RIVAROXABAN ( DrugBank: Rivaroxaban )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ1
49全身性エリテマトーデス3
91バッド・キアリ症候群2
210単心室症4

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR1800014584
2018-03-012018-01-22Clinical efficacy of small dose aspirin in the prevention of deep venous thrombosis and pulmonary embolism after total knee arthroplasty.Clinical efficacy of small dose aspirin in the prevention of deep venous thrombosis and pulmonary embolism after total knee arthroplasty. Knee osteoartritis;Rheumatoid arthritisExperimental group:Asprin;Controlled group:Rivaroxaban;Department of Orthopaedics, West China Hospital, Sichuan UniversityNULLPending70100BothExperimental group:90;Controlled group:30;China

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03684564
(ClinicalTrials.gov)
July 9, 202113/8/2018RIvaroxaban for Stroke Patients With AntiPhospholipid SyndromeRivaroxaban Versus Warfarin for Stroke Patients With Antiphospholipid Syndrome, With or Without SLE (RISAPS): a Randomised, Controlled, Open Label, Phase II/III, Non-inferiority TrialAntiphospholipid Syndrome;Systemic Lupus Erythematosus;Stroke;Ischemic Stroke;Brain IschemiaDrug: Rivaroxaban;Drug: WarfarinUniversity College, LondonUniversity College London Hospitals;Barking, Havering and Redbridge University Hospitals NHS Trust;Hammersmith Hospitals NHS Trust;Epsom and St Helier University Hospitals NHS Trust;Barts & The London NHS Trust;King's College Hospital NHS Trust;Versus Arthritis (Funder)Recruiting18 YearsN/AAll140Phase 2/Phase 3United Kingdom
2EUCTR2018-001735-49-GB
(EUCTR)
01/07/201922/01/2019RIvaroxaban for Stroke patients with AntiPhospholipid SyndromeRivaroxaban versus warfarin for stroke patients with antiphospholipid syndrome, with or without SLE (RISAPS): a randomised, controlled, open-label, phase II/III, non-inferiority trial - RIvaroxaban for Stroke patients with AntiPhospholipid Syndrome Patients with stroke or other ischaemic brain injury who have antiphospholipid syndrome (APS), with or without systemic lupus erythematosus (SLE)
MedDRA version: 20.0;Level: PT;Classification code 10002817;Term: Antiphospholipid syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Rivaroxaban
Product Name: Rivaroxaban
INN or Proposed INN: Rivaroxaban
Other descriptive name: Trade Name Xarelto
Trade Name: Warfarin Sodium
Product Name: Warfarin Sodium
INN or Proposed INN: Warfarin sodium
University College LondonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 2;Phase 3United Kingdom
3EUCTR2012-002345-38-GB
(EUCTR)
30/10/201208/10/2012Comparison of rivaroxaban (Xarelto®; Bayer HealthCare), fixed-dose oral anticoagulant (blood thinner), versus warfarin in patients with antiphospholipid syndrome (called APS), with or without 'lupus' (systemic lupus erythematosus)A prospective randomised controlled phase II/III clinical trial of rivaroxaban versus warfarin in patients with thrombotic antiphospholipid syndrome, with or without SLE. - Rivaroxaban in Antiphospholipid Syndrome (RAPS) Patients with antiphospholipid syndrome (APS), with or without systemic lupus erythematosus (SLE).
MedDRA version: 14.1;Level: PT;Classification code 10002817;Term: Antiphospholipid syndrome;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Xarelto
Product Name: Rivaroxaban
INN or Proposed INN: Rivaroxaban
Other descriptive name: Trade name Xarelto
Trade Name: The generic name is warfarin and many producers will be involved
Product Name: Warfarin
INN or Proposed INN: Warfarin
University College LondonNULLNot Recruiting Female: yes
Male: yes
156 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom

91. バッド・キアリ症候群


臨床試験数 : 4 薬物数 : 5 - (DrugBank : 4) / 標的遺伝子数 : 4 - 標的パスウェイ数 : 14
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2100046725
2022-01-012021-05-27The efficacy and safety of Warfarin and Rivaroxaban to prevent re-occlusion for Budd-Chiari syndrome with membranous obstruction after percutanouse balloon angioplastyTo compare the efficacy and safety of Warfarin and Rivaroxaban to prevent re-occlusion for Budd-Chiari syndrome with membranous obstruction after percutanouse balloon angioplasty Budd-Chiari syndromeWarfarin group:oral take Warfarin;Rivaroxaban group:oral take rivaroxaban;The First Affiliated Hospital of Zhengzhou UniversityNULLRecruiting1875BothWarfarin group:40;Rivaroxaban group:40;N/AChina
2EUCTR2014-005162-29-NL
(EUCTR)
09/04/202013/06/2019Treatment of thrombosis in the abdominal veinsTreatment of portal, mesenteric, and splenic vein thrombosis with rivaroxaban. A pilot, prospective cohort study - RIVASVT100 Splanchnic vein thrombosis (SVT) is an unusual site manifestation of venous thromboembolism (VTE). It includes the Budd-Chiari syndrome (BCS), portal vein thrombosis (PVT), mesenteric vein thrombosis (MVT) and splenic vein thrombosis (spVT). PVT is the most frequent manifestation of SVT, followed by MVT. ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: rivaroxaban 20 mg
Product Name: rivaroxaban
University of InsubriaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 4France;Canada;Germany;Netherlands;Italy

210. 単心室症


臨床試験数 : 51 薬物数 : 53 - (DrugBank : 22) / 標的遺伝子数 : 32 - 標的パスウェイ数 : 67
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-002610-76-NL
(EUCTR)
12/04/201712/10/2016A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan ProcedureA Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure thromboprophylaxis
MedDRA version: 20.0;Level: LLT;Classification code 10040729;Term: Single ventricle;System Organ Class: 100000011789;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Xarelto
Product Code: JNJ-39039039; BAY 59-7939
INN or Proposed INN: RIVAROXABAN
Trade Name: Aspirin
Product Name: acetylsalicylic acid
INN or Proposed INN: ACETYLSALICYLIC ACID
Janssen-Cilag International N.VNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Thailand;Spain;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Brazil;Malaysia;Australia;Netherlands;China;Japan;Korea, Republic of
2EUCTR2015-002610-76-BE
(EUCTR)
21/09/201618/07/2016A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan ProcedureA Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure thromboprophylaxis
MedDRA version: 19.0;Level: LLT;Classification code 10040729;Term: Single ventricle;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Xarelto
Product Code: JNJ-39039039; BAY 59-7939
INN or Proposed INN: RIVAROXABAN
Trade Name: Aspirin
Product Name: acetylsalicylic acid
INN or Proposed INN: ACETYLSALICYLIC ACID
Janssen-Cilag International N.VNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Thailand;Spain;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Brazil;Malaysia;Australia;Netherlands;China;Japan;Korea, Republic of
3EUCTR2015-002610-76-ES
(EUCTR)
19/09/201605/08/2016A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan ProcedureA Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure Thromboprophylaxis
MedDRA version: 19.0;Level: LLT;Classification code 10040729;Term: Single ventricle;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Xarelto
Product Code: JNJ-39039039; BAY 59-7939
INN or Proposed INN: RIVAROXABAN
Trade Name: Aspirin
Product Name: acetylsalicylic acid
INN or Proposed INN: ACETYLSALICYLIC ACID
Janssen-Cilag International N.VNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Thailand;United Kingdom;France;Mexico;Canada;Argentina;Malaysia;Belgium;Brazil;Australia;Netherlands;China;Japan;Korea, Republic of
4EUCTR2015-002610-76-FR
(EUCTR)
01/08/2016A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan ProcedureA Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure - UNIVERSE thromboprophylaxis
MedDRA version: 20.0;Level: LLT;Classification code 10040729;Term: Single ventricle;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Xarelto
Product Code: JNJ-39039039; BAY 59-7939
INN or Proposed INN: RIVAROXABAN
Trade Name: Aspirin
Product Name: acetylsalicylic acid
INN or Proposed INN: ACETYLSALICYLIC ACID
Janssen-Cilag International N.VNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Thailand;United Kingdom;France;Mexico;Canada;Argentina;Malaysia;Belgium;Brazil;Australia;Netherlands;China;Japan;Korea, Republic of