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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01145859




Registration number
NCT01145859
Ethics application status
Date submitted
16/06/2010
Date registered
17/06/2010
Date last updated
6/08/2015

Titles & IDs
Public title
Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects
Scientific title
Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism
Secondary ID [1] 0 0
2009-017313-30
Secondary ID [2] 0 0
12892
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis 0 0
Pediatrics 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)

Experimental: Arm 1 -


Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetics parameters (AUC and Cmax)
Timepoint [1] 0 0
From Day 1 to Day 2
Primary outcome [2] 0 0
Pharmacodynamics parameters (PT, aPTT and anti-factor Xa)
Timepoint [2] 0 0
From Day 1 to Day 2
Secondary outcome [1] 0 0
Safety and tolerability of rivaroxaban in pediatric subjects
Timepoint [1] 0 0
Day 1, day 2 plus 7 days follow up

Eligibility
Key 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
Minimum age
6 Months
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2015
Sample size
Target
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
- Brisbane
Recruitment hospital [2] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
Austria
State/province [11] 0 0
Linz
Country [12] 0 0
Austria
State/province [12] 0 0
Wien
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
France
State/province [15] 0 0
CLERMONT-FERRAND Cedex 1
Country [16] 0 0
France
State/province [16] 0 0
Montpellier
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
France
State/province [18] 0 0
TOULOUSE Cedex 9
Country [19] 0 0
Germany
State/province [19] 0 0
Schleswig-Holstein
Country [20] 0 0
Ireland
State/province [20] 0 0
Dublin
Country [21] 0 0
Israel
State/province [21] 0 0
Jerusalem
Country [22] 0 0
Israel
State/province [22] 0 0
Tel Hashomer
Country [23] 0 0
Italy
State/province [23] 0 0
Genova
Country [24] 0 0
Italy
State/province [24] 0 0
Milano
Country [25] 0 0
Italy
State/province [25] 0 0
Pavia
Country [26] 0 0
Italy
State/province [26] 0 0
Torino
Country [27] 0 0
Switzerland
State/province [27] 0 0
Basel-Stadt

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Janssen Research & Development, LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01145859
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01145859