Trial · NCT02564718
Rivaroxaban for Treatment in Venous or Arterial Thrombosis in Neonates
NCT02564718, Phase 1, Phase 2, Completed, Bayer; results first posted 2018-07-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rivaroxaban for Treatment in Venous or Arterial Thrombosis in Neonates. Trials, record NCT02564718. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02564718
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rivaroxaban for Treatment in Venous or Arterial Thrombosis in Neonates
- NCT number
- NCT02564718
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Thromboembolism
- Interventions
- Rivaroxaban (Xarelto, BAY59-7939)
- First posted
- 2015-10-01
- Last updated
- 2018-07-10
- Other registries' IDs
- eudract:2014-002385-74
- Results first posted
- 2018-07-10
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1 | 30 minutes to 1.5 hours post-dose; 2 to 4 hours post-dose (bid dosing) and 30 minutes to 3 hours post-dose; 7 to 8 hours post-dose on Day 1 (tid dosing) | Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated. |
| Primary | Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 3 | 2 to 8 hours post-dose (bid dosing) and 30 minutes to 3 hours post-dose; 7 to 8 hours post-dose on Day 3 (tid dosing) | Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated. |
| Primary | Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 8 | 10 to 16 hours post-dose on Day 8 (bid dosing) | Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated. |
| Primary | Change From Baseline in Prothrombin Time at Day 1 | 10-16 hours post-dose on Day 8 (baseline), 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing) | Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade. |
| Primary | Change From Baseline in Prothrombin Time at Day 3 | 10-16 hours post-dose on Day 8 (baseline), 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing) | Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade. |
| Primary | Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 1 | 10-16 hours post-dose on Day 8 (baseline), 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing) | The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway and is sensitive for deficiencies of factors I, II, V, VIII, IX, X, XI and XII. |
| Primary | Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 3 | 10-16 hours post-dose on Day 8 (baseline), 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing) | The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway and is sensitive for deficiencies of factors I, II, V, VIII, IX, X, XI and XII. |
| Primary | Anti-factor Xa Activity (Anti-Xa) Values at Day 1 | 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing) | The individual anti-Factor Xa activity was determined ex-vivo using a photometric method. |
| Primary | Anti-factor Xa Activity (Anti-Xa) Values at Day 3 | 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing) | The individual anti-Factor Xa activity was determined ex-vivo using a photometric method. |
| Primary | Anti-factor Xa Activity (Anti-Xa) Values at Day 8 | 10-16 hours post-dose on Day 8 (both bid and tid dosing) | The individual anti-Factor Xa activity was determined ex-vivo using a photometric method. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1 | 30 minutes to 1.5 hours post-dose; 2 to 4 hours post-dose (bid dosing) and 30 minutes to 3 hours post-dose; 7 to 8 hours post-dose on Day 1 (tid dosing) | Pharmacokinetic (PK) analysis set (PKS) included all participants with at least one PK sample in accordance with the PK sampling strategy. | microgram per liter (mcg/L) | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events | From start of study drug administration until 30-day post study treatment period | Safety analysis set (SAF) included all participants who received at least one dose of rivaroxaban. | count of participants | NUMBER |
| SECONDARY | Number of Participants With Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging | From start of study drug administration until 30-day post study treatment period | Full analysis set (FAS) included all participants from whom informed consent was obtained and who contributed any data thereafter. | count of participants | NUMBER |
| PRIMARY | Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 3 | 2 to 8 hours post-dose (bid dosing) and 30 minutes to 3 hours post-dose; 7 to 8 hours post-dose on Day 3 (tid dosing) | PKS included all participants with at least one PK sample in accordance with the PK sampling strategy. | microgram per liter (mcg/L) | GEOMETRIC_MEAN |
| PRIMARY | Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 8 | 10 to 16 hours post-dose on Day 8 (bid dosing) | PKS included all participants with at least one PK sample in accordance with the PK sampling strategy. | microgram per liter (mcg/L) | GEOMETRIC_MEAN |
| PRIMARY | Change From Baseline in Prothrombin Time at Day 1 | 10-16 hours post-dose on Day 8 (baseline), 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing) | Pharmacodynamic (PD) analysis set (PDS) included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis. | seconds (sec) | MEAN |
| PRIMARY | Change From Baseline in Prothrombin Time at Day 3 | 10-16 hours post-dose on Day 8 (baseline), 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing) | PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis. | seconds (sec) | MEAN |
| PRIMARY | Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 1 | 10-16 hours post-dose on Day 8 (baseline), 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing) | PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis. | seconds (sec) | MEAN |
| PRIMARY | Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 3 | 10-16 hours post-dose on Day 8 (baseline), 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing) | PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis. | seconds (sec) | MEAN |
| PRIMARY | Anti-factor Xa Activity (Anti-Xa) Values at Day 1 | 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing) | PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis. | microgram per liter (mcg/L) | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1 | Rivaroxaban (BAY59-7939) Suspension Bid | 30 minutes to 1.5 hours post-dose | 85.2001 | Geometric Coefficient of Variation 37.72 | microgram per liter (mcg/L) |
| Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1 | Rivaroxaban (BAY59-7939) Suspension Tid | 30 minutes to 3 hours post-dose | 42.6837 | Geometric Coefficient of Variation 39.35 | microgram per liter (mcg/L) |
| Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1 | Rivaroxaban (BAY59-7939) Suspension Bid | 2 to 4 hours post-dose | 73.7641 | Geometric Coefficient of Variation 64.38 | microgram per liter (mcg/L) |
| Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1 | Rivaroxaban (BAY59-7939) Suspension Tid | 7 to 8 hours post-dose | 12.1027 | Geometric Coefficient of Variation 130.13 | microgram per liter (mcg/L) |
| Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events | Rivaroxaban (BAY59-7939) Suspension Bid | Major bleeding events | 0 | count of participants | |
| Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events | Rivaroxaban (BAY59-7939) Suspension Tid | Major bleeding events | 0 | count of participants | |
| Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events | Rivaroxaban (BAY59-7939) Suspension Bid | Clinically relevant non-major bleeding events | 0 | count of participants | |
| Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events | Rivaroxaban (BAY59-7939) Suspension Tid | Clinically relevant non-major bleeding events | 0 | count of participants | |
| Number of Participants With Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging | Rivaroxaban (BAY59-7939) Suspension Bid | Symptomatic recurrent venous thromboembolism | 0 | count of participants | |
| Number of Participants With Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging | Rivaroxaban (BAY59-7939) Suspension Tid | Symptomatic recurrent venous thromboembolism | 0 | count of participants |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rivaroxaban (BAY59-7939) Suspension Bid | 5 | |
| Overall Study | STARTED | Rivaroxaban (BAY59-7939) Suspension Tid | 5 | |
| Overall Study | COMPLETED | Rivaroxaban (BAY59-7939) Suspension Bid | 5 | |
| Overall Study | COMPLETED | Rivaroxaban (BAY59-7939) Suspension Tid | 4 | |
| Overall Study | NOT COMPLETED | Rivaroxaban (BAY59-7939) Suspension Bid | 0 | |
| Overall Study | NOT COMPLETED | Rivaroxaban (BAY59-7939) Suspension Tid | 1 |
Source ClinicalTrials.gov
Adverse events4
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 | Vomiting | Gastrointestinal disorders | Rivaroxaban (BAY59-7939) Suspension Bid | 1 | 5 | 1 |
| other | Vomiting | Gastrointestinal disorders | Rivaroxaban (BAY59-7939) Suspension Tid | 0 | 5 | 0 |
| serious | Atrial thrombosis | Cardiac disorders | Rivaroxaban (BAY59-7939) Suspension Bid | 0 | 5 | 0 |
| serious | Atrial thrombosis | Cardiac disorders | Rivaroxaban (BAY59-7939) Suspension Tid | 1 | 5 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rivaroxaban (BAY59-7939) Suspension Bid | 0 | 5 |
| Total, all-cause mortality | Rivaroxaban (BAY59-7939) Suspension Tid | 0 | 5 |
| Total, other adverse events | Rivaroxaban (BAY59-7939) Suspension Bid | 1 | 5 |
| Total, other adverse events | Rivaroxaban (BAY59-7939) Suspension Tid | 0 | 5 |
| Total, serious adverse events | Rivaroxaban (BAY59-7939) Suspension Bid | 0 | 5 |
| Total, serious adverse events | Rivaroxaban (BAY59-7939) Suspension Tid | 1 | 5 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31420317 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rivaroxaban (BAY59-7939) Suspension Bid vs Rivaroxaban (BAY59-7939) Suspension Tid: deaths from any cause | Trial comparisons |
| Rivaroxaban (BAY59-7939) Suspension Bid vs Rivaroxaban (BAY59-7939) Suspension Tid: serious adverse events | Trial comparisons |
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.
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/NCT02564718
GET https://conductscience.org/api/trials/v1/NCT02564718/results?page=2