86. Pulmonary arterial hypertension
1,083 clinical trials,   667 drugs   (DrugBank: 122 drugs),   98 drug target genes,   185 drug target pathways

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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
44 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04084678
(ClinicalTrials.gov)
October 29, 20206/9/2019A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PHA Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by CPET in Subjects With WHO Group 1 Pulmonary Hypertension Who Recently Initiated TherapyPAH;Pulmonary Hypertension;Hypertension;Connective Tissue Disease;Familial Primary Pulmonary Hypertension;Vascular Diseases;Cardiovascular Diseases;Hypertension, Pulmonary;Lung Diseases;Respiratory Tract Disease;Pulmonary Arterial HypertensionDrug: Ralinepag;Drug: PlaceboUnited TherapeuticsNULLRecruiting18 YearsN/AAll193Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Poland;Spain
2EUCTR2019-003309-88-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
3EUCTR2019-003309-88-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
4EUCTR2018-001189-40-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
5EUCTR2019-003309-88-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-003309-88-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
7NCT03683186
(ClinicalTrials.gov)
September 23, 201919/9/2018A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label ExtensionA Phase 3 Open-label Extension (OLE) Study to Evaluate the Long-term Safety and Efficacy of Ralinepag in Subjects With World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH)PAH;Pulmonary Hypertension;Pulmonary Arterial Hypertension;Hypertension;Connective Tissue Diseases;Familial Primary Pulmonary Hypertension;Vascular Diseases;Cardiovascular Diseases;Hypertension, Pulmonary;Lung Diseases;Respiratory Tract DiseaseDrug: RalinepagUnited TherapeuticsNULLEnrolling by invitation18 Years75 YearsAll1000Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Croatia;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Netherlands;Poland;Romania;Serbia;Singapore;Spain;Taiwan;Turkey;Ukraine;United Kingdom;Sweden
8EUCTR2018-001187-33-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
9EUCTR2018-001189-40-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
10EUCTR2018-001189-40-HR
(EUCTR)
21/05/201905/06/2019An 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]
Arena Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000Phase 3United States;Serbia;Taiwan;Greece;Thailand;Ukraine;Chile;Israel;Switzerland;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2018-001187-33-HR
(EUCTR)
20/05/201905/06/2019 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]
Arena Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
700Phase 3United 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
12EUCTR2018-001187-33-NL
(EUCTR)
16/04/201918/12/2018 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]
Arena Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: 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
13EUCTR2018-001187-33-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
14EUCTR2018-001189-40-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
15EUCTR2018-001187-33-GB
(EUCTR)
03/04/201931/10/2018 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]
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finished Female: 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
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-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
17EUCTR2018-001187-33-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
18EUCTR2018-001187-33-DE
(EUCTR)
18/03/201929/10/2018 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]
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finished Female: 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
19EUCTR2018-001189-40-GB
(EUCTR)
11/03/201926/11/2018An 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]
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finished Female: 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
20EUCTR2018-001189-40-BE
(EUCTR)
05/03/201910/12/2018An 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]
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finished Female: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2018-001189-40-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
22EUCTR2018-001189-40-DK
(EUCTR)
20/02/201911/12/2018An 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) - 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]
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finished Female: 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
23EUCTR2018-001187-33-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
24EUCTR2018-001189-40-FR
(EUCTR)
15/02/201916/11/2018An 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]
Arena Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000Phase 3United States;Serbia;Taiwan;Greece;Thailand;Ukraine;Chile;Israel;Switzerland;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Japan;Sweden
25EUCTR2018-001189-40-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2018-001187-33-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
27EUCTR2018-001187-33-DK
(EUCTR)
29/01/201926/11/2018 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]
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finished Female: 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
28EUCTR2018-001187-33-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
29EUCTR2018-001189-40-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
30EUCTR2018-001189-40-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2018-001187-33-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
32NCT03626688
(ClinicalTrials.gov)
August 30, 201827/7/2018A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH PatientsA Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ralinepag When Added to PAH Standard of Care or PAH Specific Background Therapy in Subjects With WHO Group 1 PAHPAH;Pulmonary Hypertension;Pulmonary Arterial Hypertension;Hypertension;Connective Tissue Diseases;Familial Primary Pulmonary Hypertension;Vascular Diseases;Cardiovascular Diseases;Hypertension, Pulmonary;Lung Diseases;Respiratory Tract DiseaseDrug: Ralinepag;Drug: PlaceboUnited TherapeuticsNULLRecruiting18 Years75 YearsAll700Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Croatia;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Netherlands;Poland;Romania;Serbia;Singapore;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom
33EUCTR2014-003042-27-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
34EUCTR2014-000667-40-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
35EUCTR2014-000667-40-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2014-003042-27-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
37EUCTR2014-003042-27-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
38NCT02279745
(ClinicalTrials.gov)
July 201525/10/2014Long Term Safety and Efficacy of Ralinepag in Pulmonary Arterial HypertensionAn Open-Label Extension Study of Ralinepag in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: RalinepagUnited TherapeuticsNULLActive, not recruiting18 Years75 YearsAll60Phase 2United States;Australia;Bulgaria;Czechia;Hungary;Poland;Romania;Serbia;Slovakia;Spain
39EUCTR2014-003042-27-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
40EUCTR2014-000667-40-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2014-003042-27-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
42EUCTR2014-003042-27-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
43EUCTR2014-000667-40-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
44NCT02279160
(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