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 | EUCTR2019-003309-88-DE (EUCTR) | 30/07/2020 | 21/02/2020 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 193 | Phase 3 | United States;Argentina;Spain;Poland;Belgium;Brazil;Austria;Australia;Germany;United Kingdom;Italy | ||
| 2 | EUCTR2019-003309-88-AT (EUCTR) | 14/07/2020 | 20/02/2020 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 193 | Phase 3 | United States;Canada;Argentina;Spain;Poland;Belgium;Brazil;Australia;Austria;Germany;United Kingdom;Italy | ||
| 3 | EUCTR2018-001189-40-NL (EUCTR) | 07/07/2020 | 19/12/2018 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-Label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 4 | EUCTR2019-003309-88-ES (EUCTR) | 03/06/2020 | 21/02/2020 | A randomized double blind, placebo controlled study in pulmonary arterial hypertension using cardiopulmonary exercise testing. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy (ADVANCE Capacity) - ADVANCE Capacity | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 193 | Phase 3 | United States;Czech Republic;Argentina;Poland;Brazil;Belgium;Spain;Austria;Australia;Germany;United Kingdom;Italy | ||
| 5 | EUCTR2019-003309-88-GB (EUCTR) | 02/06/2020 | 11/02/2020 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 193 | Phase 3 | United States;Czech Republic;Argentina;Spain;Poland;Brazil;Belgium;Austria;Australia;Germany;Italy;United Kingdom | ||
| 6 | EUCTR2019-003309-88-PL (EUCTR) | 14/05/2020 | 26/02/2020 | A Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity in Subjects with Pulmonary Hypertension | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 193 | Phase 3 | United States;Argentina;Belgium;Spain;Brazil;Poland;Austria;Australia;Germany;United Kingdom;Italy | ||
| 7 | EUCTR2019-003309-88-IT (EUCTR) | 06/05/2020 | 24/05/2021 | na | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: [APD811] INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: [APD811] INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: [APD811] INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 | UNITED THERAPEUTICS CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 193 | Phase 3 | United States;Czechia;Argentina;Spain;Poland;Belgium;Brazil;Austria;Australia;Germany;United Kingdom;Italy | ||
| 8 | EUCTR2018-001189-40-CZ (EUCTR) | 11/03/2020 | 27/11/2018 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 9 | EUCTR2018-001189-40-PT (EUCTR) | 02/09/2019 | 27/03/2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutic Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 10 | EUCTR2018-001189-40-HR (EUCTR) | 21/05/2019 | 05/06/2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 11 | EUCTR2018-001189-40-BG (EUCTR) | 10/04/2019 | 29/01/2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;Taiwan;Greece;Ukraine;Israel;Chile;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 12 | EUCTR2018-001187-33-DE (EUCTR) | 18/03/2019 | 29/10/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Singapore;United States;Portugal;Greece;Sweden;Netherlands;China;Brazil;Korea, Republic of;Poland;Chile;Serbia;Bulgaria;Croatia;Argentina;Romania;Hungary;Ukraine;United Kingdom;Canada;Turkey;Belgium;European Union;Taiwan;Denmark;Mexico;Israel;Australia;Germany | ||
| 13 | EUCTR2018-001189-40-BE (EUCTR) | 05/03/2019 | 10/12/2018 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-term Efficacy and Safety of Ralinepag inSubjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Singapore;United States;Portugal;Greece;Sweden;Netherlands;China;Brazil;Korea, Republic of;Poland;Chile;Serbia;France;Bulgaria;Croatia;Argentina;Hungary;Ukraine;United Kingdom;Canada;Czech Republic;Turkey;Belgium;European Union;Taiwan;Denmark;Mexico;Italy;Israel;Australia | ||
| 14 | EUCTR2018-001189-40-DK (EUCTR) | 20/02/2019 | 11/12/2018 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 15 | EUCTR2018-001187-33-BE (EUCTR) | 18/02/2019 | 10/12/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Bulgaria;Germany;Sweden | ||
| 16 | EUCTR2018-001187-33-SE (EUCTR) | 05/02/2019 | 29/10/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden | ||
| 17 | EUCTR2018-001189-40-PL (EUCTR) | 16/01/2019 | 21/03/2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-Label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 18 | EUCTR2018-001187-33-PL (EUCTR) | 16/01/2019 | 06/12/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden | ||
| 19 | EUCTR2018-001189-40-HU (EUCTR) | 14/01/2019 | 21/01/2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A study evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;United States;Serbia;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Bulgaria;Sweden | ||
| 20 | EUCTR2014-000667-40-SK (EUCTR) | 17/01/2017 | 01/04/2016 | A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension. | A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension 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] - Respiratory Tract Diseases [C08] | Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria | ||
| 21 | EUCTR2014-003042-27-SK (EUCTR) | 26/05/2016 | 01/04/2016 | Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003) | An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension 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] - Respiratory Tract Diseases [C08] | Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria | ||
| 22 | EUCTR2014-000667-40-PL (EUCTR) | 30/07/2015 | 29/04/2015 | A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension. | A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension | 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] - Respiratory Tract Diseases [C08] | Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Slovakia;Spain;Poland;Romania;Australia;Bulgaria | ||
| 23 | EUCTR2014-003042-27-RO (EUCTR) | 30/07/2015 | 05/10/2015 | Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003) | An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension | 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] - Respiratory Tract Diseases [C08] | Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Serbia;United States;Hungary;Czech Republic;Poland;Spain;Romania;Australia;Bulgaria | |||
| 24 | EUCTR2014-000667-40-RO (EUCTR) | 30/07/2015 | 02/10/2015 | A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension. | A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension | 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] - Respiratory Tract Diseases [C08] | Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Poland;Spain;Romania;Australia;Bulgaria | ||
| 25 | EUCTR2014-003042-27-PL (EUCTR) | 23/07/2015 | 28/05/2015 | Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003) | An Open-Label Extension Study of APD811-003 in Patients 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] | Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Serbia;Hungary;Czech Republic;Slovakia;Spain;Poland;Romania;Australia;Bulgaria | ||
| 26 | EUCTR2014-003042-27-ES (EUCTR) | 29/05/2015 | 09/03/2015 | Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003) | An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension MedDRA version: 17.1;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] | Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Serbia;United States;Hungary;Czech Republic;Poland;Spain;Romania;Australia;Bulgaria | |||
| 27 | EUCTR2014-000667-40-ES (EUCTR) | 27/05/2015 | 09/03/2015 | A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension. | A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension | 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] - Respiratory Tract Diseases [C08] | Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria | ||
| 28 | EUCTR2014-000667-40-CZ (EUCTR) | 23/04/2015 | 14/01/2015 | A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension. | A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension 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] - Respiratory Tract Diseases [C08] | Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria | ||
| 29 | EUCTR2014-003042-27-CZ (EUCTR) | 23/04/2015 | 14/01/2015 | Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003) | An Open-Label Extension Study of APD811-003 in Patients 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] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Serbia;Czechia;Hungary;Czech Republic;Slovakia;Spain;Poland;Romania;Australia;Bulgaria | ||
| 30 | EUCTR2014-000667-40-HU (EUCTR) | 17/02/2015 | 19/01/2015 | A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension. | A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension | 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] - Respiratory Tract Diseases [C08] | Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Czech Republic;Hungary;Slovakia;Poland;Spain;Romania;Australia;Bulgaria | ||
| 31 | EUCTR2014-003042-27-HU (EUCTR) | 17/02/2015 | 19/01/2015 | Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003) | An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension | 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] - Respiratory Tract Diseases [C08] | Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Serbia;Czech Republic;Hungary;Slovakia;Spain;Poland;Romania;Australia;Bulgaria |