JNJ-39039039 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
210単心室症4

210. 単心室症


臨床試験数 : 49 薬物数 : 53 - (DrugBank : 23) / 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