86. 肺動脈性肺高血圧症 Pulmonary arterial hypertension Clinical trials / Disease details


臨床試験数 : 1,181 薬物数 : 701 - (DrugBank : 126) / 標的遺伝子数 : 105 - 標的パスウェイ数 : 192

  
81 trials found
No.TrialIDDate_
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agemin
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PhaseCountries
1NCT04435782
(ClinicalTrials.gov)
July 7, 202115/6/2020A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance ImagingA Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance ImagingPulmonary Arterial HypertensionDrug: JNJ-67896049ActelionNULLRecruiting18 Years65 YearsAll80Phase 4United States;Argentina;Brazil;China;France;Germany;Hong Kong;Israel;Korea, Republic of;Malaysia;Netherlands;Russian Federation;Saudi Arabia;Singapore;United Arab Emirates;United Kingdom
2EUCTR2019-002817-21-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;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
3EUCTR2019-004783-22-NL
(EUCTR)
03/12/202030/06/2020A clinical trial to study the effects of selexipag on the heart in patients with Pulmonary Arterial HypertensionA Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging - RESTORE 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: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 4United Arab Emirates;United States;Hong Kong;Saudi Arabia;Israel;Russian Federation;United Kingdom;France;Argentina;Brazil;Malaysia;Singapore;Germany;Netherlands;China;Korea, Republic of
4EUCTR2019-004783-22-DE
(EUCTR)
23/11/202017/07/2020A clinical trial to study the effects of selexipag on the heart in patients with Pulmonary Arterial HypertensionA Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging - RESTORE 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: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 4United Arab Emirates;United States;Hong Kong;Saudi Arabia;Israel;Russian Federation;United Kingdom;France;Argentina;Brazil;Malaysia;Singapore;Netherlands;Germany;China;Korea, Republic of
5JPRN-JapicCTI-205391
18/11/202030/07/2020An exploratory study of NS-304A phase 2 exploratory study of NS-304 in Japanese pediatric patients with pulmonary arterial hypertension Pulmonary arterial hypertensionIntervention name : NS-304
INN of the intervention : Selexipag
Dosage And administration of the intervention : Oral administration
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Nippon Shinyaku Co., Ltd.NULLrecruiting214BOTH6Phase 2Japan
6EUCTR2019-004783-22-GB
(EUCTR)
16/11/202026/08/2020A clinical trial to study the effects of selexipag on the heart in patients with Pulmonary Arterial HypertensionA Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging - RESTORE 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: Uptravi
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Uptravi
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Uptravi
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Uptravi
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Uptravi
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Uptravi
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 4United States;United Arab Emirates;Hong Kong;Saudi Arabia;Israel;Russian Federation;United Kingdom;France;Argentina;Brazil;Germany;Netherlands;China;Korea, Republic of
7NCT04589390
(ClinicalTrials.gov)
October 15, 20208/10/2020Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial HypertensionSelexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial HypertensionPulmonary Hypertension;SchistosomiasisDrug: SelexipagUniversity of Sao Paulo General HospitalJanssen-Cilag Ltd.Recruiting18 YearsN/AAll20Phase 2Brazil
8NCT04567602
(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.NULLRecruiting18 YearsN/AAll200Italy
9EUCTR2019-002817-21-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
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
10EUCTR2019-002817-21-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 3Serbia;Belarus;Portugal;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
11EUCTR2019-002817-21-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
12EUCTR2019-002817-21-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
13EUCTR2019-002817-21-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
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3Serbia;Portugal;Taiwan;Spain;United States;Belarus;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Sweden
14EUCTR2019-002817-21-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
15NCT04175600
(ClinicalTrials.gov)
January 16, 20208/11/2019A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial HypertensionA 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 HypertensionHypertension, PulmonaryDrug: Selexipag;Drug: PlaceboActelionNULLRecruiting2 Years17 YearsAll237Phase 3United States;Australia;Belarus;Belgium;Brazil;Bulgaria;Canada;China;Colombia;Croatia;Finland;France;Germany;Hungary;Ireland;Israel;Italy;Korea, Republic of;Lithuania;Malaysia;Mexico;Poland;Portugal;Russian Federation;Serbia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;Vietnam;Argentina;Austria;Denmark;Romania
16EUCTR2019-002817-21-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
17JPRN-UMIN000035389
2019/04/0101/04/2019Effects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertensionEffects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension - SETOUCHI PH study Pulmonary arterial hypertensionDose: macitentan 10 mg/day+riociguat 3 mg/day. Max dose of riociguat is 7.5 mg/day.Intervention period: 8 month
Dose: macitentan 10 mg/day+selexipag 0.4 mg/day. Max dose of selexipag is 3.2 mg/day. Intervention period: 8 month
Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical ScienceNULLRecruiting20years-oldNot applicableMale and Female76Not selectedJapan
18EUCTR2018-000145-39-DE
(EUCTR)
25/10/201805/06/2018A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertensionA prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension 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: ACT-293987
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: ACT-293987
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Belarus;Serbia;United States;Taiwan;Ukraine;Israel;Russian Federation;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Poland;Belgium;Malaysia;Singapore;Romania;Netherlands;Germany;China
19EUCTR2018-000145-39-GB
(EUCTR)
22/10/201828/03/2018A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertensionA prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension 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: ACT-293987
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;Serbia;Belarus;Taiwan;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Malaysia;Poland;Singapore;Romania;Germany;Netherlands;China
20EUCTR2017-000216-42-FR
(EUCTR)
27/09/201823/07/2018Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;Portugal;France;Ireland;Austria;Norway;Germany;United Kingdom;Switzerland;Sweden
21NCT03492177
(ClinicalTrials.gov)
July 23, 20183/4/2018A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial HypertensionA Prospective, Multicenter, Open Label, Single Arm, Phase 2 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Selexipag in Children With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: selexipag (Uptravi)ActelionNULLActive, not recruiting2 Years17 YearsAll63Phase 2United States;Belarus;Belgium;Canada;China;France;Germany;Hungary;Israel;Malaysia;Poland;Russian Federation;Serbia;Taiwan;Ukraine;United Kingdom;Romania
22EUCTR2018-000145-39-HU
(EUCTR)
03/07/201818/07/2018A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertensionA prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension Pulmonary arterial hypertension
MedDRA version: 20.0;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: ACT-293987
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 2Serbia;United States;Belarus;Taiwan;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Poland;Malaysia;Singapore;Romania;Netherlands;Germany;China
23EUCTR2015-003438-28-GB
(EUCTR)
21/06/201813/11/2017The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH Pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: TADALAFIL
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
238Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Sweden
24EUCTR2017-000216-42-PT
(EUCTR)
14/05/201803/11/2017Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE 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] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;France;Portugal;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
25EUCTR2015-003438-28-ES
(EUCTR)
19/01/201801/12/2017The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON Pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: TADALAFIL
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
238Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden
26NCT03187678
(ClinicalTrials.gov)
December 4, 20179/6/2017Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial HypertensionA Multicenter, Open-label, Single-sequence Cross-over Study to Assess Safety, Tolerability, and Pharmacokinetics of Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension Switching From an Oral Stable Dose of SelexipagPulmonary Arterial HypertensionDrug: i.v. selexipag;Drug: oral selexipag (Uptravi)ActelionNULLCompleted18 Years75 YearsAll20Phase 3United States;Germany
27EUCTR2017-000216-42-DE
(EUCTR)
30/11/201726/05/2017Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE 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] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
28NCT03078907
(ClinicalTrials.gov)
November 8, 20176/3/2017Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.A Multi-center, Double-blind, Placebo-controlled Phase 4 Study in Patients With Pulmonary Arterial Hypertension to Assess the Effect of Selexipag on Daily Life Physical Activity and Patient's Self-reported Symptoms and Their ImpactsPulmonary Arterial HypertensionDrug: Selexipag;Drug: PlaceboActelionNULLCompleted18 Years75 YearsAll108Phase 4United States;Austria;France;Germany;Ireland;Norway;Portugal;Sweden;Switzerland;United Kingdom
29EUCTR2017-000216-42-SE
(EUCTR)
24/10/201716/05/2017Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
30EUCTR2017-000216-42-IE
(EUCTR)
12/09/201705/05/2017Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 3b study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
31EUCTR2017-000216-42-AT
(EUCTR)
29/08/201709/06/2017Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
32EUCTR2017-000216-42-GB
(EUCTR)
11/07/201705/05/2017Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;Switzerland;United Kingdom;Sweden
33EUCTR2016-004035-21-DE
(EUCTR)
23/05/201714/02/2017 A study to evaluate whether it is safe for patients with pulmonary arterial hypertension to temporarily change from selexipag tablets (Uptravi®) to selexipag given directly into a vein (intravenous selexipag)A multicenter, open-label, single-sequence cross-over study to assess safety, tolerability, and pharmacokinetics of intravenous selexipag in subjects with stable pulmonary arterial hypertension switching from an oral stable dose of selexipag Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Germany
34NCT03016468
(ClinicalTrials.gov)
May 20176/1/2017Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAHA Multicenter, 16-Week, Open-label Study Evaluating the Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Parenteral Remodulin (treprostinil) injection;Drug: Oral TreprostinilUnited TherapeuticsNULLWithdrawn18 Years75 YearsAll0Phase 2NULL
35JPRN-UMIN000025176
2017/01/0115/12/2016Efficacy, tolerability, and safety of transition from beraprost to selexipag in patients with pulmonary arterial hypertension.Efficacy, tolerability, and safety of transition from beraprost to selexipag in patients with pulmonary arterial hypertension. - Efficacy, tolerability, and safety of transition from beraprost to selexipag Pulmonary arterial hypertensionMedicine transition from beraprost to selexipag

In accordance with the Japanese package insert (http://www.info.pmda.go.jp/go/pack/2190037F1020_1_02/), selexipag is initiated at a dose of 0.2mg twice daily and is increased in twice-daily increments of 0.2mg until unmanageable adverse effects associated with prostacyclin use, such as headache or jaw pain, developed.
The maximum dose allowed is 1.6mg twice daily.
Hamamatsu University School of MedicineNULLRecruiting16years-oldNot applicableMale and Female33Not selectedJapan
36EUCTR2016-003495-53-NL
(EUCTR)
29/11/201615/12/2016Study on the effect of the drug selexipag in adult patients with elevated pressure in the pulmonary arteries due to a cardiac birth defectProstacyclin receptor agonist Selexipag in patients with pulmonary arterial hypertension and congenital heart disease - SELECT trial Pulmonary arterial hypertension related to congenital heart disease.;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: Selexipag
Product Name: Selexipag
Academic Medical Center - CardiologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 3Netherlands
37EUCTR2015-003438-28-DK
(EUCTR)
17/08/201630/05/2016The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH Pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: TADALAFIL
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
238Phase 3United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Sweden
38EUCTR2015-003438-28-FR
(EUCTR)
20/06/201621/04/2016The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON Pulmonary arterial hypertension (PAH)
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: Tadalafil
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
144Phase 3United States;Spain;Austria;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
39NCT02558231
(ClinicalTrials.gov)
May 1, 201622/9/2015The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial HypertensionThe Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension: A Multi-center, Double-blind, Placebo-controlled, Phase 3b StudyPulmonary Arterial HypertensionDrug: Macitentan;Drug: Tadalafil;Drug: SelexipagActelionNULLCompleted18 Years75 YearsAll247Phase 3United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom;Norway
40EUCTR2015-003438-28-NO
(EUCTR)
11/04/201609/03/2016The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON Pulmonary arterial hypertension (PAH)
MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: Tadalafil
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
144Phase 3United States;Spain;Austria;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden
41EUCTR2015-003438-28-DE
(EUCTR)
04/03/201619/01/2016The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH Pulmonary arterial hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: TADALAFIL
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
238Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden
42EUCTR2015-003438-28-BE
(EUCTR)
03/03/201609/06/2020The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH Pulmonary arterial hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: TADALAFIL
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
238Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden
43EUCTR2015-003438-28-AT
(EUCTR)
12/01/201625/07/2017The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON Pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: Tadalafil
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
238Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden
44NCT02471183
(ClinicalTrials.gov)
November 4, 201511/6/2015Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial HypertensionMulticenter, Open-label, Single-group Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Adult Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: SelexipagActelionNULLCompleted18 Years75 YearsAll30Phase 3United States
45EUCTR2009-014992-31-GB
(EUCTR)
28/10/201317/03/2010Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
46JPRN-JapicCTI-111532
01/3/201127/06/2011NS-304 PAHThe clinical study to assess the efficacy, safety and pharmacokinetics of NS-304 in patients with pulmonary arterial hypertension (PAH) Pulmonary arterial hypertension (PAH)Intervention name : NS-304
INN of the intervention : Selexipag
Dosage And administration of the intervention : Oral administration
NIPPON SHINYAKU CO., LTD. / Actelion Pharmaceuticals Japan Ltd.NULL18BOTH30Phase 2NULL
47EUCTR2009-014992-31-NL
(EUCTR)
16/02/201118/02/2011Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Austria;United Kingdom;United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
48EUCTR2009-014490-41-NL
(EUCTR)
16/02/201118/02/2011Study to evaluate if selexipag is safe and efficacious for the treatment ofpulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Peru;Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
49EUCTR2009-014992-31-SK
(EUCTR)
09/02/201109/06/2010Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
670Phase 3United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
50EUCTR2009-014992-31-IE
(EUCTR)
16/11/201015/04/2010Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot Recruiting Female: yes
Male: yes
1150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
51EUCTR2009-014490-41-IE
(EUCTR)
15/11/201014/04/2010Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
52EUCTR2009-014992-31-PL
(EUCTR)
19/10/201020/05/2010Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
53EUCTR2009-014992-31-DE
(EUCTR)
24/08/201008/06/2010Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
54EUCTR2009-014490-41-DE
(EUCTR)
24/08/201010/06/2010Study to evaluate if selexipag is safe and efficacious for the treatment ofpulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
55EUCTR2009-014992-31-CZ
(EUCTR)
20/08/201019/08/2010Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is 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] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
56EUCTR2009-014490-41-IT
(EUCTR)
06/08/201028/12/2011Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertensionA multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate the efficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
670Phase 3Belarus;United States;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Singapore;Germany;Sweden
57EUCTR2009-014992-31-IT
(EUCTR)
06/08/201028/12/2011Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term, single-arm, open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON-OL Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
670Phase 3Belarus;United States;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Germany;Sweden
58EUCTR2009-014992-31-AT
(EUCTR)
28/07/201028/05/2010Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag (ACT-293987) in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
59EUCTR2009-014490-41-AT
(EUCTR)
28/07/201028/05/2010Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessing the safety and efficacy of selexipag on morbidity and mortality in patients with pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
60EUCTR2009-014490-41-HU
(EUCTR)
27/07/201018/05/2010Study to evaluate if selexipag is safe and efficacious for the treatment ofpulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
61EUCTR2009-014992-31-HU
(EUCTR)
27/07/201001/06/2010Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
62EUCTR2009-014490-41-GB
(EUCTR)
23/03/201017/03/2010Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
63EUCTR2009-014490-41-BE
(EUCTR)
22/02/201023/11/2009Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 15.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
64EUCTR2009-014992-31-BE
(EUCTR)
22/02/201023/11/2009Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
65EUCTR2009-014490-41-CZ
(EUCTR)
19/02/201019/02/2010Study to evaluate if selexipag is safe and efficacious for the treatment ofpulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
66EUCTR2009-014992-31-SE
(EUCTR)
06/02/201014/12/2009Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
67EUCTR2009-014490-41-SE
(EUCTR)
06/02/201014/12/2009Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden;Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of
68EUCTR2009-014992-31-DK
(EUCTR)
05/02/201017/12/2009Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden;China;Netherlands;Peru;Denmark;Australia;Malaysia;France;India;Italy;Switzerland;Colombia;Israel;Chile;Russian Federation;Ireland;Ukraine;Spain;Thailand;Greece;Slovakia;Taiwan;Belarus;Serbia;United States
69EUCTR2009-014490-41-DK
(EUCTR)
08/12/200923/11/2009Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
70NCT01106014
(ClinicalTrials.gov)
December 20092/4/2010Selexipag (ACT-293987) in Pulmonary Arterial HypertensionA Multicenter, Double-blind, Placebo-controlled Phase 3 Study Assessing the Safety and Efficacy of Selexipag on Morbidity and Mortality in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Selexipag;Drug: PlaceboActelionNULLCompleted18 Years75 YearsAll1156Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Canada;Chile;China;Colombia;Czech Republic;Denmark;France;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;United Kingdom
71EUCTR2007-006453-12-AT
(EUCTR)
19/03/200923/06/2008Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertensionA multi-centre, multinational, open-label study to evaluate the long-term safety, tolerability and efficacy of selexipag / ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS 304/-02) Pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: Selexipag, ACT-293987 (NS-304)
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom
72EUCTR2007-006453-12-BE
(EUCTR)
03/10/200807/07/2008Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertensionA multi-centre, multinational, open-label study to evaluate the long-term safety, tolerability and efficacy of selexipag / ACT 293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS 304/-02) pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use
MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: Selexipag, ACT-293987 (NS-304)
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom
73EUCTR2007-006453-12-DE
(EUCTR)
12/09/200819/12/2008Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertensionA multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of selexipag / ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02) Pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use
MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: Selexipag, ACT-293987 (NS-304)
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom
74EUCTR2019-002817-21-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
75EUCTR2019-002817-21-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
76EUCTR2018-000145-39-PL
(EUCTR)
02/04/2019A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertensionA prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension 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: ACT-293987
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
55Phase 2Canada;Serbia;United States;Belarus;Taiwan;Ukraine;Russian Federation;Israel;Italy;United Kingdom;Vietnam;France;Hungary;Malaysia;Poland;Singapore;Romania;Netherlands;Germany;China
77EUCTR2019-002817-21-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
78EUCTR2019-002817-21-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
79EUCTR2019-002817-21-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
Actelion Pharmaceuticals Ltd.NULLNAFemale: yes
Male: yes
237Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Malaysia;Viet Nam;Australia;China;Korea, Republic of;Finland;Turkey;Lithuania;Hungary;Mexico;Canada;Belgium;Poland;Brazil;Bulgaria;Germany;Sweden
80EUCTR2018-000145-39-BE
(EUCTR)
03/03/2021A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertensionA prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension 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: ACT-293987
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNAFemale: yes
Male: yes
60Phase 2Belarus;Serbia;United States;Taiwan;Ukraine;Israel;Russian Federation;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Poland;Belgium;Malaysia;Singapore;Romania;Netherlands;Germany;China
81EUCTR2018-000145-39-FR
(EUCTR)
26/04/2018A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertensionA prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension Pulmonary arterial hypertension
MedDRA version: 20.0;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: ACT-293987
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNAFemale: yes
Male: yes
55Phase 2Serbia;United States;Belarus;Taiwan;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Poland;Malaysia;Singapore;Romania;Netherlands;Germany;China