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
| 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 | EUCTR2018-004887-74-DE (EUCTR) | 20/05/2020 | 17/06/2019 | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 74 | Phase 2 | United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Canada;Brazil;Belgium;Poland;Germany;Netherlands | ||
| 2 | EUCTR2018-004887-74-IT (EUCTR) | 13/09/2019 | 17/06/2021 | A 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 LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 74 | Phase 2;Phase 3 | United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Canada;Brazil;Belgium;Poland;Germany;Netherlands | ||
| 3 | EUCTR2018-004887-74-HU (EUCTR) | 29/08/2019 | 25/06/2019 | A 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 Ltd | NULL | Authorised-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): no | Portugal;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 | ||
| 4 | EUCTR2018-004887-74-ES (EUCTR) | 19/08/2019 | 04/07/2019 | A 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 Ltd | NULL | Authorised-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): no | Portugal;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 | ||
| 5 | EUCTR2018-004887-74-GB (EUCTR) | 14/08/2019 | 03/06/2019 | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 74 | Phase 2 | United States;Czechia;Spain;United Kingdom;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;Germany;Netherlands | ||
| 6 | EUCTR2018-004887-74-PL (EUCTR) | 13/08/2019 | 26/06/2019 | A 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 Ltd | NULL | Authorised-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): no | Portugal;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 | ||
| 7 | EUCTR2018-004887-74-NL (EUCTR) | 29/07/2019 | 05/06/2019 | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 74 | Phase 2 | France;United States;Hungary;Canada;Poland;Spain;Belgium;Brazil;Germany;Netherlands;United Kingdom;Italy |