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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03833323
(ClinicalTrials.gov)
August 1, 20215/2/2019Implantable System for Remodulin Post-Approval StudyImplantable System for Remodulin Post-Approval StudyPulmonary Arterial HypertensionCombination Product: Implantable System for Remodulin (treprostinil)Medtronic Cardiac Rhythm and Heart FailureUnited TherapeuticsNot yet recruiting22 YearsN/AAll50NULL
2NCT04039464
(ClinicalTrials.gov)
April 1, 20211/7/2019Mono vs. Dual Therapy for Pediatric Pulmonary Arterial HypertensionKids MoD PAH Trial: Mono- vs. Duo-Therapy for Pediatric Pulmonary Arterial HypertensionPediatric Pulmonary HypertensionDrug: Mono-Therapy with Sildenafil;Drug: Duo-Therapy with Sildenafil + BosentanJohns Hopkins UniversityNULLNot yet recruiting4 Months18 YearsAll100Phase 3United States
3NCT04451850
(ClinicalTrials.gov)
January 1, 202125/6/2020HRV as a Marker of Treatment Response in PAH Arterial HypertensionHeart Rate Variability (HRV) as a Marker of Treatment Response in Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionOther: Noninvasive actigraphy monitorUniversity of CincinnatiNULLNot yet recruiting18 Years70 YearsAll35NULL
4NCT04435782
(ClinicalTrials.gov)
December 14, 202015/6/2020A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance ImagingA Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance ImagingPulmonary Arterial HypertensionDrug: JNJ-67896049ActelionNULLNot yet recruiting18 Years65 YearsAll80Phase 4United States;Argentina;Brazil;China;France;Germany;Hong Kong;Israel;Korea, Republic of;Malaysia;Netherlands;Russian Federation;Saudi Arabia;United Kingdom
5EUCTR2019-004783-22-NL
(EUCTR)
03/12/202030/06/2020A clinical trial to study the effects of selexipag on the heart in patients with Pulmonary Arterial HypertensionA Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging - RESTORE 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]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 4United States;United Arab Emirates;Hong Kong;Saudi Arabia;Israel;Russian Federation;United Kingdom;France;Argentina;Brazil;Netherlands;Germany;China;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04456998
(ClinicalTrials.gov)
December 202030/6/2020GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)Pulmonary Artery HypertensionDrug: GB002;Drug: Placebo;Device: Generic Dry Powder InhalerGB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.NULLRecruiting18 Years80 YearsAll80Phase 2United States
7NCT04576988
(ClinicalTrials.gov)
December 202028/9/2020A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (STELLAR)A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAHPulmonary Arterial HypertensionDrug: Sotatercept;Drug: PlaceboAcceleron Pharma, Inc.NULLNot yet recruiting18 YearsN/AAll284Phase 3United States
8EUCTR2019-004131-24-GB
(EUCTR)
23/11/202026/05/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary 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] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3United States;United Arab Emirates;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;France;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan
9NCT04483115
(ClinicalTrials.gov)
November 16, 202015/7/2020Acute Haemodynamic Study of TPN171H in Patients With Pulmonary Arterial HypertensionMulti-center, Randomized,Placebo and Positive Controlled Clinical Study of TPN171H Tablets on Acute Haemodynamics in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: TPN171H;Drug: Placebo;Drug: TadalafilVigonvita Life SciencesShanghai Institute of Materia Medica, Chinese Academy of SciencesRecruiting18 Years75 YearsAll60Phase 2China
10EUCTR2019-004783-22-GB
(EUCTR)
16/11/202026/08/2020A clinical trial to study the effects of selexipag on the heart in patients with Pulmonary Arterial HypertensionA Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging - RESTORE 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]
Trade Name: Uptravi
Product Name: Uptravi
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Uptravi
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Uptravi
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Uptravi
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Uptravi
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Uptravi
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 4United States;United Arab Emirates;Hong Kong;Saudi Arabia;Israel;Russian Federation;United Kingdom;France;Argentina;Brazil;Germany;Netherlands;China;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04280523
(ClinicalTrials.gov)
November 15, 202015/1/2020TranspulmonarY Estrogen Gradient and Estrogen Receptors (TYEGER) in PAHTranspulmonarY Estrogen Gradient and Estrogen Receptors (TYEGER) in PAHPulmonary Arterial HypertensionDrug: ESR-specific PET scanVanderbilt University Medical CenterNULLNot yet recruiting13 YearsN/AAll40Phase 2United States
12EUCTR2019-002533-11-SK
(EUCTR)
12/11/202013/08/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS 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] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden
13EUCTR2019-004131-24-LT
(EUCTR)
10/11/202022/09/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary 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] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;France;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan
14EUCTR2019-002533-11-NO
(EUCTR)
29/10/202003/08/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS 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] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Norway;Germany;Japan;Sweden
15NCT04084678
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16JPRN-JapicCTI-194971
23/10/202025/09/2019Clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed-dose combination therapy in subjects with pulmonary arterial hypertension (PAH)Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies with the Corresponding Fixed Dose Combination in Subjects with Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period with Macitentan and Tadalafil Fixed Dose Combination Therapy pulmonary arterial hypertensionIntervention name : ACT-064992D
INN of the intervention : -
Dosage And administration of the intervention : Subjects to receive FDC macitentan/tadalafil (macitentan 10 mg and tadalafil 40 mg) plus matching placebos for the two other study treatments.
Control intervention name : Macitentan
INN of the control intervention : -
Dosage And administration of the control intervention : Film-coated tablet with 10 mg macitentan, to be administered orally once daily.
Control intervention name : Tadalafil
INN of the control intervention : -
Dosage And administration of the control intervention : Film-coated tablet with 40 mg tadalafil (2 x 20 mg tablets), to be administered orally once daily.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : FDC therapy + Placebo macitentan + Placebo tadalafil , Macitentan mono-therapy + Placebo tadalafil + Placebo FDC, Tadalafil mono-therapy + Placebo macitentan + Placebo FDC
Janssen Pharmaceutical K.K.NULLrecruiting18BOTH170Phase 3Japan, South America, Europe
17NCT04589390
(ClinicalTrials.gov)
October 15, 20208/10/2020Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial HypertensionSelexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial HypertensionPulmonary Hypertension;SchistosomiasisDrug: SelexipagUniversity of Sao Paulo General HospitalJanssen-Cilag Ltd.Recruiting18 YearsN/AAll20Phase 2Brazil
18EUCTR2019-002669-37-GB
(EUCTR)
08/10/202011/05/2020Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: GB002 Capsules
Product Code: GB002
INN or Proposed INN: Seralutinib
Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM
GB002, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2United States;Serbia;France;Austria;Australia;Israel;Germany;United Kingdom;Canada;Belgium;Singapore
19NCT04567602
(ClinicalTrials.gov)
October 6, 202023/9/2020A Study of Pulmonary Arterial Hypertension Participants Treated With Macitentan or SelexipagNon-Interventional Study on Pulmonary Arterial Hypertension Patients Treated With Macitentan or Selexipag: Experience From an Italian Cohort (INSPECTIO)Pulmonary Arterial HypertensionDrug: PAH medicationJanssen-Cilag S.p.A.NULLRecruiting18 YearsN/AAll200Italy
20ChiCTR2000036852
2020-10-012020-08-25Establishment of an artificial intelligence screening and evaluation system based on multimodal imaging of pulmonary arterial hypertension: Study on clinical diagnosis modelEstablishment of an artificial intelligence screening and evaluation system based on multimodal imaging of pulmonary arterial hypertension: Study on clinical diagnosis model pulmonary arterial hypertensionGold Standard:Right heart catheterization;Index test:multimodal imaging artificial intelligence screening and evaluation system;Shanghai Pulmonary HospitalNULLPendingBothTarget condition:1000;Difficult condition:1000NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2019-002669-37-FR
(EUCTR)
01/10/202015/07/2020Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: GB002 Capsules
Product Code: GB002
INN or Proposed INN: Seralutinib
Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM
GB002, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2United States;Serbia;France;Canada;Belgium;Singapore;Austria;Australia;Israel;Germany;United Kingdom
22EUCTR2019-002533-11-NL
(EUCTR)
29/09/202029/04/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS 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] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
655Phase 3United States;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Norway;Germany;Japan;Sweden
23NCT04266197
(ClinicalTrials.gov)
September 25, 202022/1/2020Effects of RT234 on Exercise Parameters Accessed by CPET in Subjects With PAHA Phase 2, Open-label, Single Dose Study to Evaluated the Safety and Efficacy of RT234 on Exercise Parameters Assessed by Cardiopulmonary Exercise Testing (CPET) in Subjects With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionCombination Product: Drug: RT234 - vardenafil inhalation powder; Device: Axially Oscillating Sphere dry powder inhaler (AOS DPI)Respira Therapeutics, Inc.Argint International;Precision For MedicineRecruiting18 Years80 YearsAll20Phase 2Serbia
24EUCTR2020-002788-80-DE
(EUCTR)
09/09/202008/06/2020Study to evaluate the safety, tolerability and efficacy of AZD4831 in thetreatment of patients with pulmonary hypertensionAn explorative study to assess the safety, tolerability, and efficacy of AZD4831 in the treatment of pulmonary arterial hypertension (PAH)(MPO-PAH) 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] - Cardiovascular Diseases [C14]
Product Name: AZD4831University of CologneNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10Phase 2Germany
25NCT04505137
(ClinicalTrials.gov)
September 2, 202031/7/2020A Study to Investigate Safe and Tolerable Dose of GMA301 Injection in Healthy VolunteersA Phase 1, Placebo-Controlled, Double-Blind, Dose-Escalation Study To Investigate The Safety, Tolerability, And Pharmacokinetics Of A Single Intravenous Dose Of GMA301 Injection In Healthy VolunteersPulmonary Arterial HypertensionDrug: GMA301 Injection;Other: GMA301 Placebo InjectionGmax Biopharm Australia Pty Ltd.Metaclinical;Syneos HeathActive, not recruiting18 Years60 YearsAll16Phase 1Australia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT04416750
(ClinicalTrials.gov)
September 1, 202028/5/2020Positioning Imatinib for Pulmonary Arterial HypertensionPositioning Imatinib for Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Imatinib MesylateImperial College LondonNational Institute for Health Research, United Kingdom;Medical Research Council;University of Cambridge;University of SheffieldNot yet recruiting18 Years75 YearsAll43Phase 2United Kingdom
27EUCTR2019-002817-21-LT
(EUCTR)
13/08/202025/05/2020A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO 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]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3Bulgaria;Germany;Sweden;United States;Serbia;Belarus;Portugal;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania
28EUCTR2019-004131-24-DE
(EUCTR)
10/08/202026/05/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary 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] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan;Saudi Arabia;Serbia;United States;United Arab Emirates
29JPRN-JapicCTI-205391
03/8/202030/07/2020An exploratory study of NS-304A phase 2 exploratory study of NS-304 in Japanese pediatric patients with pulmonary arterial hypertension Pulmonary arterial hypertensionIntervention name : NS-304
INN of the intervention : Selexipag
Dosage And administration of the intervention : Oral administration
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Nippon Shinyaku Co., Ltd.NULLpending214BOTH6Phase 2Japan
30NCT04528056
(ClinicalTrials.gov)
August 1, 202014/8/2020Pilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial HypertensionPilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Sulfasalazine;Drug: Ambrisentan;Drug: Sulfasalazine's placebo;Drug: Ambrisentan's placeboRenJi HospitalNULLRecruiting18 Years75 YearsAll80Phase 1;Phase 2China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2019-003309-88-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
32EUCTR2020-001157-48-GB
(EUCTR)
28/07/202009/07/2020PIPAH study: Using imatinib (drug) in Pulmonary Arterial HypertensionIdentifying a safe and tolerated dose of Imatinib forpatients with Pulmonary Arterial Hypertension (PAH) - Positioning Imatinib for Pulmonary Arterial Hypertension (PIPAH) Pulmonary Arterial Hypertension (Idiopathic, heritable, or assosicated with anorexigens)
MedDRA version: 21.1;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10050701;Term: Congenital pulmonary hypertension;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Imatinib mesilate
Product Name: Imatinib mesilate
INN or Proposed INN: Imatinib mesilate
Imperial College LondonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
43Phase 2United Kingdom
33EUCTR2019-002817-21-PT
(EUCTR)
27/07/202006/02/2020A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged greater or equal than 2 to under 18 years with Pulmonary Arterial Hypertension. - SALTO 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]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3Serbia;United States;Portugal;Belarus;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden
34EUCTR2019-004131-24-HU
(EUCTR)
27/07/202028/05/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary 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] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3Serbia;United States;United Arab Emirates;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan
35EUCTR2019-003309-88-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2018-001189-40-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
37EUCTR2019-004131-24-PL
(EUCTR)
02/07/202002/06/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary 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] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3United States;United Arab Emirates;Serbia;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan
38NCT04503733
(ClinicalTrials.gov)
July 1, 202024/7/2020A Study of GMA301 in Subjects With Pulmonary Arterial HypertensionA Randomized, Double-blind, Placebo-Controlled, Dose Escalation Study to Assess Safety, Efficacy and Pharmacokinetics of GMA301 in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Q4W GMA301 IV injections (300 mg);Drug: Q4W GMA301 IV injections (600 mg);Drug: Q4W GMA301 IV injections (1000 mg);Other: Q4W placebo IV injectionsGmax Biopharm LLC.NULLRecruiting18 Years75 YearsAll36Phase 1United States;China
39EUCTR2019-002533-11-GB
(EUCTR)
30/06/202016/03/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS 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] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden
40NCT04273945
(ClinicalTrials.gov)
June 30, 202031/1/2020Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial HypertensionA Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mgPulmonary Arterial HypertensionDrug: Macitentan 10 mg;Drug: Macitentan 37.5 mg;Drug: Macitentan 75 mg;Drug: PlaceboActelionNULLRecruiting18 YearsN/AAll900Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Brazil;Canada;China;Colombia;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Vietnam;Romania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2019-002533-11-DE
(EUCTR)
17/06/202014/02/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS 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] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden
42EUCTR2019-003309-88-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
43EUCTR2019-002533-11-DK
(EUCTR)
27/05/202031/03/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS 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] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Norway;Germany;Japan;Sweden
44EUCTR2019-001598-10-PL
(EUCTR)
26/05/202013/02/2020Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial HypertensionA Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension Symptomatic 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] - Cardiovascular Diseases [C14]
Product Name: Vasomera (PB1046) Injection
Product Code: PB1046
INN or Proposed INN: not available
Other descriptive name: PB1046, VIP-ELP1-120, Vasomera
PhaseBio Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
63Phase 2Serbia;United States;Greece;Spain;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Romania;Bulgaria;Germany
45EUCTR2019-003309-88-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
46EUCTR2019-002533-11-HU
(EUCTR)
10/05/202011/03/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS 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] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3United States;Portugal;Taiwan;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan;Sweden
47EUCTR2019-002533-11-CZ
(EUCTR)
07/05/202011/03/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS 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] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden
48EUCTR2019-002533-11-SE
(EUCTR)
06/05/202013/03/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS 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] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden
49ChiCTR2000032622
2020-05-012020-05-04Research for right cardiac function evaluation and warning model of neonatal pulmonary arterial hypertensionResearch for right cardiac function evaluation and warning model of neonatal pulmonary arterial hypertension pulmonary arterial hypertensionGold Standard:Clinical outcome;Index test:echocardiographic;Sichuan Academy of Medical Sciences & Sichuan Provincial People's HospitalNULLPendingMaleTarget condition:100;Difficult condition:0China
50EUCTR2019-002817-21-DE
(EUCTR)
16/04/202030/10/2019A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO 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]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3United States;Serbia;Belarus;Portugal;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;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
51NCT04278404
(ClinicalTrials.gov)
March 5, 202018/2/2020Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied DrugsCoronavirus Infection (COVID-19);Pulmonary Arterial Hypertension;Urinary Tract Infections in Children;Hypertension;Pain;Hyperphosphatemia;Primary Hyperaldosteronism;Edema;Hypokalemia;Heart Failure;Hemophilia;Menorrhagia;Insomnia;Pneumonia;Skin Infection;Arrythmia;Asthma in Children;Bronchopulmonary Dysplasia;Adrenal Insufficiency;Fibrinolysis; Hemorrhage;Attention Deficit Hyperactivity Disorder;Multisystem Inflammatory Syndrome in Children (MIS-C);Kawasaki Disease;Coagulation Disorder;Down SyndromeDrug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:Duke UniversityThe Emmes Company, LLC;Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)RecruitingN/A20 YearsAll5000United States;Canada
52NCT04309838
(ClinicalTrials.gov)
March 202020/2/2020Observation Study With Implantable Medication Pump for Intravenous Treprostinil Therapy in Patients With Pulmonary Arterial HypertensionLENUS Pro® Study (LPS-II) - Observation Study With Implantable Medication Pump for Intravenous REMODULIN® (Treprostinil) Therapy in Patients With Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;PAHCombination Product: Treprostinil via implanted pumpUniversity Medicine GreifswaldOMT GmbH & Co. KGNot yet recruiting18 YearsN/AAll30Germany
53EUCTR2019-001598-10-GR
(EUCTR)
28/02/202013/12/2019Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial HypertensionA Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension Symptomatic 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] - Cardiovascular Diseases [C14]
PhaseBio Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
63Phase 2United States;Serbia;Greece;Spain;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Romania;Bulgaria;Germany
54EUCTR2019-001598-10-ES
(EUCTR)
28/02/202020/12/2019Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial HypertensionA Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension Symptomatic 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] - Cardiovascular Diseases [C14]
PhaseBio Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
63Phase 2United States;Serbia;Greece;Spain;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Romania;Bulgaria;Germany
55EUCTR2019-001598-10-BG
(EUCTR)
12/02/202009/01/2020Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial HypertensionA Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension Symptomatic 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] - Cardiovascular Diseases [C14]
Product Name: Vasomera (PB1046) Injection
Product Code: PB1046
INN or Proposed INN: not available
Other descriptive name: PB1046, VIP-ELP1-120, Vasomera
PhaseBio Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
63Phase 2Serbia;United States;Greece;Spain;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Romania;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2019-002817-21-BG
(EUCTR)
11/02/202006/01/2020A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO 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]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3United States;Serbia;Belarus;Portugal;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
57EUCTR2019-002817-21-HU
(EUCTR)
05/02/202029/11/2019A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO 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]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3Serbia;Portugal;United States;Belarus;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden
58NCT03926793
(ClinicalTrials.gov)
February 4, 202022/4/2019Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial HypertensionA Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: GB002;Drug: Placebo;Device: Generic Dry Powder InhalerGB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.NULLRecruiting18 Years75 YearsAll16Phase 1United States;United Kingdom
59EUCTR2019-001598-10-HU
(EUCTR)
24/01/202010/12/2019Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial HypertensionA Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension Symptomatic 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] - Cardiovascular Diseases [C14]
PhaseBio Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
63Phase 2United States;Serbia;Greece;Spain;Austria;Italy;Hungary;Czech Republic;Belgium;Poland;Romania;Bulgaria;Germany
60NCT04175600
(ClinicalTrials.gov)
January 16, 20208/11/2019A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial HypertensionA Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study With Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged >=2 to <18 Years With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: Selexipag;Drug: PlaceboActelionNULLRecruiting2 Years17 YearsAll237Phase 3United States;Australia;Belarus;Belgium;Brazil;Bulgaria;Canada;China;Colombia;Denmark;Finland;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Malaysia;Mexico;Poland;Portugal;Russian Federation;Serbia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;Vietnam;Argentina;Austria;Romania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2019-002817-21-ES
(EUCTR)
07/01/202011/11/2019A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO 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]
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
237Phase 3Serbia;Portugal;Belarus;United States;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden
62ChiCTR1900028152
2020-01-012019-12-13Serum interleukins-6: a predictive biomarker for connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH)Serum interleukins-6: a predictive biomarker for connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) pulmonary arterial hypertensionGold Standard:Clinical outcome;Index test:serum IL-6;Zhongda Hospital Affiliated to Southeast UniversityNULLPending1880BothTarget condition:200;Difficult condition:0N/AChina
63EUCTR2019-002414-40-GB
(EUCTR)
17/12/201924/10/2019An extension study, at multiple study sites, for patients with Pulmonary Arterial Hypertension who took part in study CXA-10-301, to look at the continuing safety of CXA-10 and how well it works long term: all patients will receive CXA-10 treatment.A Phase 2, Multi-Center, Open-Label Study to Evaluate Long-term Safety and Efficacy of CXA-10 in Subjects with Pulmonary Arterial Hypertension on Stable Background Therapy: Extension to Study CXA-10-301. - Open label extension of CXA-10 in Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension (PAH).
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: CXA-10
Product Code: CXA-10
INN or Proposed INN: 10-nitro-9(E)-octadec-9-enoic acid
Complexa Inc.NULLNot RecruitingFemale: yes
Male: yes
115Phase 2United States;United Kingdom
64NCT03782818
(ClinicalTrials.gov)
November 20, 201917/12/2018Olaparib for PAH: a Multicenter Clinical TrialOlaparib for Pulmonary Arterial Hypertension: a Multicenter Clinical TrialPulmonary Arterial HypertensionDrug: OlaparibLaval UniversityCanadian Institutes of Health Research (CIHR);AstraZenecaRecruiting18 Years75 YearsAll20Phase 1;Phase 2Canada
65NCT03884465
(ClinicalTrials.gov)
November 11, 20194/3/2019Hemodynamic Evaluation of Dose-response and Safety of Dry Powder Inhalation of TreprostinilA Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) SubjectsPulmonary Arterial HypertensionDrug: Inhaled dry powder treprostinil (LIQ861)Liquidia Technologies, Inc.FGK Clinical Research GmbHRecruiting18 YearsN/AAll32Phase 2France;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2018-002448-10-DE
(EUCTR)
08/11/201917/08/2018Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH Pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: Zamicastat
Product Code: BIA 5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Portugal;France;Belgium;Spain;Ukraine;Austria;Germany;Italy;United Kingdom
67NCT04125745
(ClinicalTrials.gov)
October 31, 201928/8/2018Oral CXA-10 in Pulmonary Arterial HypertensionPhase 2 Open-Label Study of Safety and Efficacy Trial of CXA-10 in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: CXA-10Gladwin, Mark, MDNational Heart, Lung, and Blood Institute (NHLBI);Complexa, Inc.Terminated18 Years80 YearsAll2Phase 2United States
68EUCTR2014-004786-25-BG
(EUCTR)
11/10/201901/07/2019A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH).Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy 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] - Cardiovascular Diseases [C14]
Product Code: CJNJ-68150420-ZZZ-G001 (ACT-064992D)
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
INN or Proposed INN: TADALAFIL
Other descriptive name: ACT-178418
Trade Name: Adcirca®
INN or Proposed INN: TADALAFIL
Other descriptive name: ACT-178418
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Taiwan;Spain;Turkey;Russian Federation;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Malaysia;Poland;Australia;South Africa;Bulgaria;Germany;China;Japan
69NCT03683186
(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
70EUCTR2017-003934-10-PL
(EUCTR)
19/09/201926/07/2019A clinical study to investigate the long term safety of the drug macitentan in patients with pulmonary arterial hypertension and who were previously treated with macitentan in clinical studies.mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary arterial hypertension previousLy treated with mAcitentan in clinical studies - UMBRELLA Pulmonary arterial hypertension (PAH)
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]
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
152Phase 3France;Belarus;Poland;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT03950739
(ClinicalTrials.gov)
September 17, 20199/5/2019Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using TyvasoAn Open-label, Clinical Study to Evaluate the Safety and Tolerability of Treprostinil Inhalation Powder (TreT) in Subjects With Pulmonary Arterial Hypertension Currently Using TyvasoPulmonary Arterial HypertensionDrug: Treprostinil Inhalation PowderUnited TherapeuticsNULLRecruiting18 YearsN/AAll45Phase 1United States
72EUCTR2014-004786-25-DE
(EUCTR)
05/09/201902/05/2019A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH).Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy 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] - Cardiovascular Diseases [C14]
Product Code: CJNJ-68150420-ZZZ-G001 (ACT- 064992D)
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
INN or Proposed INN: TADALAFIL
Other descriptive name: ACT-178418
Trade Name: Adcirca®
INN or Proposed INN: TADALAFIL
Other descriptive name: ACT-178418
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Brazil;Malaysia;Poland;Australia;South Africa;Bulgaria;Germany;China;Japan
73EUCTR2018-001187-33-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
74EUCTR2018-001189-40-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
75EUCTR2019-001699-12-GB
(EUCTR)
27/08/201930/07/2019Relative bioavailability study of marketed and lower dose ambrisentan in healthy adult participantsAn open-label, randomized three period cross-over relative bioavailability study to compare the pharmacokinetic parameters of a lower dose formulation of ambrisentan (GSK1325760) with marketed ambrisentan in healthy adult participants 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] - Cardiovascular Diseases [C14]
Product Name: Ambrisentan Tablet
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: (S)-2-(4,6-dimethylpyrimidin-2-yloxy)-3-methoxy-3,3-diphenylpropanoic acid
Trade Name: Volibris
Product Name: Ambrisentan 5mg film-coated tablets [marketed product]
INN or Proposed INN: AMBRISENTAN
Other descriptive name: (S)-2-(4,6-dimethylpyrimidin-2-yloxy)-3-methoxy-3,3-diphenylpropanoic acid
GlaxoSmithKline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
24Phase 1United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT03655704
(ClinicalTrials.gov)
August 22, 201928/8/2018Apabetalone for Pulmonary Arterial Hypertension: a Pilot StudyApabetalone for Pulmonary Arterial Hypertension: a Pilot StudyPulmonary Arterial HypertensionDrug: ApabetaloneSteeve ProvencherResverlogix CorpRecruiting18 Years75 YearsAll10Early Phase 1Canada
77EUCTR2018-003093-27-GB
(EUCTR)
16/08/201912/06/2019Clinical Study of Inhaled GB002 for the Treatment of WHO Group I Pulmonary Arterial Hypertension (PAH)A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension (PAH) - GB002 in Adult Subjects with PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
GB002, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
16Phase 1;Phase 2France;United States;Denmark;Netherlands;United Kingdom;Sweden
78EUCTR2014-004786-25-ES
(EUCTR)
13/08/201911/06/2019A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH).Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy 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] - Cardiovascular Diseases [C14]
Product Code: ACT-064992D
INN or Proposed INN: MACITENTAN
INN or Proposed INN: TADALAFIL
Trade Name: Adcirca®
INN or Proposed INN: TADALAFIL
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 3United States;Taiwan;Spain;Turkey;Russian Federation;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Malaysia;Brazil;Australia;Bulgaria;Germany;Japan;China
79EUCTR2014-004786-25-PL
(EUCTR)
10/08/201928/05/2019A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH).Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy 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] - Cardiovascular Diseases [C14]
Product Code: CJNJ-68150420-ZZZ-G001(ACT-064992D)
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
INN or Proposed INN: TADALAFIL
Other descriptive name: ACT-178418
Trade Name: Adcirca®
INN or Proposed INN: TADALAFIL
Other descriptive name: ACT-178418
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Taiwan;Spain;Turkey;Russian Federation;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;South Africa;Bulgaria;Germany;China;Japan
80NCT04053543
(ClinicalTrials.gov)
August 9, 201919/7/2019CXA-10 Study in Subjects With Pulmonary Arterial HypertensionA Phase 2, Multi-Center, Open-Label Study to Evaluate Long-term Safety and Efficacy of CXA-10 in Subjects With Pulmonary Arterial Hypertension on Stable Background Therapy: Extension to Study CXA-10-301PAHDrug: CXA-10Complexa, Inc.Medpace, Inc.;Innovative Analytics;Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Terminated18 YearsN/AAll33Phase 2United States;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT04055415
(ClinicalTrials.gov)
August 1, 20198/8/2019Clinical Study of Adipose Derived Mesenchymal Stem Cells for Treatment of Pulmonary Arterial HypertensionSafety and Efficacy of Transplantation of Adipose Derived Mesenchymal Stem Cells to Treat Pulmonary Arterial HypertensionPulmonary HypertensionBiological: adipose derived mesenchymal stem cells;Drug: Conventional drug therapy(expectorant,bronchodilator)Liaocheng People's HospitalNULLRecruiting40 Years75 YearsAll60Phase 1;Phase 2China
82NCT03924154
(ClinicalTrials.gov)
August 1, 20195/4/2019A Study of RVT-1201 in Patients With Pulmonary Arterial Hypertension (ELEVATE 1)A Phase 2a, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of RVT-1201 in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: RVT-1201;Drug: PlaceboAltavant Sciences GmbHAltavant Sciences, Inc.;PPDTerminated18 Years75 YearsAll3Phase 2United States;Canada
83EUCTR2018-002796-18-PT
(EUCTR)
30/07/201930/10/2018To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH.An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease 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] - Cardiovascular Diseases [C14]
Product Name: Zamicastat
Product Code: BIA-5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Portugal;Spain;Belgium;Ukraine;Austria;Germany;United Kingdom;Italy
84NCT03904693
(ClinicalTrials.gov)
July 29, 20194/4/2019Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed Dose Combination in Subjects With Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period With Macitentan and Tadalafil Fixed Dose Combination TherapyPulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)Drug: FDC macitentan/tadalafil;Drug: Macitentan 10 mg;Drug: Tadalafil 40 mg;Drug: Placebo FDC;Drug: Placebo macitentan;Drug: Placebo tadalafilActelionNULLRecruiting18 YearsN/AAll170Phase 3United States;Australia;Brazil;Bulgaria;Canada;Czechia;Germany;Hungary;Italy;Japan;Malaysia;Mexico;Poland;Russian Federation;South Africa;Spain;Taiwan;Turkey
85NCT03992755
(ClinicalTrials.gov)
July 18, 20195/6/2019Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Dry Powder Inhalation of TreprostinilA Global, Open-Label Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) PatientsPrimary Pulmonary HypertensionDrug: LIQ861 Inhaled TreprostinilLiquidia Technologies, Inc.Nuventra, Inc.Active, not recruiting18 YearsN/AAll92Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT03863990
(ClinicalTrials.gov)
July 15, 201919/2/2019Study Performed at Various Medical Centers to Learn More About Survival and Expected Course of Pulmonary Arterial Hypertension, a Type of High Blood Pressure in the Lungs Related to the Narrowing of the Small Blood Vessels in the LungsSurvival and Prognostic Factors in Pulmonary Arterial Hypertension. A Multicenter Observational Registry (START)Pulmonary Arterial HypertensionDrug: PAH medicationBayerNULLCompleted18 YearsN/AAll104Argentina
87EUCTR2016-001062-28-FI
(EUCTR)
03/07/201903/07/2019A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH)A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide 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] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Portugal;United States;Philippines;Finland;Spain;Thailand;Ukraine;Austria;Russian Federation;Israel;Colombia;Vietnam;France;Hungary;Mexico;Canada;Poland;Malaysia;Brazil;Australia;South Africa;China;Korea, Republic of
88NCT04316143
(ClinicalTrials.gov)
June 6, 201918/3/2020Pharmacokinetics, Safety and Efficacy of BIA 5-1058 in PAHAn Open-label, Multicentre Study to Evaluate Pharmacokinetics, Safety and Efficacy of Zamicastat as Adjunctive Therapy in Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: ZamicastatBial - Portela C S.A.NULLRecruiting18 Years65 YearsAll32Phase 2Spain
89EUCTR2018-001189-40-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
90EUCTR2018-001187-33-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2016-001067-36-PL
(EUCTR)
08/05/201918/02/2019A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
92NCT03738150
(ClinicalTrials.gov)
May 1, 20192/11/2018A Study of Sotatercept for the Treatment of Pulmonary Arterial HypertensionA Phase 2a Single-Arm, Open-Label, Multicenter Exploratory Study to Assess the Effects of Sotatercept (ACE-011) for the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionBiological: SotaterceptAcceleron Pharma, Inc.NULLRecruiting18 YearsN/AAll25Phase 2United States
93NCT03554291
(ClinicalTrials.gov)
May 1, 201931/5/2018Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary HypertensionRepurposing a Histamine Antagonist to Benefit Patients With Pulmonary HypertensionPulmonary Arterial Hypertension;Right Heart FailureDrug: Famotidine 20 MG;Other: PlaceboUniversity of WashingtonNational Heart, Lung, and Blood Institute (NHLBI)Recruiting18 Years80 YearsAll80Phase 2United States
94NCT03835676
(ClinicalTrials.gov)
May 1, 20196/2/2019Effects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial HypertensionEffects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: TreprostinilMagdi H. YacoubNULLRecruiting18 YearsN/AAll30Phase 4Egypt
95EUCTR2018-001187-33-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT03795428
(ClinicalTrials.gov)
April 10, 201918/12/2018Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) in PAH Subjects Following Completion of Study PB1046-PT-CL-0004A Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) Subcutaneous Injections in Pulmonary Arterial Hypertension Subjects Following Completion of Study PB1046-PT-CL-0004Pulmonary Arterial HypertensionDrug: Pemziviptadil (PB1046) InjectionPhaseBio Pharmaceuticals Inc.NULLRecruiting18 Years79 YearsAll63Phase 2United States
97EUCTR2018-001187-33-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
98EUCTR2018-001189-40-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
99EUCTR2018-001187-33-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
100EUCTR2018-001187-33-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
101EUCTR2018-001189-40-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
102JPRN-UMIN000035389
2019/04/0101/04/2019Effects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertensionEffects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension - SETOUCHI PH study Pulmonary arterial hypertensionDose: macitentan 10 mg/day+riociguat 3 mg/day. Max dose of riociguat is 7.5 mg/day.Intervention period: 8 month
Dose: macitentan 10 mg/day+selexipag 0.4 mg/day. Max dose of selexipag is 3.2 mg/day. Intervention period: 8 month
Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical ScienceNULLRecruiting20years-oldNot applicableMale and Female76Not selectedJapan
103NCT04207593
(ClinicalTrials.gov)
April 1, 201917/12/2019The Effect of Oxygen Therapy on 6MWD in PAH and CTEPH Patients With HypoxemiaProspective, Randomized, Controlled Trial of the Effect of Long-term Oxygen Therapy on 6-minute Walking Distance, Clinical Parameters and Hemodynamics in Patients With PAH and CTEPHOxygen Deficiency;Pulmonary Arterial Hypertension;CTEPHDrug: OxygenHeidelberg UniversityNULLRecruiting18 YearsN/AAll40Phase 2Germany
104NCT04062565
(ClinicalTrials.gov)
March 25, 201929/3/2019Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAHA Prospective Trial to Evaluate Up-front Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Patients With Advanced Pulmonary Arterial Hypertension (IIR-3810)Pulmonary Arterial HypertensionDrug: Treprostinil Injectable Product;Drug: Riociguat PillUniversity of ArizonaNULLRecruiting18 YearsN/AAll20Phase 3United States
105EUCTR2018-001187-33-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT03522935
(ClinicalTrials.gov)
March 18, 20191/2/2018Subcutaneous Elafin in Healthy SubjectsSafety and Tolerability of Escalating Doses of Subcutaneous Elafin (Tiprelestat) Injection in Healthy Normal SubjectsPulmonary Arterial HypertensionDrug: Elafin;Drug: PlaceboRoham T. ZamanianDuke University;SRI InternationalActive, not recruiting18 Years55 YearsAll30Phase 1United States
107EUCTR2018-001387-39-DE
(EUCTR)
15/03/201930/01/2019The effect of oxygen therapy in patients with pulmonary Hypertension.A prospective, randomized, controlled trial to assess the effect of long-term oxygen therapy on 6-minute walking distance, clinical parameters and hemodynamics in patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) - SOPHA pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Thoraxklinik-Heidelberg gGmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
20Phase 2Germany
108JPRN-JapicCTI-194651
12/3/201905/03/2019MD-711 Phase 2/3 Study in PAHMD-711 Phase 2/3 Study in Pulmonary Arterial Hypertension Pulmonary arterial hypertensionIntervention name : MD-711
INN of the intervention : treprostinil
Dosage And administration of the intervention : Inhaled admistration
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Mochida Pharmaceutical Co., Ltd.NULLpending1875BOTH15Phase 2;Phase 3Japan
109EUCTR2018-002796-18-GB
(EUCTR)
12/03/201919/06/2019To study the safety and how effective Long-term Zamicastat treatment is for Pulmonary Arterial HypertensionAn open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease. - Safety and efficacy of BIA 5-1058 in PAH 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] - Cardiovascular Diseases [C14]
Product Name: Zamicastat
Product Code: BIA 5-1058
INN or Proposed INN: Zamicastat
Bial - Portela & Ca, S.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 2Portugal;Belgium;Spain;Ukraine;Austria;Netherlands;Germany;United Kingdom
110EUCTR2018-001189-40-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2018-001189-40-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
112NCT03789643
(ClinicalTrials.gov)
March 201926/12/2018Study to Evaluate Efficacy and Safety of JTT-251 in Participants With Pulmonary Arterial HypertensionA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JTT-251 Administered for 24 Weeks to Participants With Pulmonary Arterial Hypertension (RELIEF-PAH)Pulmonary Arterial HypertensionDrug: JTT-251;Drug: PlaceboAkros Pharma Inc.NULLWithdrawn18 Years80 YearsAll0Phase 2NULL
113EUCTR2018-001189-40-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
114EUCTR2018-001189-40-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
115EUCTR2018-001187-33-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2018-001189-40-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
117EUCTR2018-001189-40-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
118EUCTR2018-002448-10-GB
(EUCTR)
11/02/201919/06/2019Multi centre study to assess the safety, effective and movement of Zamicastat within the body when given to a patient with pulmonary arterial hypertension as an additional medication.An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmcokinetics, safety and efficacy of BIA-5-1058 in PAH 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] - Cardiovascular Diseases [C14]
Product Name: Zamicastat
Product Code: BIA 5-1058
Bial - Portela & Ca, S.ANULLNot RecruitingFemale: yes
Male: yes
32Phase 2Portugal;Spain;Ukraine;Austria;Netherlands;Germany;United Kingdom
119EUCTR2018-001187-33-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
120EUCTR2018-003414-40-DE
(EUCTR)
31/01/201906/11/2018A Two Part Clinical Study to Evaluate the Effect of Different Doses and the Safety of Inhaled Treprostinil Dry Powder in Pulmonary Arterial Hypertension PatientsA Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects Pulmonary Arterial Hypertension (WHO Group 1)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: LIQ861 26.5 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 53 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 79.5 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 106 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: Nitric Oxide
INN or Proposed INN: NITRIC OXIDE
Liquidia Technologies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 2Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2018-001187-33-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
122NCT03754660
(ClinicalTrials.gov)
January 21, 201923/11/2018This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH)A Non-randomized Two Part Multi-Center, Open-label, Single Dose Trial With an Escalation Part in Untreated Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Patients (Part A), Followed by a Parallel Group Part in Untreated and Pre-treated Patients With PAH and CTEPH (Part B) to Investigate the Safety, Tolerability and Pharmacodynamics of Inhaled BAY1237592Hypertension, PulmonaryDrug: BAY1237592;Drug: PH-monotherapy;Drug: PH-combination therapy;Procedure: NO gasBayerNULLRecruiting18 Years80 YearsAll60Phase 1Austria;Czechia;Germany;Poland
123EUCTR2018-003414-40-FR
(EUCTR)
21/01/201906/11/2018A Two Part Clinical Study to Evaluate the Effect of Different Doses and the Safety of Inhaled Treprostinil Dry Powder in Pulmonary Arterial Hypertension PatientsA Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects Pulmonary Arterial Hypertension (WHO Group 1)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: LIQ861 25 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 50 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 75 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 100 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Liquidia Technologies, Inc.NULLNot RecruitingFemale: yes
Male: yes
32Phase 2France;Germany
124NCT03744637
(ClinicalTrials.gov)
January 18, 201913/11/2018A Study of Single Doses of MK -5475 on Pulmonary Vascular Resistance (MK-5475-002)A Study to Assess the Effect of Single Doses of MK -5475 on Pulmonary Vascular Resistance in Patients With Moderate to Severe Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: MK-5475;Drug: PlaceboMerck Sharp & Dohme Corp.NULLActive, not recruiting18 Years70 YearsAll25Phase 1Moldova, Republic of
125EUCTR2018-002796-18-ES
(EUCTR)
17/01/201916/11/2018To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH.An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease 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] - Cardiovascular Diseases [C14]
Bial - Portela & Ca, S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40Phase 2Portugal;Spain;Ukraine;Austria;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2018-001189-40-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
127EUCTR2018-001187-33-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
128EUCTR2018-001189-40-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
129EUCTR2018-001187-33-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
130NCT03648385
(ClinicalTrials.gov)
January 9, 201910/8/2018Effects of DHEA in Pulmonary HypertensionEffects of DHEA in Pulmonary HypertensionPulmonary Arterial HypertensionDrug: DHEA tablet;Other: PlaceboRhode Island HospitalNULLRecruiting18 YearsN/AAll24Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2017-004738-27-BE
(EUCTR)
04/01/201931/08/2018A Phase 2 Study of Sotatercept for the Treatment of PAHA Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Acceleron Pharma Inc.NULLNot Recruiting Female: yes
Male: yes
100Phase 2France;United States;Brazil;Spain;Belgium;Australia;Israel;Germany;United Kingdom
132EUCTR2018-002796-18-AT
(EUCTR)
20/12/201806/11/2018To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH.An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease 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] - Cardiovascular Diseases [C14]
Product Name: Zamicastat
Product Code: BIA-5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy
133NCT03657095
(ClinicalTrials.gov)
December 10, 201818/5/2018A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial HypertensionAn Open-label Extension of BPS-314d-MR-PAH-302 in Pulmonary Arterial Hypertension PatientsPulmonary Arterial HypertensionDrug: Esuberaprost;Drug: PlaceboLung Biotechnology PBCNULLTerminated18 Years85 YearsAll112Phase 3United States;Israel
134EUCTR2018-002448-10-PT
(EUCTR)
26/11/201804/09/2018Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH 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] - Cardiovascular Diseases [C14]
Product Name: Zamicastat
Product Code: BIA 5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France;Portugal;Spain;Belgium;Ukraine;Austria;Netherlands;Germany;United Kingdom;Italy
135EUCTR2018-002448-10-ES
(EUCTR)
21/11/201809/10/2018Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH 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] - Cardiovascular Diseases [C14]
Product Name: Zamicastat
Product Code: BIA 5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Portugal;Spain;Ukraine;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT04041648
(ClinicalTrials.gov)
November 9, 201823/7/2019Single Ascending Dose Study for Evaluation of Safety, Tolerability and Pharmacokinetics of L606A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dose of L606 for Inhalation in Healthy SubjectsPulmonary Arterial HypertensionDrug: L606 (Liposomal Treprostinil) Inhalation Solution 51ug;Device: L606 Inhalation System;Other: Placebo SolutionPharmosa Biopharm Inc.PPDRecruiting18 Years50 YearsAll64Phase 1United States
137EUCTR2018-002448-10-AT
(EUCTR)
31/10/201808/08/2018Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH Pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: Zamicastat
Product Code: BIA 5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy
138NCT03251872
(ClinicalTrials.gov)
October 25, 201813/8/2017Olaparib for PAH: a Pilot StudyOlaparib for Pulmonary Arterial Hypertension: a Pilot Clinical StudyPulmonary Arterial HypertensionDrug: OlaparibLaval UniversityNULLTerminated18 Years75 YearsAll6Early Phase 1Canada
139EUCTR2018-000145-39-DE
(EUCTR)
25/10/201805/06/2018A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertensionA prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children 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]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Serbia;United States;Belarus;Taiwan;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Poland;Malaysia;Singapore;Romania;Netherlands;Germany;China
140EUCTR2018-000145-39-GB
(EUCTR)
22/10/201828/03/2018A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertensionA prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children 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]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;Serbia;Belarus;Taiwan;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Malaysia;Poland;Singapore;Romania;Germany;Netherlands;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141EUCTR2017-004738-27-GB
(EUCTR)
18/10/201824/06/2019A Phase 2 Study of Sotatercept for the Treatment of PAHA Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
90Phase 2France;United States;Brazil;Belgium;Spain;Australia;Israel;Germany;United Kingdom
142EUCTR2013-004362-34-LV
(EUCTR)
03/10/201802/07/2018A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSIONA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) 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: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
429Phase 3;Phase 4United States;Portugal;Serbia;Hong Kong;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Malaysia;Australia;South Africa;Latvia;Netherlands;Bosnia and Herzegovina;Turkey;Austria;Czech Republic;Mexico;Belgium;Poland;Singapore;Croatia;Romania;Germany;Sweden
143NCT03528902
(ClinicalTrials.gov)
October 1, 201821/3/2018Tamoxifen Therapy to Treat Pulmonary Arterial HypertensionTamoxifen Therapy to Treat Pulmonary Arterial HypertensionHypertension;Pulmonary Arterial Hypertension;Familial Primary Pulmonary Hypertension;Primary Pulmonary Hypertension;Lung Diseases;Tamoxifen;Estrogen Receptor Antagonist;Hormone Antagonists;EstrogensDrug: Tamoxifen;Drug: Placebo Oral TabletVanderbilt University Medical CenterNULLRecruiting18 YearsN/AAll24Phase 2United States
144EUCTR2017-000216-42-FR
(EUCTR)
27/09/201823/07/2018Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE 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] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;Portugal;France;Ireland;Austria;Norway;Germany;United Kingdom;Switzerland;Sweden
145NCT03497689
(ClinicalTrials.gov)
September 21, 201820/3/2018EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial HypertensionEXPEDITE: A 16-Week, Multicenter, Open-label Study of Remodulin Induction Followed by Orenitram Optimization in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Intravenous/Subcutaneous Treprostinil; Oral TreprostinilUnited TherapeuticsNULLRecruiting17 Years85 YearsAll30Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2017-004738-27-ES
(EUCTR)
04/09/201805/09/2018A Phase 2 Study of Sotatercept for the Treatment of PAHA Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2France;United States;Brazil;Belgium;Spain;Australia;Israel;Germany;United Kingdom
147NCT03626688
(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
148NCT03617458
(ClinicalTrials.gov)
August 23, 20182/5/2018Interventions Against Insulin Resistance in Pulmonary Arterial HypertensionInterventions Against Insulin Resistance in Pulmonary Arterial HypertensionPulmonary Artery HypertensionDrug: Metformin;Drug: Placebo;Device: mHealth Intervention;Device: Usual CareVanderbilt University Medical CenterMayo Clinic;The Cleveland ClinicRecruiting18 YearsN/AAll130Phase 2United States
149EUCTR2015-005223-90-BE
(EUCTR)
16/08/201824/05/2016This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) 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 Name: inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: NITRIC OXIDE
Other descriptive name: inhaled NO with pulsed delivery
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
150EUCTR2017-004738-27-DE
(EUCTR)
15/08/201803/08/2018A Phase 2 Study of Sotatercept for the Treatment of PAHA Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;France;Spain;Brazil;Belgium;Australia;Israel;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151NCT03449524
(ClinicalTrials.gov)
August 1, 201814/2/2018PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH)Phase 2 Multicenter, Double-Blind, Placebo Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects With Pulmonary Arterial HypertensionPAHDrug: 75mg CXA-10;Drug: 150mg CXA-10;Other: PlaceboComplexa, Inc.Medpace, Inc.;Philips Healthcare;Cardiovascular Clinical Science Foundation;MicroConstants;Innovative Analytics;Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Terminated18 Years80 YearsAll69Phase 2United States;United Kingdom
152NCT03602781
(ClinicalTrials.gov)
August 20186/7/2018Study of PAH Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use of Inhaled NitricPhase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Withdrawal Study of Pulmonary Arterial Hypertension(PAH) Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use of Inhaled Nitric Oxide (INO)Pulmonary Arterial HypertensionDrug: Placebo;Drug: iNOBellerophon Pulse TechnologiesWorldwide Clinical TrialsWithdrawn18 YearsN/AAll0Phase 3United States;Canada
153NCT03492177
(ClinicalTrials.gov)
July 23, 20183/4/2018A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial HypertensionA Prospective, Multicenter, Open Label, Single Arm, Phase 2 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Selexipag in Children With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: selexipag (Uptravi)ActelionNULLRecruiting2 Years18 YearsAll66Phase 2United States;Belarus;Canada;China;France;Germany;Hungary;Israel;Malaysia;Poland;Russian Federation;Serbia;Taiwan;Ukraine;United Kingdom;Romania
154NCT03556020
(ClinicalTrials.gov)
July 15, 20181/6/2018Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC Pemziviptadil (PB1046) in Subjects With Symptomatic PAHA Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous (SC) Injections of a Sustained-Release Vasoactive Intestinal Peptide (VIP) Analogue, Pemziviptadil (PB1046), in Adult Subjects With Symptomatic Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Pemziviptadil (PB1046)PhaseBio Pharmaceuticals Inc.NULLRecruiting18 Years79 YearsAll63Phase 2United States
155EUCTR2018-000145-39-HU
(EUCTR)
03/07/201818/07/2018A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertensionA prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children 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]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 2Serbia;United States;Belarus;Taiwan;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Poland;Malaysia;Singapore;Romania;Netherlands;Germany;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156NCT03496207
(ClinicalTrials.gov)
June 27, 201829/3/2018A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Placebo;Drug: SotaterceptAcceleron Pharma, Inc.NULLActive, not recruiting18 YearsN/AAll100Phase 2United States;Australia;Brazil;France;Germany;Israel;Spain;United Kingdom
157EUCTR2015-003438-28-GB
(EUCTR)
21/06/201813/11/2017The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH Pulmonary arterial hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: TADALAFIL
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
238Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Sweden
158NCT03683082
(ClinicalTrials.gov)
June 5, 201820/9/2018Oxygen Treatment and Pulmonary Arterial HypertensionAcute Effects of Oxygen Supplementation Among Pulmonary Arterial Hypertension PatientsPulmonary Arterial HypertensionDrug: Oxygen supplementation;Drug: Sham O2 (medical air)George Papanicolaou HospitalNULLUnknown status18 Years80 YearsAll10N/AGreece
159NCT03708146
(ClinicalTrials.gov)
May 28, 201812/10/2018Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 5-1058A Double-Blind, Randomised, Placebo-Controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of BIA 5 1058 in Healthy VolunteersCardiovascular Disease+Pulmonary Disease;Pulmonary Arterial HypertensionDrug: BIA 5-1058;Drug: PlaceboBial - Portela C S.A.NULLCompleted18 Years55 YearsAll157Phase 1United Kingdom
160EUCTR2017-000216-42-PT
(EUCTR)
14/05/201803/11/2017Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE 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] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;France;Portugal;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT03166306
(ClinicalTrials.gov)
May 1, 20189/5/2017Angiogenic Imaging in Pulmonary Arterial HypertensionAngiogenic Imaging in Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;Exercise Associated Pulmonary Arterial HypertensionDiagnostic Test: PET-CT Imaging with [89Zr]-bevacizumabBrigham and Women's HospitalNULLUnknown status18 YearsN/AAll30Phase 1;Phase 2United States
162NCT03489005
(ClinicalTrials.gov)
April 9, 201829/3/2018Effect of BIA 5 1058 on Cardiac RepolarizationA Randomized, Double-blind, Placebo-controlled and Open-label, Active Controlled, 4 Period Crossover Trial to Evaluate the Effect of BIA 5 1058 on Cardiac Repolarization in Healthy Adult Males and Females Under Fed ConditionsCardiovascular Disease;Pulmonary Arterial Hypertension;Heart FailureDrug: BIA 5-1058;Drug: Placebo Oral Tablet;Drug: Moxifloxacin 400 mgBial - Portela C S.A.CovanceCompleted18 Years55 YearsAll49Phase 1United Kingdom
163NCT03422328
(ClinicalTrials.gov)
April 4, 201830/1/2018A Clinical Study to Investigate the Long-term Safety of the Drug Macitentan in Patients With Pulmonary Hypertension Who Were Previously Treated With Macitentan in Clinical Studies.mUlticenter, Single-arM, Open-laBel, Long-teRm Safety Study With macitEntan in Patients With puLmonary Hypertension previousLy Treated With mAcitentan in Clinical Studies (UMBRELLA)Pulmonary Arterial Hypertension;Chronic Thromboembolic Pulmonary HypertensionDrug: macitentanActelionNULLEnrolling by invitationN/AN/AAll94Phase 3Belarus;France;Ukraine;Poland
164NCT03344159
(ClinicalTrials.gov)
April 1, 201828/9/2017Spironolactone Therapy in Chronic Stable Right HF TrialSpironolactone Therapy in Chronic Stable Right HF TrialChronic Right-Sided Heart Failure;Pulmonary Arterial Hypertension;Pulmonary Hypertension, Primary, 2;Pulmonary Hypertension, Primary, 3;Pulmonary Hypertension, Primary, 4;Cardiomyopathy Right VentricularDrug: Spironolactone;Drug: Placebo;Radiation: PET/CT Scan: Two PET scans using 1. C-11 HED and 2. N-13 Ammonia or rubidium-82;Diagnostic Test: Cardiac MRI (Gadolinium enhanced)Ottawa Heart Institute Research CorporationNULLSuspended18 YearsN/AAll30Phase 4Canada
165EUCTR2017-003934-10-FR
(EUCTR)
19/03/201819/01/2018A clinical study to investigate the long term safety of the drug macitentan in patients with pulmonary arterial hypertension and who were previously treated with macitentan in clinical studies.mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary arterial hypertension previousLy treated with mAcitentan in clinical studies - UMBRELLA Pulmonary arterial hypertension (PAH)
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]
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
94Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166NCT03464864
(ClinicalTrials.gov)
March 9, 20181/3/2018Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal VolunteersA Phase 1, Single-center, Open-label, Dose-Rising Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder (TrIP) in Healthy Normal VolunteersPulmonary Arterial HypertensionDrug: Treprostinil Inhalation PowderMannkind CorporationNULLCompleted18 Years55 YearsAll36Phase 1United States
167NCT03362047
(ClinicalTrials.gov)
March 1, 201822/11/2017(RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment)Untersuchung Des Einflusses PAH-spezifischer Medikation Auf Die rechtsventrikuläre Funktion Bei Patienten Mit Pulmonaler Arterieller Hypertonie (PAH) Unter Basalen BedingungenPulmonary Arterial Hypertension (PAH)Drug: Riciguat Group;Drug: Macitentan GroupUniversity of GiessenPhilipps University Marburg Medical CenterRecruiting18 Years85 YearsAll30Phase 2Germany
168NCT03177603
(ClinicalTrials.gov)
February 21, 201823/5/2017A Dose-escalation Study in Subjects With Pulmonary Arterial Hypertension (PAH)An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: GSK2586881GlaxoSmithKlineNULLCompleted18 Years75 YearsAll23Phase 2United States;Germany;Spain
169NCT03293407
(ClinicalTrials.gov)
February 1, 201820/9/2017Evaluation of Inhaled Iloprost Effects Using the Breelib Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial HypertensionVentavis® (Iloprost): Evaluation of Inhaled Iloprost Effects Using the Breelib™ Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: Iloprost (Ventavis, BAYQ6256);Device: Breelib nebulizerBayerNULLCompleted18 YearsN/AAll31Germany
170NCT02939599
(ClinicalTrials.gov)
February 1, 201812/10/2016Long-term Extension Study of the Safety and Pharmacokinetics of QCC374 in PAH PatientsLong-term, Open Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of QCC374 in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: QCC374Novartis PharmaceuticalsNULLTerminated18 YearsN/AAll5Phase 2United States;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2015-003438-28-ES
(EUCTR)
19/01/201801/12/2017The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON Pulmonary arterial hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: TADALAFIL
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
238Phase 3United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Sweden
172EUCTR2016-001411-20-GB
(EUCTR)
12/01/201809/01/2017Long-term extension study of the safety and pharmacokinetics of QCC374 in PAH patientsLong-term, open label, multicenter, extension study to evaluate the safety and tolerability of QCC374 in patients with PAH 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: QCC374 0.015 mg
INN or Proposed INN: TBD
Product Code: QCC374 0.06 mg
INN or Proposed INN: TBD
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
38Phase 2United States;Taiwan;Germany;United Kingdom;Korea, Republic of
173NCT03399604
(ClinicalTrials.gov)
January 2, 20183/1/2018Investigation of the Safety and Pharmacology of Dry Powder Inhalation of TreprostinilA Phase 3 Open-label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861(Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) PatientsPrimary Pulmonary HypertensionDrug: LIQ861 Inhaled TreprostinilLiquidia Technologies, Inc.Nuventra, Inc.Completed18 YearsN/AAll121Phase 3United States
174EUCTR2017-000137-31-NL
(EUCTR)
19/12/201719/07/2017Treatment of Pulmonary Hypertension with 6 MercaptopurinePulmonary Hypertension REversal in Clusters of Patients With Identical Pathobiological Substrates. 6-Mercaptopurine Proof-of-Concept Trial - PRECISE-MP Pulmonary arterial hypertension
MedDRA version: 20.0;Level: HLGT;Classification code 10037454;Term: Pulmonary vascular disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Trade Name: Puri-NetholVU University Medical CenterNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Netherlands
175NCT03229499
(ClinicalTrials.gov)
December 7, 201718/7/2017Pulmonary Hypertension and Anastrozole TrialPulmonary Hypertension and Anastrozole Trial (PHANTOM)Pulmonary Arterial HypertensionDrug: Anastrozole;Drug: Placebo Oral TabletUniversity of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI);Johns Hopkins University;University of Colorado, Denver;Rhode Island Hospital;Stanford University;Vanderbilt University;Washington University School of MedicineRecruiting18 YearsN/AAll84Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176NCT03187678
(ClinicalTrials.gov)
December 4, 20179/6/2017Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial HypertensionA Multicenter, Open-label, Single-sequence Cross-over Study to Assess Safety, Tolerability, and Pharmacokinetics of Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension Switching From an Oral Stable Dose of SelexipagPulmonary Arterial HypertensionDrug: i.v. selexipag;Drug: oral selexipag (Uptravi)ActelionNULLCompleted18 Years75 YearsAll20Phase 3United States;Germany
177EUCTR2017-000216-42-DE
(EUCTR)
30/11/201726/05/2017Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE 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] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
178NCT03364244
(ClinicalTrials.gov)
November 30, 201730/11/2017Revavtio Special Investigation for Long-term Use in Pediatric PatientsREVATIO SPECIAL INVESTIGATION - INVESTIGATION FOR LONG-TERM USE OF REVATIO IN PEDIATRIC PATIENTS -Pulmonary Arterial HypertensionDrug: SildenafilPfizerNULLRecruitingN/A14 YearsAll190Japan
179NCT02932410
(ClinicalTrials.gov)
November 28, 201712/10/2016A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)A Multicenter, Open-label, Randomized, Event-driven Study to Assess Efficacy, Safety and Pharmacokinetics of Macitentan Versus Standard of Care in Children With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Macitentan;Other: Standard-of-careActelionNULLRecruiting2 YearsN/AAll300Phase 3United States;Australia;Austria;Canada;China;Colombia;Finland;France;Hungary;Israel;Korea, Republic of;Malaysia;Mexico;Philippines;Poland;Portugal;Russian Federation;South Africa;Spain;Thailand;Ukraine;Vietnam;Argentina;Bulgaria
180NCT03078907
(ClinicalTrials.gov)
November 8, 20176/3/2017Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.A Multi-center, Double-blind, Placebo-controlled Phase 4 Study in Patients With Pulmonary Arterial Hypertension to Assess the Effect of Selexipag on Daily Life Physical Activity and Patient's Self-reported Symptoms and Their ImpactsPulmonary Arterial HypertensionDrug: Selexipag;Drug: PlaceboActelionNULLCompleted18 Years75 YearsAll108Phase 4United States;Austria;France;Germany;Ireland;Norway;Portugal;Sweden;Switzerland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181EUCTR2017-000216-42-SE
(EUCTR)
24/10/201716/05/2017Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE 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] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
182NCT03315507
(ClinicalTrials.gov)
October 20, 20172/10/2017A Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046 in Subjects With PAHAn Open-Label, Dose Titration Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046, A Sustained-Release Analogue of Vasoactive Intestinal Peptide, In Adult Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: PB1046 Subcutaneous InjectionPhaseBio Pharmaceuticals Inc.NULLCompleted18 YearsN/AAll3Phase 1United States
183EUCTR2016-001411-20-DE
(EUCTR)
17/10/201707/08/2017Long-term extension study of the safety and pharmacokinetics of QCC374 in PAH patientsLong-term, open label, multicenter, extension study to evaluate the safety and tolerability of QCC374 in patients with PAH 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]
Novartis Pharma AGNULLNot Recruiting Female: yes
Male: yes
38Phase 2United States;Taiwan;Germany;United Kingdom;Korea, Republic of
184NCT03270332
(ClinicalTrials.gov)
October 12, 201730/8/2017Effect of Inhaled Albuterol in Pulmonary HypertensionEffect of Inhaled Albuterol on Pulmonary Hemodynamics in Patients With Group 1 Pulmonary Arterial Hypertension on Oral Pulmonary Vasodilator Therapy: A Proof of Concept StudyPulmonary HypertensionDrug: albuterol first then placebo;Drug: placebo first then albuterolUniversity of MiamiNULLRecruiting18 YearsN/AAll6Early Phase 1United States
185NCT03145298
(ClinicalTrials.gov)
October 1, 20172/5/2017ALlogeneic Cardiosphere-derived Stem Cells (CDCs) for Pulmonary Hypertension therApyA Phase I Study of the Safety and Feasibility of Central Intravenous Delivery of Allogeneic Human Cardiosphere-Derived Stem Cells in Patients With Pulmonary Arterial Hypertension ALPHA TrialPulmonary Arterial Hypertension (PAH)Biological: Allogeneic Human Cardiosphere-Derived Stem Cells;Biological: PlaceboCedars-Sinai Medical CenterCalifornia Institute for Regenerative Medicine (CIRM)Recruiting18 Years75 YearsAll26Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186NCT02999906
(ClinicalTrials.gov)
October 201719/12/2016Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial HypertensionA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Oral Treprostinil;Drug: PlaceboUnited TherapeuticsNULLWithdrawn18 Years79 YearsAll0Phase 3NULL
187NCT03001414
(ClinicalTrials.gov)
September 28, 201715/12/2016Study of Angiogenic Cell Therapy for Progressive Pulmonary Hypertension: Intervention With Repeat Dosing of eNOS-enhanced EPCsA Multicentre, Phase 2 Clinical Trial to Establish the Efficacy and Safety of Repeat Dosing of Autologous Endothelial Progenitor Cells (EPCs) Transfected With Human Endothelial NO-synthase (eNOS) in Patients With Pulmonary Arterial Hypertension (PAH) on Top of Conventional TreatmentsHypertension,PulmonaryBiological: Placebo followed by Autologous EPCs transfected with human eNOS;Biological: Autologous EPCs transfected with human eNOS followed by Placebo;Biological: Autologous EPCs transfected with human eNOSNorthern TherapeuticsOttawa Hospital Research InstituteRecruiting18 Years80 YearsAll45Phase 2Canada
188NCT02927366
(ClinicalTrials.gov)
September 19, 20175/10/2016Safety, Pharmacokinetics and Efficacy Study of QCC374 in PAH PatientsA Randomized, Parallel-group, Placebo-controlled Subject and Investigator Blinded Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of QCC374 in the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: QCC374;Drug: Placebo MatchingNovartis PharmaceuticalsNULLTerminated18 YearsN/AAll8Phase 2United States;Germany;Korea, Republic of;United Kingdom;Taiwan
189EUCTR2017-000216-42-IE
(EUCTR)
12/09/201705/05/2017Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 3b study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE 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] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
190NCT03273387
(ClinicalTrials.gov)
September 10, 20173/9/2017The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial HypertensionThe Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension Patients in National Cardiovascular Center Harapan Kita Hospital IndonesiaPrecapillary Pulmonary HypertensionDrug: Trimetazidine;Drug: Placebo oral capsuleIndonesia UniversityNULLCompleted18 Years65 YearsAll26Phase 2;Phase 3Indonesia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191EUCTR2017-000212-41-DE
(EUCTR)
01/09/201727/06/2017Study to test a new drug to treat patients with Pulmonary Arterial Hypertension (PAH)An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants with Pulmonary Arterial Hypertension - PH 2a, SD, DE, safety, PK/PD study of GSK2586881 in Pulmonary Arterial Hypertension pts 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
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: GSK2586881
Product Code: GSK2586881
INN or Proposed INN: GSK2586881
Other descriptive name: Recombinant Human Angiotensin-converting enzyme 2 (ACE2), APN01
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
24Phase 2United States;Spain;Germany
192EUCTR2017-000216-42-AT
(EUCTR)
29/08/201709/06/2017Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE 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] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
193EUCTR2015-005223-90-HR
(EUCTR)
23/08/201712/09/2017This is a multicenter, double-blind, randomized, placebo-controlled,parallel-group study to investigate the efficacy, tolerability and safety ofpulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longerfor 18 weeks in symptomatic subjects with pulmonary arterialhypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED,CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) 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 Name: inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: NITRIC OXIDE
Other descriptive name: inhaled NO with pulsed delivery
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
194EUCTR2017-000212-41-ES
(EUCTR)
10/08/201722/06/2017Study to test a new drug to treat patients with Pulmonary Arterial Hypertension (PAH).An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants with Pulmonary Arterial Hypertension. - PH 2a, SD, DE, safety, PK/PD study of GSK2586881 in Pulmonary Arterial Hypertension pts 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
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
GlaxoSmithKline, S.A.NULLNot Recruiting Female: yes
Male: yes
24Phase 2United States;Spain;Germany
195EUCTR2016-001412-38-DE
(EUCTR)
27/07/201703/04/2017Safety, pharmacokinetics and efficacy study of QCC374 in PAH patientsA randomized, parallel-group, placebo-controlled subject and investigator blinded study to assess the safety, tolerability, pharmacokinetics and efficacy of QCC374 in the treatment of 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: QCC374 0.015 mg
INN or Proposed INN: TBD
Product Code: QCC374 0.06 mg
INN or Proposed INN: TBD
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
38Phase 2United States;Taiwan;Germany;United Kingdom;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196NCT03045029
(ClinicalTrials.gov)
July 18, 20172/2/2017ADAPT - A Patient Registry of the Real-world Use of Orenitram®ADAPT - A Patient Registry of the Real-world Use of Orenitram®Pulmonary Arterial HypertensionDrug: Oral treprostinilUnited TherapeuticsNULLRecruiting18 YearsN/AAll300United States
197EUCTR2016-001062-28-ES
(EUCTR)
13/07/201713/01/2017A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH)A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide 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] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Portugal;United States;Philippines;Spain;Thailand;Ukraine;Austria;Russian Federation;Israel;Vietnam;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;South Africa;Bulgaria;Germany;China;Korea, Republic of
198EUCTR2017-000216-42-GB
(EUCTR)
11/07/201705/05/2017Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE 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] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;Switzerland;United Kingdom;Sweden
199NCT02800941
(ClinicalTrials.gov)
July 5, 201710/6/2016Bleeding Frequency Under Anticoagulant Treatment in Pulmonary HypertensionBleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension : HEMA-HTP Multicentric Study.Pulmonary Arterial HypertensionDrug: Oral anticoagulant treatmentCentre Hospitalier Universitaire de Saint EtienneNULLRecruiting18 YearsN/AAll203France
200JPRN-UMIN000027284
2017/07/0101/07/2017The effect of iloprost on pulmonary hypertension and exercuse capacity Pulmonary arterial hypertensioninhale of iloprostThe University of Tokushima Graduate School of Health BiosciencesNULLPending20years-old90years-oldMale and Female20Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201EUCTR2014-003952-29-BE
(EUCTR)
07/06/201703/01/2017Riociguat for treatment of PAH in children from 6 to less than 18 years oldOpen-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD Pulmonary arterial hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Bayer AGNULLNot Recruiting Female: yes
Male: yes
20Phase 3United States;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Belgium;Poland;Romania;Germany;Netherlands;Japan
202NCT02882126
(ClinicalTrials.gov)
June 201724/8/2016An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial HypertensionAn Open-Label Extension Trial to Evaluate the Safety of Continued Therapy With Subcutaneous Remodulin® in Subjects With Pulmonary Arterial Hypertension Who Completed Study CVT-CV-003Pulmonary Arterial HypertensionDrug: Subcutaneous TreprostinilUnited TherapeuticsCVie Therapeutics Co. Ltd.Withdrawn18 YearsN/AAll0Phase 4China
203EUCTR2016-004035-21-DE
(EUCTR)
23/05/201714/02/2017 A study to evaluate whether it is safe for patients with pulmonary arterial hypertension to temporarily change from selexipag tablets (Uptravi®) to selexipag given directly into a vein (intravenous selexipag)A multicenter, open-label, single-sequence cross-over study to assess safety, tolerability, and pharmacokinetics of intravenous selexipag in subjects with stable pulmonary arterial hypertension switching from an oral stable dose of selexipag 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] - Cardiovascular Diseases [C14]
Actelion Pharmaceuticals LtdNULLNot Recruiting Female: yes
Male: yes
20Phase 3United States;Germany
204EUCTR2016-001062-28-PT
(EUCTR)
15/05/201723/12/2016A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH)A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide 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] - Cardiovascular Diseases [C14]
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300Phase 3Portugal;United States;Philippines;Finland;Spain;Thailand;Ukraine;Austria;Russian Federation;Israel;Colombia;Vietnam;France;Hungary;Mexico;Canada;Poland;Australia;South Africa;Germany;China;Korea, Republic of
205NCT03401476
(ClinicalTrials.gov)
May 8, 201730/4/2017Effect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial HypertensionEffect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Morphine SulfateJohn GrantonNULLUnknown status18 YearsN/AAll15Phase 2Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206NCT03365479
(ClinicalTrials.gov)
May 1, 201727/11/2017Acute Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial HypertensionAcute Hemodynamic Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial HypertensionPulmonary Hypertension;Pulmonary Arterial HypertensionDrug: IloprostUniversity of GiessenNULLCompleted18 YearsN/AAll30N/AGermany
207NCT03016468
(ClinicalTrials.gov)
May 20176/1/2017Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAHA Multicenter, 16-Week, Open-label Study Evaluating the Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Parenteral Remodulin (treprostinil) injection;Drug: Oral TreprostinilUnited TherapeuticsNULLWithdrawn18 Years75 YearsAll0Phase 2NULL
208NCT02911844
(ClinicalTrials.gov)
April 10, 201719/9/2016Estrogen Receptor Antagonist in Patients With Pulmonary Arterial HypertensionEstrogen Receptor Antagonist in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: FulvestrantUniversity of PennsylvaniaNULLCompleted18 YearsN/AFemale5Phase 2United States
209NCT02587325
(ClinicalTrials.gov)
April 1, 201723/10/2015ABI-009, an mTOR Inhibitor, for Patients With Severe Pulmonary Arterial HypertensionA Phase 1 Clinical Trial of ABI-009, an mTOR Inhibitor, for Patients With Severe Pulmonary Arterial Hypertension (PAH)Pulmonary HypertensionDrug: ABI-009, nab-rapamycin, albumin-bound rapamycinAadi, LLCNULLRecruiting18 YearsN/AAll25Phase 1United States
210NCT03431649
(ClinicalTrials.gov)
April 1, 201729/7/2017Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in ChildrenEfficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Pulmonary Arterial Hypertension Children Associated With Left to Right Shunt Congenital Heart DefectPediatric Pulmonary HypertensionDrug: Beraprost Sodium;Drug: Sildenafil CitrateDr. Soetomo General HospitalNULLCompleted1 Year17 YearsAll40Phase 4Indonesia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211EUCTR2016-001067-36-DE
(EUCTR)
22/03/201710/11/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
212EUCTR2016-001067-36-DK
(EUCTR)
15/03/201723/12/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
213EUCTR2016-001067-36-GR
(EUCTR)
02/03/201717/01/2017A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4Switzerland;Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
214EUCTR2015-005223-90-AT
(EUCTR)
28/02/201716/01/2017This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) 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 Name: inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: NITRIC OXIDE
Other descriptive name: inhaled NO with pulsed delivery
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
215EUCTR2016-001067-36-NL
(EUCTR)
23/02/201707/12/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216EUCTR2016-001067-36-BE
(EUCTR)
20/02/201714/11/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
217EUCTR2016-001062-28-AT
(EUCTR)
07/02/201721/12/2016A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH)A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide 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] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Portugal;Philippines;Finland;Thailand;Spain;Ukraine;Austria;Russian Federation;Israel;Colombia;Vietnam;France;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;South Africa;China;Korea, Republic of
218NCT02893995
(ClinicalTrials.gov)
February 201724/8/2016Safety, Tolerability, Pharmacokinetics and Efficacy of Two Different Rates of Subcutanous Remodulin® Dose Titration in Pulmonary Arterial HypertensionA 16-Week, Open-Label, Multi-Center, Parallel, Randomized Controlled Study to Compare the Safety, Tolerability, Pharmacokinetics and Efficacy of Slow and Rapid Dose Titration Regimens of Subcutaneous Remodulin Therapy in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Slow Dose Titration Group of Subcutaneous Treprostinil;Drug: Rapid Dose Titration Group of Subcutaneous TreprostinilUnited TherapeuticsCVie Therapeutics Co. Ltd.Withdrawn18 YearsN/AAll0Phase 4China
219EUCTR2016-001062-28-HU
(EUCTR)
25/01/201715/12/2016A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH)A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide 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] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Portugal;United States;Philippines;Spain;Thailand;Ukraine;Austria;Russian Federation;Israel;Vietnam;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;South Africa;Bulgaria;Germany;China;Korea, Republic of
220EUCTR2016-001067-36-CZ
(EUCTR)
19/01/201713/10/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Revatio
Product Name: Revatio 20 mg film-coated tablets
INN or Proposed INN: SILDENAF
Bayer AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
218Phase 4Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221EUCTR2014-000667-40-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
222EUCTR2015-005223-90-NL
(EUCTR)
17/01/201705/09/2016This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) which provides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) 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]
Bellerophon Pulse Technologies LLCNULLNot Recruiting Female: yes
Male: yes
188Phase 3Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
223NCT02891850
(ClinicalTrials.gov)
January 11, 201726/8/2016Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapyA Prospective, Randomized, International, Multicenter, Double-arm, Controlled, Open-label Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Are on a Stable Dose of Phosphodiesterase-5 Inhibitors (PDE-5i) With or Without Endothelin Receptor Antagonist (ERA), But Not at Treatment GoalPulmonary Arterial HypertensionDrug: Adempas (Riociguat, BAY63-2521);Drug: Sildenafil;Drug: TadalafilBayerNULLCompleted18 Years75 YearsAll225Phase 4United States;Austria;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Spain;Taiwan;Turkey;United Kingdom;Australia;Switzerland
224JPRN-UMIN000025176
2017/01/0115/12/2016Efficacy, tolerability, and safety of transition from beraprost to selexipag in patients with pulmonary arterial hypertension. Pulmonary arterial hypertensionMedicine transition from beraprost to selexipag

In accordance with the Japanese package insert (http://www.info.pmda.go.jp/go/pack/2190037F1020_1_02/), selexipag is initiated at a dose of 0.2mg twice daily and is increased in twice-daily increments of 0.2mg until unmanageable adverse effects associated with prostacyclin use, such as headache or jaw pain, developed.
The maximum dose allowed is 1.6mg twice daily.
Hamamatsu University School of MedicineNULLOpen public recruiting16years-oldNot applicableMale and Female33Not selectedJapan
225NCT02682511
(ClinicalTrials.gov)
January 20178/2/2016Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial HypertensionA Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients With Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension (SSc-PAH)Scleroderma, Diffuse;Scleroderma, Systemic;Scleroderma, Limited;Sclerosis, Progressive Systemic;Skin Diseases;Connective Tissue Diseases;Pathologic Processes;Autoimmune DiseasesDrug: Oral Ifetroban;Drug: Oral PlaceboCumberland PharmaceuticalsNULLRecruiting18 Years80 YearsAll34Phase 2United States;India
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226EUCTR2016-001067-36-PT
(EUCTR)
29/12/201613/09/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: Tadalafil
INN or Proposed INN: TADALAFIL
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
227EUCTR2016-001067-36-GB
(EUCTR)
21/12/201624/10/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: Tadalafil
INN or Proposed INN: TADALAFIL
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
228EUCTR2015-005223-90-DE
(EUCTR)
16/12/201609/05/2016This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part2) which provides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) 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]
Bellerophon Pulse Technologies LLCNULLNot Recruiting Female: yes
Male: yes
188Phase 3Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
229EUCTR2016-001067-36-IT
(EUCTR)
12/12/201605/11/2020A study to find out whether some PAH patients may benefit by replacing their current hosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: ADEMPAS - 1 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
Product Name: Adempas¿ 1.0
INN or Proposed INN: Riociguat
Other descriptive name: Riociguat
Trade Name: ADEMPAS - 1,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
Product Name: Adempas¿ 1.5 mg
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: ADEMPAS - 0,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
Product Name: Adempas¿ 0.5 mg compressa rivestita con film
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: ADEMPAS - 2 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
Product Name: Adempas¿ 2.0 mg
INN or Proposed INN: Riociguat
Other descriptive name: Riociguat
Trade Name: ADEMPAS - 2,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
Product Name: Adempas¿ 2.5 mg
INN or Proposed INN: Riociguat
BAYER AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Germany;Japan;New Zealand;Portugal;United States;Taiwan;Greece;Spain;Italy;Switzerland
230EUCTR2010-024585-22-DE
(EUCTR)
01/12/201617/08/2016What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency?What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency? - Ferinject® for iron deficiency in IPAH patients Idiopathic or familial pulmonary arterial hypertension
MedDRA version: 19.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Ferinject
Product Name: Ferinject
INN or Proposed INN: FERRIC CARBOXYMALTOSE
Imperial College Academic Healthsciences CentreNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231NCT03053739
(ClinicalTrials.gov)
December 201629/12/2016To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic SclerosisRandomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic SclerosisAssociated Pulmonary Arterial HypertensionDrug: Sildenafil 20mg and Bosentan 62.5mg;Drug: Sildenafil 20mg and PlaceboPostgraduate Institute of Medical Education and ResearchNULLRecruiting18 YearsN/AAll50Phase 4India
232NCT02981082
(ClinicalTrials.gov)
December 201630/11/2016Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial HypertensionA Double-blinded, Placebo-controlled Pilot Study of Dimethyl Fumarate (DMF) in Pulmonary Arterial Hypertension (PAH) Associated With Systemic Sclerosis (SSc-PAH): The Effect of DMF on Clinical Disease and Biomarkers of Oxidative Stress.Systemic Sclerosis;Pulmonary; HypertensionDrug: Dimethyl Fumarate (DMF);Drug: Placebo Oral TabletRobert LafyatisBiogenTerminated18 Years80 YearsAll6Phase 1United States
233NCT02736149
(ClinicalTrials.gov)
December 20164/4/2016Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)A Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety and Efficacy of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)Pulmonary Arterial HypertensionDrug: ubenimexEiger BioPharmaceuticalsNULLTerminated18 Years75 YearsAll51Phase 2United States;Canada
234EUCTR2015-005223-90-PT
(EUCTR)
30/11/201609/05/2016This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 16 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 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 Name: inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: NITRIC OXIDE
Other descriptive name: inhaled NO with pulsed delivery
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
235EUCTR2016-003495-53-NL
(EUCTR)
29/11/201615/12/2016Study on the effect of the drug selexipag in adult patients with elevated pressure in the pulmonary arteries due to a cardiac birth defectProstacyclin receptor agonist Selexipag in patients with pulmonary arterial hypertension and congenital heart disease - SELECT trial Pulmonary arterial hypertension related to congenital heart disease.;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: Selexipag
Product Name: Selexipag
Academic Medical Center - CardiologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 3Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236EUCTR2016-001067-36-ES
(EUCTR)
21/11/201609/09/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Revatio
Product Name: Revatio 20 mg film-coated tablets
INN or Proposed INN: SILDENAF
Bayer AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
218Phase 4United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
237EUCTR2016-001067-36-AT
(EUCTR)
10/11/201620/09/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
MedDRA version: 19.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Revatio
Product Name: Revatio 20 mg film-coated tablets
INN or Proposed INN: SILDENAF
Bayer AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
218Phase 4Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
238ChiCTR-DDD-16009406
2016-11-012016-10-14System Construction of Precious Diagnosis and Evaluation for Pulmonary Arterial HpyertensionSystem Construction of Precious Diagnosis and Evaluation for Pulmonary Arterial Hpyertension Pulmonary arterial hypertensionGold Standard:;Index test:;Shanghai Pulmonary HospitalNULLPendingBothTarget condition:0;Difficult condition:0China
239NCT03049995
(ClinicalTrials.gov)
November 20162/2/2017Stress Echo 2020 - The International Stress Echo StudyThe International Stress Echo Study in Ischemic and Non-ischemic Heart DiseaseCoronary Artery Disease;Heart Failure;Hypertrophic Cardiomyopathy;Aortic Valve Disease;Athletes Heart;Tetralogy of Fallot;Pulmonary Arterial HypertensionProcedure: Left ventricular contractile reserve SE;Procedure: B-lines SE;Procedure: Left ventricular outflow tract gradient SE;Procedure: Diastolic function SE;Procedure: Mitral regurgitation SE;Procedure: Pulmonary hemodynamics SE;Procedure: Coronary flow reserve SEFatebenefratelli HospitalInstitute of Clinical Physiology, CNR, Pisa,Italy;Salerno Hospital, Italy;Monaldi Hospital, Napoli, Italy;University of Pisa, Italy;San Luca Hospital, Lucca, Italy;Careggi University Hospital, Florence, Italy;Federico II University, Napoli, Italy;San Carlo Public Hospital, Potenza, Italy;Royal Brompton & Harefield NHS Foundation Trust;Ospedale dell'Angelo, Venezia-Mestre, Italy;University of Parma;Hospital Clinics, Trieste, Italy;Hospital de Clinicas de Porto Alegre - Universidade Federal do Rio Grande do Sul, Porto Alegre, Brasil;Hospital San José, Criciuma, Brasil;Hospital San Vicente de Paulo, Passo Fundo, Brasil;University of Belgrade,Serbia;University of Szeged, Hungary;Elisabeth Hospital, Hodmezovasarhely, Hungary;Sandro Pertini Hospital, Rome, Italy;Hospital Clinics, Bari, Italy;Ospedale Nottola, Siena, Italy;University of Catania, Italy;Medika Cardiocenter, Saint Petersburg, Russian Federation;Acibadem City Clinic, University Hospital,Sofia,Bulgaria;Investigaciones Medicas, Buenos Aires, Argentina;Tomsk National Research Scientific Centre of Russian Academy of Sciences, Tomsk, Russian FederationRecruiting18 Years85 YearsAll300N/AItaly
240EUCTR2016-000196-24-GB
(EUCTR)
18/10/201628/11/2016A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSIONA STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Reata Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
241EUCTR2016-000196-24-BE
(EUCTR)
17/10/201611/07/2016A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSIONA STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Reata Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
130Phase 3United States;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan
242EUCTR2016-000196-24-NL
(EUCTR)
10/10/201613/07/2016BADOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSIONA STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Reata Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan
243NCT02657356
(ClinicalTrials.gov)
October 4, 201613/1/2016Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYSTA Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial HypertensionConnective Tissue Disease-Associated Pulmonary Arterial HypertensionDrug: Placebo capsules;Drug: Bardoxolone methyl capsulesReata Pharmaceuticals, Inc.NULLTerminated18 Years75 YearsAll202Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;Germany;Israel;Japan;Mexico;Netherlands;Philippines;Spain;United Kingdom;Chile;Czech Republic
244EUCTR2015-005223-90-CZ
(EUCTR)
27/09/201622/06/2016This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) 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 Name: inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: NITRIC OXIDE
Other descriptive name: inhaled NO with pulsed delivery
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
245NCT02826252
(ClinicalTrials.gov)
September 15, 20165/7/2016Examination of Ventavis (Iloprost) Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 µg/mL (V10) to 20 µg/mL (V20)VENTASWITCH, Examination of Ventavis® (Iloprost) Inhalation Behavior Using the I-Neb® AAD® System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 µg/mL (V10) to 20 µg/mL (V20)Hypertension, PulmonaryDrug: Iloprost,(Ventavis, BAYQ6256);Device: I-Neb AAD systemBayerNULLCompleted18 YearsN/AAll64N/AGermany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246JPRN-UMIN000025158
2016/09/0107/12/2016A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial HypertensionA Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension - A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension Connective Tissue Disease-Associated Pulmonary Arterial HypertensionDrug: Bardoxolone Methyl
Bardoxolone methyl dose escalated to a maximum of 10 mg. Dosing period is up to 6 months.
Drug: Placebo Oral Capsule
Capsule containing an inert placebo is administrated up to 6 months.
Reata Pharmaceuticals, Inc.NULLComplete: follow-up complete18years-old75years-oldMale and Female20Phase 3Japan,North America,South America,Australia,Europe
247EUCTR2016-000196-24-CZ
(EUCTR)
30/08/201618/07/2016A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSIONA STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Reata Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan
248EUCTR2015-003438-28-DK
(EUCTR)
17/08/201630/05/2016The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH Pulmonary arterial hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: TADALAFIL
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
238Phase 3United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Sweden
249EUCTR2016-000196-24-DE
(EUCTR)
11/08/201627/06/2016BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSIONA STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Reata Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Germany;Netherlands;Japan
250NCT02825160
(ClinicalTrials.gov)
August 1, 201615/6/2016Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH)Drug Use Investigation of Ventavis for Pulmonary Arterial Hypertension (PAH)Hypertension, PulmonaryDrug: Ventavis (Iloprost, BAYQ6256)BayerNULLRecruitingN/AN/AAll270Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251EUCTR2014-003952-29-PL
(EUCTR)
28/07/201613/04/2016Riociguat for treatment of PAH in children from 6 to less than 18 years oldOpen-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD Pulmonary arterial hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Bayer AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
20Phase 3United States;Taiwan;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Poland;Belgium;Romania;Netherlands;Germany;Japan
252EUCTR2015-005223-90-GB
(EUCTR)
12/07/201611/04/2016This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) which provides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) 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 Name: inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: NITRIC OXIDE
Other descriptive name: inhaled NO with pulsed delivery
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3United States;Serbia;Portugal;Spain;Ukraine;Austria;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
253EUCTR2016-000196-24-ES
(EUCTR)
04/07/201601/06/2016A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSIONA STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Reata Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
130Phase 3United States;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan
254NCT02899533
(ClinicalTrials.gov)
July 20162/8/2016[18F]FES PET/CT in PAH[18F]Fluoroestradiol (FES) PET/CT Imaging To Evaluate In Vivo ER In Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: [18F] FESUniversity of PennsylvaniaNULLActive, not recruiting18 YearsN/AFemale5United States
255NCT02782052
(ClinicalTrials.gov)
July 201617/5/2016Bronchodilator's Effects on Exertional Dyspnoea in Pulmonary Arterial HypertensionBronchodilator's Effects on Exertional Dyspnoea in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Nebulized ipratropium bromide;Drug: Nebulized combination ipratropium bromide with salbutamol;Drug: Nebulized PlaceboAssistance Publique - Hôpitaux de ParisNULLWithdrawn18 YearsN/AAll0Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256EUCTR2015-003438-28-FR
(EUCTR)
20/06/201621/04/2016The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON Pulmonary arterial hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: Tadalafil
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
144Phase 3United States;Spain;Austria;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
257NCT02759419
(ClinicalTrials.gov)
June 16, 201629/4/2016A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension.An Open-label, Multi-national, Multi-center, Single-arm, Uncontrolled, Long-term Extension Study of Orally Administered Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) Who Received Riociguat in a Bayer Clinical Trial.Hypertension, PulmonaryDrug: Adempas (Riociguat, BAY63-2521)BayerNULLRecruiting18 YearsN/AAll25Phase 4France;Italy;Korea, Republic of;Poland;Thailand
258NCT02885012
(ClinicalTrials.gov)
June 20163/5/2016Crossover Study From Macitentan or Bosentan Over to AmbrisentanA Safety and Clinical Efficacy Study Measuring Echocardiographic Composite Comparing Ambrisentan (Letairis®) After a Switch From Bosentan (Tracleer®) or Macintentan (Opsumit®) in Treatment of Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: AmbrisentanMedical University of South CarolinaOchsner Health SystemTerminated18 Years80 YearsAll3Phase 4United States
259EUCTR2014-003042-27-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
260NCT02558231
(ClinicalTrials.gov)
May 1, 201622/9/2015The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial HypertensionThe Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension: A Multi-center, Double-blind, Placebo-controlled, Phase 3b StudyPulmonary Arterial HypertensionDrug: Macitentan;Drug: Tadalafil;Drug: SelexipagActelionNULLCompleted18 Years75 YearsAll247Phase 3United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom;Norway
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261NCT02705807
(ClinicalTrials.gov)
May 201625/2/2016Evaluation of a New Thermostable Formulation of FLOLAN in Japanese SubjectsAn Open Label, Single-arm Study Evaluating a New Thermostable Formulation of FLOLAN™ in Japanese Subjects With Pulmonary Arterial Hypertension (PAH)Cardiovascular DiseaseDrug: FLOLAN injection with currently marketed diluent;Drug: FLOLAN injection with reformulated diluentGlaxoSmithKlineNULLCompleted18 Years75 YearsAll10Phase 4Japan
262NCT03809156
(ClinicalTrials.gov)
April 26, 20169/1/2019Upfront Combination Pulmonary Arterial Hypertension TherapyUpfront Riociguat and Ambrisentan Combination Therapy for Pulmonary Arterial Hypertension: A Safety and Efficacy Pilot StudyPulmonary HypertensionDrug: Riociguat Oral ProductUniversity of CalgaryBayerRecruiting18 YearsN/AAll20Phase 4Canada
263EUCTR2014-003952-29-DE
(EUCTR)
21/04/201610/08/2015Riociguat for treatment of PAH in children from 6 to less than 18 years oldOpen-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD Pulmonary arterial hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: Riociguat granules 0.3% for oral application
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Bayer AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3United States;Taiwan;Spain;Turkey;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Belgium;Poland;Romania;Germany;Japan
264EUCTR2014-003952-29-ES
(EUCTR)
01/04/201617/02/2016Riociguat for treatment of PAH in children from 6 to less than 18 years oldOpen-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD Pulmonary arterial hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: Riociguat granules 0.3% for oral application
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Bayer Healthcare AGNULLNot RecruitingFemale: yes
Male: yes
20Phase 3United Kingdom;France;Hungary;Belgium;Poland;Spain;Turkey;Netherlands;Germany;Japan;Italy
265NCT02734953
(ClinicalTrials.gov)
April 201626/3/2016Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAHEffects of iNO on Invasively Derived Pulmonary Vascular Parameters in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Nitric OxideAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)NULLCompleted18 Years80 YearsAll10Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266NCT02664558
(ClinicalTrials.gov)
April 201621/1/2016A Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)A Phase 2, Randomized, Double-BLInd, Placebo- Controlled Study of UBEnimex in Patients With Pulmonary ARTerial HYpertension (WHO Group 1) (LIBERTY)Pulmonary Arterial HypertensionDrug: ubenimex;Other: placeboEiger BioPharmaceuticalsNULLCompleted18 Years75 YearsAll61Phase 2United States;Canada
267NCT03057028
(ClinicalTrials.gov)
April 20164/5/2016Pilot Study of the Safety and Efficacy of Anakinra in Pulmonary Arterial HypertensionPilot Study of the Safety and Efficacy of Anakinra in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: AnakinraVirginia Commonwealth UniversityNULLCompleted18 YearsN/AAll7Phase 1United States
268NCT02725372
(ClinicalTrials.gov)
April 201619/1/2016Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAHA Phase 3, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine Efficacy, Safety, and Tolerability of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo in Symptomatic Subjects With PAH (Part 1 and Part 2)Pulmonary Arterial HypertensionDrug: Inhaled Nitric Oxide 75 mcg/kg IBW/hr;Drug: PlaceboBellerophon Pulse TechnologiesWorldwide Clinical TrialsTerminated18 Years85 YearsAll162Phase 3United States;Australia;Austria;Belgium;Canada;Colombia;Croatia;Czechia;France;Germany;Israel;Italy;Netherlands;Portugal;Serbia;Spain;Ukraine;United Kingdom
269EUCTR2015-003438-28-DE
(EUCTR)
04/03/201619/01/2016The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH Pulmonary arterial hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: TADALAFIL
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
238Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden
270EUCTR2015-003438-28-BE
(EUCTR)
03/03/201609/06/2020The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH Pulmonary arterial hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: TADALAFIL
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
238Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271NCT02652429
(ClinicalTrials.gov)
March 201617/12/2015Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAHAn Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for PAH for Subjects in the PULSE-PAH-006 and PULSE-PAH-004 Studies Who Continue to Need iNO TherapyPulmonary Arterial HypertensionDrug: Inhaled Nitric OxideBellerophon Pulse TechnologiesNULLActive, not recruitingN/AN/AAll22Phase 3United States;Canada
272EUCTR2012-000098-21-PL
(EUCTR)
27/02/201620/01/2016An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 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] - Cardiovascular Diseases [C14]
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
850Phase 3United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden
273EUCTR2012-000097-26-PL
(EUCTR)
27/02/201620/01/2016International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapyA Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. 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] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
850Phase 3Israel;Chile;Italy;United Kingdom;India;United States;Taiwan;Greece;Austria;France;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden
274EUCTR2014-002590-10-FR
(EUCTR)
11/02/201602/03/2016Effect of bronchodilators on effort induced dyspnoea in lung hypertension patientsEffect of bronchodilators on effort induced dyspnoea in patients suffering lung hypertension - BD-HTAP Idiopathic or heritable patients with pulmonary arterial hypertension (PAH).
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]
Trade Name: Bromure d'Ipratropium
Product Name: Bromure d'Ipratropium
INN or Proposed INN: Bromure d'Ipratropium
Trade Name: Salbutamol
Product Name: Salbutamol
INN or Proposed INN: Salbutamol
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot RecruitingFemale: yes
Male: yes
18Phase 3France
275NCT02507011
(ClinicalTrials.gov)
January 31, 201622/7/2015Beta-blockers in Pulmonary Arterial HypertensionBeta-blockers in Pulmonary Arterial Hypertension - A Phase 2 Double-Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy, and Safety of Carvedilol for Right Ventricular Dysfunction in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Carvedilol;Drug: PlaceboUniversity of MinnesotaNULLTerminated18 YearsN/AAll2Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276EUCTR2015-002835-17-DE
(EUCTR)
18/01/201626/11/2015RIGHT HEART III Study – Right ventricular hemodynamic evaluation and response to treatmentInvestigation of the influence of PAH-specific medication on right ventricular function in patients with pulmonary arterial hypertension (PAH) under basal conditions - RIGHT HEART III Pulmonary arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10037403;Term: Pulmonary hypertension NOS;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Adempas®
INN or Proposed INN: RIOCIGUAT
Trade Name: Opsumit®
INN or Proposed INN: MACITENTAN
Justus Liebig Universität GießenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2Germany
277EUCTR2015-003438-28-AT
(EUCTR)
12/01/201625/07/2017The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON Pulmonary arterial hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: Tadalafil
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
238Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden
278NCT02676947
(ClinicalTrials.gov)
January 201621/12/2015A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial HypertensionA Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: TocilizumabPapworth Hospital NHS Foundation TrustRoche Pharma AG;National Institute for Health Research, United KingdomCompleted18 Years70 YearsAll29Phase 2United Kingdom
279EUCTR2014-003952-29-GB
(EUCTR)
25/11/201527/07/2015Riociguat for treatment of PAH in children from 6 to less than 18 years oldOpen-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD Pulmonary arterial hypertension (PAH)
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] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: Riociguat granules 0.3% for oral application
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
20Phase 3United States;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Belgium;Poland;Romania;Germany;Netherlands;Japan
280EUCTR2012-004411-31-GB
(EUCTR)
25/11/201512/06/2013Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000164933 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Actelion Pharmaceuticals LtdNULLNot Recruiting Female: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281EUCTR2012-000098-21-FR
(EUCTR)
24/11/201526/09/2012An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 Pulmonary Arterial Hypertension
MedDRA version: 15.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
858Phase 3United States;Taiwan;Greece;Austria;Israel;Italy;United Kingdom;France;Mexico;Canada;Poland;Belgium;Brazil;Denmark;Australia;Germany;Netherlands;Sweden;Korea, Republic of
282NCT02551653
(ClinicalTrials.gov)
November 17, 201514/9/2015Positron Emission Tomography (PET) Study to Evaluate Biodistribution of [11C]-GSK2256098 in Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) PatientsA Microdose Study to Evaluate the Biodistribution of [11C]-GSK2256098 in the Lungs and Heart of Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) Patients Using Positron Emission Tomography (PET)Hypertension, PulmonaryDrug: [11C]-GSK2256098 500 MBqGlaxoSmithKlineNULLCompleted40 Years70 YearsAll10Phase 1United Kingdom
283NCT02471183
(ClinicalTrials.gov)
November 4, 201511/6/2015Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial HypertensionMulticenter, Open-label, Single-group Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Adult Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: SelexipagActelionNULLCompleted18 Years75 YearsAll30Phase 3United States
284NCT02746237
(ClinicalTrials.gov)
November 201518/3/2016Single and Multiple Ascending Doses Clinical Pharmacology Study With KAR5585A Randomized, Double-blind, Placebo-controlled, Phase 1, First-in-human, Single-center, Safety, Tolerability, Ventricular Repolarization and Pharmacokinetic Study of Single and Multiple Ascending Doses of KAR5585 in Healthy SubjectsPulmonary Arterial HypertensionDrug: KAR5585 Capsules;Drug: Placebo CapsulesKaros PharmaceuticalsNULLCompleted18 Years65 YearsBoth120Phase 1United States
285NCT02562235
(ClinicalTrials.gov)
October 29, 201528/9/2015Riociguat in Children With Pulmonary Arterial Hypertension (PAH)Open-label, Individual Dose Titration Study to Evaluate Safety, Tolerability and Pharmacokinetics of Riociguat in Children From 6 to Less Than 18 Years of Age With Pulmonary Arterial Hypertension (PAH)Hypertension, PulmonaryDrug: Riociguat (Adempas, BAY63-2521)BayerMerck Sharp & Dohme Corp.Active, not recruiting6 Years17 YearsAll24Phase 3Colombia;Germany;Hungary;Italy;Japan;Mexico;Poland;Taiwan;Turkey;Belgium;Brazil;France;Netherlands;Romania;Spain;United Kingdom;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286EUCTR2015-002799-26-GB
(EUCTR)
27/10/201521/09/2015A therapeutic trial of blockade of interleukin-6 using the drug Tocilizumab in pulmonary arterial hypertensionTRANSFORM-UK: A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension - An open label study of Tocilizumab in PAH Pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
Other descriptive name: n/a
Papworth Hospital NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
26Phase 2United Kingdom
287EUCTR2013-004362-34-HR
(EUCTR)
21/10/201526/05/2015A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSIONA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) 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: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
429United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark;Australia;South Africa;Netherlands;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
288EUCTR2015-000709-38-AT
(EUCTR)
20/10/201528/07/2015Effects of the drug Benzbromaron on the pulmonary vesselsAcute Effects of Benzbromaron on the pulmonary circulation 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] - Cardiovascular Diseases [C14]
Trade Name: Benzbromaron AL
Product Name: Benzbromaron
INN or Proposed INN: BENZBROMARONE
Medical University of GrazNULLNot RecruitingFemale: yes
Male: yes
Phase 2Austria
289EUCTR2015-002078-19-FR
(EUCTR)
14/10/201505/08/2015Prospective, multicenter, open-label study evaluating the effects of first-line oral combination therapy of macitentan and tadalafil in patients with newly diagnosed pulmonary arterial hypertensionProspective, multicenter, open-label study evaluating the effects of first-line oral combination therapy of macitentan and tadalafil in patients with newly diagnosed pulmonary arterial hypertension. - OPTIMA 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]
ACTELION Pharmaceuticals FranceNULLNot Recruiting Female: yes
Male: yes
60Phase 4France
290EUCTR2012-004411-31-CZ
(EUCTR)
01/10/201512/12/2013Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 18.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
291NCT02790450
(ClinicalTrials.gov)
October 201530/5/2016Acute Effects of Benzbromaron on the Pulmonary CirculationAcute Effects of Benzbromaron on the Pulmonary CirculationIdiopathic Pulmonary Arterial HypertensionDrug: BenzbromaroneMedical University of GrazLudwig Boltzmann Institute for Lung Vascular ResearchCompleted18 Years90 YearsBoth10Phase 2Austria
292NCT02576002
(ClinicalTrials.gov)
October 201513/10/2015Epidemiology and Treatment Patterns of Paediatric PAH (Pulmonary Arterial Hypertension)Study to Estimate the Incidence and Prevalence and Treatment Patterns of Pediatric Pulmonary Hypertension in the USHypertension, PulmonaryDrug: Assigned pulmonary hypertension medicationBayerNULLCompletedN/A18 YearsBoth2691N/AUnited States
293NCT02545465
(ClinicalTrials.gov)
September 15, 20158/9/2015A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical PracticeRetrospective Chart Review of Patients With PAH or Inoperable/Persistent/Recurrent CTEPH Who Transition Their PH Treatment to AdempasHypertension, PulmonaryDrug: Riociguat (Adempas, BAY63-2521)BayerNULLCompletedN/AN/AAll125N/ABelgium;Canada;Colombia;Germany;Japan;Sweden;Turkey;Denmark;United Kingdom
294EUCTR2014-003952-29-IT
(EUCTR)
09/09/201515/07/2015Riociguat for treatment of PAH in children from 6 to less than 18 years oldOpen-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: Adempas
Product Name: Adempas 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: Riociguat granules 0.3% for oral application
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer Healthcare AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Spain;Turkey;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Germany;Netherlands;Japan
295NCT02968901
(ClinicalTrials.gov)
September 1, 201514/11/2016Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA)Prospective, Multicenter, Open-label Study Evaluating the Effects of First-line Oral Combination Therapy of Macitentan and Tadalafil in Patients With Newly Diagnosed Pulmonary Arterial Hypertension (OPTIMA).Pulmonary Arterial HypertensionDrug: macitentan;Drug: tadalafilActelionNULLTerminated18 Years75 YearsAll46Phase 4France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
296NCT02253394
(ClinicalTrials.gov)
September 201517/9/2014The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension StudyThe Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study (The CAPS-PAH Study)Pulmonary Arterial HypertensionDrug: Ambrisentan plus Spironolactone;Drug: Ambrisentan plus PlaceboBrigham and Women's HospitalGilead SciencesTerminated18 YearsN/AAll2Phase 4United States
297EUCTR2013-004362-34-SE
(EUCTR)
26/08/201513/03/2014A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSIONA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) 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: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
429Phase 3;Phase 4Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
298EUCTR2014-003952-29-HU
(EUCTR)
25/08/201506/07/2015Riociguat for treatment of PAH in children from 6 to less than 18 years oldOpen-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: Adempas
Product Name: Adempas 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: Riociguat granules 0.3% for oral application
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Bayer AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3United States;Taiwan;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Belgium;Poland;Romania;Germany;Netherlands;Japan
299EUCTR2014-000667-40-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
300EUCTR2014-000667-40-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
301EUCTR2014-003042-27-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
302EUCTR2014-002131-34-NL
(EUCTR)
29/07/201505/03/2015A clinical trial with GS-4997 in Subjects with Pulmonary Arterial HypertensionA Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension Men and women, ages 18 through 75 years, with a diagnosis of idiopathic PAH, heritable PAH or PAH associated with connective tissue disease (PAH-CTD), congenital heart defects (repaired), drug and toxin use, or human immunodeficiency virus (HIV) infection.
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] - Cardiovascular Diseases [C14]
Product Code: GS-4997 2 mg
INN or Proposed INN: Not available
Product Code: GS-4997 6 mg
INN or Proposed INN: Not available
Product Code: GS-4997 18 mg
INN or Proposed INN: Not available
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Canada;Spain;Germany;Netherlands;Italy;United Kingdom
303EUCTR2014-004066-20-DE
(EUCTR)
27/07/201509/03/2015A study of the effects of macitentan on the heart in patients with elevated blood pressure in blood vessels of the lungs.A prospective, multicenter, single-arm, open-label, phase 4 study to evaluate the effects of macitentan on Right vEntricular remodeling in Pulmonary ArterIal hypeRtension assessed by cardiac magnetic resonance imaging - REPAIR: Right vEntricular remodeling in 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] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;France;Hong Kong;Malaysia;Singapore;Australia;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy
304EUCTR2014-003042-27-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
305NCT02279745
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
306NCT02428985
(ClinicalTrials.gov)
June 29, 201521/4/2015Prospective, Non-interventional, Multi-center, Post-authorization Safety Study of Riociguat for Pulmonary Arterial Hypertension (PAH)Drug Use Investigation of Riociguat for Pulmonary Arterial Hypertension (PAH)Hypertension, PulmonaryDrug: Riociguat (ADEMPAS, BAY63-2521)BayerNULLRecruitingN/AN/AAll600Japan
307NCT02310672
(ClinicalTrials.gov)
June 1, 20154/12/2014REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtensionA Prospective, Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Effects of Macitentan on Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension Assessed by Cardiac Magnetic Resonance ImagingPulmonary Arterial HypertensionDrug: MacitentanActelionNULLCompleted18 Years64 YearsAll89Phase 4United States;Australia;France;Germany;Hong Kong;Israel;Italy;Malaysia;Netherlands;Russian Federation;Singapore;United Kingdom
308NCT02436512
(ClinicalTrials.gov)
June 201513/4/2015Study to Assess Acute Vasodilation Response of Inhaled Nitric OxideA Phase 3 Open-label Multi-Center, Two-Part Single-arm Study to Evaluate the Acute Vasodilation Response of Inhaled Nitric Oxide as a Predictor of Successful Wean From Parental Prostacyclins in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Inhaled Nitric OxideGeno LLCNULLWithdrawn18 Years70 YearsBoth0Phase 3United States
309EUCTR2014-003042-27-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
310EUCTR2014-000667-40-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
311EUCTR2014-002131-34-ES
(EUCTR)
18/05/201511/03/2015A clinical trial with GS-4997 in Subjects with Pulmonary Arterial HypertensionA Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension Men and women, ages 18 through 75 years, with a diagnosis of idiopathic PAH, heritable PAH or PAH associated with connective tissue disease (PAH-CTD), congenital heart defects (repaired), drug and toxin use, or human immunodeficiency virus (HIV) infection.
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] - Cardiovascular Diseases [C14]
Product Code: GS-4997 2 mg
INN or Proposed INN: Not available
Product Code: GS-4997 6 mg
INN or Proposed INN: Not available
Product Code: GS-4997 18 mg
INN or Proposed INN: Not available
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Canada;Spain;Netherlands;Germany;Italy;United Kingdom
312