84. サルコイドーシス Sarcoidosis Clinical trials / Disease details


臨床試験数 : 149 薬物数 : 202 - (DrugBank : 78) / 標的遺伝子数 : 66 - 標的パスウェイ数 : 169

  
8 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT03942211
(ClinicalTrials.gov)
February 26, 20217/5/2019A Study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral SelexipagA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Participants With Sarcoidosis-Associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag.Sarcoidosis-associated Pulmonary HypertensionDrug: Selexipag;Drug: PlaceboActelionNULLActive, not recruiting18 Years75 YearsAll10Phase 2United States;Belgium;Brazil;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom;Czechia
2EUCTR2018-004887-74-DE
(EUCTR)
20/05/202017/06/2019A study of the effectiveness and safety of selexipag in patients with sarcoidosis-associated pulmonary hypertension.A Multicenter, Randomized, Double-blind, Placebo-controlled study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag. sarcoidosis-associated pulmonary hypertension (SAPH)
MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary 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 / JNJ-67896049
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
74Phase 2United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Canada;Brazil;Belgium;Poland;Germany;Netherlands
3EUCTR2018-004887-74-IT
(EUCTR)
13/09/201917/06/2021A study of the effectiveness and safety of selexipag in patients with sarcoidosis-associated pulmonary hypertension.A multicenter, randomized, double-blind, placebo-controlled study in participants with sarcoidosis-associated pulmonary hypertension (SAPH) to assess the efficacy and safety of oral selexipag. - AC-065D301 sarcoidosis-associated pulmonary hypertension (SAPH)
MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary 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 / JNJ-67896049]
INN or Proposed INN: selexipag
Other descriptive name: selexipag
ACTELION PHARMACEUTICALS LTDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
74Phase 2;Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Canada;Brazil;Belgium;Poland;Germany;Netherlands
4EUCTR2018-004887-74-HU
(EUCTR)
29/08/201925/06/2019A study of the effectiveness and safety of selexipag in patients with sarcoidosis-associated pulmonary hypertension.A multicenter, randomized, double-blind, group-sequential, placebo-controlled 52-week period followed by a 104-week, single-arm, open-label period study in participants with sarcoidosis-associated pulmonary hypertension (SAPH) to assess the efficacy and safety of oral selexipag. sarcoidosis-associated pulmonary hypertension (SAPH)
MedDRA version: 20.0;Level: PT;Classification code 10037400;Term: Pulmonary 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 / JNJ-67896049
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Spain;Turkey;Russian Federation;Italy;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;China;Sweden
5EUCTR2018-004887-74-ES
(EUCTR)
19/08/201904/07/2019A study of the effectiveness and safety of selexipag in patients with sarcoidosis-associated pulmonary hypertension.A multicenter, randomized, double-blind, group-sequential, placebo-controlled 52-week period followed by a 104-week, single-arm, open-label period study in participants with sarcoidosis-associated pulmonary hypertension (SAPH) to assess the efficacy and safety of oral selexipag. sarcoidosis-associated pulmonary hypertension (SAPH)
MedDRA version: 20.0;Level: PT;Classification code 10037400;Term: Pulmonary 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 / JNJ-67896049
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Spain;Turkey;Russian Federation;Italy;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;China;Sweden
6EUCTR2018-004887-74-GB
(EUCTR)
14/08/201903/06/2019A study of the effectiveness and safety of selexipag in patients with sarcoidosis-associated pulmonary hypertension.A Multicenter, Randomized, Double-blind, Placebo-controlled Study inParticipants with Sarcoidosis-associated Pulmonary Hypertension (SAPH)to Assess the Efficacy and Safety of Oral Selexipag. sarcoidosis-associated pulmonary hypertension (SAPH)
MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary 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 / JNJ-67896049
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
74Phase 2United States;Czechia;Spain;United Kingdom;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;Germany;Netherlands
7EUCTR2018-004887-74-PL
(EUCTR)
13/08/201926/06/2019A study of the effectiveness and safety of selexipag in patients with sarcoidosis-associated pulmonary hypertension.A multicenter, randomized, double-blind, group-sequential, placebo-controlled 52-week period followed by a 104-week, single-arm, open-label period study in participants with sarcoidosis-associated pulmonary hypertension (SAPH) to assess the efficacy and safety of oral selexipag. sarcoidosis-associated pulmonary hypertension (SAPH)
MedDRA version: 20.0;Level: PT;Classification code 10037400;Term: Pulmonary 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 / JNJ-67896049
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Spain;Turkey;Russian Federation;Italy;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;China;Sweden
8EUCTR2018-004887-74-NL
(EUCTR)
29/07/201905/06/2019A study of the effectiveness and safety of selexipag in patients with sarcoidosis-associated pulmonary hypertension.A Multicenter, Randomized, Double-blind, Placebo-controlled Study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag. sarcoidosis-associated pulmonary hypertension (SAPH)
MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary 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 / JNJ-67896049
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
74Phase 2France;United States;Hungary;Canada;Poland;Spain;Belgium;Brazil;Germany;Netherlands;United Kingdom;Italy