[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540512":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":329,"collaborators":331,"id":341,"slug":342,"hasResults":343,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":347,"eligibilityCriteria":348,"healthyVolunteers":343,"sex":349,"minAge":350,"maxAge":351,"enrollmentInfo":352,"targetDuration":32,"studyType":355,"phases":356,"briefSummary":358,"conditions":359,"keywords":361,"overallStatus":42,"whyStopped":32,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":373},{"fullName":5,"class":6},"AOP Orphan Pharmaceuticals AG","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Initial triple therapy","EXPERIMENTAL","Assigned treatment: double oral (background therapy consisting of 1 endothelin receptor antagonist ERA and 1 phosphodiesterase type-5 inhibitor PDE-5i) with subcutaneous (SC)\u002Fintravenous (IV) treprostinil on top",[13,14],"Drug: Generic treprostinil sodium + Standard of Care (Double Oral)","Drug: Standard of Care - Double Oral",{"label":16,"type":17,"description":18,"interventionNames":19},"• Initial double therapy","ACTIVE_COMPARATOR","double oral (background therapy consisting of 1 endothelin receptor antagonist ERA and 1 phosphodiesterase type-5 inhibitor PDE-5i)",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Generic treprostinil sodium + Standard of Care (Double Oral)","Treprostinil (prostacyclin analogue) solution for continuous subcutaneous (SC) or intravenous (IV) infusion (1 mg\u002Fml; 2.5 mg\u002Fml; 5 mg\u002Fml; 10 mg\u002Fml in 10 mL glass vial) will be administered by an infusion pump system and up-titrated to ≥40 ng\u002Fkg\u002Fmin or to the maximum tolerated dose within 24 weeks. Further up-titration shall be performed until trial completion according to the discretion of the investigator.",[9],[27],"Trisuva, Tresuvi, Treposa, Treprostinil Orpha-Devel, Treprostinil Amomed, Treprostinil OrPha, Treposuvi",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Standard of Care - Double Oral","All patients will receive standard of care double oral background treatment consisting of one Phosphodiesterase type 5 inhibitor (i.e., tadalafil or sildenafil) and one Endothelin Receptor Antagonist (i.e. ambrisentan, bosentan or macitentan)",[9,16],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Clinical Project Manager","CONTACT","+43676 3464650","tripletre@aoporphan.com",[40,60,75,91,105,121,135,151,165,179,195,209,225,240,254,270,285,299,315],{"facility":41,"status":42,"city":43,"state":32,"zip":32,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Ordensklinikum Linz","RECRUITING","Linz","Austria","AT",{"type":47,"coordinates":48},"Point",[49,50],14.28611,48.30639,{"lat":50,"lon":49},[53,58],{"name":54,"role":36,"phone":55,"phoneExt":56,"email":57},"Regina Steringer-Mascherbauer","+437327676","4916","regina.steringer-mascherbauer@ordensklinikum.at",{"name":54,"role":59,"phone":32,"phoneExt":32,"email":32},"PRINCIPAL_INVESTIGATOR",{"facility":61,"status":42,"city":62,"state":32,"zip":32,"country":44,"countryCode":45,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Medical University Vienna","Vienna",{"type":47,"coordinates":64},[65,66],16.37208,48.20849,{"lat":66,"lon":65},[69,74],{"name":70,"role":36,"phone":71,"phoneExt":72,"email":73},"Irene Lang","+43140400","4623","irene.lang@meduniwien.ac.at",{"name":70,"role":59,"phone":32,"phoneExt":32,"email":32},{"facility":76,"status":77,"city":78,"state":32,"zip":32,"country":79,"countryCode":32,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Fakultní Nemocnice Olomouc","NOT_YET_RECRUITING","Olomouc","Czechia",{"type":47,"coordinates":81},[82,83],17.25175,49.59552,{"lat":83,"lon":82},[86,90],{"name":87,"role":36,"phone":88,"phoneExt":32,"email":89},"Jan Přeček","+420588445102","jan.precek@fnol.cz",{"name":87,"role":59,"phone":32,"phoneExt":32,"email":32},{"facility":92,"status":77,"city":93,"state":32,"zip":32,"country":79,"countryCode":32,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Všeobecná fakultní nemocnice v Praze","Prague",{"type":47,"coordinates":95},[96,97],14.42076,50.08804,{"lat":97,"lon":96},[100,104],{"name":101,"role":36,"phone":102,"phoneExt":32,"email":103},"Pavel Jansa","+420224962629","pavel.jansa@vfn.cz",{"name":101,"role":59,"phone":32,"phoneExt":32,"email":32},{"facility":106,"status":77,"city":107,"state":32,"zip":32,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Hôpital Bicêtre-- Assistance Publique Hopitaux de Paris","Paris","France","FR",{"type":47,"coordinates":111},[112,113],2.3488,48.85341,{"lat":113,"lon":112},[116,120],{"name":117,"role":36,"phone":118,"phoneExt":32,"email":119},"Olivier Sitbon","+33145217883","olivier.sitbon@abc.aphp.fr",{"name":117,"role":59,"phone":32,"phoneExt":32,"email":32},{"facility":122,"status":77,"city":123,"state":32,"zip":32,"country":108,"countryCode":109,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Hôpitaux Universitaires de Strasbourg","Strasbourg",{"type":47,"coordinates":125},[126,127],7.74553,48.58392,{"lat":127,"lon":126},[130,134],{"name":131,"role":36,"phone":132,"phoneExt":32,"email":133},"Marianne Riou","+330369550686","marianne.riou@chru-strasbourg.fr",{"name":131,"role":59,"phone":32,"phoneExt":32,"email":32},{"facility":136,"status":77,"city":137,"state":32,"zip":32,"country":138,"countryCode":139,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"DRK Kliniken Berlin Westend","Berlin","Germany","DE",{"type":47,"coordinates":141},[142,143],13.41053,52.52437,{"lat":143,"lon":142},[146,150],{"name":147,"role":36,"phone":148,"phoneExt":32,"email":149},"Christian Opitz","+493030354815","c.opitz@drk-kliniken-berlin.de",{"name":147,"role":59,"phone":32,"phoneExt":32,"email":32},{"facility":152,"status":77,"city":153,"state":32,"zip":32,"country":138,"countryCode":139,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"University Hospital Carl Gustav Carus of Technical University Dresden","Dresden",{"type":47,"coordinates":155},[156,157],13.73832,51.05089,{"lat":157,"lon":156},[160,164],{"name":161,"role":36,"phone":162,"phoneExt":32,"email":163},"Michael Halank","+4935145813981","michael.halank@uniklinikum-dresden.de",{"name":161,"role":59,"phone":32,"phoneExt":32,"email":32},{"facility":166,"status":77,"city":167,"state":32,"zip":32,"country":138,"countryCode":139,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Universitätsmedizin Greifswald","Greifswald",{"type":47,"coordinates":169},[170,171],13.40244,54.08905,{"lat":171,"lon":170},[174,178],{"name":175,"role":36,"phone":176,"phoneExt":32,"email":177},"Ralf Ewert","+4938348680500","ewert@uni-greifswald.de",{"name":175,"role":59,"phone":32,"phoneExt":32,"email":32},{"facility":180,"status":77,"city":181,"state":32,"zip":32,"country":182,"countryCode":183,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"Gottsegen National Cardiovascular lnstitute","Budapest","Hungary","HU",{"type":47,"coordinates":185},[186,187],19.04045,47.49835,{"lat":187,"lon":186},[190,194],{"name":191,"role":36,"phone":192,"phoneExt":32,"email":193},"Olga Hajnalka Balint","+3612152139","titkarsag@kardio.hu",{"name":191,"role":59,"phone":32,"phoneExt":32,"email":32},{"facility":196,"status":77,"city":197,"state":32,"zip":32,"country":182,"countryCode":183,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Medical University of Szeged","Szeged",{"type":47,"coordinates":199},[200,201],20.14824,46.253,{"lat":201,"lon":200},[204,208],{"name":205,"role":36,"phone":206,"phoneExt":32,"email":207},"Gergely Ágoston","+3662545553","agoston.gergely@med.u-szeged.hu",{"name":205,"role":59,"phone":32,"phoneExt":32,"email":32},{"facility":210,"status":42,"city":211,"state":32,"zip":32,"country":212,"countryCode":213,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"Sapienza University of Rome","Rome","Italy","IT",{"type":47,"coordinates":215},[216,217],12.51133,41.89193,{"lat":217,"lon":216},[220,224],{"name":221,"role":36,"phone":222,"phoneExt":32,"email":223},"Roberto Badagliacca","+39064402727","roberto.badagliacca@uniroma1.it",{"name":221,"role":59,"phone":32,"phoneExt":32,"email":32},{"facility":226,"status":77,"city":227,"state":32,"zip":32,"country":228,"countryCode":229,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"John Paul II Hospital Krakow","Krakow","Poland","PL",{"type":47,"coordinates":231},[232,233],19.93658,50.06143,{"lat":233,"lon":232},[236,239],{"name":237,"role":36,"phone":238,"phoneExt":32,"email":32},"Grzegorz Kopeć","+48126143399",{"name":237,"role":59,"phone":32,"phoneExt":32,"email":32},{"facility":241,"status":77,"city":242,"state":32,"zip":32,"country":228,"countryCode":229,"cosmosGeoPoint":243,"geoPoint":247,"contacts":248},"Fryderyk Chopin Hospital in European Health Centre Otwock","Otwock",{"type":47,"coordinates":244},[245,246],21.26129,52.10577,{"lat":246,"lon":245},[249,253],{"name":250,"role":36,"phone":251,"phoneExt":32,"email":252},"Marcin Kurzyna","+48227103052","marcin.kurzyna@ecz-otwock.pl",{"name":250,"role":59,"phone":32,"phoneExt":32,"email":32},{"facility":255,"status":77,"city":256,"state":32,"zip":32,"country":257,"countryCode":258,"cosmosGeoPoint":259,"geoPoint":263,"contacts":264},"Centro Hospitalar Lisboa Norte - Santa Maria University Hospital","Lisbon","Portugal","PT",{"type":47,"coordinates":260},[261,262],-9.1498,38.72509,{"lat":262,"lon":261},[265,269],{"name":266,"role":36,"phone":267,"phoneExt":32,"email":268},"Rui Miguel Freire Plácido","+351217805306","rui.placido@chln.min-saude.pt",{"name":266,"role":59,"phone":32,"phoneExt":32,"email":32},{"facility":271,"status":77,"city":272,"state":32,"zip":32,"country":273,"countryCode":274,"cosmosGeoPoint":275,"geoPoint":279,"contacts":280},"Emergency Institute for Cardiovascular Diseases Prof. Dr. C.C.Iliescu","Bucharest","Romania","RO",{"type":47,"coordinates":276},[277,278],26.10626,44.43225,{"lat":278,"lon":277},[281,284],{"name":282,"role":36,"phone":283,"phoneExt":32,"email":32},"Ioan Mircea Coman","+40213175222",{"name":282,"role":59,"phone":32,"phoneExt":32,"email":32},{"facility":286,"status":77,"city":287,"state":32,"zip":32,"country":273,"countryCode":274,"cosmosGeoPoint":288,"geoPoint":292,"contacts":293},"Emergency Clinical County Hospital of Targu Mures","Târgu Mureş",{"type":47,"coordinates":289},[290,291],24.55747,46.54245,{"lat":291,"lon":290},[294,298],{"name":295,"role":36,"phone":296,"phoneExt":32,"email":297},"Ioan Tilea","+40265215551","ioan.tilea@umfst.ro",{"name":295,"role":59,"phone":32,"phoneExt":32,"email":32},{"facility":300,"status":77,"city":301,"state":32,"zip":32,"country":302,"countryCode":303,"cosmosGeoPoint":304,"geoPoint":308,"contacts":309},"Hospital Clinic of Barcelona","Barcelona","Spain","ES",{"type":47,"coordinates":305},[306,307],2.15899,41.38879,{"lat":307,"lon":306},[310,314],{"name":311,"role":36,"phone":312,"phoneExt":32,"email":313},"Isabel Blanco Vich","+34932275779","iblanco2@clinic.cat",{"name":311,"role":59,"phone":32,"phoneExt":32,"email":32},{"facility":316,"status":77,"city":317,"state":32,"zip":32,"country":302,"countryCode":303,"cosmosGeoPoint":318,"geoPoint":322,"contacts":323},"Hospital Ramon y Cajal","Madrid",{"type":47,"coordinates":319},[320,321],-3.70256,40.4165,{"lat":321,"lon":320},[324,328],{"name":325,"role":36,"phone":326,"phoneExt":32,"email":327},"Jose Andres Tenes Mayen","+34913368263","jtenes@salud.madrid.org",{"name":325,"role":59,"phone":32,"phoneExt":32,"email":32},{"type":330,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[332,335,337,339],{"name":333,"class":334},"ANOVA CRO s.r.o.","UNKNOWN",{"name":336,"class":334},"PharmaLex Belgium",{"name":338,"class":334},"Aixial s.r.o.",{"name":340,"class":6},"GCP-Service International Ltd. & Co. KG","100540512","phase-4-initial-triple-therapy-including-parenteral-treprostinil-vs-initial-double-oral-therapy-in-pah-group-i-patients-100540512",false,"NCT06317805","Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients","Randomized Trial Comparing Efficacy and Safety of Initial Triple Therapy Including Parenteral Treprostinil to Initial Double Oral Therapy in Pulmonary Arterial Hypertension (PAH) Group I Patients (TripleTRE)","TripleTRE","Inclusion Criteria:\n\n* Signed informed consent prior to any trial-mandated procedure\n* Male or female ≥ 18 and ≤ 70 years of age\n* Symptomatic treatment-naïve PAH patients (group I) with confirmed diagnosis of one of the following subgroups:\n\n  * idiopathic pulmonary arterial hypertension (IPAH)\n  * hereditary pulmonary arterial hypertension (HPAH)\n  * Drug and toxin-induced pulmonary arterial hypertension (DPAH)\n  * PAH associated with Connective Tissue Disease\n  * PAH with corrected congenital heart disease 4. Intermediate-high risk patients rated acc. the simplified four-strata risk-assessment tool or intermediate-low risk with severe hemodynamic impairment as defined in current PH guidelines i.e., mean right atrial pressure (RAP) ≥ 20 mmHg, cardiac index (CI) \\\u003C 2.0 L\u002Fmin, stroke volume index (SVI) \\\u003C 31 mL\u002Fm2 and\u002For pulmonary vascular resistance (PVR) ≥ 12 WU\n* Right Heart Catheterization (RHC) meeting all the following criteria:\n\n  * Mean pulmonary arterial pressure (mPAP) \\> 20 mmHg\n  * Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg\n  * PVR \\> 2 Wood Units\n* Women of childbearing potential must not be pregnant or lactating, must perform regular pregnancy tests, if sexually active, agrees to continue to use reliable method(s) of contraception until study completion\n\nExclusion Criteria:\n\n* PAH patients (group I) belonging to one of the following subgroups:\n\n  * Schistosomiasis\n  * HIV infection\n  * Portal hypertension\n  * Diffuse systemic sclerosis\n  * Uncorrected congenital heart disease including uncorrected systemic-to-pulmonary shunts\n* Any PAH-specific drug therapy in the past 3 months\n* Patients responding to vasoreactivity testing with calcium channel blockers (CCB)\n* Post-capillary PH and left heart disease\n* Known or suspected pulmonary veno-occlusive disease (PVOD)\n* Any PH due to lung disease\n* Any disorder of the respiratory system expressed by Diffusing Capacity of Lung for Carbon Monoxide (DLCO) \\\u003C40% and a noticeable imaging result (e.g., CT) and (Total Lung Capacity) TLC \\\u003C60% and (Forced Expiratory Volume) FEV1 \\\u003C70% by plethysmography (a pulmonary function test)\n* Patients with need of ambulatory or long-term oxygen therapy\n* Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) \\> 480 msec at screening\n* Body mass index (BMI) \\> 35 (kg\u002Fm2)\n* Age \\> 70 years\n* History of restrictive, constrictive or congestive cardiomyopathy, atrial septostomy, any symptomatic coronary disease events within 6 months, severe uncontrolled arterial hypertension, acutely decompensated heart failure and myocardial infarction within 30 days, significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease, chronic systemic hypotension, unstable angina pectoris, permanent\u002Fpersistent atrial fibrillation and\u002For need for pacemaker\n* Patients with acute anemia with hemoglobin (Hb) values \\\u003C11g\u002FdL\n* Cerebrovascular accident within 3 months\n* Documented severe hepatic impairment (with or without cirrhosis) according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin \\> 3× upper limit of the normal range (ULN) accompanied by aspartate aminotransferase (AST) \\> ULN and\u002For Child-Pugh Class C\n* Documented renal insufficiency with Glomerular Filtration Rate (GFR) \\\u003C30 ml\u002Fmin\n* Patients with untreated sleep apnea\n* Patient with other cardiovascular, liver, renal, hematologic, gastrointestinal (including active gastrointestinal ulcer), immunologic, endocrine (e.g., uncontrolled diabetes), metabolic, or central nervous system disease and acute bleeding and injuries (e.g., intracranial hemorrhage) that, in the opinion of the investigator, may adversely affect the safety of the patient and \u002For efficacy of the therapy or significantly limit the lifespan (\\\u003C 12 months)\n* Patients with major surgery in the last 12 months\n* Known history of alcohol abuse\n* Treatment of a a cytochrome P450 (CYP)2C8 enzyme inducer (e.g., rifampicin) ≤ 28 days and\u002For treatment of a CYP2C8 enzyme inhibitor (e.g., gemfibrozil) ≤ 28 days\n* Treatment with another investigational drug (planned, or taken ≤ 12 weeks)\n* Hypersensitivity to any of the trial treatments or any excipient of their formulations\n* Pregnancy, breastfeeding, or intention to become pregnant during the trial\n* Any other significant disease or disorder which, in the opinion of the investigator, may put the patients at risk when participating in the trial\n* Any factor or condition likely to affect protocol compliance of the patient, as judged by the investigator.","ALL","18 Years","70 Years",{"count":353,"type":354},110,"ESTIMATED","INTERVENTIONAL",[357],"PHASE4","TripleTRE investigates the effect of initial triple combination therapy (oral endothelin receptor antagonist (ERA) + oral phosphodiesterase tyüe-5 inhibitor (PDE-5i) + parenteral treprostinil) compared to double oral therapy (oral ERA + oral PDE-5i) in pulmonary arterial hypertension (PAH) patients (group I) with intermediate-high risk or patients with intermediate-low risk with severe hemodynamic impairment at baseline in a prospective, randomized, unblinded setting with scope of increasing evidence for optimization of therapy concepts in PAH.\n\nThe effect of initial triple combination therapy vs initial double oral therapy (standard of care (SoC)) will be measured by primary endpoint: (non)response to the assigned treatment.",[360],"Pulmonary Arterial Hypertension",[362,363],"intermediate-high risk","intermediate-low risk with severe hemodynamic impairment","2024-03-12",{"date":366,"type":367},"2024-03-19","ACTUAL",{"date":369,"type":367},"2023-12-06",{"date":371,"type":354},"2027-06-30",{"name":5,"class":6},19]