210. Single Ventricle Clinical trials / Disease details
Clinical trials : 51 / Drugs : 53 - (DrugBank : 22) / Drug target genes : 32 - Drug target pathways : 67
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2015-002610-76-NL (EUCTR) | 12/04/2017 | 12/10/2016 | A 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 | A 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.V | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Thailand;Spain;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Brazil;Malaysia;Australia;Netherlands;China;Japan;Korea, Republic of | ||
| 2 | EUCTR2015-002610-76-BE (EUCTR) | 21/09/2016 | 18/07/2016 | A 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 | A 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.V | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Thailand;Spain;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Brazil;Malaysia;Australia;Netherlands;China;Japan;Korea, Republic of | ||
| 3 | EUCTR2015-002610-76-ES (EUCTR) | 19/09/2016 | 05/08/2016 | A 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 | A 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.V | NULL | Not 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): no | United States;Spain;Thailand;United Kingdom;France;Mexico;Canada;Argentina;Malaysia;Belgium;Brazil;Australia;Netherlands;China;Japan;Korea, Republic of | ||
| 4 | EUCTR2015-002610-76-FR (EUCTR) | 01/08/2016 | A 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 | A 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.V | NULL | Not 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): no | United States;Spain;Thailand;United Kingdom;France;Mexico;Canada;Argentina;Malaysia;Belgium;Brazil;Australia;Netherlands;China;Japan;Korea, Republic of |