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Last Updated: May 28, 2022

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.
>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 Janssen Research & Development, LLC 2009-02-01 The main goal is to provide additional information to the risk-benefit assessment of the drug.
NCT00831714 ↗ Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty Completed Bayer 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 Janssen Research & Development, LLC 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
>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 16
Venous Thrombosis 6
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Condition MeSH

Condition MeSH for Xarelto
Intervention Trials
Thrombosis 28
Atrial Fibrillation 27
Thromboembolism 25
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Clinical Trial Locations for Xarelto

Trials by Country

Trials by Country for Xarelto
Location Trials
United States 145
Canada 51
China 26
Brazil 19
Germany 17
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Trials by US State

Trials by US State for Xarelto
Location Trials
California 9
Florida 8
New York 7
Illinois 7
Texas 6
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Clinical Trial Progress for Xarelto

Clinical Trial Phase

Clinical Trial Phase for Xarelto
Clinical Trial Phase Trials
Phase 4 31
Phase 3 29
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Xarelto
Clinical Trial Phase Trials
Completed 58
Recruiting 23
Unknown status 12
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Clinical Trial Sponsors for Xarelto

Sponsor Name

Sponsor Name for Xarelto
Sponsor Trials
Bayer 38
Janssen Research & Development, LLC 19
Janssen Scientific Affairs, LLC 8
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Sponsor Type

Sponsor Type for Xarelto
Sponsor Trials
Other 218
Industry 86
NIH 4
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