Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2013-02-19
2016-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rivaroxaban (BAY59-7939) tablet, OD, Age: 12 - <18
Subjects aged from 12 - \<18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR (immediate-release) tablet once daily (OD) under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram \[mg\] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
Rivaroxaban (Xarelto, BAY59-7939)
Subjects were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
Comparator, Age: 12 - <18 years
Subjects aged from 12 - \<18 years received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist).
Active comparator
Subjects received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist).
Rivaroxaban (BAY59-7939) tablet, OD, Age: 6 - <12 years
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kg received a dose (equivalent to 20 mg in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
Rivaroxaban (Xarelto, BAY59-7939)
Subjects were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
Rivaroxaban (BAY59-7939) suspension, BID, Age: 6 - <12 years
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily (BID). Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
Rivaroxaban (BAY59-7939) suspension
Subjects aged were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily.
Comparator, Age: 6 - <12 years
Subjects aged from 6 - \<12 years received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or INR-adjusted (vitamin K antagonist).
Active comparator
Subjects received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist).
Interventions
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Rivaroxaban (Xarelto, BAY59-7939)
Subjects were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
Active comparator
Subjects received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist).
Rivaroxaban (BAY59-7939) suspension
Subjects aged were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily.
Eligibility Criteria
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Inclusion Criteria
* Informed consent provided and, if applicable, child assent provided
Exclusion Criteria
* Symptomatic progression of venous thrombosis during preceding anticoagulant treatment
* Planned invasive procedures, including lumbar puncture and removal of non peripherally placed central lines during study treatment
* An estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2
* Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk or ALT \> 5x upper level of normal (ULN) or total bilirubin \> 2x ULN with direct bilirubin \> 20% of the total
* Platelet count \< 50 x 10\^9/L
* Hypertension defined as \> 95th age percentile
* Life expectancy \< 3 months
* Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), i.e. all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically
* Concomitant use of strong inducers of CYP3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
6 Years
17 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Little Rock, Arkansas, United States
Los Angeles, California, United States
Orange, California, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
New Hyde Park, New York, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Richmond, Virginia, United States
Westmead, New South Wales, Australia
Parkville, Victoria, Australia
South Brisbane, , Australia
Graz, Styria, Austria
Innsbruck, Tyrol, Austria
Linz, Upper Austria, Austria
Vienna, , Austria
Edmonton, Alberta, Canada
Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Québec, , Canada
Bordeaux, , France
Montpellier, , France
Nantes, , France
Paris, , France
Paris, , France
Rennes, , France
Toulouse, , France
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Erlangen, Bavaria, Germany
Frankfurt am Main, Hesse, Germany
Dresden, Saxony, Germany
Lübeck, Schleswig-Holstein, Germany
Berlin, , Germany
Beersheba, , Israel
Haifa, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Bari, Apulia, Italy
Genoa, Liguria, Italy
Milan, Lombardy, Italy
Pavia, Lombardy, Italy
Turin, Piedmont, Italy
Padua, Veneto, Italy
Amsterdam, , Netherlands
Amsterdam, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
Utrecht, , Netherlands
Basel, Canton of Basel-City, Switzerland
Sankt Gallen, Canton of St. Gallen, Switzerland
Bern, , Switzerland
Lucerne, , Switzerland
Zurich, , Switzerland
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2011-004539-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14373
Identifier Type: -
Identifier Source: org_study_id