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Last Updated: March 1, 2021

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CLINICAL TRIALS PROFILE FOR XARELTO

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505(b)(2) Clinical Trials for Xarelto

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT04511611 Study to Compare the Effect of the Formulations (Orally Disintegrating Tablet and Film-coated Tablet) on Bioequivalence of Drug Rivaroxaban (Xarelto) at Dose of 10 mg in Japanese Healthy Male Adult Subjects Completed Janssen Research & Development, LLC Phase 1 2019-01-24 Researchers in this study wanted to compare the effect of the formulation (orally disintegrating tablet and film-coated tablet) on the bioequivalence of drug Rivaroxaban (brand name: Xarelto) at dose of 10 mg in Japanese healthy male subjects aged 20 to 40 years. Rivaroxaban is an approved drug to be used for the prevention of events/diseases caused by blood clots. Currently, there are two formulations of Rivaroxaban available on the market in Japan and they are film-coated tablets and fine granules. To further improve patients' convenience, a new formulation, orally disintegrating tablet (ODT, a drug dosage form designed to be dissolved on the tongue rather than swallowed whole) is under development. The goal of this study was to compare the effect of this new formulation with film-coated tablets when taken with or without water. Participants in this study received one oral dose of rivaroxaban 10 mg ODT either with or without water and one oral dose of rivaroxaban 10 mg film-tablet. There were at least 5 days between the two doses. Observation for each participant lasted about 6 weeks in total. Blood samples were collected from the participants to measure the blood level of the study drug.
New Formulation NCT04511611 Study to Compare the Effect of the Formulations (Orally Disintegrating Tablet and Film-coated Tablet) on Bioequivalence of Drug Rivaroxaban (Xarelto) at Dose of 10 mg in Japanese Healthy Male Adult Subjects Completed Bayer Phase 1 2019-01-24 Researchers in this study wanted to compare the effect of the formulation (orally disintegrating tablet and film-coated tablet) on the bioequivalence of drug Rivaroxaban (brand name: Xarelto) at dose of 10 mg in Japanese healthy male subjects aged 20 to 40 years. Rivaroxaban is an approved drug to be used for the prevention of events/diseases caused by blood clots. Currently, there are two formulations of Rivaroxaban available on the market in Japan and they are film-coated tablets and fine granules. To further improve patients' convenience, a new formulation, orally disintegrating tablet (ODT, a drug dosage form designed to be dissolved on the tongue rather than swallowed whole) is under development. The goal of this study was to compare the effect of this new formulation with film-coated tablets when taken with or without water. Participants in this study received one oral dose of rivaroxaban 10 mg ODT either with or without water and one oral dose of rivaroxaban 10 mg film-tablet. There were at least 5 days between the two doses. Observation for each participant lasted about 6 weeks in total. Blood samples were collected from the participants to measure the blood level of the study drug.
New Formulation NCT04511637 Study to Compare the Effect of the Formulations (Orally Disintegrating Tablet and Film-coated Tablet) on the Bioequivalence of Drug Rivaroxaban (Xarelto) at Dose of 15 mg in Japanese Healthy Male Adult Subjects Completed Janssen Research & Development, LLC Phase 1 2019-01-21 Researchers in this study wanted to compare the effect of the formulation (orally disintegrating tablet and film-coated tablet) on the bioequivalence of drug Rivaroxaban (brand name: Xarelto) at dose of 15 mg in Japanese healthy male subjects aged 20 to 40 years. Rivaroxaban is an approved drug to be used for the prevention of events/diseases caused by blood clots. Currently, there are two formulations of Rivaroxaban available on the market in Japan and they are film-coated tablets and fine granules. To further improve patients' convenience, a new formulation, orally disintegrating tablet (ODT, a drug dosage form designed to be dissolved on the tongue rather than swallowed whole) is under development. The goal of this study was to compare the effect of this new formulation with film-coated tablets when taken with or without water. Participants in this study received one oral dose of rivaroxaban 15 mg ODT either with or without water and one oral dose of rivaroxaban 15 mg film-tablet. There were at least 5 days between the two doses. Observation for each participant lasted about 6 weeks in total. Blood samples were collected from the participants to measure the blood level of the study drug.
New Formulation NCT04511637 Study to Compare the Effect of the Formulations (Orally Disintegrating Tablet and Film-coated Tablet) on the Bioequivalence of Drug Rivaroxaban (Xarelto) at Dose of 15 mg in Japanese Healthy Male Adult Subjects Completed Bayer Phase 1 2019-01-21 Researchers in this study wanted to compare the effect of the formulation (orally disintegrating tablet and film-coated tablet) on the bioequivalence of drug Rivaroxaban (brand name: Xarelto) at dose of 15 mg in Japanese healthy male subjects aged 20 to 40 years. Rivaroxaban is an approved drug to be used for the prevention of events/diseases caused by blood clots. Currently, there are two formulations of Rivaroxaban available on the market in Japan and they are film-coated tablets and fine granules. To further improve patients' convenience, a new formulation, orally disintegrating tablet (ODT, a drug dosage form designed to be dissolved on the tongue rather than swallowed whole) is under development. The goal of this study was to compare the effect of this new formulation with film-coated tablets when taken with or without water. Participants in this study received one oral dose of rivaroxaban 15 mg ODT either with or without water and one oral dose of rivaroxaban 15 mg film-tablet. There were at least 5 days between the two doses. Observation for each participant lasted about 6 weeks in total. Blood samples were collected from the participants to measure the blood level of the study drug.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Xarelto

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00831714 Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty Completed Bayer N/A 2009-02-01 The main goal is to provide additional information to the risk-benefit assessment of the drug.
NCT01029743 Xarelto Regulatory Post-Marketing Surveillance Completed Bayer N/A 2009-12-01 This study is to identify the following problems and questions with respect to the safety and effectiveness of Xarelto in comparison with other pharmacologic agents in the prophylaxis of venous thromboembolism (VTE) in a large sample of patients who undergo elective total hip replacement (THR) or total knee replacement (TKR) in the real-life conditions in its registered indication(s) as required by Korean Food and Drug Administration (KFDA). 1. Known and unknown adverse reactions, especially serious adverse reactions 2. Incidence of adverse reactions under the routine drug use 3. Factors that may affect the safety of the drug 4. Factors that may affect the effectiveness of the drug 5. Other safety information related to overuse, drug interaction and laboratory abnormalities 6. Other adverse reactions
NCT01210755 Study in Healthy Volunteers of the Reversion by Haemostatic Drugs of the Anticoagulant Effect of New Anti-thrombotics Completed University Hospital, Grenoble Phase 4 2010-11-01 The purpose of this study is to evaluate whether the effect of the two new anticoagulants, Dabigatran and Rivaroxaban, can be reversed by non-specific and specific inhibitors. For Dabigatran the investigators will test the non-specific inhibitors: prothrombin complex concentrate (PCC), recombinant activated coagulation factor VII, and activated prothrombin-complex (FEIBA). For Rivaroxaban the investigators will test a specific Rivaroxaban decoy (FXa-GLAless). This will be done in a laboratory using blood plasma from healthy male volunteers.
NCT01344954 Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery Completed BioInvent International AB Phase 2 2011-04-01 The purpose of this study is to evaluate the safety and efficacy of two doses of TB-402 administered as a single intravenous infusion for the prevention of VTE in subjects undergoing total hip replacement surgery.
NCT01344954 Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery Completed ThromboGenics Phase 2 2011-04-01 The purpose of this study is to evaluate the safety and efficacy of two doses of TB-402 administered as a single intravenous infusion for the prevention of VTE in subjects undergoing total hip replacement surgery.
NCT01444586 Russian Non-Interventional Study on Compliance of Venous Thromboembolism (VTE) Completed Bayer N/A 2011-10-01 This is a local, prospective, multicenter, non-interventional, observational study. Primary objective is to describe how in "real life" thromboprophylaxis is carried out after the discharge from a hospital in the patients who undergo elective knee and hip replacement and who receive Xarelto during hospitalization.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Xarelto

Condition Name

Condition Name for Xarelto
Intervention Trials
Atrial Fibrillation 22
Venous Thromboembolism 15
Venous Thrombosis 6
Bleeding 4
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Condition MeSH

Condition MeSH for Xarelto
Intervention Trials
Atrial Fibrillation 26
Thrombosis 25
Thromboembolism 24
Venous Thromboembolism 22
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Clinical Trial Locations for Xarelto

Trials by Country

Trials by Country for Xarelto
Location Trials
United States 61
Canada 31
Brazil 14
China 12
Japan 11
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Trials by US State

Trials by US State for Xarelto
Location Trials
California 5
Florida 5
North Carolina 5
New York 4
Illinois 4
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Clinical Trial Progress for Xarelto

Clinical Trial Phase

Clinical Trial Phase for Xarelto
Clinical Trial Phase Trials
Phase 4 32
Phase 3 27
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Xarelto
Clinical Trial Phase Trials
Recruiting 33
Not yet recruiting 30
Completed 28
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Clinical Trial Sponsors for Xarelto

Sponsor Name

Sponsor Name for Xarelto
Sponsor Trials
Bayer 33
Janssen Research & Development, LLC 6
Canadian Institutes of Health Research (CIHR) 4
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Sponsor Type

Sponsor Type for Xarelto
Sponsor Trials
Other 171
Industry 58
NIH 2
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