86. 肺動脈性肺高血圧症 Pulmonary arterial hypertension Clinical trials / Disease details
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04435782 (ClinicalTrials.gov) | July 7, 2021 | 15/6/2020 | A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance Imaging | A 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 | Pulmonary Arterial Hypertension | Drug: JNJ-67896049 | Actelion | NULL | Recruiting | 18 Years | 64 Years | All | 80 | Phase 4 | United States;Argentina;Brazil;China;France;Germany;Hong Kong;Israel;Italy;Korea, Republic of;Malaysia;Netherlands;Russian Federation;Saudi Arabia;Singapore;United Arab Emirates;United Kingdom |
| 2 | EUCTR2019-002817-21-FI (EUCTR) | 16/04/2021 | 11/02/2021 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Portugal;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 | ||
| 3 | EUCTR2019-004783-22-NL (EUCTR) | 03/12/2020 | 30/06/2020 | A clinical trial to study the effects of selexipag on the heart in patients with Pulmonary Arterial Hypertension | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 4 | United Arab Emirates;United States;Hong Kong;Saudi Arabia;Israel;Russian Federation;United Kingdom;France;Argentina;Brazil;Malaysia;Singapore;Germany;Netherlands;China;Korea, Republic of | ||
| 4 | EUCTR2019-004783-22-DE (EUCTR) | 23/11/2020 | 17/07/2020 | A clinical trial to study the effects of selexipag on the heart in patients with Pulmonary Arterial Hypertension | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 4 | United Arab Emirates;United States;Hong Kong;Saudi Arabia;Israel;Russian Federation;United Kingdom;France;Argentina;Brazil;Malaysia;Singapore;Netherlands;Germany;China;Korea, Republic of | ||
| 5 | JPRN-JapicCTI-205391 | 18/11/2020 | 30/07/2020 | An exploratory study of NS-304 | A phase 2 exploratory study of NS-304 in Japanese pediatric patients with pulmonary arterial hypertension | Pulmonary arterial hypertension | Intervention 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. | NULL | complete | 2 | 14 | BOTH | 6 | Phase 2 | Japan |
| 6 | EUCTR2019-004783-22-GB (EUCTR) | 16/11/2020 | 26/08/2020 | A clinical trial to study the effects of selexipag on the heart in patients with Pulmonary Arterial Hypertension | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 4 | United States;United Arab Emirates;Hong Kong;Saudi Arabia;Israel;Russian Federation;United Kingdom;France;Argentina;Brazil;Germany;Netherlands;China;Korea, Republic of | ||
| 7 | NCT04589390 (ClinicalTrials.gov) | October 15, 2020 | 8/10/2020 | Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension | Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension | Pulmonary Hypertension;Schistosomiasis | Drug: Selexipag | University of Sao Paulo General Hospital | Janssen-Cilag Ltd. | Recruiting | 18 Years | N/A | All | 20 | Phase 2 | Brazil |
| 8 | NCT04567602 (ClinicalTrials.gov) | October 6, 2020 | 23/9/2020 | A Study of Pulmonary Arterial Hypertension Participants Treated With Macitentan or Selexipag | Non-Interventional Study on Pulmonary Arterial Hypertension Patients Treated With Macitentan or Selexipag: Experience From an Italian Cohort (INSPECTIO) | Pulmonary Arterial Hypertension | Drug: PAH medication | Janssen-Cilag S.p.A. | NULL | Active, not recruiting | 18 Years | N/A | All | 186 | Italy | |
| 9 | EUCTR2019-002817-21-LT (EUCTR) | 13/08/2020 | 25/05/2020 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Serbia;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 | ||
| 10 | EUCTR2019-002817-21-PT (EUCTR) | 27/07/2020 | 06/02/2020 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Germany;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 | ||
| 11 | EUCTR2019-002817-21-IT (EUCTR) | 22/04/2020 | 17/06/2021 | A 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 LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Portugal;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 | ||
| 12 | EUCTR2019-002817-21-DE (EUCTR) | 16/04/2020 | 30/10/2019 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Portugal;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 | ||
| 13 | EUCTR2019-002817-21-BG (EUCTR) | 11/02/2020 | 06/01/2020 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Serbia;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 | ||
| 14 | EUCTR2019-002817-21-HU (EUCTR) | 05/02/2020 | 29/11/2019 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Serbia;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 | ||
| 15 | NCT04175600 (ClinicalTrials.gov) | January 16, 2020 | 8/11/2019 | A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension | 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 | Hypertension, Pulmonary | Drug: Selexipag;Drug: Placebo | Actelion | NULL | Recruiting | 2 Years | 17 Years | All | 237 | Phase 3 | Turkey;United 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;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Taiwan;Thailand;Ukraine;Vietnam;Argentina;Austria;Denmark |
| 16 | EUCTR2019-002817-21-ES (EUCTR) | 07/01/2020 | 11/11/2019 | A 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. | NULL | Authorised-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): no | Serbia;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 | ||
| 17 | JPRN-UMIN000035389 | 2019/04/01 | 01/04/2019 | Effects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension | Effects 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 hypertension | Dose: 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 Science | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 76 | Not selected | Japan |
| 18 | EUCTR2018-000145-39-DE (EUCTR) | 25/10/2018 | 05/06/2018 | A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Belarus;Serbia;United States;Taiwan;Ukraine;Israel;Russian Federation;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Poland;Belgium;Malaysia;Singapore;Romania;Netherlands;Germany;China | ||
| 19 | EUCTR2018-000145-39-GB (EUCTR) | 22/10/2018 | 28/03/2018 | A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | United States;Serbia;Belarus;Taiwan;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Malaysia;Poland;Singapore;Romania;Germany;Netherlands;China | ||
| 20 | EUCTR2017-000216-42-FR (EUCTR) | 27/09/2018 | 23/07/2018 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;Portugal;France;Ireland;Austria;Norway;Germany;United Kingdom;Switzerland;Sweden | ||
| 21 | NCT03492177 (ClinicalTrials.gov) | July 23, 2018 | 3/4/2018 | A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension | A 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 | Drug: selexipag (Uptravi) | Actelion | NULL | Active, not recruiting | 2 Years | 17 Years | All | 63 | Phase 2 | United States;Belarus;Belgium;Canada;China;France;Germany;Hungary;Israel;Malaysia;Poland;Russian Federation;Serbia;Taiwan;Ukraine;United Kingdom;Romania |
| 22 | EUCTR2018-000145-39-HU (EUCTR) | 03/07/2018 | 18/07/2018 | A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 2 | Serbia;United States;Belarus;Taiwan;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Poland;Malaysia;Singapore;Romania;Netherlands;Germany;China | ||
| 23 | EUCTR2015-003438-28-GB (EUCTR) | 21/06/2018 | 13/11/2017 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 24 | EUCTR2017-000216-42-PT (EUCTR) | 14/05/2018 | 03/11/2017 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;France;Portugal;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden | ||
| 25 | EUCTR2015-003438-28-ES (EUCTR) | 19/01/2018 | 01/12/2017 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 26 | NCT03187678 (ClinicalTrials.gov) | December 4, 2017 | 9/6/2017 | Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension | 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 | Drug: i.v. selexipag;Drug: oral selexipag (Uptravi) | Actelion | NULL | Completed | 18 Years | 75 Years | All | 20 | Phase 3 | United States;Germany |
| 27 | EUCTR2017-000216-42-DE (EUCTR) | 30/11/2017 | 26/05/2017 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden | ||
| 28 | NCT03078907 (ClinicalTrials.gov) | November 8, 2017 | 6/3/2017 | Effect 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 Impacts | Pulmonary Arterial Hypertension | Drug: Selexipag;Drug: Placebo | Actelion | NULL | Completed | 18 Years | 75 Years | All | 108 | Phase 4 | United States;Austria;France;Germany;Ireland;Norway;Portugal;Sweden;Switzerland;United Kingdom |
| 29 | EUCTR2017-000216-42-SE (EUCTR) | 24/10/2017 | 16/05/2017 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden | ||
| 30 | EUCTR2017-000216-42-IE (EUCTR) | 12/09/2017 | 05/05/2017 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden | ||
| 31 | EUCTR2017-000216-42-AT (EUCTR) | 29/08/2017 | 09/06/2017 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden | ||
| 32 | EUCTR2017-000216-42-GB (EUCTR) | 11/07/2017 | 05/05/2017 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;Switzerland;United Kingdom;Sweden | ||
| 33 | EUCTR2016-004035-21-DE (EUCTR) | 23/05/2017 | 14/02/2017 | 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 Ltd | NULL | Not 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): no | United States;Germany | ||
| 34 | NCT03016468 (ClinicalTrials.gov) | May 2017 | 6/1/2017 | Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAH | A Multicenter, 16-Week, Open-label Study Evaluating the Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Parenteral Remodulin (treprostinil) injection;Drug: Oral Treprostinil | United Therapeutics | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 2 | NULL |
| 35 | JPRN-UMIN000025176 | 2017/01/01 | 15/12/2016 | 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 in patients with pulmonary arterial hypertension. - Efficacy, tolerability, and safety of transition from beraprost to selexipag | Pulmonary arterial hypertension | Medicine 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 Medicine | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 33 | Not selected | Japan |
| 36 | EUCTR2016-003495-53-NL (EUCTR) | 29/11/2016 | 15/12/2016 | Study on the effect of the drug selexipag in adult patients with elevated pressure in the pulmonary arteries due to a cardiac birth defect | Prostacyclin 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 - Cardiology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 3 | Netherlands | |||
| 37 | EUCTR2015-003438-28-DK (EUCTR) | 17/08/2016 | 30/05/2016 | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension | The 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Sweden | ||
| 38 | EUCTR2015-003438-28-FR (EUCTR) | 20/06/2016 | 21/04/2016 | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension | The 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | United States;Spain;Austria;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 39 | NCT02558231 (ClinicalTrials.gov) | May 1, 2016 | 22/9/2015 | The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension | The 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 | Pulmonary Arterial Hypertension | Drug: Macitentan;Drug: Tadalafil;Drug: Selexipag | Actelion | NULL | Completed | 18 Years | 75 Years | All | 247 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom;Norway |
| 40 | EUCTR2015-003438-28-NO (EUCTR) | 11/04/2016 | 09/03/2016 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | United States;Spain;Austria;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 41 | EUCTR2015-003438-28-DE (EUCTR) | 04/03/2016 | 19/01/2016 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 42 | EUCTR2015-003438-28-BE (EUCTR) | 03/03/2016 | 09/06/2020 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 43 | EUCTR2015-003438-28-AT (EUCTR) | 12/01/2016 | 25/07/2017 | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension | The 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 44 | NCT02471183 (ClinicalTrials.gov) | November 4, 2015 | 11/6/2015 | Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial Hypertension | Multicenter, 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 Hypertension | Pulmonary Arterial Hypertension | Drug: Selexipag | Actelion | NULL | Completed | 18 Years | 75 Years | All | 30 | Phase 3 | United States |
| 45 | EUCTR2009-014992-31-GB (EUCTR) | 28/10/2013 | 17/03/2010 | Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension | Long-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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1150 | Phase 3 | Serbia;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 | ||
| 46 | JPRN-JapicCTI-111532 | 01/3/2011 | 27/06/2011 | NS-304 PAH | The 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. | NULL | 18 | BOTH | 30 | Phase 2 | NULL | ||
| 47 | EUCTR2009-014992-31-NL (EUCTR) | 16/02/2011 | 18/02/2011 | Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension | Long-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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | Austria;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 | ||
| 48 | EUCTR2009-014490-41-NL (EUCTR) | 16/02/2011 | 18/02/2011 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | Peru;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 | ||
| 49 | EUCTR2009-014992-31-SK (EUCTR) | 09/02/2011 | 09/06/2010 | Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension | Long-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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 670 | Phase 3 | 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;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden | ||
| 50 | EUCTR2009-014992-31-IE (EUCTR) | 16/11/2010 | 15/04/2010 | Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension | Long-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 Ltd | NULL | Not 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): no | Serbia;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 | ||
| 51 | EUCTR2009-014490-41-IE (EUCTR) | 15/11/2010 | 14/04/2010 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | 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;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden | ||
| 52 | EUCTR2009-014992-31-PL (EUCTR) | 19/10/2010 | 20/05/2010 | Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension | Long-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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | 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;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden | ||
| 53 | EUCTR2009-014992-31-DE (EUCTR) | 24/08/2010 | 08/06/2010 | Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension | Long-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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | 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;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden | ||
| 54 | EUCTR2009-014490-41-DE (EUCTR) | 24/08/2010 | 10/06/2010 | Study 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 | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | 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;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden | ||
| 55 | EUCTR2009-014992-31-CZ (EUCTR) | 20/08/2010 | 19/08/2010 | Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension | Long-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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | 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;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden | ||
| 56 | EUCTR2009-014992-31-IT (EUCTR) | 06/08/2010 | 28/12/2011 | Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension | Long-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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 670 | Phase 3 | Belarus;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 | ||
| 57 | EUCTR2009-014490-41-IT (EUCTR) | 06/08/2010 | 28/12/2011 | Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 670 | Phase 3 | Belarus;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 | ||
| 58 | EUCTR2009-014992-31-AT (EUCTR) | 28/07/2010 | 28/05/2010 | Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension | Long-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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | 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;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden | ||
| 59 | EUCTR2009-014490-41-AT (EUCTR) | 28/07/2010 | 28/05/2010 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | 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;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden | ||
| 60 | EUCTR2009-014992-31-HU (EUCTR) | 27/07/2010 | 01/06/2010 | Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension | Long-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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | 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;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden | ||
| 61 | EUCTR2009-014490-41-HU (EUCTR) | 27/07/2010 | 18/05/2010 | Study 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. | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | 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;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden | ||
| 62 | EUCTR2009-014490-41-GB (EUCTR) | 23/03/2010 | 17/03/2010 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | 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;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden | ||
| 63 | EUCTR2009-014992-31-BE (EUCTR) | 22/02/2010 | 23/11/2009 | Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension | Long-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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | 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;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden | ||
| 64 | EUCTR2009-014490-41-BE (EUCTR) | 22/02/2010 | 23/11/2009 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | 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;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden | ||
| 65 | EUCTR2009-014490-41-CZ (EUCTR) | 19/02/2010 | 19/02/2010 | Study 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 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1150 | Phase 3 | 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;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden | ||
| 66 | EUCTR2009-014992-31-SE (EUCTR) | 06/02/2010 | 14/12/2009 | Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension | Long-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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | 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;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden | ||
| 67 | EUCTR2009-014490-41-SE (EUCTR) | 06/02/2010 | 14/12/2009 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | Turkey;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 | ||
| 68 | EUCTR2009-014992-31-DK (EUCTR) | 05/02/2010 | 17/12/2009 | Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension | Long-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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden | ||
| 69 | EUCTR2009-014490-41-DK (EUCTR) | 08/12/2009 | 23/11/2009 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | Serbia;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 | ||
| 70 | NCT01106014 (ClinicalTrials.gov) | December 2009 | 2/4/2010 | Selexipag (ACT-293987) in 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 | Pulmonary Arterial Hypertension | Drug: Selexipag;Drug: Placebo | Actelion | NULL | Completed | 18 Years | 75 Years | All | 1156 | Phase 3 | United 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 |
| 71 | EUCTR2007-006453-12-AT (EUCTR) | 19/03/2009 | 23/06/2008 | Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom | ||
| 72 | EUCTR2007-006453-12-BE (EUCTR) | 03/10/2008 | 07/07/2008 | Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom | ||
| 73 | EUCTR2007-006453-12-DE (EUCTR) | 12/09/2008 | 19/12/2008 | Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom | ||
| 74 | EUCTR2019-002817-21-SE (EUCTR) | 29/10/2019 | A 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. | NULL | NA | Female: yes Male: yes | 237 | Phase 3 | Portugal;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 | |||
| 75 | EUCTR2018-000145-39-BE (EUCTR) | 03/03/2021 | A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension | A 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 Ltd | NULL | NA | Female: yes Male: yes | 60 | Phase 2 | Belarus;Serbia;United States;Taiwan;Ukraine;Israel;Russian Federation;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Poland;Belgium;Malaysia;Singapore;Romania;Netherlands;Germany;China | |||
| 76 | EUCTR2018-000145-39-PL (EUCTR) | 02/04/2019 | A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | Canada;Serbia;United States;Belarus;Taiwan;Ukraine;Russian Federation;Israel;Italy;United Kingdom;Vietnam;France;Hungary;Malaysia;Poland;Singapore;Romania;Netherlands;Germany;China | |||
| 77 | EUCTR2018-000145-39-FR (EUCTR) | 26/04/2018 | A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension | A 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 Ltd | NULL | NA | Female: yes Male: yes | 55 | Phase 2 | Serbia;United States;Belarus;Taiwan;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Poland;Malaysia;Singapore;Romania;Netherlands;Germany;China | |||
| 78 | EUCTR2019-002817-21-BE (EUCTR) | 02/12/2019 | A 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. | NULL | NA | Female: yes Male: yes | 237 | Phase 3 | Portugal;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 | |||
| 79 | EUCTR2019-002817-21-PL (EUCTR) | 15/10/2019 | A 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. | NULL | NA | Female: yes Male: yes | 237 | Phase 3 | Serbia;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 | |||
| 80 | EUCTR2019-002817-21-FR (EUCTR) | 14/10/2019 | A 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. | NULL | NA | Female: yes Male: yes | 237 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;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 | |||
| 81 | EUCTR2019-002817-21-IE (EUCTR) | 11/11/2021 | A 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. | NULL | NA | Female: yes Male: yes | 237 | Phase 3 | Portugal;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 |