001, Israel | |
Terminated | Philadelphia, 19104, United States | |
Completed | Toronto, M5G 1X8, Canada | |
Terminated | Brisbane, 4029, Australia | |
Terminated | Cleveland, 44106-6007, United States | |
Terminated | Orange, 92868, United States | |
Terminated | Indianapolis, 46260, United States | |
Completed | Indianapolis, 46202, United States | |
Completed | Milano, 20122, Italy | |
Completed | TOULOUSE Cedex 9, 31059, France | |
Terminated | Crumlin, 12, Ireland | |
Completed | PARIS, 75015, France | |
Terminated | CLERMONT-FERRAND Cedex 1, 63003, France | |
Terminated | MONTPELLIER, 34059, France | |
Completed | Little Rock, 72202-3500, United States | |
Terminated | Basel, 4056, Switzerland | |
Terminated | St. Petersburg, 33701, United States | |
Completed | New Hyde Park, 11040, United States | |
Terminated | Linz, 4020, Austria | |
Terminated | Pittsburgh, 15224, United States | |
Terminated | Gainesville, 32610, United States | |
Terminated | Los Angeles, 90095, United States | |
Terminated | Durham, 27710, United States | |
Completed | Chapel Hill, 27514, United States | |
Terminated | Pavia, 27100, Italy |
Primary Outcome
- Pharmacokinetics parameters (AUC and Cmax)date_rangeTime Frame:From Day 1 to Day 2enhanced_encryptionNoSafety Issue:
- Pharmacodynamics parameters (PT, aPTT and anti-factor Xa)date_rangeTime Frame:From Day 1 to Day 2enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Safety and tolerability of rivaroxaban in pediatric subjectsdate_rangeTime Frame:Day 1, day 2 plus 7 days follow upenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1