Trial Condition(s):

Venous thrombosis, Pediatrics

Rivaroxaban pharmacokinetics/pharmacodynamics (PK/PD) study in Pediatric subjects

Bayer Identifier:

12892

ClinicalTrials.gov Identifier:

NCT01145859

EudraCT Number:

2009-017313-30

Study Completed

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.

Inclusion Criteria
- Pediatric subjects > 6 months and < 18 years of age at the time of administration of study drug.
 - Patients who have completed treatment of VTE, but are considered to have risk for recurrence of VTE
Exclusion Criteria
- Any major or clinically relevant bleeding during prior VTE treatment
 - Abnormal coagulation tests within 7 days prior to study drug administration
 - Severe renal impairment
 - Planned invasive procedures prior to or after 24 hours of study drug administration

Trial Summary

Enrollment Goal
59
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Lübeck, Germany, 23538

Status
Terminated
 
Locations

Investigative Site

Los Angeles, United States, 90027-6089

Status
Completed
 
Locations

Investigative Site

Genova, Italy, 16147

Status
Completed
 
Locations

Investigative Site

Torino, Italy, 10126

Status
Completed
 
Locations

Investigative Site

Hamilton, Canada, L8N 3Z5

Status
Completed
 
Locations

Investigative Site

Edmonton, Canada, T6G 1C9

Status
Completed
 
Locations

Investigative Site

Ramat Gan, Israel, 5262000

Status
Completed
 
Locations

Investigative Site

Parkville, Australia, 3052

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1090

Status
Completed
 
Locations

Investigative Site

Chicago, United States, 60611

Status
Completed
 
Locations

Investigative Site

Detroit, United States, 48201-2196

Status
Terminated
 
Locations

Investigative Site

Jerusalem, Israel, 9112001

Status
Completed
 
Locations

Investigative Site

Philadelphia, United States, 19104

Status
Terminated
 
Locations

Investigative Site

Toronto, Canada, M5G 1X8

Status
Completed
 
Locations

Investigative Site

Brisbane, Australia, 4029

Status
Terminated
 
Locations

Investigative Site

Cleveland, United States, 44106-6007

Status
Terminated
 
Locations

Investigative Site

Orange, United States, 92868

Status
Terminated
 
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Investigative Site

Indianapolis, United States, 46260

Status
Terminated
 
Locations

Investigative Site

Indianapolis, United States, 46202

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20122

Status
Completed
 
Locations

Investigative Site

TOULOUSE Cedex 9, France, 31059

Status
Completed
 
Locations

Investigative Site

Crumlin, Ireland, 12

Status
Terminated
 
Locations

Investigative Site

PARIS, France, 75015

Status
Completed
 
Locations

Investigative Site

CLERMONT-FERRAND Cedex 1, France, 63003

Status
Terminated
 
Locations

Investigative Site

MONTPELLIER, France, 34059

Status
Terminated
 
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Investigative Site

Little Rock, United States, 72202-3500

Status
Completed
 
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Investigative Site

Basel, Switzerland, 4056

Status
Terminated
 
Locations

Investigative Site

St. Petersburg, United States, 33701

Status
Terminated
 
Locations

Investigative Site

New Hyde Park, United States, 11040

Status
Completed
 
Locations

Investigative Site

Linz, Austria, 4020

Status
Terminated
 
Locations

Investigative Site

Pittsburgh, United States, 15224

Status
Terminated
 
Locations

Investigative Site

Gainesville, United States, 32610

Status
Terminated
 
Locations

Investigative Site

Los Angeles, United States, 90095

Status
Terminated
 
Locations

Investigative Site

Durham, United States, 27710

Status
Terminated
 
Locations

Investigative Site

Chapel Hill, United States, 27514

Status
Completed
 
Locations

Investigative Site

Pavia, Italy, 27100

Status
Terminated
 

Trial Design