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"
316 trials found
No.TrialIDDate_
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sponsor
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agemin
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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
5NCT04576988
(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
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
7NCT04483115
(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
8NCT04280523
(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
9NCT04084678
(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
10NCT04589390
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
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Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04567602
(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
12NCT04266197
(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
13NCT04505137
(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
14NCT04416750
(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
15NCT04528056
(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_
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size
PhaseCountries
16NCT04503733
(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
17NCT04273945
(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
18NCT04278404
(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
19NCT04309838
(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
20NCT03926793
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
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PhaseCountries
21NCT04175600
(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
22EUCTR2019-002414-40-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
23NCT03782818
(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
24NCT03884465
(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
25NCT04125745
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Inclusion_
agemin
Inclusion_
agemax
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size
PhaseCountries
26NCT03683186
(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
27NCT03950739
(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
28NCT03655704
(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
29NCT04053543
(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
30NCT04055415
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
Inclusion_
agemin
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agemax
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gender
Target_
size
PhaseCountries
31NCT03924154
(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
32NCT03904693
(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
33NCT03992755
(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
34NCT03863990
(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
35NCT04316143
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
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PhaseCountries
36NCT03738150
(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
37NCT03554291
(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
38NCT03835676
(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
39NCT03795428
(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
40NCT04207593
(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
No.TrialIDDate_
enrollment
Date_
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Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
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Inclusion_
agemin
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PhaseCountries
41NCT04062565
(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
42NCT03522935
(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
43NCT03789643
(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
44NCT03754660
(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
45NCT03744637
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT03648385
(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
47NCT03657095
(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
48NCT04041648
(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
49NCT03251872
(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
50NCT03528902
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT03497689
(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
52NCT03626688
(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
53NCT03617458
(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
54EUCTR2015-005223-90-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
55NCT03449524
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT03602781
(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
57NCT03492177
(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
58NCT03556020
(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
59NCT03496207
(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
60NCT03683082
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT03708146
(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
62NCT03166306
(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
63NCT03489005
(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
64NCT03422328
(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
65NCT03344159
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT03464864
(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
67NCT03362047
(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
68NCT03177603
(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
69NCT03293407
(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
70NCT02939599
(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
71NCT03399604
(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
72NCT03229499
(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
73NCT03187678
(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
74NCT03364244
(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
75NCT02932410
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT03078907
(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
77NCT03315507
(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
78NCT03270332
(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
79NCT03145298
(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
80NCT02999906
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT03001414
(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
82NCT02927366
(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
83NCT03273387
(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
84EUCTR2015-005223-90-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
85NCT03045029
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT02800941
(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
87NCT02882126
(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
88NCT03401476
(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
89NCT03365479
(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
90NCT03016468
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT02587325
(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
92NCT03431649
(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
93EUCTR2015-005223-90-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
94NCT02893995
(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
95EUCTR2015-005223-90-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT02891850
(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
97JPRN-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
98NCT02682511
(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
99EUCTR2015-005223-90-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
100NCT03053739
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101NCT02736149
(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
102NCT02981082
(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
103NCT03049995
(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
104NCT02657356
(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
105EUCTR2015-005223-90-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT02826252
(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
107NCT02825160
(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
108EUCTR2015-005223-90-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
109NCT02782052
(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
110NCT02759419
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT02885012
(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
112NCT02558231
(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
113NCT02705807
(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
114NCT03809156
(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
115NCT02734953
(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
116NCT02664558
(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
117NCT02725372
(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
118NCT03057028
(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
119NCT02652429
(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
120NCT02507011
(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
121NCT02676947
(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
122NCT02551653
(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
123NCT02471183
(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
124NCT02562235
(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
125EUCTR2015-000709-38-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
126NCT02545465
(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
127NCT02968901
(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
128NCT02253394
(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
129NCT02279745
(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
130NCT02428985
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131NCT02310672
(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
132NCT03195543
(ClinicalTrials.gov)
March 12, 20158/6/2017Assessment of Blood Coagulation Disorders in Patients With Pulmonary HypertensionAssessment of Blood Coagulation Disorders in Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension.Pulmonary Artery Hypertension;Chronic Thromboembolic Pulmonary HypertensionDiagnostic Test: Platelet function analyzer-100;Diagnostic Test: Light transmission aggregometry;Diagnostic Test: Rotational thromboelastometry;Diagnostic Test: Endogenous thrombin potentialNational and Kapodistrian University of AthensNULLRecruiting18 YearsN/AAll60Greece
133NCT02276872
(ClinicalTrials.gov)
December 18, 201421/10/2014Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 YearsA Multicenter, Open-Label, 24-Week, Uncontrolled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil Extended Release Tablets Following Transition From Remodulin or Inhaled Prostacyclin Therapy or as Add-on to Current PAH Therapy in De Novo Prostacyclin Pediatric Subjects Aged 7 to 17 Years With Pulmonary Arterial HypertensionPAHDrug: oral treprostinilUnited TherapeuticsNULLCompleted7 Years17 YearsAll32Phase 2United States
134NCT02279160
(ClinicalTrials.gov)
December 201425/10/2014Safety and Efficacy of APD811 in Pulmonary Arterial HypertensionA Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of Ralinepag, an Oral IP Receptor Agonist, in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: APD811;Drug: PlaceboUnited TherapeuticsNULLCompleted18 Years75 YearsAll61Phase 2United States;Australia;Bulgaria;Czechia;Hungary;Poland;Romania;Serbia;Spain;Czech Republic
135NCT02284737
(ClinicalTrials.gov)
November 28, 201428/10/2014A Study to Investigate the Efficacy of PADN to Improved Functional Capacity and Hemodynamics in Patients With PAHA Prospective, Multi-center, Randomized Control Trial to Investigate the Efficacy of Pulmonary Artery Denervation to Improved Functional Capacity and Hemodynamics in Patients With Pulmonary Artery HypertensionPulmonary Arterial HypertensionProcedure: PADN;Procedure: sham PADN;Drug: SildenafilNanjing First Hospital, Nanjing Medical UniversityNULLRecruiting18 YearsN/AAll270Phase 4China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT02234141
(ClinicalTrials.gov)
November 20142/9/2014Selonsertib in Adults With Pulmonary Arterial HypertensionA Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Placebo;Drug: SelonsertibGilead SciencesNULLCompleted18 Years75 YearsAll151Phase 2United States;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom
137NCT02191137
(ClinicalTrials.gov)
September 23, 201427/6/2014Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)A Phase IV, Prospective, Single-Arm, Open-Label Study to Measure Outcomes in Patients With Pulmonary Arterial Hypertension Not on Active TreatmentHypertension, PulmonaryDrug: Riociguat (Adempas, BAY63-2521)BayerNULLCompleted18 Years80 YearsAll75Phase 4United States;Puerto Rico
138NCT02060487
(ClinicalTrials.gov)
September 22, 201429/1/2014Effects of Oral Sildenafil on Mortality in Adults With PAHA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)Pulmonary Arterial HypertensionDrug: sildenafil citratePfizerNULLActive, not recruiting18 Years74 YearsAll385Phase 4United States;Australia;Belgium;Bosnia and Herzegovina;Croatia;Czechia;Germany;Greece;Hong Kong;Israel;Latvia;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;Singapore;South Africa;Spain;Thailand;Turkey;Ukraine;Austria;Czech Republic;Netherlands;Portugal
139NCT02290613
(ClinicalTrials.gov)
July 1, 201431/10/2014Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH)Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) A Randomized, Controlled, Double-blind, Parallel Group, Proof-of-concept Trial EDITASystemic Sclerosis;Pulmonary HypertensionDrug: Ambrisentan;Drug: PlaceboHeidelberg UniversityGlaxoSmithKlineCompleted18 YearsN/AAll38Phase 2Germany
140NCT02112487
(ClinicalTrials.gov)
June 23, 20148/4/2014Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAHAn Extension of AC-055-310, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™Pulmonary Arterial HypertensionDrug: MacitentanActelionNULLCompleted18 Years80 YearsAll88Phase 3France;Italy;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT02108743
(ClinicalTrials.gov)
June 20147/4/2014Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial HypertensionAlbuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial HypertensionIdiopathic Pulmonary Arterial Hypertension.Drug: Albuterol.;Drug: Normal saline placeboAmerican Medical Association FoundationNULLWithdrawn18 Years75 YearsBoth0Phase 2United States
142NCT02036970
(ClinicalTrials.gov)
May 201413/1/2014Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIATA Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary HypertensionPulmonary Arterial Hypertension;Pulmonary Hypertension;Interstitial Lung Disease;Idiopathic Interstitial Pneumonia;Idiopathic Pulmonary Fibrosis;Sarcoidosis;Respiratory Bronchiolitis Associated Interstitial Lung Disease;Desquamative Interstitial Pneumonia;Cryptogenic Organizing Pneumonia;Acute Interstitial Pneumonitis;Idiopathic Lymphoid Interstitial Pneumonia;Idiopathic Pleuroparenchymal FibroelastosisDrug: Bardoxolone methyl;Drug: PlaceboReata Pharmaceuticals, Inc.NULLCompleted18 Years75 YearsAll166Phase 2United States;Germany;Spain;United Kingdom
143NCT02120339
(ClinicalTrials.gov)
May 201417/4/2014Carvedilol PAH A Pilot Study of Efficacy and SafetyBeta Blockers in Pulmonary Arterial Hypertension (PAH) A Pilot Study of Efficacy and SafetyPulmonary Hypertension;Cardiac MRI <40Drug: CarvedilolUniversity of MinnesotaNULLTerminated18 Years99 YearsAll5Phase 1United States
144NCT02126943
(ClinicalTrials.gov)
April 30, 201429/4/2014OPsumit USers RegistryUS-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical PracticePulmonary Arterial HypertensionDrug: Opsumit (macitentan)ActelionNULLCompletedN/AN/AAll2686United States;Puerto Rico
145NCT02032836
(ClinicalTrials.gov)
March 10, 20149/1/2014Comparative PK PD Study in PAH Patients (Fox vs. I-Neb)A Multi-center, Open-label, Randomized Cross-over Study to Compare the Acute Tolerability and Pharmacokinetics of BAYQ6256 (Iloprost; Ventavis) Inhalation Using the I-Neb Nebulizer and the FOX Nebulizer in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: lloprost(Ventavis,BAYQ6252, 20 µg/mL);Drug: lloprost(Ventavis,BAYQ6252, 10 µg/mL)BayerNULLCompleted18 YearsN/AAll27Phase 1;Phase 2Austria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146NCT02081690
(ClinicalTrials.gov)
March 1, 20145/3/2014A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and SpainA Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™Pulmonary Arterial HypertensionDrug: MacitentanActelionNULLTerminated18 Years80 YearsAll160Phase 3France;Italy;Spain
147NCT02007629
(ClinicalTrials.gov)
February 18, 20146/12/2013Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 InhibitorAn Open-label, International, Multicenter, Single-arm, Uncontrolled, Phase IIIb Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Demonstrate an Insufficient Response to Treatment With Phosphodiesterase-5 Inhibitors (PDE-5i)Hypertension, PulmonaryDrug: Riociguat (Adempas, BAY63-2521)BayerNULLCompleted18 Years75 YearsAll61Phase 3United States;Belgium;Canada;Czechia;France;Germany;Italy;Switzerland;United Kingdom;Czech Republic
148NCT01824290
(ClinicalTrials.gov)
February 5, 20141/4/2013A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: Tadalafil;Drug: Placebo;Drug: ERA as specific PAH treatmentEli Lilly and CompanyNULLActive, not recruiting6 Months17 YearsAll35Phase 3United States;Austria;Belgium;Brazil;France;Germany;Israel;Italy;Japan;Mexico;Netherlands;Poland;Spain;Turkey;Canada;Romania;Switzerland
149NCT02042014
(ClinicalTrials.gov)
January 22, 201417/1/2014Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in JapanAn Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan and Are Judged by the Investigator to Benefit From Continued QTI571 TreatmentSevere Pulmonary Arterial HypertensionDrug: QTI571Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll8Phase 3Japan
150NCT01712620
(ClinicalTrials.gov)
January 10, 201420/10/2012Spironolactone for Pulmonary Arterial HypertensionA Pilot Study of the Effect of Spironolactone Therapy on Exercise Capacity and Endothelial Dysfunction in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Spironolactone;Drug: PlaceboNational Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI);National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);University of Pennsylvania;University of Maryland, College Park;Medstar Health Research Institute;New England Medical Center, Tufts University School of MedicineRecruiting18 YearsN/AAll70Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
151NCT01934647
(ClinicalTrials.gov)
November 22, 201330/8/2013Acute Dosing of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-003)A Non-randomized, Single-Panel, Open-Label Trial to Study the Safety, Tolerability and Pharmacodynamics of MK-8892 Acute Dosing in Subjects With Moderate to Severe Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: MK-8892Merck Sharp & Dohme Corp.NULLTerminated18 Years70 YearsAll7Phase 1Germany
152NCT01926509
(ClinicalTrials.gov)
November 14, 201319/8/2013Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-005)A 28-Day Multiple-Dose Titration Study to Assess the Effects of MK-8892 on Safety, Tolerability and Pharmacokinetics in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: MK-8892;Drug: Placebo for MK-8892Merck Sharp & Dohme Corp.NULLCompleted18 Years70 YearsAll23Phase 1Bulgaria;Germany;Moldova, Republic of
153EUCTR2013-001100-10-ES
(EUCTR)
12/11/201312/11/2013This study is to allow continued access to QTI571 for patients whoreceived QTI571 for pulmonary arterial hypertension in one of thelong-term extension studies (A2301E1, A2102E1 and E2203) andhave been judged by the investigator to benefit from continuedQTI571 treatment.An open-label, multi-center protocol to provide QTI571 to PAH patients who participated in one of the extension studies and are judged by the investigator to benefit from continued QTI571 treatment Pulmonary Arterial Hypertension
MedDRA version: 16.1;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: GLIVEC 100 mg comprimidos recubiertos con película
Product Name: Imatinib mesilate
Product Code: QTI571
INN or Proposed INN: IMATINIB MESILATE
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
81United States;Spain;Australia;Switzerland
154NCT03638908
(ClinicalTrials.gov)
November 201312/7/2018Fluoxetine in Pulmonary Arterial Hypertension (PAH) TrialA Phase 2, Open-label, Clinical Trial of Fluoxetine, a Selective Serotonin Reuptake Inhibitor, in the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: FluoxetineUniversity of Texas Southwestern Medical CenterNULLCompleted16 Years80 YearsAll8Phase 2United States
155NCT02000856
(ClinicalTrials.gov)
November 201319/11/2013BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial HypertensionBEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDietary Supplement: Beetroot juiceUppsala UniversityKarolinska InstitutetCompleted18 YearsN/AAll15N/ASweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
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gender
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size
PhaseCountries
156NCT01966302
(ClinicalTrials.gov)
November 201315/10/2013Compassionate Use of Beraprost Sodium 314d Modified Release for Patients With Pulmonary Arterial Hypertension (PAH)Compassionate Use of Beraprost Sodium 314d Modified Release (BPS-314d-MR) for Three Patients With Pulmonary Arterial Hypertension (PAH).Pulmonary Arterial HypertensionDrug: BPS-314d-MRLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterLung Biotechnology PBCCompleted18 Years75 YearsAll1Phase 2United States
157NCT01827059
(ClinicalTrials.gov)
October 20135/4/2013Bosentan In Exercise Induced Pulmonary Arterial Hypertension in CongenitaL Heart diseasEA Randomized Placebo Controlled Trial to Analyze Changes in Pulmonary Arterial Pressures at Peak Exercise in Congenital Heart Disease Patients With Exercise-induced Pulmonary Arterial Hypertension Before and After Treatment With Bosentan, Compared to PlaceboPulmonary Arterial Hypertension;Congenital Heart DiseaseDrug: Bosentan;Drug: PlaceboAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)NULLActive, not recruiting18 YearsN/AAll12Phase 2Netherlands
158NCT01894035
(ClinicalTrials.gov)
September 23, 20133/7/2013Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for InhalationStudy to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost.Pulmonary HypertensionDrug: Iloprost (Ventavis, BAYQ 6256)BayerNULLCompleted18 YearsN/AAll13Portugal
159NCT01781052
(ClinicalTrials.gov)
September 11, 201322/1/2013Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension PatientsDAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension PatientsPulmonary Arterial HypertensionDrug: Ventavis (Iloprost, BAYQ6256)BayerNULLCompleted18 YearsN/AAll17N/AFrance
160NCT01739400
(ClinicalTrials.gov)
September 10, 201329/11/2012Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With 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 SyndromePulmonary Arterial HypertensionDrug: Macitentan 10 mg tablet, once daily.ActelionNULLTerminated12 YearsN/AAll217Phase 3United States;Austria;Bulgaria;Chile;China;France;Germany;Greece;Malaysia;Mexico;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;United Kingdom;Vietnam;Belgium;Canada;Czech Republic;Hungary;India;Israel;Italy;Netherlands;South Africa;Taiwan;Turkey
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT01950585
(ClinicalTrials.gov)
September 6, 201321/9/2013Hydroxyurea in Pulmonary Arterial HypertensionHydroxyurea in Pulmonary Arterial HypertensionPulmonary HypertensionDrug: HydroxyureaNational Heart, Lung, and Blood Institute (NHLBI)The Cleveland ClinicWithdrawn18 Years110 YearsAll0Early Phase 1United States
162NCT01847014
(ClinicalTrials.gov)
September 1, 20132/5/2013Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT InstrumentAC-055-402: An Extension of AC-055-401, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT InstrumentPulmonary Arterial HypertensionDrug: MacitentanActelionNULLTerminated18 Years80 YearsAll4Phase 3United States
163NCT01934582
(ClinicalTrials.gov)
August 201329/8/2013A Pharmacokinetic Substudy of the TDE-PH-304 ProtocolA Pharmacokinetic Substudy of Subjects Transitioning From Twice Daily to Three Times Daily Dosing of UT-15C SR (Treprostinil Diethanolamine) in the TDE-PH-304 ProtocolPulmonary Arterial HypertensionDrug: UT-15C SR;Drug: treprostinil diethanolamineUnited TherapeuticsNULLCompleted12 Years75 YearsAll13Phase 3United States
164NCT01897740
(ClinicalTrials.gov)
July 20138/7/2013Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With SildenafilA LOCAL, SINGLE-CENTRE, EXTENSION, OPEN LABEL ACCESS STUDY, TO PROVIDE SILDENAFIL THERAPY FOR SUBJECTS WHO COMPLETED A1481156 STUDY AND ARE JUDGED BY THE INVESTIGATOR TO DERIVE CLINICAL BENEFIT FROM CONTINUED TREATMENT WITH SILDENAFIL, PRIOR TO REIMBURSEMENT AND AVAILABILITY FOR SUBJECTS IN RUSSIAN FEDERATIONPulmonary Arterial HypertensionDrug: sildenafilPfizerNULLNo longer available10 Years30 YearsAllRussian Federation
165NCT01908699
(ClinicalTrials.gov)
May 31, 201316/7/2013Beraprost-314d Added-on to Tyvaso® (BEAT)A Multicenter, Double-blind, Randomized, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of Oral BPS-314d-MR added-on to Treprostinil, Inhaled (Tyvaso®) in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Beraprost Sodium 314d Modified Release Tablets;Drug: PlaceboLung Biotechnology PBCNULLCompleted18 Years80 YearsAll273Phase 3United States;Israel
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166NCT01743001
(ClinicalTrials.gov)
May 21, 201329/11/2012Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger SyndromeA Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 3 Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger SyndromePulmonary Arterial HypertensionDrug: Macitentan 10 mg;Drug: PlaceboActelionNULLCompleted12 YearsN/AAll226Phase 3United States;Austria;Bulgaria;Chile;China;France;Germany;Greece;Israel;Malaysia;Mexico;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Turkey;United Kingdom;Vietnam;Belgium;Canada;Czech Republic;Hungary;India;Italy;Netherlands;South Africa;Taiwan
167NCT03236818
(ClinicalTrials.gov)
May 201318/3/2013Goal Oriented Strategy to Preserve Ejection Fraction TrialRaising the Bars in the Treatment of Pulmonary Arterial Hypertension: Goal Oriented Strategy to Preserve Ejection Fraction TrialPulmonary Arterial HypertensionDrug: ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan)VU University Medical CenterNULLActive, not recruiting18 Years80 YearsAll30Phase 4Netherlands
168NCT01841762
(ClinicalTrials.gov)
April 1, 201327/3/2013Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT InstrumentA Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT InstrumentPulmonary Arterial HypertensionDrug: MacitentanActelionNULLCompleted18 YearsN/AAll284Phase 3United States
169NCT01808313
(ClinicalTrials.gov)
December 1, 201228/2/2013Efficacy Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH)An Open Label Phase IIIb Study to Evaluate Efficacy and Safety of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH)Vascular DiseaseDrug: ambrisentanGlaxoSmithKlineNULLCompleted18 Years75 YearsAll134Phase 3China
170NCT01586156
(ClinicalTrials.gov)
December 201223/4/2012PAHTCH Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart Failure (Carvedilol)Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart FailurePulmonary HypertensionDrug: Carvedilol;Drug: placeboThe Cleveland ClinicNational Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI)Completed18 Years65 YearsAll30N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171NCT01517854
(ClinicalTrials.gov)
November 14, 201214/12/2011Revatio Portal-Pulmonary Arterial Hypertension TrialRevatio Portal-Pulmonary Arterial Hypertension Trial (RePo1 Trial): A Randomized, Double-blinded, Placebo-controlled, Multi-center Study to Evaluate the Effects of Sildenafil Citrate (Revatio) 20 mg TID on Patients With Portal Pulmonary Arterial Hypertension (PPAH)Portopulmonary HypertensionDrug: Sildenafil;Drug: PlaceboUniversity Health Network, TorontoNULLTerminated18 Years75 YearsAll12Phase 2Canada
172NCT01582438
(ClinicalTrials.gov)
November 201219/4/2012An Open Label Access Study For Subjects Who Completed A1481156A Local, Multicentre, Open Label Access Study, To Provide Sildenafil Therapy For Subjects Who Completed A1481156 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil For Subjects In IndiaPulmonary Arterial HypertensionDrug: Access program - sildenafil citrate, Viagra, RevatioPfizerNULLNo longer available12 Years30 YearsAllN/AIndia
173NCT01545336
(ClinicalTrials.gov)
October 201229/2/2012Anastrozole in Patients With Pulmonary Arterial HypertensionA Double-blind, Placebo-controlled Phase II Study of Anastrozole in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Anastrozole;Drug: PlaceboUniversity of PennsylvaniaNULLCompleted18 YearsN/AAll18Phase 2United States
174NCT02169752
(ClinicalTrials.gov)
September 20126/5/2014Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial HypertensionAmbrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial HypertensionPre-Pulmonary Atrial HypertensionDrug: AmbrisentanNational Jewish HealthNULLTerminated18 Years80 YearsAll7N/AUnited States
175NCT01642407
(ClinicalTrials.gov)
August 24, 201215/6/2012Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial HypertensionA Phase 3, Multi-center, Open-label Study To Investigate Safety, Efficacy, And Tolerability Of Sildenafil Citrate In Pediatric Patients With Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;Hypertension, PulmonaryDrug: SildenafilPfizerNULLCompleted1 Year17 YearsAll6Phase 4Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176NCT01484431
(ClinicalTrials.gov)
July 17, 201230/11/2011A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial HypertensionA Multiple Ascending Dose Study of Tadalafil to Assess the Pharmacokinetics and Safety in a Pediatric Population With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Tadalafil- Tablet or Oral suspensionEli Lilly and CompanyNULLCompleted6 Months17 YearsAll20Phase 1;Phase 2United States;Canada;France;Poland;Spain;United Kingdom
177NCT01615627
(ClinicalTrials.gov)
July 1, 20126/6/2012Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site PainHypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site PainPulmonary Arterial HypertensionDrug: HypotonicTreprostinil Solution;Drug: Eutonic Treprostinil SolutionJewish General HospitalNULLWithdrawn18 YearsN/AAll0Phase 4Canada
178NCT01645826
(ClinicalTrials.gov)
July 201218/10/2011Efficacy Study of Cardizem in Pulmonary Arterial HypertensionCalcium Channel Blockers in Nitric Oxide Non-responder Pulmonary Arterial Hypertension.Idiopathic Pulmonary Arterial Hypertension;Primary Pulmonary Hypertension;Pulmonary Arterial Hypertension;Familial Primary Pulmonary HypertensionDrug: Diltiazem Hydrochloride;Drug: Sugar PillUniversity of South FloridaNULLWithdrawn18 YearsN/AAll0N/AUnited States
179NCT01523548
(ClinicalTrials.gov)
July 201227/1/2012Carbon Monoxide Therapy for Severe Pulmonary Arterial HypertensionCarbon Monoxide Therapy for Severe Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: Carbon MonoxideUniversity of Illinois at ChicagoNational Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI)Withdrawn18 YearsN/AAll0Phase 1;Phase 2United States
180NCT01647945
(ClinicalTrials.gov)
July 201218/7/2012FK506 (Tacrolimus) in Pulmonary Arterial HypertensionSingle-Center Randomized Controlled Phase II Study of Safety and Efficacy of FK-506 (Tacrolimus) in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Placebo;Drug: FK506 level < 2 ng/ml;Drug: FK506 level 2-3 ng/ml;Drug: FK506 level 3-5 ng/mlEdda SpiekerkoetterStanford UniversityCompleted18 Years70 YearsAll23Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT01560624
(ClinicalTrials.gov)
June 26, 20129/3/2012Phase III Clinical Worsening Study of UT-15C in Subjects With PAH 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 MonotherapyPulmonary Arterial HypertensionDrug: Treprostinil Diolamine;Drug: PlaceboUnited TherapeuticsNULLCompleted18 Years75 YearsAll690Phase 3United States;Argentina;Australia;Austria;Brazil;Canada;Chile;China;Denmark;France;Germany;Greece;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Singapore;Sweden;Taiwan;United Kingdom
182NCT01469169
(ClinicalTrials.gov)
June 19, 20128/11/2011Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation StudyA Multi-center, Non-randomized, Open Label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of BAY q 6256 (Iloprost) Inhalation in Patients With Pulmonary Arterial Hypertension (PAH)Hypertension, PulmonaryDrug: Iloprost (Ventavis inhaled, BAYQ6256)BayerNULLCompleted18 Years75 YearsAll27Phase 3Japan
183NCT01560637
(ClinicalTrials.gov)
May 20129/3/2012An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial HypertensionOpen-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310Pulmonary Arterial HypertensionDrug: UT-15C (treprostinil diethanolamine)United TherapeuticsNULLActive, not recruiting18 Years75 YearsAll471Phase 3United States;Argentina;Australia;Austria;Brazil;Canada;Chile;China;Denmark;France;Germany;Greece;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Singapore;Sweden;Taiwan;United Kingdom
184NCT01588405
(ClinicalTrials.gov)
April 20126/1/2012Remodulin® to Oral Treprostinil TransitionA Multicenter, Open-Label Study of the Safety and Tolerability of Transitioning From Remodulin® to Oral Treprostinil in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: UT-15C SRUnited TherapeuticsNULLCompleted15 Years80 YearsAll33Phase 2United States
185NCT02847260
(ClinicalTrials.gov)
April 201225/7/2016Safety and Tolerability of Rapid Dose Titration of Subcutaneous Remodulin® Therapy in PAH Subjects (RAPID)A 16 Week, Open Label, Multi-centre, Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of a Rapid Dose Titration Regimen of Subcutaneous Remodulin® Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: RemodulinUnited TherapeuticsNULLCompleted18 YearsN/AAll39Phase 4NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186NCT01457781
(ClinicalTrials.gov)
April 201212/10/2011Inhaled Nitric Oxide/INOpulse DS for Pulmonary Arterial Hypertension (PAH)A Phase 2, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine Safety, Tolerability and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo as Add-On Therapy in Symptomatic Subjects With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial Hypertension;Pulmonary HypertensionDrug: Nitric Oxide;Other: PlaceboBellerophon Pulse TechnologiesNULLCompleted16 Years80 YearsAll80Phase 2United States;Canada
187NCT01433328
(ClinicalTrials.gov)
January 20129/9/2011Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site PainLidocaine Subcutaneous Infusion for Control of Treprostinil Related Site PainPulmonary Arterial HypertensionDrug: Lidocaine;Drug: PlaceboJewish General HospitalNULLTerminated18 Years85 YearsAll4Phase 4Canada
188NCT01462565
(ClinicalTrials.gov)
November 1, 201113/10/2011Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH)A Single-arm, Open Label Study Evaluating the Impact on Lifestyle of a New Thermo Stable Formulation of FLOLAN® in Subjects With Pulmonary Arterial Hypertension (PAH). (FLOLAN® is a Registered Trademark of the GlaxoSmithKline Group of Companies.)Hypertension, PulmonaryDrug: current marketed FLOLAN (epoprostenol sodium);Drug: new thermo stable formulation of epoprostenol sodiumGlaxoSmithKlineNULLCompleted18 Years75 YearsAll16Phase 4United States;Canada;Netherlands
189NCT01431326
(ClinicalTrials.gov)
November 201117/8/2011Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of CarePharmacokinetics of Understudied Drugs Administered to Children Per Standard of CareAdenovirus;Anesthesia;Anxiety;Anxiolysis;Autism;Autistic Disorder;Bacterial Meningitis;Bacterial Septicemia;Benzodiazepine;Bipolar Disorder;Bone and Joint Infections;Central Nervous System Infections;Convulsions;Cytomegalovirus Retinitis;Early-onset Schizophrenia Spectrum Disorders;Epilepsy;General Anesthesia;Gynecologic Infections;Herpes Simplex Virus;Infantile Hemangioma;Infection;Inflammation;Inflammatory Conditions;Intra-abdominal Infections;Lower Respiratory Tract Infections;Migraines;Pain;Pneumonia;Schizophrenia;Sedation;Seizures;Skeletal Muscle Spasms;Skin and Skin-structure Infections;Treatment-resistant Schizophrenia;Urinary Tract Infections;Withdrawal;Sepsis;Gram-negative Infection;Bradycardia;Cardiac Arrest;Cardiac Arrhythmia;Staphylococcal Infections;Nosocomial Pneumonia;Neuromuscular Blockade;Methicillin Resistant Staphylococcus Aureus;Endocarditis;Neutropenia;Headache;Fibrinolytic Bleeding;Pulmonary Arterial Hypertension;CMV Retinitis;Hypertension;Chronic Kidney Diseases;Hyperaldosteronism;Hypokalemia;Heart Failure;Hemophilia;Heavy Menstrual Bleeding;InsomniaDrug: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:Daniel BenjaminEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);The Emmes Company, LLCCompletedN/A21 YearsAll3520United States;Canada;Israel;Singapore;United Kingdom;Australia
190NCT01477333
(ClinicalTrials.gov)
October 201114/11/2011Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®An Evaluation of the Safety and Efficacy of the Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®Pulmonary Arterial HypertensionDrug: UT-15C SR;Drug: Tyvaso Inhalation SolutionUnited TherapeuticsNULLCompleted18 Years75 YearsAll18Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191NCT01447628
(ClinicalTrials.gov)
October 20114/10/2011IV Iron Replacement for Iron Deficiency in Idiopathic Pulmonary Arterial Hypertension (IPAH) PatientsWhat is the Effect of Intravenous Iron Supplementation on Cardiopulmonary Haemodynamics, Exercise Capacity and Quality of Life in Patients With IPAH and Iron Deficiency?Pulmonary Arterial Hypertension;Iron DeficiencyDrug: Saline;Drug: Ferinject or CosmoFerImperial College LondonFu Wai Hospital, Beijing, ChinaCompleted16 Years75 YearsAll40Phase 2China;Germany;United Kingdom
192NCT01548950
(ClinicalTrials.gov)
September 20115/3/2012Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary HypertensionCombined Clinical and Surgical Approaches to Congenital Heart Disease Associated With Pulmonary Arterial Hypertension (PAH-CHD)Congenital Heart Disease;Pulmonary Arterial HypertensionDrug: Sildenafil singly or in association with BosentanUniversity of Sao Paulo General HospitalInstituto do Coracao;Fundação de Amparo à Pesquisa do Estado de São PauloCompleted2 MonthsN/AAll50N/ABrazil
193NCT01757808
(ClinicalTrials.gov)
August 201126/4/2012A Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial HypertensionA Phase I Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Ranolazine;Drug: PlaceboUniversity of ChicagoNULLCompleted18 Years72 YearsAll12Phase 1United States
194NCT01365585
(ClinicalTrials.gov)
July 20111/6/2011Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses =20mg TID For The Treatment Of Pulmonary Arterial HypertensionEvaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses =20mg TID For The Treatment Of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: sildenafil citratePfizerNULLCompleted18 YearsN/AAll227N/AGermany;Ireland
195NCT01086540
(ClinicalTrials.gov)
June 24, 201111/3/2010Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)Systemic Sclerosis-Associated PAHBiological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophenNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.Completed18 Years75 YearsAll57Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196NCT01342952
(ClinicalTrials.gov)
June 21, 201126/4/2011Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529An Open-label, Long Term Extension Study for Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 Years Who Have Participated in AMB112529 and in Whom Continued Treatment With Ambrisentan is DesiredHypertension, PulmonaryDrug: AmbrisentanGlaxoSmithKlineNULLActive, not recruiting8 Years18 YearsAll66Phase 2United States;Argentina;France;Germany;Hungary;Italy;Japan;Russian Federation;Spain;Brazil;Canada;Mexico;Netherlands
197NCT01389206
(ClinicalTrials.gov)
June 1, 20116/7/2011Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension ProgramPulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension ProgramPulmonary Arterial HypertensionDrug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or UptraviActelionCanadian Heart Research CentreCompleted18 YearsN/AAll797United States;Puerto Rico
198NCT01470144
(ClinicalTrials.gov)
June 1, 201128/10/2011Epoprostenol for Injection in Patients With Pulmonary Arterial HypertensionAn Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: EpoprostenolActelionChiltern International Ltd.;Effi-statCompletedN/AN/AAll41Phase 3Belgium;Canada;France;Italy;Netherlands;Spain
199NCT01392495
(ClinicalTrials.gov)
June 201111/7/2011Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)An Open-label Extension Study to CQTI571A2102 to Evaluate the Long-term Safety, Tolerability and Efficacy of QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: ImatinibNovartis PharmaceuticalsNULLTerminatedN/AN/AAll17Phase 3United States;Australia;Belgium;Germany;Italy;Lithuania;United Kingdom;Turkey
200NCT01319045
(ClinicalTrials.gov)
June 201118/3/2011Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart DiseasePulmonary Arterial Hypertension;Congenital Heart Disease;Eisenmenger's SyndromeDrug: IloprostUniversity of California, Los AngelesActelionTerminated18 YearsN/AAll5N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201NCT01330108
(ClinicalTrials.gov)
May 20114/4/2011Safely Change From Bosentan to Ambrisentan in Pulmonary HypertensionSafely Change From Bosentan to Ambrisentan in Pulmonary HypertensionPulmonary Arterial HypertensionDrug: ambrisentanUniversity of Alabama at BirminghamNULLCompleted19 YearsN/AAll32Phase 4United States
202EUCTR2010-021793-12-ES
(EUCTR)
28/04/201103/03/2011Estudio de extensión, prospectivo, multicéntrico y abierto del estudio FUTURE 3 para evaluar la seguridad, tolerabilidad y eficacia utilizando la formulación pediátrica de bosentan dos veces frente a tres veces al día en niños con hipertensión arterial pulmonarEstudio de extensión, prospectivo, multicéntrico y abierto del estudio FUTURE 3 para evaluar la seguridad, tolerabilidad y eficacia utilizando la formulación pediátrica de bosentan dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar Hipertensión arterial pulmonar (PAH) en niños.
MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: TRACLEER 62,5 mg comprimidos recubiertos con película
INN or Proposed INN: BOSENTAN MONOHIDRATO
Other descriptive name: BOSENTAN MONOHIDRATO
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Czech Republic;Hungary;Spain;Netherlands;Germany;Italy
203NCT01392469
(ClinicalTrials.gov)
April 20, 201110/5/2011Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension PatientsA Non-randomized, Multiple Dose, Three Treatment Period, Open-label, Single Sequence, Single Group Study to Evaluate the Pharmacokinetic Effect of Two Doses of QTI571 (Imatinib) on the Co-administered Drugs Sildenafil and Bosentan in Pulmonary Arterial Hypertension (PAH) PatientsPulmonary Arterial HypertensionDrug: ImatinibNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll21Phase 3United States;Australia;Belgium;Germany;Italy;Lithuania;United Kingdom;Romania;Turkey
204NCT01223352
(ClinicalTrials.gov)
March 8, 201112/10/2010Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial HypertensionAn Open-label, Prospective Multicenter Study to Assess the Pharmacokinetics, Tolerability, Safety and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: bosentanActelionNULLCompleted3 Months12 YearsAll64Phase 3United States;Australia;Belarus;China;Czechia;France;Germany;Hungary;India;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;Czech Republic
205NCT01338415
(ClinicalTrials.gov)
March 8, 201115/4/2011FUTURE 3 Study ExtensionA Prospective, Multicenter, Open-label Extension of FUTURE 3 to Assess the Safety, Tolerability and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: BosentanActelionNULLCompleted3 Months12 YearsAll58Phase 3United States;Australia;Belarus;China;Czechia;France;Germany;Hungary;India;Israel;Italy;Mexico;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;Czech Republic;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206NCT01431716
(ClinicalTrials.gov)
March 20117/9/2011Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial HypertensionA Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to EFI/ACT-385781A in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: EFI/ACT-385781AActelionNULLCompleted18 YearsN/AAll42Phase 3Belgium;Canada;France;Italy;Netherlands;Spain
207NCT01302444
(ClinicalTrials.gov)
March 201116/2/2011Treprostinil Combined With Tadalafil for Pulmonary HypertensionRandomized Placebo Controlled Trial of Treprostinil Infusion Combined With Oral Tadalafil or Placebo in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Tadalafil;Drug: PlaceboRhode Island HospitalUnited TherapeuticsTerminated18 Years80 YearsAll1Phase 4United States
208ChiCTR-ONC-11001799
2011-02-172011-12-15A single center, open lable clinical study of bosentan therapy in pediatric patients with severe pulmonary arterial hypertension due to congenital heart diseaseA single center, open lable clinical study of bosentan therapy in pediatric patients with severe pulmonary arterial hypertension due to congenital heart disease pediatric patients with severe pulmonary arterial hypertension due to congenital heart diseaseAll groups:Bosentan therapy ;Beijing Anzhen HospitalNULLCompleted018BothAll groups:50;China
209NCT01332331
(ClinicalTrials.gov)
January 4, 201124/3/2011Efficacy and Safety of Ambrisentan in Children 8-18yrsA Randomized, Open Label Study Comparing Safety and Efficacy Parameters for a High and a Low Dose of Ambrisentan (Adjusted for Body Weight) for the Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 YearsHypertension, PulmonaryDrug: Ambrisentan - low dose;Drug: Ambrisentan - high doseGlaxoSmithKlineNULLTerminated8 Years18 YearsAll41Phase 2United States;Argentina;France;Germany;Hungary;Italy;Japan;Russian Federation;Spain;Brazil;Canada;Greece;Mexico;Netherlands
210NCT01028651
(ClinicalTrials.gov)
January 20118/12/2009A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary HypertensionAn Open-Label Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary HypertensionPortopulmonary Hypertension;Pulmonary Arterial Hypertension;Pulmonary HypertensionDrug: TreprostinilUnited TherapeuticsUniversity of California, Los Angeles;Brigham and Women's Hospital;University of Texas;Emory UniversityCompletedN/AN/AAll13N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211EUCTR2010-021825-11-ES
(EUCTR)
22/12/201012/11/2010Estudio multicéntrico, prospectivo, abierto para evaluar la farmacocinética, tolerabilidad, seguridad y eficacia de la formulación pediátrica de bosentan, dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar - FUTURE 3Estudio multicéntrico, prospectivo, abierto para evaluar la farmacocinética, tolerabilidad, seguridad y eficacia de la formulación pediátrica de bosentan, dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar - FUTURE 3 Hpertensión arterial pulmonar (PAH) en niños
MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: TRACLEER 62,5 mg comprimidos recubiertos con película
INN or Proposed INN: BOSENTAN MONOHIDRATO
Other descriptive name: BOSENTAN MONOHIDRATO
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Phase 3Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy
212NCT01406327
(ClinicalTrials.gov)
December 14, 201028/7/2011Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)Hypertension, PulmonaryDrug: AmbrisentanGlaxoSmithKlineNULLCompletedN/AN/AAll900NULL
213NCT01251835
(ClinicalTrials.gov)
December 20101/12/2010Effect Of Rifampin On Pharmacokinetics Of SitaxsentanA Phase 1, Open Label, Fixed Sequence Design, Multiple Dose Study To Assess The Effect Of Rifampin On The Pharmacokinetics Of Sitaxsentan In Healthy SubjectsPulmonary Arterial HypertensionDrug: Sitaxsentan alone;Drug: Sitaxsentan;Drug: RifampinPfizerNULLWithdrawn21 Years55 YearsBoth0Phase 1NULL
214NCT01266265
(ClinicalTrials.gov)
December 201022/12/2010Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH TherapiesA Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation SolutionPulmonary Arterial HypertensionDrug: inhaled prostacyclin;Drug: prostacyclin;Drug: subcutaneous and intravenous prostacyclin;Drug: oral ERA;Drug: oral PDE5 inhibitorsUnited TherapeuticsNULLCompletedN/AN/AAll1333N/AUnited States
215NCT01244620
(ClinicalTrials.gov)
November 201015/11/2010A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple DosesA Phase 1, Open Label, Randomized, Four Period, Crossover, Multiple Dose Study To Assess The Pharmacokinetic Interaction Between Sitaxsentan and Tadalafil and The Effect Of Sildenafil On Sitaxsentan PK In Healthy SubjectsPulmonary Arterial HypertensionDrug: sitaxentan;Drug: tadalafil;Drug: sitaxsentan;Drug: sildenafilPfizerNULLTerminated21 Years55 YearsAll16Phase 1Singapore
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216NCT01260454
(ClinicalTrials.gov)
November 20109/12/2010The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site PainThe Qutenza® Patch for Disabling Treprostinil Infusion Site PainPulmonary Hypertension;Pulmonary Arterial HypertensionDrug: Qutenza (8% capsaicin)University of RochesterUnited TherapeuticsCompleted15 Years80 YearsAll6Phase 2United States
217NCT01210443
(ClinicalTrials.gov)
November 201011/8/2010Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension PatientsA Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: SitaxentanPfizerNULLTerminated16 Years80 YearsAll2Phase 3Japan
218EUCTR2010-019547-19-ES
(EUCTR)
06/10/201015/07/2010 Estudio abierto, aleatorizado, para comparar parámetros de seguridad y eficacia para una dosis alta y una baja de ambrisentan (ajustadas al peso corporal), como tratamiento para la hipertensión arterial pulmonar en pacientes pediátricos entre 8 y 18 años. A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. Estudio abierto, aleatorizado, para comparar parámetros de seguridad y eficacia para una dosis alta y una baja de ambrisentan (ajustadas al peso corporal), como tratamiento para la hipertensión arterial pulmonar en pacientes pediátricos entre 8 y 18 años. A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. Hipertensión arterial pulmonar
MedDRA version: 13;Level: LLT;Classification code 10064911;Term: Hipertensión arterial pulmonar
MedDRA version: 13;Level: PT;Classification code 10065150;Term: Hipertensión pulmonar arterial primaria asociada
MedDRA version: 13;Classification code 10065151;Term: Hipertensión pulmonar arterial primaria idiopática
MedDRA version: 13;Classification code 10065152;Term: Hipertensión pulmonar arterial primaria familiar
GlaxoSmithKline, S.A.NULLNot Recruiting Female: yes
Male: yes
66Phase 2France;Hungary;Greece;Spain;Germany;Netherlands;Italy
219NCT01178073
(ClinicalTrials.gov)
October 1, 201015/7/2010A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)Hypertension, PulmonaryDrug: ambrisentan;Drug: tadalafilGlaxoSmithKlineGilead SciencesCompleted18 Years75 YearsAll610Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;Greece;Italy;Japan;Netherlands;Spain;Sweden;United Kingdom
220NCT01092559
(ClinicalTrials.gov)
October 201016/2/2010Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric OxideAn Open Label Pilot Study Evaluating Preliminary Safety and Performance of the GeNO Nitrosyl Delivery SystemPulmonary Arterial HypertensionDrug: Nitric Oxide generated by the GeNO nitrosyl delivery systemGeno LLCNULLCompleted18 YearsN/AAll10Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221NCT01054105
(ClinicalTrials.gov)
October 201021/1/2010Effect of BMPR-2 Gene Mutations on Hemodynamic Response by Iloprost Inhalation in Pulmonary Arterial HypertensionThe Prevalence of BMPR-2 Gene Mutations in Korean Patients With Pulmonary Arterial Hypertension (PAH) and the Effects of Gene Mutations on Hemodynamic Response by Drug TherapyPulmonary Arterial HypertensionDrug: IloprostGachon University Gil Medical CenterSeoul National University Hospital;Seoul National University Bundang Hospital;The Catholic University of Korea;BayerCompleted20 Years80 YearsAll73Korea, Republic of
222NCT01094067
(ClinicalTrials.gov)
September 1, 201025/3/2010Tezosentan in Patients With Pulmonary Arterial HypertensionMulti-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Demonstrate That a Single Infusion of Tezosentan Has Minimal Effect on Blood Pressure in Patients With Pulmonary Arterial Hypertension, Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or a Combination of Both.Pulmonary Arterial HypertensionDrug: ACT-050089;Other: PlaceboIdorsia Pharmaceuticals Ltd.NULLTerminated18 YearsN/AAll2Phase 2United States;France;Japan
223NCT01165047
(ClinicalTrials.gov)
September 201016/7/2010Nitric Oxide, GeNO Nitrosyl Delivery SystemAn Open Label, Non-Randomized Pilot Study to Evaluate the Safety and Performance of the GeNO Nitrosyl Delivery System in Subjects Being Evaluated for Orthotopic Heart Transplantation (OHT), or Left Ventricular Assist Device (LVAD) ImplantationPulmonary Arterial HypertensionDrug: Nitric OxideAurora Health CareNULLCompleted18 YearsN/AAll10Phase 2United States
224NCT01355380
(ClinicalTrials.gov)
August 5, 201017/5/2011Efficacy of Ventavis Used in Real-life Setting.The Efficacy of Inhaled Iloprost in Patients Treated Within the Pulmonary Arterial Hypertension Therapeutic Programme.Pulmonary Arterial HypertensionDrug: Inhaled iloprost (Ventavis, BAYQ6256)BayerNULLCompleted18 YearsN/AAll55N/APoland
225NCT01179334
(ClinicalTrials.gov)
August 201010/8/2010Evaluation of the Pharmacodynamic Effect of the Combination of Sildenafil and Riociguat on Blood Pressure and Other Safety Parameters.An Interaction Study to Evaluate Changes in Blood Pressure Following 1, 1.5, 2, and 2.5 mg Riociguat Tid (Dose Titration) Compared to Placebo Treatment on the Background of Stable Sildenafil Pretreatment in Subjects With Symptomatic Pulmonary Arterial HypertensionPulmonary HypertensionDrug: Riociguat (Adempas, BAY63-2521);Drug: Placebo;Drug: SildenafilBayerNULLCompleted18 Years75 YearsAll18Phase 2United States;Austria;Czech Republic;Germany;Italy;New Zealand;Poland;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226NCT01077297
(ClinicalTrials.gov)
August 201025/2/2010Tezosentan in Pulmonary Arterial HypertensionMulticenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or ProstacyclinesPulmonary Arterial HypertensionDrug: TezosentanIdorsia Pharmaceuticals Ltd.NULLTerminated18 YearsN/AAll3Phase 2United States;France;Switzerland
227NCT01204853
(ClinicalTrials.gov)
August 20106/8/2010A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension PatientsA Phase 3, Multi-Center, Open Label Study To Evaluate The Safety And Efficacy Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: SitaxentanPfizerNULLTerminated16 Years80 YearsAll2Phase 3Japan
228NCT01268553
(ClinicalTrials.gov)
August 201029/12/2010Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin MedicationTransition From Parenteral Prostanoids to Inhaled TreprostinilPulmonary Arterial HypertensionDrug: TreprostinilLos Angeles Biomedical Research InstituteUnited TherapeuticsCompleted18 Years80 YearsAll6Phase 4United States
229EUCTR2009-011150-17-ES
(EUCTR)
13/07/201002/06/2010AMBITION: Estudio multicéntrico aleatorizado del tratamiento combinado de primera línea con ambrisentán y tadalafilo en sujetos con hipertensión arterial primariaAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITIONAMBITION: Estudio multicéntrico aleatorizado del tratamiento combinado de primera línea con ambrisentán y tadalafilo en sujetos con hipertensión arterial primariaAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Hipertensión arterial pulmonar
MedDRA version: 11;Level: PT;Classification code 10064911;Term: Hipertensión arterial pulmonar
MedDRA version: 11;Level: LLT;Term: Hipertensión arterial pulmonar
Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película
INN or Proposed INN: AMBRISENTAN
Other descriptive name: AMBRISENTAN
Trade Name: CIALIS 20 mg comprimidos recubiertos con película
INN or Proposed INN: TADALAFILO
Other descriptive name: TADALAFIL
GlaxoSmithKline,S.A.NULLNot RecruitingFemale: yes
Male: yes
352France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
230NCT01112306
(ClinicalTrials.gov)
July 7, 20108/4/2010ACT-293987 in Pulmonary Arterial HypertensionLong-term Single-arm Open-label Study, to Assess the Safety and Tolerability of ACT-293987 in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: ACT-293987ActelionNULLActive, not recruiting18 YearsN/AAll1187Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Canada;Chile;China;Colombia;Czechia;Denmark;France;Germany;Greece;Hungary;India;Ireland;Israel;Korea, Republic of;Malaysia;Mexico;Netherlands;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Czech Republic;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231NCT01179737
(ClinicalTrials.gov)
July 20103/8/2010Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)A 24 Week, Randomized, Double Blind, Multicenter, Placebocontrolled Efficacy, Safety, Tolerability and PK Trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Nilotinib;Drug: Placebo to nilotinibNovartis PharmaceuticalsNULLTerminated18 YearsN/AAll23Phase 2United States;Canada;Germany;Korea, Republic of;Singapore;Switzerland;Hungary;Italy
232NCT00796510
(ClinicalTrials.gov)
July 201020/11/2008Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term SafetyA Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;Pulmonary HypertensionDrug: Sitaxsentan;Drug: Sitaxsentan and SildenafilPfizerNULLTerminated16 Years80 YearsAll3Phase 3United States;Romania;Ukraine;Argentina;Bulgaria;Chile;China;Colombia;Costa Rica;Czech Republic;Dominican Republic;India;Mexico;Peru;Philippines;Russian Federation;Saudi Arabia;Serbia;Slovakia;South Africa;Thailand
233NCT01305252
(ClinicalTrials.gov)
July 20102/11/2010A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil).CombinatiON Up-FRON t Therapy for PAH - A Phase 4, Randomized, Multicenter Study of Inhaled Treprostinil in Treatment naïve Pulmonary Arterial Hypertension Patients Starting on TadalafilHypertension, PulmonaryDrug: treprostinil inhalations;Drug: tadalafilStanford UniversityNorthwestern UniversityCompleted18 Years69 YearsAll21Phase 4United States
234NCT01174173
(ClinicalTrials.gov)
June 201023/7/2010Ranolazine and Pulmonary HypertensionEffects of Ranolazine in Patients With Angina Due to Right Ventricular Ischemia in Pulmonary Arterial HypertensionAngina;Pulmonary Arterial HypertensionDrug: RanolazineNorthwestern UniversityGilead SciencesCompleted18 Years80 YearsAll11Phase 3United States
235NCT00964678
(ClinicalTrials.gov)
June 201024/8/2009Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial HypertensionPilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: CarvedilolVirginia Commonwealth UniversityGlaxoSmithKlineCompleted18 YearsN/AAll10Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236NCT01105117
(ClinicalTrials.gov)
May 201015/4/2010Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401An Open-label Extension of Study AC-066A401 Investigating the Safety and Tolerability of ACT-385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan®ActelionNULLCompleted18 Years65 YearsAll2Phase 4United States
237NCT01117987
(ClinicalTrials.gov)
April 20103/5/2010Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)An Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Oral QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension: IMPRES ExtensionPulmonary Arterial HypertensionDrug: Imatinib;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 YearsN/AAll144Phase 3United States;Austria;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Spain;Switzerland;United Kingdom;Sweden
238NCT00995566
(ClinicalTrials.gov)
April 201017/9/2009A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed ThelinThelin (Sitaxentan Sodium) Patient Safety Registry A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed ThelinPulmonary Arterial HypertensionDrug: Sitaxentan sodiumPfizerNULLTerminated18 YearsN/AAll54N/ABelgium;France;Germany;Sweden
239NCT01083524
(ClinicalTrials.gov)
March 20108/3/2010Dichloroacetate (DCA) for the Treatment of Pulmonary Arterial HypertensionA Phase I, Open-Label, Two Centre Study to Evaluate Dichloroacetate(DCA) in Advanced Pulmonary Arterial Hypertension.Pulmonary Hypertension (Idiopathic, Familial or Anorexigen-associated)Drug: Dichloroacetate SodiumUniversity of AlbertaImperial College LondonCompleted18 YearsN/ABoth30Phase 1Canada;United Kingdom
240NCT01105091
(ClinicalTrials.gov)
March 201015/4/2010Epoprostenol for Injection in Pulmonary Arterial HypertensionA Phase IV, Open-label, Randomized, Multicenter Study of the Safety, Tolerability,and Pharmacokinetics of ACT- 385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan®ActelionNULLCompleted18 Years65 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
241NCT00989963
(ClinicalTrials.gov)
February 1, 20105/10/2009Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH)A 12-week, Double-blind, International, Multicenter, Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Beraprost Sodium Modified ReleaseLung Biotechnology PBCNULLCompleted18 Years75 YearsAll36Phase 2United States;Belgium;Czechia;Germany;Ireland;Romania;Czech Republic
242NCT01042158
(ClinicalTrials.gov)
January 20104/1/2010A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic SclerosisA Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic SclerosisPulmonary Arterial Hypertension;Systemic Sclerosis;Scleroderma Spectrum of Diseases;Connective Tissue Disease;Pulmonary HypertensionDrug: tadalafil and ambrisentan upfront combination therapyJohns Hopkins UniversityNational Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);Eli Lilly and Company;United Therapeutics;The Cleveland Clinic;University of Texas;Stanford UniversityCompleted18 YearsN/AAll25Phase 4United States
243NCT01148836
(ClinicalTrials.gov)
January 201019/3/2010Coenzyme Q-10 and Pulmonary Arterial HypertensionCoenzyme Q-10 in the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDietary Supplement: Coenzyme Q-10 in Pulmonary Hypertension subjects;Dietary Supplement: Coenzyme Q-10 in Normal Control subjectsThe Cleveland ClinicNULLCompleted18 Years55 YearsAll18N/AUnited States
244NCT01445873
(ClinicalTrials.gov)
December 1, 200930/9/2011Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)NON-INTERVENTIONAL (NI) DRUG STUDY PROTOCOL: THREE-COUNTRY PILOT STUDY FOR RETROSPECTIVE CHART REVIEW OF EFFECTIVENESS OF THELIN® (SITAXSENTAN) IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)Pulmonary Arterial HypertensionDrug: Sitaxentan sodiumPfizerNULLCompleted18 YearsN/AAll36NULL
245NCT01106014
(ClinicalTrials.gov)
December 20092/4/2010Selexipag (ACT-293987) in Pulmonary Arterial HypertensionA Multicenter, Double-blind, Placebo-controlled Phase 3 Study Assessing the Safety and Efficacy of Selexipag on Morbidity and Mortality in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Selexipag;Drug: PlaceboActelionNULLCompleted18 Years75 YearsAll1156Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Canada;Chile;China;Colombia;Czech Republic;Denmark;France;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246NCT00990314
(ClinicalTrials.gov)
November 30, 20095/10/2009Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) PatientsAn Open-label Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) PatientsPulmonary Arterial HypertensionDrug: Beraprost Sodium Modified ReleaseLung Biotechnology PBCNULLCompleted18 Years75 YearsAll31Phase 2United States;Belgium;Czechia;Germany;Ireland;Romania;Czech Republic
247EUCTR2009-009366-13-ES
(EUCTR)
18/11/200924/09/2009Estudio internacional, multicéntrico, aleatorizado, doble ciego y controlado con placebo de 16 semanas de duración sobre la eficacia y la seguridad de UT-15C por vía oral en comprimidos de liberación lenta en pacientes con hipertensión arterial pulmonarA 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2Estudio internacional, multicéntrico, aleatorizado, doble ciego y controlado con placebo de 16 semanas de duración sobre la eficacia y la seguridad de UT-15C por vía oral en comprimidos de liberación lenta en pacientes con hipertensión arterial pulmonarA 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 Hipertensión Arterial PulmonarPulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: treprostinil dietanolamina
Product Code: UT-15C SR
INN or Proposed INN: treprostinil dietanolamina
Product Name: treprostinil dietanolamina
Product Code: UT-15C
INN or Proposed INN: treprostinil dietanolamina
Product Name: treprostinil dietanolamina
Product Code: UT-15C
INN or Proposed INN: treprostinil dietanolamina
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
248EUCTR2009-012057-38-ES
(EUCTR)
02/10/200902/07/2009Ensayo clínico multicéntrico, aleatorizado controlado con placebo, doble ciego y de 24 semanas de duración, para evaluar la eficacia y seguridad de QTI571 oral como terapia adicional en el tratamiento de la hipertensión arterial pulmonar severa: Imatinib en hipertensión arterial pulmonar, un estudio aleatorizado de eficacia (IMPRES) - IMPRESEnsayo clínico multicéntrico, aleatorizado controlado con placebo, doble ciego y de 24 semanas de duración, para evaluar la eficacia y seguridad de QTI571 oral como terapia adicional en el tratamiento de la hipertensión arterial pulmonar severa: Imatinib en hipertensión arterial pulmonar, un estudio aleatorizado de eficacia (IMPRES) - IMPRES Pacientes con Hipertensión Arterial Pulmonar (HAP) que tienen una RVP>1000 dynes.sec.cm-5 a pesar de estar en tratamiento con dos o mas terapias específicas para la HAP.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: GLIVEC 100 mg comprimidos recubiertos con película
INN or Proposed INN: IMATINIB
Other descriptive name: IMATINIB
Novartis Farmacéutica SANULLNot RecruitingFemale: yes
Male: yes
200France;Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
249EUCTR2008-007455-26-ES
(EUCTR)
28/09/200923/04/2009A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects with Pulmonary Arterial HypertensionEstudio en fase II , de asignación aleatoria, doblemente ciego, controlado con placebo y multicéntrico. Estudio de búsqueda de dosis con cicletanina en sujetos con hipertensión arterial pulmonarA Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects with Pulmonary Arterial HypertensionEstudio en fase II , de asignación aleatoria, doblemente ciego, controlado con placebo y multicéntrico. Estudio de búsqueda de dosis con cicletanina en sujetos con hipertensión arterial pulmonar Pulmonary hypertension (PH) is a serious and life-threatening disease of the pulmonary vasculature, characterized by profound vasoconstriction and an abnormal proliferation of smooth muscle cells in the walls of the pulmonary arteries.La hipertensión pulmonar (PH) es una enfermedad grave y potencialmente mortal de la vasculatura pulmonar, caracterizada por una vasoconstricción profunda y una proliferación anómala de células musculares lisas en las paredes de las arterías pulmonares
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: Cicletanine hydrochloride
Product Name: Cicletanine hydrochloride
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
160Phase 2United Kingdom;Germany;Belgium;Spain;Austria
250JPRN-JapicCTI-121998
01/9/200926/10/2012Bosentan PAH (WHO-FC II)Open label multicenter study to assess the efficacy, safety, and tolerability of bosentan in Japanese patients with pulmonary arterial hypertension (PAH) in WHO functional class II. Pulmonary arterial hypertension (PAH)Intervention name : Ro47-0203
INN of the intervention : Bosentan
Dosage And administration of the intervention : Oral administration, Initial dose: 62.5 mg b.i.d. for 4 weeks for all patients, Target dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)
Actelion Pharmaceuticals Japan Ltd.NULL1874BOTH16Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251NCT00942708
(ClinicalTrials.gov)
September 200919/7/2009Safety and Efficacy of Fluoxetine in Pulmonary Arterial HypertensionSafety and Efficacy of Fluoxetine in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: FluoxetineUniversity of Texas Southwestern Medical CenterNational Center for Research Resources (NCRR)Completed16 Years75 YearsAll6Phase 2United States
252NCT00902174
(ClinicalTrials.gov)
September 200913/5/2009Imatinib (QTI571) in Pulmonary Arterial HypertensionA 24-week Randomized Placebo-controlled, Double-blind Multi-center Clinical Trial Evaluating the Efficacy and Safety of Oral QTI571 as an add-on Therapy in the Treatment of Severe Pulmonary Arterial Hypertension: Imatinib in Pulmonary Arterial Hypertension, a Randomized, Efficacy Study (IMPRES)Pulmonary Arterial HypertensionDrug: imatinib mesylate;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll202Phase 3United States;Austria;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Spain;Sweden;Switzerland;United Kingdom
253EUCTR2008-003482-68-ES
(EUCTR)
08/06/200924/10/2008 Ensayo clínico, multinacional, multicéntrico, aleatorizado ,doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de BAY 63-2521 (1 mg, 1.5 mg, 2mg, o 2.5 mg ,tid )administrado por vía oral, en pacientes con Hipertensión Arterial Pulmonar (HAP) sintomática-Estudio PATENT -1 Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study Ensayo clínico, multinacional, multicéntrico, aleatorizado ,doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de BAY 63-2521 (1 mg, 1.5 mg, 2mg, o 2.5 mg ,tid )administrado por vía oral, en pacientes con Hipertensión Arterial Pulmonar (HAP) sintomática-Estudio PATENT -1 Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study Hipertensión Arterial Pulmonar (HAP) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
462Phase 3Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
254NCT00887978
(ClinicalTrials.gov)
June 200923/4/2009Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial HypertensionA 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: UT-15C SR;Drug: PlaceboUnited TherapeuticsNULLCompleted18 Years75 YearsAll310Phase 3United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Portugal;Spain;Sweden;United Kingdom;Ireland;Norway
255NCT00796666
(ClinicalTrials.gov)
May 200920/11/2008Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding SildenafilA Phase 3, Multi-Center, Randomized, Double-Blind, Efficacy And Safety Study Of Monotherapy Sitaxsentan Sodium Versus Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension Who Have Completed Study B1321001 (NCT00795639)Pulmonary Arterial Hypertension;Pulmonary HypertensionDrug: Sitaxsentan;Drug: Sitaxsentan and SildenafilPfizerNULLTerminated16 Years80 YearsAll131Phase 3United States;Argentina;Bulgaria;Chile;China;Colombia;Czech Republic;India;Malaysia;Mexico;Peru;Romania;Russian Federation;Serbia;South Africa;Thailand;Turkey;Ukraine;Costa Rica;Dominican Republic;Philippines;Saudi Arabia;Slovakia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256NCT00853112
(ClinicalTrials.gov)
April 200927/2/2009A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial HypertensionA Phase 2a, Randomized, Double Blind, Placebo-controlled, Parallel Group Study Investigating The Dose-response Of Pf-00489791 On Acute Hemodynamics In Subjects With Idiopathic And Familial Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: PF-00489791;Drug: placebo;Drug: sildenafilPfizerNULLTerminated18 YearsN/AAll48Phase 2United States;Canada;Germany;India;Russian Federation;Spain;Sweden;Switzerland;Belgium
257NCT00878943
(ClinicalTrials.gov)
March 31, 20098/4/2009Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 StudyA Local, Multi-centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study In India Or Ongoing In A1481269 Study Who Continue To Receive Benefit From Sildenafil Therapy.Pulmonary Arterial HypertensionDrug: Sildenafil citratePfizerNULLNo longer available18 YearsN/AAllN/AIndia
258NCT00863681
(ClinicalTrials.gov)
March 12, 200913/3/2009BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial HypertensionLong-term Extension, Multicentre, Multi-national Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg,1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)Hypertension, PulmonaryDrug: Riociguat (BAY63-2521)BayerNULLCompleted18 Years80 YearsAll396Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czechia;Denmark;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Russian Federation;Singapore;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom;Czech Republic;Ireland;Israel;Netherlands;New Zealand;Slovakia;Spain
259NCT00792571
(ClinicalTrials.gov)
February 28, 200914/11/2008An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) PatientsAn Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients.Pulmonary Arterial HypertensionDrug: Beraprost Sodium Modified ReleaseLung Biotechnology PBCNULLCompleted18 Years75 YearsAll18Phase 2United States;Belgium;Ireland
260NCT00781885
(ClinicalTrials.gov)
January 31, 200927/10/2008A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH PatientsA Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH PatientsPulmonary Arterial HypertensionDrug: Beraprost sodium modified releaseLung Biotechnology PBCNULLCompleted18 Years75 YearsAll19Phase 2United States;Belgium;Ireland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261EUCTR2008-003572-21-ES
(EUCTR)
15/01/200915/10/2008Estudio en fase 2a, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para investigar la respuesta a la dosis de PF-00489791 sobre la hemodinamia a corto plazo en sujetos con hipertensión arterial pulmonar idiopática y familiarA PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED,PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OFPF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHICAND FAMILIAL PULMONARY ARTERIAL HYPERTENSIONEstudio en fase 2a, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para investigar la respuesta a la dosis de PF-00489791 sobre la hemodinamia a corto plazo en sujetos con hipertensión arterial pulmonar idiopática y familiarA PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED,PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OFPF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHICAND FAMILIAL PULMONARY ARTERIAL HYPERTENSION Hipertensión arterial pulmonarPulmonary arterial hypertension.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: PF-00489791
Product Name: PF-00489791
Product Name: PF-00489791
Trade Name: REVATIO 20 mg, comprimidos recubiertos con película
INN or Proposed INN: SILDENAFILO
Other descriptive name: SILDENAFIL
Pfizer, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
79Phase 2AGermany;Belgium;Spain;Sweden
262NCT00795639
(ClinicalTrials.gov)
December 200820/11/2008Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety And Efficacy Study Of Sitaxsentan Sodium In Subjects With Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;Pulmonary HypertensionDrug: Sitaxsentan;Drug: PlaceboPfizerNULLTerminated16 Years80 YearsAll183Phase 3United States;Argentina;Bulgaria;Chile;China;Colombia;Costa Rica;Czech Republic;Dominican Republic;Guatemala;India;Malaysia;Mexico;Peru;Philippines;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;South Africa;Thailand;Turkey;Ukraine;Egypt;Jordan;Lebanon;United Arab Emirates
263NCT00810693
(ClinicalTrials.gov)
December 200817/12/2008A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)Pulmonary HypertensionDrug: Riociguat (Adempas, BAY63-2521);Drug: PlaceboBayerNULLCompleted18 Years80 YearsAll445Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czech Republic;Denmark;France;Germany;Greece;Ireland;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Singapore;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom;Slovakia
264NCT00667823
(ClinicalTrials.gov)
October 17, 200824/4/2008Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial HypertensionLong-term Single-arm Open-label Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: MacitentanActelionNULLActive, not recruiting12 YearsN/AAll550Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;China;Colombia;Croatia;Finland;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Malaysia;Mexico;Netherlands;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Sweden;Taiwan;Thailand;Ukraine;United Kingdom;Brazil;Czech Republic;Denmark;Japan;Korea, Republic of;Norway;Portugal;Spain
265NCT00800592
(ClinicalTrials.gov)
October 200819/11/2008Sildenafil IV Bolus StudyAn Open Single Dose Study To Assess The Safety, Tolerability And Pharmacokinetics Of An Intravenous Bolus Dose (10 Mg) Of Sildenafil In Patients With Pulmonary Arterial Hypertension (PAH).Hypertension, PulmonaryDrug: sildenafilPfizerNULLCompleted18 YearsN/AAll12Phase 1Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266NCT00709098
(ClinicalTrials.gov)
September 20081/7/2008Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial HypertensionA Multicenter, Double-blind, Randomized Study Comparing the Safety and Tolerability of Iloprost Inhalation Solution Delivered by I-neb Utilizing Power Disc-15 and Power Disc-6 in Patients With Symptomatic Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: iloprostActelionNULLCompleted18 YearsN/AAll49Phase 3United States;Austria;Germany
267NCT01338636
(ClinicalTrials.gov)
September 200818/4/2011An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Participants With Exercise-Induced Pulmonary Arterial Hypertension (PAH)An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Patients With Exercise Induced Pulmonary Arterial HypertensionExercise-induced Pulmonary Arterial HypertensionDrug: AmbrisentanBrigham and Women's HospitalGilead SciencesCompleted18 YearsN/AAll30Phase 4United States
268NCT00825266
(ClinicalTrials.gov)
September 200816/1/2009Insulin Resistance in Pulmonary Arterial HypertensionThe Effect of Bosentan and Pioglitazone on Insulin Resistance in Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: bosentan;Drug: PioglitazoneStanford UniversityNULLTerminated18 Years75 YearsAll2Phase 2United States
269NCT00741819
(ClinicalTrials.gov)
September 200823/8/2008Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) SubjectsAn Open Label, Multi-center Study Evaluating the Safety of Long-term Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis® (Iloprost) in Subjects With Pulmonary Arterial Hypertension.Pulmonary Arterial HypertensionDrug: Inhaled treprostinilUnited TherapeuticsNULLCompleted18 Years75 YearsAll73Phase 4United States
270EUCTR2007-003621-24-ES
(EUCTR)
07/07/200812/05/2008Estudio doble ciego, aleatorizado, controlado por placebo, de determinación de dosis, de grupos paralelos, para valorar los efectos hemodinámicos, la eficacia clínica, la tolerabilidad y la seguridad de Aviptadil (Péptido intestinal Vasoactivo) tras una inhalación, e inhalaciones repetidas, en pacientes con hipertensión arterial pulmonar.Estudio doble ciego, aleatorizado, controlado por placebo, de determinación de dosis, de grupos paralelos, para valorar los efectos hemodinámicos, la eficacia clínica, la tolerabilidad y la seguridad de Aviptadil (Péptido intestinal Vasoactivo) tras una inhalación, e inhalaciones repetidas, en pacientes con hipertensión arterial pulmonar. Hipertensión arterial pulmonar (HAP) debida a hipertensión arterial pulmonar idiopática (HAPI), HAP familiar o HAP asociada con enfermedades del tejido conjuntivo (ETC) (p. ej. esclerosis sistémica, lupus eritematoso sistémico) o con defectos cardiacos congénitos reparados(DCCR).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP
MondoGEN AGNULLNot RecruitingFemale: yes
Male: yes
48Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271NCT00723554
(ClinicalTrials.gov)
July 200824/7/2008Iloprost Power Disc-15 in Pulmonary Arterial HypertensionA Phase IIIb, Multicenter, Open-label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 (PD-6) to Power Disc-15 (PD-15) With the I-neb® AAD®Pulmonary Arterial HypertensionDrug: Iloprost PD-6;Drug: Iloprost PD-15ActelionNULLTerminated18 Years85 YearsAll63Phase 3United States
272NCT00705133
(ClinicalTrials.gov)
July 200823/6/2008Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial HypertensionUsing Either Intravenous (IV) or Subcutaneous (SQ) Treprostinil to Treat Pulmonary Hypertension Related to Underlying Interstitial Lung DiseasePulmonary Arterial Hypertension;Interstitial Lung Disease;Idiopathic Pulmonary FibrosisDrug: TreprostinilRajan SaggarUnited TherapeuticsCompletedN/AN/AAll15Phase 2United States
273NCT00709956
(ClinicalTrials.gov)
July 20081/7/2008Iloprost Power 15 in Pulmonary Arterial HypertensionA Multicenter, Double-blind, Randomized, Placebo-controlled, Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients With Symptomatic Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: iloprost (5 µg);Drug: placeboActelionNULLCompleted18 YearsN/AAll64Phase 3United States;Austria;Germany
274EUCTR2005-005068-97-ES
(EUCTR)
11/05/200803/03/2008Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - COMPASS 2Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - COMPASS 2 Hipertensión Arterial PulmonarPatients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
MedDRA version: 9.1;Classification code 10064909;Term:
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Ro-47-0203
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Ro-47-0203
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 4Portugal;Czech Republic;United Kingdom;Germany;Denmark;Spain;Greece;Sweden
275NCT00660179
(ClinicalTrials.gov)
May 200814/4/2008Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial HypertensionA Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: macitentan (ACT-064992);Drug: placeboActelionNULLCompleted12 YearsN/AAll742Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;China;Colombia;Croatia;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Malaysia;Mexico;Netherlands;Norway;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Brazil;Czech Republic;Denmark;Finland;Former Serbia and Montenegro;Portugal
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276NCT00430716
(ClinicalTrials.gov)
April 8, 200831/1/2007To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH)Pulmonary Arterial HypertensionDrug: Sildenafil citratePfizerNULLTerminated18 YearsN/AAll130Phase 4United States;Belgium;Brazil;Bulgaria;China;Greece;India;Italy;Latvia;Malaysia;Netherlands;Philippines;Poland;Romania;Russian Federation;Thailand;United Kingdom;Denmark;Panama
277NCT00617305
(ClinicalTrials.gov)
April 20086/2/2008Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1)An Open-label, Multicenter Study of Ambrisentan and a Phosphodiesterase Type-5 Inhibitor Combination Therapy in Subjects With Pulmonary Arterial Hypertension Who Have Demonstrated a Sub-Optimal Response to a Phosphodiesterase Type-5 InhibitorPulmonary Arterial HypertensionDrug: Ambrisentan;Drug: Placebo;Drug: Sildenafil;Drug: TadalafilGilead SciencesNULLCompleted16 Years75 YearsAll38Phase 4United States
278NCT00643604
(ClinicalTrials.gov)
March 200820/3/2008Rapid Switch From Flolan to Remodulin in the Outpatient ClinicRapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension in the Outpatient Clinic: Safety, Efficacy and Treatment SatisfactionHypertension, PulmonaryDrug: treprostinil sodiumUnited TherapeuticsNULLTerminated18 Years70 YearsAll7Phase 4United States
279NCT00554619
(ClinicalTrials.gov)
February 20085/11/2007A Study to Evaluate GSK1325760A - a Long-Term Extension StudyStudy AMB107818, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open Label Study of GSK1325760A to Evaluate the Safety and Efficacy of GSK1325760A - a Long-term Extension Study -Pulmonary Arterial Hypertension;Hypertension, PulmonaryDrug: GSK1325760AGlaxoSmithKlineNULLCompletedN/AN/AAll21Phase 3Japan
280NCT00625469
(ClinicalTrials.gov)
October 200719/2/2008Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With BosentanTreatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot StudyPulmonary Arterial Hypertension;Idiopathic Pulmonary FibrosisDrug: bosentanRajan SaggarActelionWithdrawnN/AN/AAll0Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281NCT00540436
(ClinicalTrials.gov)
August 20075/10/2007Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial HypertensionStudy AMB107816, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open-Label Phase II/III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A -Hypertension, PulmonaryDrug: GSK1325760AGlaxoSmithKlineNULLCompleted18 YearsN/AAll25Phase 2Japan
282EUCTR2006-000800-17-ES
(EUCTR)
29/05/200702/03/2010Estudio internacional, multicéntrico, doble ciego, aleatorizado, controlado con placebo y de 16 semanas de duración para comparar la eficacia y la seguridad de UT-15C en comprimidos orales de liberación prolongada en combinación con un antagonista del receptor de la endotelina y/o con un inhibidor de la fosfodiesterasa-5 en sujetos con hipertensión arterial pulmonarA 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-CEstudio internacional, multicéntrico, doble ciego, aleatorizado, controlado con placebo y de 16 semanas de duración para comparar la eficacia y la seguridad de UT-15C en comprimidos orales de liberación prolongada en combinación con un antagonista del receptor de la endotelina y/o con un inhibidor de la fosfodiesterasa-5 en sujetos con hipertensión arterial pulmonarA 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C HAP idiopática o familiar incluyendo HAP asociada a:1) Uso de un inhibidor del apetito2) Corticircuito sistémico-pulmonar congénito corregido (corrección = 5 años)3) HAP asociada a enfermedad del tejido conjuntivo vascular4) HIV
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Dietanolamina de treprostinilo
Product Code: UT-15C LP
INN or Proposed INN: Dietanolamina de treprostinilo
Product Name: Dietanolamina de treprostinilo
Product Code: UT-15C LP
INN or Proposed INN: Treprostinil diethanolamine
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Germany;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria
283NCT00454207
(ClinicalTrials.gov)
April 200728/3/2007Open Label Study of Sildenafil in Patients With Pulmonary Arterial HypertensionA Phase 3, Multi-Center, Open-Label Study to Assess Safety and Efficacy of Sildenafil Citrate 20 mg TID in Subjects With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: sildenafil citrate (UK-92,480)PfizerNULLCompleted16 YearsN/AAll44Phase 3Japan
284NCT00433329
(ClinicalTrials.gov)
March 20077/2/2007Combination Therapy in Pulmonary Arterial HypertensionCOMPASS 3: An Open-label, Multi-Center Study Employing a Targeted 6-Minute Walk Test (6-MWT) Distance Threshold Approach to Guide Bosentan-Based Therapy and to Assess the Utility of Magnetic Resonance Imaging (MRI) on Cardiac RemodelingPulmonary Arterial HypertensionDrug: Bosentan;Drug: SildenafilActelionNULLCompleted12 YearsN/AAll100Phase 4United States
285NCT00625079
(ClinicalTrials.gov)
February 200719/2/2008Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With SildenafilRandomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot StudyPulmonary Arterial Hypertension;Idiopathic Pulmonary Fibrosis;Interstitial Lung Disease;Pulmonary HypertensionDrug: sildenafilUniversity of California, Los AngelesPfizerWithdrawnN/AN/AAll0Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286NCT00439946
(ClinicalTrials.gov)
February 200722/2/2007Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAHRapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) Using the Crono Five Ambulatory Infusion Pump in Patients With Stable Pulmonary Arterial Hypertension (PAH): Safety, Efficacy and Treatment SatisfactionPulmonary Arterial HypertensionDrug: treprostinil;Device: Crono Five ambulatory pumpUnited TherapeuticsNULLTerminated18 Years65 YearsAll8Phase 4United States
287NCT00325442
(ClinicalTrials.gov)
October 200611/5/2006FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: Oral treprostinil (UT-15C) sustained release tablets;Drug: PlaceboUnited TherapeuticsNULLCompleted12 Years70 YearsAll354Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Poland;Spain;United Kingdom
288NCT00325403
(ClinicalTrials.gov)
October 200611/5/2006FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: Oral treprostinil (UT-15C) Sustained Release Tablets;Other: PlaceboUnited TherapeuticsNULLCompleted12 Years75 YearsAll349Phase 3United States;Austria;Belgium;Canada;China;France;India;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico
289NCT00373360
(ClinicalTrials.gov)
September 20067/9/2006Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to RemodulinRapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment SatisfactionPulmonary HypertensionDrug: treprostinil sodiumUnited TherapeuticsNULLCompleted18 Years70 YearsAll10Phase 4United States
290NCT00384865
(ClinicalTrials.gov)
September 200630/9/2006A Study of Aspirin and Simvastatin in Pulmonary Arterial HypertensionA Clinical Trial of Aspirin and Simvastatin in Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: Simvastatin;Drug: Aspirin;Drug: PlaceboUniversity of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI)Terminated18 YearsN/AAll64Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
291NCT00323297
(ClinicalTrials.gov)
September 20065/5/2006Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial HypertensionA Multinational, Multicentre, Randomized, Double-blind Study To Assess The Efficacy And Safety Of Oral Sildenafil 20mg Tid Or Placebo When Added To Bosentan In The Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (Pah)Pulmonary Arterial HypertensionDrug: Bosentan;Other: Placebo;Drug: Sildenafil CitratePfizerNULLCompleted18 YearsN/AAll105Phase 4United States;Australia;Czech Republic;France;Germany;Greece;Israel;Italy;Taiwan;United Kingdom;Belgium
292EUCTR2005-006192-13-ES
(EUCTR)
09/06/200612/05/2006Estudio aleatorio, doble-ciego, controlado con placebo para evaluar la seguridad y eficacia de la adición de Iloprost inhalado en pacientes con hipertensión arterial pulmonar que reciben Sildenafilo por vía oral - VISIONEstudio aleatorio, doble-ciego, controlado con placebo para evaluar la seguridad y eficacia de la adición de Iloprost inhalado en pacientes con hipertensión arterial pulmonar que reciben Sildenafilo por vía oral - VISION Spanish: hipertensión arterial pulmonar English: Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death.
MedDRA version: 8.1;Classification code 10037400
Trade Name: **Comment**- IMP inhalation solution identical to ventavis inhalation solution, but IMP is in a different volume presentation. Please see covering letter.
Product Name: Iloprost (Ventavis®)
INN or Proposed INN: Iloprost
CoTherix, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Portugal;Germany;United Kingdom;Spain;Italy;Austria
293EUCTR2005-005066-37-DE
(EUCTR)
09/06/200606/11/2006COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxinsPatients are already on prescribed bosentan therapy for at least 12 weeks.Product Name: sildenafil
Product Code: N/A
INN or Proposed INN: Sildenafil citrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
44Phase 2United Kingdom;Germany;Italy
294NCT00946114
(ClinicalTrials.gov)
June 200622/7/2009To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 WeeksA Local, Multi-Centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For One Hundred Twelve Weeks / Prior To Reimbursement And Availability For Patients In Poland.Pulmonary HypertensionDrug: sildenafilPfizerNULLCompleted18 YearsN/AAll32N/APoland
295NCT00303459
(ClinicalTrials.gov)
May 200616/3/2006Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH)Effects of Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Morbidity and Mortality in Symptomatic Patients With Pulmonary Arterial Hypertension - A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Prospective, Event Driven Phase IV StudyPulmonary Arterial HypertensionDrug: bosentan;Drug: placeboActelionNULLCompleted12 YearsN/AAll334Phase 4United States;Brazil;Czech Republic;Denmark;Germany;Greece;Portugal;Saudi Arabia;Slovakia;Spain;Sweden;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
296NCT01027949
(ClinicalTrials.gov)
May 20064/12/2009An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial HypertensionAn Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Treprostinil diethanolamineUnited TherapeuticsNULLActive, not recruiting12 YearsN/AAll900Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;India;Ireland;Israel;Italy;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Spain;Sweden;United Kingdom;Czech Republic
297EUCTR2005-005066-37-BE
(EUCTR)
21/04/200615/02/2006COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxinsPatients are already on prescribed bosentan therapy for at least 12 weeks.Trade Name: viagra
Product Name: sildenafil
Product Code: N/A
INN or Proposed INN: Sildenafil citrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
44Phase 2Belgium;Germany;Italy;United Kingdom
298NCT01721564
(ClinicalTrials.gov)
April 20061/11/2012Bosentan and Pulmonary Endothelial FunctionPulmonary Artery Remodelling With BosentanPulmonary Arterial HypertensionDrug: BosentanProf David S CelermajerNULLCompleted18 Years80 YearsAll8N/ANULL
299NCT00477269
(ClinicalTrials.gov)
April 200622/5/2007Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial HypertensionA Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of the Six Months Treatment With the Tyrosine Kinase Inhibitor STI571 for the Treatment of Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Imatinib mesylate;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll59Phase 2;Phase 3United States;Austria;Germany;United Kingdom
300EUCTR2005-005066-37-GB
(EUCTR)
15/03/200613/02/2006COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxins Patients are already on prescribed bosentan therapy for at least 12 weeks.Actelion Pharmaceuticals Ltd.NULLNot Recruiting Female: yes
Male: yes
44Phase 2Belgium;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
301EUCTR2005-002692-33-ES
(EUCTR)
02/02/200612/12/2005Estudio aleatorizado, doble ciego, comparativo con placebo y Fase III del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGYEstudio aleatorizado, doble ciego, comparativo con placebo y Fase III del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY La hipertensión arterial pulmonar (HAP) es una enfermedad crónica y progresiva caracterizada por el aumento de la presión arterial pulmonar y de la resistencia vascular pulmonar, conduciendo a insuficiencia cardíaca derecha y muerteTrade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Lilly ICOS LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3Germany;United Kingdom;Ireland;Spain;Italy
302NCT00302211
(ClinicalTrials.gov)
February 1, 200610/3/2006The VISION Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial HypertensionA Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients With Pulmonary Arterial Hypertension Receiving Oral SildenafilPulmonary HypertensionDrug: Inhaled Iloprost (5 µg);Drug: Inhaled Placebo;Drug: Sildenafil;Drug: BosentanActelionNULLTerminated12 Years85 YearsAll67Phase 3United States
303NCT00549302
(ClinicalTrials.gov)
December 200523/10/2007Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the LungsAn Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: tadalafilEli Lilly and CompanyICOS CorporationCompleted12 YearsN/AAll357Phase 3United States;Belgium;Canada;France;Germany;Ireland;Italy;Japan;Spain;United Kingdom
304NCT00319020
(ClinicalTrials.gov)
August 23, 200526/4/2006Bosentan in Children With Pulmonary Arterial Hypertension Extension StudyAn Open Label, Long-term, Safety, and Tolerability Extension Study Using the Pediatric Formulation of Bosentan in the Treatment of Children With Idiopathic or Familial Pulmonary Arterial Hypertension Who Completed FUTURE 1Pulmonary Arterial HypertensionDrug: BosentanActelionNULLCompleted2 Years11 YearsAll33Phase 3United States;France;Germany;Italy;Netherlands;Switzerland;United Kingdom
305NCT00593905
(ClinicalTrials.gov)
July 20053/1/2008Pharmacogenomics in Pulmonary Arterial HypertensionPharmacogenomics in Pulmonary Arterial Hypertension: A Multi-Center International Study to Determine Whether in PAH Patients Clinical Associations Exist Between the Efficacy and Toxicity of Endothelin Receptor Antagonists and Several Gene Polymorphisms in Several Key Disease-Specific and Therapy Specific GenesPulmonary Arterial Hypertension;Pulmonary Hypertension;PAH WHO Group IDrug: Sitaxsentan;Drug: Bosentan, AmbrisentanWest Penn Allegheny Health SystemNational Institutes of Health (NIH);Baylor College of Medicine;Emory University;University of Chicago;Johns Hopkins University;Tufts Medical Center;Sir Mortimer B. Davis - Jewish General Hospital;London Health Sciences Centre;University of Maryland;University of California, San Francisco;University of Calgary;Chest Medical Associates;Columbia University;Lung Diagnostics, Ltd.;Duke University;University of California, Los Angeles;Latter Day Saints Hospital;Louisiana State University Health Sciences Center in New Orleans;Massachusetts General Hospital;Mayo Clinic;Medical College of Wisconsin;Southeastern Lung Care;Suncoast Lung Center;Children's Hospital Colorado;University Hospital Case Medical Center;University of Colorado, Denver;University of Michigan;University of Pittsburgh;University of Southern California;The University of Texas, Galveston;Vanderbilt University;Wayne State University;Ohio State University;University of Alabama at Birmingham;Washington University School of Medicine;Sentara Norfolk General Hospital;University of Texas Southwestern Medical Center;Bay Area Chest PhysiciansRecruitingN/AN/ABoth1300N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
306NCT03055221
(ClinicalTrials.gov)
June 10, 20059/2/2017TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)TRUST-2: An Open-label Continuation Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Intravenous TreprostinilUnited TherapeuticsNULLCompleted16 Years75 YearsAll20Phase 4NULL
307NCT00147199
(ClinicalTrials.gov)
June 20052/9/2005Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial HypertensionPulmonary HypertensionDrug: Inhaled treprostinil;Drug: Placebo inhalation solutionUnited TherapeuticsNULLCompleted18 Years75 YearsAll235Phase 3United States;Austria;Belgium;France;Germany;Ireland;Israel;Italy;Spain;United Kingdom
308NCT00423592
(ClinicalTrials.gov)
May 200517/1/2007Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial HypertensionA Phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects With Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum Aminotransferase AbnormalitiesPulmonary HypertensionDrug: ambrisentanGilead SciencesNULLCompleted12 Years75 YearsAll36Phase 2NULL
309NCT00626028
(ClinicalTrials.gov)
September 200420/2/2008Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator TestingComparison of Supplemental Oxygen and Nitric Oxide for Inhalation Plus Oxygen in the Evaluation of the Reactivity of the Pulmonary Vasculature During Acute Pulmonary Vasodilator TestingIdiopathic Pulmonary Arterial Hypertension;CardiomyopathyDrug: Nitric Oxide for inhalation;Drug: Oxygen;Drug: Nitric Oxide plus OxygenMallinckrodtNULLCompletedN/A18 YearsAll136Phase 3United States;France;Netherlands;Spain;United Kingdom
310NCT00578786
(ClinicalTrials.gov)
February 200419/12/2007A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202)A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202)Pulmonary Arterial HypertensionDrug: ambrisentanGilead SciencesNULLCompleted18 YearsN/AAll383Phase 3Argentina;Brazil;Chile;Mexico
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
311NCT00159874
(ClinicalTrials.gov)
January 20048/9/2005A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In ChildrenA Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil Citrate In The Treatment Of Subjects Who Have Completed Study A1481131Pulmonary Arterial HypertensionDrug: Sildenafil citratePfizerNULLCompleted1 Year17 YearsAll234Phase 3United States;Brazil;Chile;Colombia;Guatemala;Hungary;India;Italy;Japan;Malaysia;Mexico;Poland;Russian Federation;Sweden;Taiwan;Canada;Costa Rica;Panama;Singapore
312NCT00367770
(ClinicalTrials.gov)
January 200421/8/2006BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger PhysiologyA Multi-Center, Open-Label Extension Study to Protocol AC-052-405 to Evaluate the Safety and Efficacy of Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger PhysiologyPulmonary Arterial HypertensionDrug: Tracleer®ActelionNULLCompleted12 YearsN/AAll37Phase 4United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom
313NCT00159913
(ClinicalTrials.gov)
August 20038/9/2005A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension.A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension.Pulmonary Arterial Hypertension, ChildrenDrug: Sildenafil citrate;Drug: PlaceboPfizerNULLCompleted1 Year17 YearsAll235Phase 3United States;Brazil;Canada;Chile;Colombia;Guatemala;Hungary;India;Italy;Japan;Malaysia;Mexico;Peru;Poland;Russian Federation;Sweden;Taiwan;Australia;Costa Rica;Panama;Singapore
314NCT00159861
(ClinicalTrials.gov)
July 20038/9/2005The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAHA Multinational, Multi-Center, Randomised, Double-Bind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Efficacy of a Subject Optimised Dose of Sildenafil Citrate (20, 40, or 80 mg. Sildenafil Citrate TID) Based on the Toleration, When Used in Combination With Intravenous Prostacyclin( Epoprostenol) in the Treatment of Pulmonary Arterial Hypertension.Pulmonary HypertensionDrug: Sildenafil citratePfizerNULLCompleted16 YearsN/AAll267Phase 3United States;Belgium;Canada;Czech Republic;Denmark;France;Israel;Italy;Netherlands;Spain;United Kingdom
315NCT00424021
(ClinicalTrials.gov)
April 200317/1/2007Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial HypertensionAn Open-Label, Long-Term Study of Ambrisentan in Pulmonary Hypertension Subjects Having Completed Myogen Study AMB-220Pulmonary HypertensionDrug: ambrisentanGilead SciencesNULLCompleted18 YearsN/AAll54Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
316NCT00811018
(ClinicalTrials.gov)
March 20039/12/2008A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial HypertensionA Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: SitaxsentanPfizerNULLTerminated12 Years75 YearsAll1192Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Spain;United Kingdom