You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 24, 2024

~ Buy the XARELTO (rivaroxaban) Drug Profile, 2024 PDF Report in the Report Store ~

CLINICAL TRIALS PROFILE FOR XARELTO


✉ Email this page to a colleague

« Back to Dashboard


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 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
NCT01029743 ↗ Xarelto Regulatory Post-Marketing Surveillance Completed Bayer 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.
>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 18
Venous Thrombosis 6
Stroke 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for xarelto
Intervention Trials
Thrombosis 30
Thromboembolism 28
Atrial Fibrillation 27
Venous Thromboembolism 25
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for xarelto

Trials by Country

Trials by Country for xarelto
Location Trials
United States 145
Canada 51
China 27
Brazil 19
Germany 17
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for xarelto
Location Trials
California 9
Florida 8
New York 7
Illinois 7
Texas 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for xarelto

Clinical Trial Phase

Clinical Trial Phase for xarelto
Clinical Trial Phase Trials
Phase 4 32
Phase 3 31
Phase 2/Phase 3 5
[disabled in preview] 26
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for xarelto
Clinical Trial Phase Trials
Completed 58
Recruiting 26
Not yet recruiting 13
[disabled in preview] 24
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 14
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for xarelto
Sponsor Trials
Other 232
Industry 86
NIH 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.