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 210. 単心室症 [臨床試験数:6,薬物数:7(DrugBank:3),標的遺伝子数:3,標的パスウェイ数:3] 

Searched query = "Single ventricle heart defect", "Complete TGA", "Univentricular heart", "Single ventricular circulation syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03997097March 1, 202015 July 2019Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart DiseasePhosphodiesterase-type 5 Inhibitors in Adult and Adolescent Patients With Univentricular Heart Disease: a Multi-center, Randomized, Double Blind Phase III StudySingle-ventricle;Pulmonary Hypertension;Univentricular HeartDrug: Sildenafil;Drug: PlacebosUniversity Hospital, MontpellierNot recruiting15 Years80 YearsAll50Phase 3
2EUCTR2018-002821-45-DE14 January 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 OLCongenital 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]
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MACITENTAN
CAS Number: 441798-33-0
Current Sponsor code: ACT-064992
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Actelion Pharmaceuticals LtdNot AvailableFemale: yes
Male: yes
134Phase 3France;United States;Czech Republic;Taiwan;Poland;Ireland;Denmark;Australia;Germany;New Zealand;China;United Kingdom
3EUCTR2016-003320-23-DK25/08/201730 April 2019Clinical 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. - RUBATOCongenital 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]
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MACITENTAN
CAS Number: 441798-33-0
Current Sponsor code: ACT-064992
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Actelion Pharmaceuticals LtdAuthorised Female: yes
Male: yes
134Phase 3United Kingdom;China;New Zealand;Germany;Denmark;Australia;Ireland;Poland;Taiwan;Czech Republic;United States;France
4EUCTR2010-022389-28-DK12/11/201012 May 2014Treatment with Endothelinantagonist to tcpc patients; a multicenter, randomized, Prospective study measuring maximal O2 uptake in ergometer bicycle test. [TEMPO-study].Treatment with Endothelinantagonist to tcpc patients; a multicenter, randomized, Prospective study measuring maximal O2 uptake in ergometer bicycle test. [TEMPO-study].Patients with a univentricular heart, who have recieved paliating surgery in the form of TCPC operation
MedDRA version: 14.1 Level: PT Classification code 10021076 Term: Hypoplastic left heart syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders
Trade Name: Tracleer
Pharmaceutical Form:
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Lars SøndergaardNot RecruitingFemale: yes
Male: yes
Denmark
5EUCTR2005-005898-29-GB04/07/200819 March 2012The effect of bosentan, a selective endothelin antagonist, on cardiovascular performance in patients with a Fontan circulation - Bosentan therapy in FontansThe effect of bosentan, a selective endothelin antagonist, on cardiovascular performance in patients with a Fontan circulation - Bosentan therapy in FontansPatients with a Fontan circulation (that is they have had a Fontan operation for a functionally univentricular heart)
MedDRA version: 9.1 Level: LLT Classification code 10045545 Term: Univentricular heart
MedDRA version: 9.1 Level: LLT Classification code 10065950 Term: Cavopulmonary anastomosis
MedDRA version: 9.1 Level: LLT Classification code 10037456 Term: Pulmonary vascular resistance abnormality
Trade Name: Tracleer
Product Name: bosentan
Pharmaceutical Form: Tablet
INN or Proposed INN: Bosentan
CAS Number: 147536978
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 62.5-
INN or Proposed INN: Bosentan
CAS Number: 147536978
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
University Hospital BirminghamAuthorisedFemale: yes
Male: yes
United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT00263406December 200219 February 2015Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan CirculationPathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan CirculationChildren With a Univentricular Heart Undergoing Surgery for Creation of a Fontan CirculationDrug: Administration of an ACE-inhibitor or notUniversity Hospital, GhentNot recruiting1 Month18 YearsBoth40Phase 2Belgium

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