Apd811    (DrugBank: -)

1 disease
告示番号疾患名(ページ内リンク)臨床試験数
86肺動脈性肺高血圧症32

86. 肺動脈性肺高血圧症 [臨床試験数:1,083,薬物数:667(DrugBank:122),標的遺伝子数:98,標的パスウェイ数:185
Searched query = "Pulmonary arterial hypertension", "PAH", "IPAH", "HPAH", "Eisenmenger syndrome"
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.
32 / 1,083 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-003309-88-DE
(EUCTR)
30/07/202021/02/2020A 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 CapacityA 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
193Phase 3United States;Czech Republic;Argentina;Spain;Poland;Brazil;Belgium;Austria;Australia;Germany;United Kingdom;Italy
2EUCTR2019-003309-88-AT
(EUCTR)
14/07/202020/02/2020A 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 TherapyA 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
193Phase 3United States;Czech Republic;Argentina;Spain;Poland;Brazil;Belgium;Australia;Austria;Germany;United Kingdom;Italy
3EUCTR2018-001189-40-NL
(EUCTR)
07/07/202019/12/2018An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertensionA StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label 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
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Arena Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3Portugal;Serbia;United States;Taiwan;Greece;Thailand;Ukraine;Israel;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Japan;Sweden
4EUCTR2019-003309-88-GB
(EUCTR)
02/06/202011/02/2020A 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 TherapyA 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
193Phase 3United States;Czech Republic;Argentina;Spain;Poland;Brazil;Belgium;Austria;Australia;Germany;Italy;United Kingdom
5EUCTR2019-003309-88-PL
(EUCTR)
14/05/202026/02/2020A Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity in Subjects with Pulmonary HypertensionA 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
193Phase 3United States;Czech Republic;Argentina;Brazil;Belgium;Spain;Poland;Austria;Australia;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2018-001187-33-PT
(EUCTR)
02/09/201922/03/2019A 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: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden;Serbia;Portugal;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico
7EUCTR2018-001189-40-PT
(EUCTR)
02/09/201927/03/2019An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertensionA 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3Serbia;Portugal;United States;Taiwan;Greece;Ukraine;Israel;Chile;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden
8EUCTR2018-001187-33-BG
(EUCTR)
10/04/201913/12/2018A 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: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;United States;Serbia;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden
9EUCTR2018-001189-40-BG
(EUCTR)
10/04/201929/01/2019An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertensionA 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United 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
10EUCTR2018-001187-33-GR
(EUCTR)
03/04/201920/03/2019A 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: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Arena Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Portugal;United States;Serbia;Taiwan;Greece;Thailand;Ukraine;Chile;Israel;Switzerland;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2018-001189-40-GR
(EUCTR)
03/04/201920/03/2019An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertensionA StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label 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
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United 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
12EUCTR2018-001189-40-IT
(EUCTR)
21/02/201914/11/2019An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertensionA StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label 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
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden
13EUCTR2018-001187-33-BE
(EUCTR)
18/02/201910/12/2018A 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;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
14EUCTR2018-001189-40-SE
(EUCTR)
11/02/201919/11/2018An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertensionA StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label 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
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Serbia;United States;Portugal;Taiwan;Greece;Ukraine;Israel;Chile;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden
15EUCTR2018-001187-33-SE
(EUCTR)
05/02/201929/10/2018A 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
700Phase 3Portugal;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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2018-001189-40-PL
(EUCTR)
16/01/201921/03/2019An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertensionA StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label 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
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Arena Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3Portugal;Serbia;United States;Taiwan;Greece;Thailand;Ukraine;Israel;Chile;Italy;Switzerland;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Japan;Sweden
17EUCTR2018-001187-33-PL
(EUCTR)
16/01/201906/12/2018A 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;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
18EUCTR2018-001187-33-HU
(EUCTR)
14/01/201906/11/2018A 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: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;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
19EUCTR2018-001189-40-HU
(EUCTR)
14/01/201921/01/2019An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertensionA 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3Portugal;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
20EUCTR2014-000667-40-SK
(EUCTR)
17/01/201701/04/2016A 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]
Arena Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
60Phase 2Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2014-003042-27-SK
(EUCTR)
26/05/201601/04/2016Follow-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria
22EUCTR2014-000667-40-PL
(EUCTR)
30/07/201529/04/2015A 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.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;United States;Hungary;Czech Republic;Slovakia;Spain;Poland;Romania;Australia;Bulgaria
23EUCTR2014-000667-40-RO
(EUCTR)
30/07/201502/10/2015A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Serbia;United States;Hungary;Czech Republic;Poland;Spain;Romania;Australia;Bulgaria
24EUCTR2014-003042-27-RO
(EUCTR)
30/07/201505/10/2015Follow-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Serbia;United States;Hungary;Czech Republic;Poland;Spain;Romania;Australia;Bulgaria
25EUCTR2014-003042-27-PL
(EUCTR)
23/07/201528/05/2015Follow-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Serbia;United States;Hungary;Czech Republic;Slovakia;Spain;Poland;Romania;Australia;Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2014-003042-27-ES
(EUCTR)
29/05/201509/03/2015Follow-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Serbia;United States;Hungary;Czech Republic;Poland;Spain;Romania;Australia;Bulgaria
27EUCTR2014-000667-40-ES
(EUCTR)
27/05/201509/03/2015A 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.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria
28EUCTR2014-000667-40-CZ
(EUCTR)
23/04/201514/01/2015A 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]
Arena Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
60Phase 2Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria
29EUCTR2014-003042-27-CZ
(EUCTR)
23/04/201514/01/2015Follow-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.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Serbia;Hungary;Czech Republic;Slovakia;Spain;Poland;Romania;Australia;Bulgaria
30EUCTR2014-003042-27-HU
(EUCTR)
17/02/201519/01/2015Follow-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.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Serbia;Czech Republic;Hungary;Slovakia;Spain;Poland;Romania;Australia;Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2014-000667-40-HU
(EUCTR)
17/02/201519/01/2015A 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.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;United States;Czech Republic;Hungary;Slovakia;Poland;Spain;Romania;Australia;Bulgaria
32NCT02279160
(ClinicalTrials.gov)
December 201425/10/2014Safety and Efficacy of APD811 in Pulmonary Arterial HypertensionA Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of Ralinepag, an Oral IP Receptor Agonist, in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: APD811;Drug: PlaceboUnited TherapeuticsNULLCompleted18 Years75 YearsAll61Phase 2United States;Australia;Bulgaria;Czechia;Hungary;Poland;Romania;Serbia;Spain;Czech Republic