88. 慢性血栓塞栓性肺高血圧症
［臨床試験数：145，薬物数：112（DrugBank：22），標的遺伝子数：13，標的パスウェイ数：52］
Searched query = "Chronic thromboembolic pulmonary hypertension", "CTEPH", "Idiopathic chronic pulmonary thromboembolism"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 | EUCTR2018-002823-41-AT (EUCTR) | 04/10/2019 | 04/04/2019 | A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi 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 | 280 | Phase 3 | United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Bulgaria;Germany;Sweden | ||
| 2 | EUCTR2018-002823-41-BG (EUCTR) | 17/07/2019 | 19/04/2019 | A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi 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 | 280 | Phase 3 | United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Bulgaria;Germany;Sweden | ||
| 3 | EUCTR2018-002823-41-DK (EUCTR) | 15/07/2019 | 26/04/2019 | A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi 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 | 280 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Switzerland;Italy;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden | ||
| 4 | EUCTR2018-002823-41-PT (EUCTR) | 18/06/2019 | 30/05/2019 | A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Singapore;Bulgaria;Germany;Sweden | |||
| 5 | EUCTR2018-002823-41-DE (EUCTR) | 03/06/2019 | 11/09/2018 | A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi 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 | 280 | Phase 3 | United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Bulgaria;Germany;Sweden | ||
| 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 |
| 6 | EUCTR2018-002823-41-NL (EUCTR) | 30/04/2019 | 20/12/2018 | A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallelgroup, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an addon to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;Australia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Bulgaria;Germany;Sweden | |||
| 7 | EUCTR2018-002823-41-GB (EUCTR) | 25/03/2019 | 18/09/2018 | A clinical study to assess the efficacy and safety of selexipag as an add-onto standard of care therapy in subjects with inoperable orpersistent/recurrent, after surgical treatment and/or ChronicThromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallelgroup,group-sequential, adaptive, Phase 3 study with open-labelextension period to assess the efficacy and safety of selexipag as an addonto standard of care therapy in subjects with inoperable orpersistent/recurrent after surgical and/or interventional treatment ChronicThromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi 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 | 280 | Phase 3 | United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Bulgaria;Germany;Sweden | ||
| 8 | EUCTR2018-002823-41-BE (EUCTR) | 18/03/2019 | 20/12/2018 | A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi 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 | 400 | Phase 3 | Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Sweden;United States;Portugal;Taiwan;Slovakia;Thailand | ||
| 9 | EUCTR2018-002823-41-HU (EUCTR) | 27/02/2019 | 08/01/2019 | A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment, Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 20.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Singapore;Bulgaria;Germany;Sweden | |||
| 10 | EUCTR2018-002823-41-CZ (EUCTR) | 22/02/2019 | 01/11/2018 | A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi 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 | 280 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Sweden | ||
| 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 |
| 11 | NCT03689244 (ClinicalTrials.gov) | January 23, 2019 | 27/9/2018 | A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential, Adaptive, Phase 3 Study With Open-label Extension Period to Assess the Efficacy and Safety of Selexipag as an add-on to Standard of Care Therapy in Subjects With Inoperable or Persistent/Recurrent After Surgical and/or Interventional Treatment Chronic Thromboembolic Pulmonary Hypertension | Chronic Thromboembolic Pulmonary Hypertension | Drug: Selexipag;Drug: Placebo | Actelion | NULL | Recruiting | 18 Years | 85 Years | All | 280 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;China;Czechia;Denmark;Germany;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Russian Federation;Singapore;Slovakia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;United Kingdom |
| 12 | JPRN-JapicCTI-163279 | 10/6/2016 | 01/06/2016 | A confirmatory (phase III) study of the efficacy and safety of NS-304 (selexipag) in patients with chronic thromboembolic pulmonary hypertension (CTEPH) | A confirmatory (phase III) study of the efficacy and safety of NS-304 (selexipag) in patients with chronic thromboembolic pulmonary hypertension (CTEPH) | Chronic thromboembolic pulmonary hypertension (CTEPH) | Intervention name : NS-304 INN of the intervention : Selexipag Dosage And administration of the intervention : Oral administration Control intervention name : NS-304 Placebo INN of the control intervention : - Dosage And administration of the control intervention : Oral administration | Nippon Shinyaku Co., Ltd. | NULL | complete | 20 | 85 | BOTH | 72 | Phase 3 | Japan |
| 13 | JPRN-JapicCTI-132159 | 01/5/2013 | 13/06/2013 | NS-304 CTEPH OE | The open-label extension study of NS-304 in patients with chronic thromboembolic pulmonary hypertension (CTEPH) | Chronic thromboembolic pulmonary hypertension (CTEPH) | Intervention name : NS-304 INN of the intervention : Selexipag Dosage And administration of the intervention : Oral administration | NIPPON SHINYAKU CO., LTD. | NULL | BOTH | 2 | Phase 2 | NULL | |||
| 14 | JPRN-JapicCTI-111666 | 01/6/2010 | 18/10/2011 | NS-304 CTEPH OL study | The open-label extension study of NS-304 in patients with chronic thromboembolic pulmonary hypertension (CTEPH) who completed the exploratory evaluation study | Chronic thromboembolic pulmonary hypertension (CTEPH) | 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 | BOTH | 32 | Phase 2 | NULL | |||
| 15 | JPRN-JapicCTI-111667 | 01/2/2010 | 18/10/2011 | NS-304 CTEPH DB study | An exploratory study to assess the efficacy and safety of NS-304 in patients with chronic thromboembolic pulmonary hypertension (CTEPH) | Chronic thromboembolic pulmonary hypertension (CTEPH) | Intervention name : NS-304 INN of the intervention : Selexipag Dosage And administration of the intervention : Oral administration Control intervention name : Placebo Dosage And administration of the control intervention : Oral administration | NIPPON SHINYAKU CO., LTD. / Actelion Pharmaceuticals Japan Ltd. | NULL | 20 | 75 | BOTH | 32 | Phase 2 | NULL |