88. 慢性血栓塞栓性肺高血圧症 Chronic thromboembolic pulmonary hypertension Clinical trials / Disease details


臨床試験数 : 159 薬物数 : 118 - (DrugBank : 23) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 53

  
17 trials found
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1JPRN-jRCT1041210122
11/01/202126/12/2021Investigational Randomized Controlled Trial of Patients with Chronic Thromboembolic Pulmonary Hypertension treated with Riociguat vs SelexipagInvestigational Randomized Controlled Trial of Patients with Chronic Thromboembolic Pulmonary Hypertensiontreated with Riociguat vs Selexipag - RISE-CTEPH study chronic thromboembolic pulmonary hypertension
chronic thromboembolic pulmonary hypertension;D006976
Patients will be randomly allocated to riociguat treated group or selexipag treated group
with PVR as a allocated factor. Riociguat is taken up to a maximum of 2.5mg taken three times a day. Selexipag is taken up to a maximum of 1.6mg taken two times a day.
Adachi ShiroNULLRecruiting>= 20age oldNot applicableBoth20N/AJapan
2EUCTR2018-002823-41-AT
(EUCTR)
04/10/201904/04/2019A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United 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
3EUCTR2018-002823-41-BG
(EUCTR)
17/07/201919/04/2019A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United 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
4EUCTR2018-002823-41-DK
(EUCTR)
15/07/201926/04/2019A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
280Phase 3Portugal;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
5EUCTR2018-002823-41-IT
(EUCTR)
03/07/201914/06/2021A 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 ChronicThromboembolic 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 addonto standard of care therapy in subjects with inoperable or persistent/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 LTDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3Portugal;United States;Taiwan;Hong Kong;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Israel;Switzerland;Italy;Denmark;South Africa;Netherlands;Latvia;China;Czechia;Finland;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Bulgaria;Germany;Sweden
6EUCTR2018-002823-41-PT
(EUCTR)
18/06/201930/05/2019A 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3Portugal;United States;Taiwan;Hong Kong;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Israel;Switzerland;Italy;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Bulgaria;Germany;Sweden
7EUCTR2018-002823-41-DE
(EUCTR)
03/06/201911/09/2018A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United 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
8EUCTR2018-002823-41-NL
(EUCTR)
30/04/201920/12/2018A 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Sweden;Hungary;Czech Republic;United Kingdom;Austria;Turkey;Finland;Czechia;Korea, Republic of;China;Netherlands;South Africa;Denmark;Australia;Italy;Switzerland;Israel;Russian Federation;Ukraine;Thailand;Spain;Slovakia;Taiwan;Portugal;United States
9EUCTR2018-002823-41-GB
(EUCTR)
25/03/201918/09/2018A 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3United 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
10EUCTR2018-002823-41-BE
(EUCTR)
18/03/201920/12/2018A 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3Portugal;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;Malaysia;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
11EUCTR2018-002823-41-HU
(EUCTR)
27/02/201908/01/2019A 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]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
400Phase 3United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Bulgaria;Germany;Sweden
12EUCTR2018-002823-41-CZ
(EUCTR)
22/02/201901/11/2018A 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3Portugal;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
13NCT03689244
(ClinicalTrials.gov)
January 23, 201927/9/2018A 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 TreatmentA 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 HypertensionChronic Thromboembolic Pulmonary HypertensionDrug: Selexipag;Drug: PlaceboActelionNULLRecruiting18 Years85 YearsAll280Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;China;Czechia;Denmark;Germany;Hungary;India;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Poland;Portugal;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Singapore;South Africa
14JPRN-JapicCTI-163279
10/6/201601/06/2016A 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.NULLcomplete2085BOTH72Phase 3Japan
15JPRN-JapicCTI-132159
01/5/201313/06/2013NS-304 CTEPH OEThe 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.NULLBOTH2Phase 2NULL
16JPRN-JapicCTI-111666
01/6/201018/10/2011NS-304 CTEPH OL studyThe 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.NULLBOTH32Phase 2NULL
17JPRN-JapicCTI-111667
01/2/201018/10/2011NS-304 CTEPH DB studyAn 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.NULL2075BOTH32Phase 2NULL