Trial · NCT01684423

Oral Rivaroxaban in Children With Venous Thrombosis

NCT01684423, Phase 2, Completed, Bayer; results first posted 2017-09-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Oral Rivaroxaban in Children With Venous Thrombosis. Trials, record NCT01684423. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01684423

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Oral Rivaroxaban in Children With Venous Thrombosis
NCT number: NCT01684423
Status: Completed
Phases: Phase 2
Enrollment: 64 participants, actual
Lead sponsor: Bayer
Conditions: Venous Thrombosis
Interventions: Rivaroxaban (Xarelto, BAY59-7939), Active comparator, Rivaroxaban (BAY59-7939) suspension
First posted: 2012-09-13
Last updated: 2017-09-21
Other registries' IDs: eudract:2011-004539-30
Results first posted: 2017-09-21

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events	From start of study drug administration until end of the 30-day treatment period	Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and: * associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or * leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or * occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or * contributing to death. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with: * medical intervention, or * unscheduled contact (visit or telephone call) with a physician, or * cessation (temporary) of study treatment, or * discomfort for the child such as pain or * impairment of activities of daily life (such as loss of school days or hospitalization).
Secondary	Number of Subjects With Symptomatic Recurrent Venous Thromboembolism	From start of study drug administration until end of the 30-day treatment period	The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence of venous thrombosis was documented by the appropriate imaging test.
Secondary	Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden	Repeat imaging at the end of the 30 day treatment period	The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. Asymptomatic deterioration in thrombotic burden was documented by the appropriate imaging test and the results were classified as normalized, improved, no relevant change, deteriorated, not evaluable or not available.
Secondary	Change From Baseline in Prothrombin Time at Specified Time Points	0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31	Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.
Secondary	Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points	0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31	The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway.
Secondary	Anti-factor Xa Values at Specified Time Points	0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31	The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.
Secondary	Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points	0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31	Geometric and percentage geometric coefficient of variation (%CV) were reported.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events	From start of study drug administration until end of the 30-day treatment period	Full analysis set. Data was evaluated only for subjects who received active study medication.	Participants	NUMBER
SECONDARY	Number of Subjects With Symptomatic Recurrent Venous Thromboembolism	From start of study drug administration until end of the 30-day treatment period	Full analysis set	Participants	NUMBER
SECONDARY	Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden	Repeat imaging at the end of the 30 day treatment period	Full analysis set	Participants	NUMBER
SECONDARY	Change From Baseline in Prothrombin Time at Specified Time Points	0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31	Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.	seconds	MEAN
SECONDARY	Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points	0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31	Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.	seconds	MEAN
SECONDARY	Anti-factor Xa Values at Specified Time Points	0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31	Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.	microgram per liter (mcg/L)	MEAN
SECONDARY	Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points	0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31	Pharmacokinetic analysis set (N= 42) included all subjects with at least one pharmacokinetic sample in accordance with the pharmacokinetic sampling strategy.	microgram per liter (mcg/L)	GEOMETRIC_MEAN

Source ClinicalTrials.gov

Results by group99

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events	Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years	Major bleeding events	0	Participants
Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events	Comparator, Age: 12 - <18 Years	Major bleeding events	0	Participants
Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events	Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years	Major bleeding events	0	Participants
Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events	Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years	Major bleeding events	0	Participants
Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events	Comparator, Age: 6 - < 12 Years	Major bleeding events	0	Participants
Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events	Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years	Clinically relevant non-major bleeding events	3	Participants
Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events	Comparator, Age: 12 - <18 Years	Clinically relevant non-major bleeding events	0	Participants
Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events	Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years	Clinically relevant non-major bleeding events	0	Participants
Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events	Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years	Clinically relevant non-major bleeding events	1	Participants
Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events	Comparator, Age: 6 - < 12 Years	Clinically relevant non-major bleeding events	0	Participants

1 to 10 of 99Source ClinicalTrials.gov

See all 99 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years	11
Overall Study	STARTED	Comparator, Age: 12 - <18 Years	13
Overall Study	STARTED	Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years	13
Overall Study	STARTED	Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years	19
Overall Study	STARTED	Comparator, Age: 6 - < 12 Years	7
Overall Study	COMPLETED	Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years	11
Overall Study	COMPLETED	Comparator, Age: 12 - <18 Years	13
Overall Study	COMPLETED	Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years	12
Overall Study	COMPLETED	Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years	19
Overall Study	COMPLETED	Comparator, Age: 6 - < 12 Years	7

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events310

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years	0	11	0
other	Anaemia	Blood and lymphatic system disorders	Comparator, Age: 12 - <18 Years	0	13	0
other	Anaemia	Blood and lymphatic system disorders	Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years	0	13	0
other	Anaemia	Blood and lymphatic system disorders	Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years	1	19	1
other	Anaemia	Blood and lymphatic system disorders	Comparator, Age: 6 - < 12 Years	0	7	0
other	Increased tendency to bruise	Blood and lymphatic system disorders	Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years	0	11	0
other	Increased tendency to bruise	Blood and lymphatic system disorders	Comparator, Age: 12 - <18 Years	0	13	0
other	Increased tendency to bruise	Blood and lymphatic system disorders	Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years	1	13	2
other	Increased tendency to bruise	Blood and lymphatic system disorders	Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years	0	19	0
other	Increased tendency to bruise	Blood and lymphatic system disorders	Comparator, Age: 6 - < 12 Years	0	7	0

1 to 10 of 310Source ClinicalTrials.gov

See all 310 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years
Total, all-cause mortality	Comparator, Age: 12 - <18 Years
Total, all-cause mortality	Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years
Total, all-cause mortality	Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years
Total, all-cause mortality	Comparator, Age: 6 - < 12 Years
Total, other adverse events	Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years	9	11
Total, other adverse events	Comparator, Age: 12 - <18 Years	8	13
Total, other adverse events	Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years	6	13
Total, other adverse events	Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years	12	19
Total, other adverse events	Comparator, Age: 6 - < 12 Years	2	7

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01684423

GET https://conductscience.org/api/trials/v1/NCT01684423/results?page=2

API reference For AI assistants