PAH medication ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
86肺動脈性肺高血圧症15

86. 肺動脈性肺高血圧症


臨床試験数 : 1,205 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-002817-21-FI
(EUCTR)
16/04/202111/02/2021A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3Portugal;Belarus;Serbia;United States;Taiwan;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Malaysia;Viet Nam;Australia;Denmark;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden
2NCT04567602
(ClinicalTrials.gov)
October 6, 202023/9/2020A Study of Pulmonary Arterial Hypertension Participants Treated With Macitentan or SelexipagNon-Interventional Study on Pulmonary Arterial Hypertension Patients Treated With Macitentan or Selexipag: Experience From an Italian Cohort (INSPECTIO)Pulmonary Arterial HypertensionDrug: PAH medicationJanssen-Cilag S.p.A.NULLActive, not recruiting18 YearsN/AAll186Italy
3EUCTR2019-002817-21-LT
(EUCTR)
13/08/202025/05/2020A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3Serbia;Portugal;United States;Belarus;Taiwan;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Malaysia;Viet Nam;Australia;China;Korea, Republic of;Finland;Turkey;Lithuania;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Bulgaria;Germany;Sweden
4EUCTR2019-002817-21-PT
(EUCTR)
27/07/202006/02/2020A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged greater or equal than 2 to under 18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3Germany;Belarus;Portugal;Serbia;United States;Taiwan;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Malaysia;Viet Nam;Australia;Denmark;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Sweden
5EUCTR2019-002817-21-IT
(EUCTR)
22/04/202017/06/2021A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel- Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: [JNJ-67896049 (ACT-293987)]
Product Name: Selexipag
Product Code: [JNJ-67896049 (ACT-293987)]
ACTELION PHARMACEUTICALS LTDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Sweden
6EUCTR2019-002817-21-DE
(EUCTR)
16/04/202030/10/2019A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden
7EUCTR2019-002817-21-BG
(EUCTR)
11/02/202006/01/2020A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Other descriptive name: Selexipag
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Other descriptive name: Selexipag
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3Serbia;Portugal;Belarus;United States;Taiwan;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Malaysia;Viet Nam;Denmark;Australia;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Bulgaria;Germany;Sweden
8EUCTR2019-002817-21-HU
(EUCTR)
05/02/202029/11/2019A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3Serbia;Portugal;United States;Belarus;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden
9EUCTR2019-002817-21-ES
(EUCTR)
07/01/202011/11/2019A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
237 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;Belarus;United States;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden
10NCT03863990
(ClinicalTrials.gov)
July 15, 201919/2/2019Study Performed at Various Medical Centers to Learn More About Survival and Expected Course of Pulmonary Arterial Hypertension, a Type of High Blood Pressure in the Lungs Related to the Narrowing of the Small Blood Vessels in the LungsSurvival and Prognostic Factors in Pulmonary Arterial Hypertension. A Multicenter Observational Registry (START)Pulmonary Arterial HypertensionDrug: PAH medicationBayerNULLCompleted18 YearsN/AAll104Argentina
11EUCTR2019-002817-21-BE
(EUCTR)
02/12/2019A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLNAFemale: yes
Male: yes
237Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden
12EUCTR2019-002817-21-FR
(EUCTR)
14/10/2019A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLNA Female: yes
Male: yes
237 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Belarus;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden
13EUCTR2019-002817-21-PL
(EUCTR)
15/10/2019A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: Selexipag
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals Ltd.NULLNAFemale: yes
Male: yes
237Phase 3Serbia;Portugal;United States;Belarus;Taiwan;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Malaysia;Viet Nam;Australia;China;Korea, Republic of;Finland;Turkey;Lithuania;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Bulgaria;Germany;Sweden
14EUCTR2019-002817-21-IE
(EUCTR)
11/11/2021A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLNAFemale: yes
Male: yes
237Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;China;Korea, Republic of;Finland;Lithuania;Turkey;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden
15EUCTR2019-002817-21-SE
(EUCTR)
29/10/2019A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLNAFemale: yes
Male: yes
237Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden