210. 単心室症 [臨床試験数:47,薬物数:54(DrugBank:23),標的遺伝子数:32,標的パスウェイ数:66

Searched query = "Single Ventricle", "SV", "Single ventricle heart defect", "Univentricular heart", "UVH", "Single ventricular circulation syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
10 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-002821-45-CZ29/04/202023/03/2020An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patientsAC-055H302, RUBATO OL, Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL Congenital Heart Failure
MedDRA version: 20.0Level: PTClassification code 10045545Term: Univentricular heartSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1Level: PTClassification code 10065950Term: Cavopulmonary anastomosisSystem Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
134Phase 3France;United States;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;New Zealand;China;United Kingdom
2EUCTR2018-002821-45-FR05/03/201903/10/2018An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patientsProspective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL Congenital Heart Failure
MedDRA version: 20.0 Level: PT Classification code 10045545 Term: Univentricular heart System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0 Level: PT Classification code 10065950 Term: Cavopulmonary anastomosis System Organ Class: 10042613 - Surgical and medical procedures ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
134 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;France;Czech Republic;Taiwan;Poland;Ireland;Denmark;Australia;Germany;New Zealand;China;United Kingdom
3EUCTR2018-002821-45-DK27/02/201902/01/2019An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patientsProspective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL Congenital Heart Failure
MedDRA version: 20.0Level: PTClassification code 10045545Term: Univentricular heartSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1Level: PTClassification code 10065950Term: Cavopulmonary anastomosisSystem Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
134Phase 3United States;France;Taiwan;Czech Republic;Poland;Ireland;Australia;Denmark;Germany;United Kingdom;New Zealand;China
4EUCTR2016-003320-23-GB11/10/201708/05/2017Clinical study assessing the safety and efficacy of macitentan in Fontan-palliated subjects.Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent subjects. - RUBATO Congenital Heart Failure
MedDRA version: 20.0Level: PTClassification code 10045545Term: Univentricular heartSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1Level: PTClassification code 10065950Term: Cavopulmonary anastomosisSystem Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
134Phase 3United States;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;New Zealand;China;United Kingdom
5EUCTR2016-003320-23-DE12/09/201711/05/2017Clinical study assessing the safety and efficacy of macitentan in Fontan-palliated subjects.Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent subjects. - RUBATO Congenital Heart Failure
MedDRA version: 20.0Level: PTClassification code 10045545Term: Univentricular heartSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0Level: PTClassification code 10065950Term: Cavopulmonary anastomosisSystem Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
134Phase 3France;United States;Czech Republic;Taiwan;Poland;Ireland;Denmark;Australia;Germany;New Zealand;China;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2016-003320-23-DK25/08/201719/05/2017Clinical study assessing the safety and efficacy of macitentan in Fontan-palliated subjects.Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent subjects. - RUBATO Congenital Heart Failure
MedDRA version: 20.0Level: PTClassification code 10045545Term: Univentricular heartSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1Level: PTClassification code 10065950Term: Cavopulmonary anastomosisSystem Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
134Phase 3United States;France;Taiwan;Czech Republic;Poland;Ireland;Australia;Denmark;Germany;United Kingdom;New Zealand;China
7EUCTR2016-003320-23-PL18/09/2018Clinical study assessing the safety and efficacy of macitentan in Fontan-palliated subjects.Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent subjects. - RUBATO Congenital Heart Failure
MedDRA version: 20.0 Level: PT Classification code 10045545 Term: Univentricular heart System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0 Level: PT Classification code 10065950 Term: Cavopulmonary anastomosis System Organ Class: 10042613 - Surgical and medical procedures ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Actelion Pharmaceuticals LtdNULLNA Female: yes
Male: yes
134 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Czech Republic;Taiwan;Poland;Ireland;Denmark;Australia;Germany;New Zealand;China;United Kingdom
8EUCTR2018-002821-45-DE27/12/2018An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patientsProspective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL Congenital Heart Failure
MedDRA version: 20.0Level: PTClassification code 10045545Term: Univentricular heartSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1Level: PTClassification code 10065950Term: Cavopulmonary anastomosisSystem Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
134Phase 3France;United States;Czech Republic;Taiwan;Poland;Ireland;Denmark;Australia;Germany;New Zealand;China;United Kingdom
9EUCTR2018-002821-45-GB28/12/2018An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patientsAC-055H302, RUBATO OL, Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL Congenital Heart Failure
MedDRA version: 20.0Level: PTClassification code 10045545Term: Univentricular heartSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1Level: PTClassification code 10065950Term: Cavopulmonary anastomosisSystem Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals LtdNULLNAFemale: yes
Male: yes
134Phase 3United States;Czechia;Taiwan;Ireland;United Kingdom;France;Czech Republic;Poland;Australia;Denmark;Germany;China;New Zealand
10EUCTR2018-002821-45-PL19/09/2019An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patientsAC-055H302, RUBATO OL, Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL Congenital Heart Failure
MedDRA version: 20.0 Level: PT Classification code 10045545 Term: Univentricular heart System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1 Level: PT Classification code 10065950 Term: Cavopulmonary anastomosis System Organ Class: 10042613 - Surgical and medical procedures ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Actelion Pharmaceuticals LtdNULLNA Female: yes
Male: yes
134 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Czech Republic;Taiwan;Poland;Ireland;Denmark;Australia;Germany;New Zealand;China;United Kingdom