Clinical trials: Rivaroxaban
Thrombosis
Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure
The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8…
- Trial name
- UNIVERSE (NCT02846532)
- Testing
- Rivaroxaban, Acetylsalicylic Acid
- Where
- 42 sites in United States, Argentina and 8 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Venous Thromboembolism
An Observational Study to Learn More About How Safe Treatment With Rivaroxaban is in Children in Japan With Venous Thromboembolism
This is an observational study in which only data will be collected from children with venous thromboembolism who are prescribed rivaroxaban or warfarin by their doctors.
- Trial name
- NCT06278051
- Testing
- Rivaroxaban granules for oral suspension, Warfarin
- Where
- 2 sites in Japan
- Volunteers
- 320 people
- Sponsor
- Bayer
Atrial Fibrillation
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
The purpose of the study is to compare the one-year and two-year risk of each of the following individual outcomes: Stroke and systemic embolism (SE), major bleeding and death between new users of anticoagulant for Stroke…
- Trial name
- BROTHER (NCT02864758)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Vitamin K antagonists, dabigatran (Pradaxa)
- Where
- France
- Volunteers
- 99,999 people
- Sponsor
- Bayer
Venous Thromboembolism
EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis
The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. Safety will be assessed by looking at the incidence and types of bleeding events.
- Trial name
- EINSTEINJr (NCT02309411)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 29 sites in United States, Australia and 13 more
- Volunteers
- 46 people
- Sponsor
- Bayer
Venous Thromboembolism
EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis
The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.
- Trial name
- EINSTEIN Jr (NCT02234843)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Standard of Care
- Where
- 109 sites in United States, Argentina and 26 more
- Volunteers
- 500 people
- Sponsor
- Bayer
Venous Thromboembolism, Children Under 2 Years
A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolism (VTE)
This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE).
- Trial name
- XAPAEDUS (NCT05900388)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Standard of care (SOC)
- Where
- 4 sites in Denmark, France and 2 more
- Volunteers
- 850 people
- Sponsor
- Bayer
Thromboembolism
Rivaroxaban for Treatment in Venous or Arterial Thrombosis in Neonates
The purpose of this study is to find out whether rivaroxaban is safe and effective to use in children age newborn to less than 6 months and how long it stays in the body and how it is used in the body.
- Trial name
- Einstein Jr (NCT02564718)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 9 sites in Austria, France and 5 more
- Volunteers
- 10 people
- Sponsor
- Bayer
Thrombosis
Phase I Study on Rivaroxaban Granules for Oral Suspension Formulation in Children
To characterize the pharmacokinetic profile of rivaroxaban administered as granules for suspension formulation and to document safety and tolerability
- Trial name
- NCT02497716
- Testing
- Rivaroxaban (Xarelto, BAY59-7939
- Where
- 21 sites in United States, Belgium and 6 more
- Volunteers
- 47 people
- Sponsor
- Bayer
Prevention of Venous Thromboembolism, Congenital Heart Disease
An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure
This is an observational study in which the data from children with congenital heart disease will be collected and studied. These children will include those who are prescribed rivaroxaban by their doctors after a heart surgery…
- Conditions
- Prevention of Venous Thromboembolism, Congenital Heart Disease, Fontan Procedure, Children
- Trial name
- NCT06193863
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- Japan
- Volunteers
- 61 people
- Sponsor
- Bayer
Venous Thrombosis, Pediatrics
Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects
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.
- Trial name
- NCT01145859
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 36 sites in United States, Australia and 8 more
- Volunteers
- 59 people
- Sponsor
- Bayer
Venous Thrombosis, Pulmonary Embolism
Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Germany)
This prospective cohort study will provide information about: characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed Phenprocoumon for the first…
- Conditions
- Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation, Acute Coronary Syndrome
- Trial name
- NCT01947959
- Testing
- Rivaroxaban (Xarelto, Bay59-7939), Standard of care
- Where
- Germany
- Volunteers
- 665,533 people
- Sponsor
- Bayer
Venous Thrombosis, Pulmonary Embolism
Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice (UK)
This prospective cohort study will provide information about: characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed Warfarin for the first time…
- Conditions
- Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation, Acute Coronary Syndrome
- Trial name
- NCT01947998
- Testing
- Rivaroxaban (Xarelto, Bay59-7939), Warfarin, Antiplatelet drugs
- Where
- United Kingdom
- Volunteers
- 50,299 people
- Sponsor
- Bayer
Acute Coronary Syndrome, Venous Thrombosis
Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Sweden)
This prospective cohort study will provide information about: Characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed standard of care for the first…
- Conditions
- Acute Coronary Syndrome, Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation
- Trial name
- NCT02468102
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Standard of care drugs
- Where
- Sweden
- Volunteers
- 99,999 people
- Sponsor
- Bayer
Venous Thrombosis
Oral Rivaroxaban in Children With Venous Thrombosis
The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. There will also be a check for bleeding and worsening of blood clots.
- Trial name
- EINSTEINJunior (NCT01684423)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Active comparator, Rivaroxaban (BAY59-7939) suspension
- Where
- 59 sites in United States, Australia and 8 more
- Volunteers
- 64 people
- Sponsor
- Bayer
Venous Thrombosis, Pulmonary Embolism
Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice (Netherlands)
This prospective cohort study will provide information about: characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed Acenocoumarol for the first…
- Conditions
- Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation, Acute Coronary Syndrome
- Trial name
- NCT01947985
- Testing
- Rivaroxoban (Xarelto, Bay59-7939), Standard of care
- Where
- Netherlands
- Volunteers
- 208,958 people
- Sponsor
- Bayer
Brain Ischemia
Xarelto [SPAF] Post-marketing Surveillance in Japan
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF.
- Trial name
- NCT01582737
- Testing
- Rivaroxaban(Xarelto, BAY59-7939)
- Where
- Japan
- Volunteers
- 11,310 people
- Sponsor
- Bayer
Venous Thromboembolism
Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)
The objective of this investigation is to assess safety and effectiveness of Xarelto under practice routine use in VTE secondary prevention after acute DVT, focusing on hemorrhagic-related AEs, recurrent venous thromboembolism…
- Trial name
- JPMS-XAR-VTE (NCT02558465)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- Japan
- Volunteers
- 2,540 people
- Sponsor
- Bayer