Clinical trial • Phase III • Cardiology
MACITENTAN for Pulmonary arterial hypertension
Phase III trial of MACITENTAN for Pulmonary arterial hypertension.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Pulmonary arterial hypertension
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 28-06-2024
- First CTIS Authorization Date
- 30-07-2024
Trial design
Randomised, open-label, macitentan 10 mg (opsumit 10 mg film-coated tablets) oral; compared with macitentan 75 mg in a double-dummy randomized design (matching placebos used).-controlled, adaptive Phase III trial across 44 sites in Belgium, France, Poland and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Macitentan 10 mg (Opsumit 10 mg film-coated tablets) oral; compared with macitentan 75 mg in a double-dummy randomized design (matching placebos used).
- Adaptive
- True; study described as group-sequential, adaptive, event-driven — i.e. a group-sequential/event-driven design with interim analyses to allow decision-making based on event accumulation (no further adaptive rules/detail provided in the public summary).
- Target Sample Size
- 790
Eligibility
Recruits 790 Vulnerable-population handling: participants must sign an informed consent form (ICF) or their legally acceptable representative must sign if applicable ("Must sign an ICF (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study."). Separate ICF required for optional biomarker/sample collection; refusal of optional biomarker consent does not exclude participation. Country-specific ICF and language versions provided (multiple country/language-specific consent documents are listed in the trial documents)..
- Pregnancy Exclusion
- A female participant of childbearing potential must have a negative highly sensitive serum (β-human chorionic gonadotropin [β-hCG]) test at Screening and a negative urine pregnancy test prior to receiving their first dose of study intervention (i.e. either at beginning of the run-in period or prior to randomization [see Section 4.1]).
- Vulnerable Population
- Vulnerable-population handling: participants must sign an informed consent form (ICF) or their legally acceptable representative must sign if applicable ("Must sign an ICF (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study."). Separate ICF required for optional biomarker/sample collection; refusal of optional biomarker consent does not exclude participation. Country-specific ICF and language versions provided (multiple country/language-specific consent documents are listed in the trial documents).
Inclusion criteria
- {"criterion_text":"- Target population: ≥ 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age.\n- A female participant of childbearing potential must have a negative highly sensitive serum (β-human chorionic gonadotropin [β-hCG]) test at Screening and a negative urine pregnancy test prior to receiving their first dose of study intervention (i.e. either at beginning of the run-in period or prior to randomization [see Section 4.1]).\n- A female participant must be (as defined in Appendix 6 (Contraceptive and Barrier Guidance and Collection ) a) Not of childbearing potential, b) Of childbearing potential and - Practicing a highly effective, preferably user-independent method of contraception (failure rate of < 1% per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until 30 days after last dose - the end of relevant systemic exposure. Examples of highly effective methods of contraception are located in Appendix 6. (Contraceptive and Barrier Guidance and Collection )\n- Willing and able to adhere to the lifestyle restrictions specified in this protocol.\n- A Belgium-specific inclusion criterion is detailed in Section 10.19 (see Appendix 19: Country/Territory-Specific Requirements).\n- Target population: Symptomatic PAH in WHO FC II, III, or IV.\n- Must sign an ICF (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n- Target population: PAH subtype falling in one of the below classifications: - Idiopathic - Heritable - Drug- or toxin-induced - Related to: *Connective tissue disease, *HIV infection, *Portal hypertension *Congenital heart disease with o small/coincidental cardiac defect with systemic-to-pulmonary shunt (eg, atrial septal defect, ventricular septal defect, patent ductus arteriosus, atrioventricular septal defect) which does not account for the elevated PVR or o persistent PAH documented by an RHC ≥ 1 year after simple systemicto pulmonary shunt repair.\n- PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior to Screening: - Mean pulmonary artery pressure (mPAP) > 20 mm Hg, AND - Pulmonary artery wedge pressure (PAWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mm Hg, AND - PVR ≥ 3 Wood Units (ie, ≥ 240 dyn∙sec∙cm−5).\n- Negative vasoreactivity test in idiopathic, heritable, and drug/toxininduced PAH. Patients for whom no vasoreactivity test was performed at diagnosis and currently treated with PAH therapy for more than 3 months, must have a confirmatory PAH diagnosis documented by hemodynamic evaluation at least 3 months after introduction of their PAH therapy.\n- Able to perform the 6MWT with a minimum distance of 50 m and maximum distance of 440 m at Screening. Patients able to walk more than 440 m at screening are eligible if they are in WHO FC III or IV and NT-proBNP level is ≥ 300 ng/L at screening, based on central laboratory results.\n- Patients already receiving PAH therapies (mono or combination therapies) must be on a stable regimen b for at least 3 months prior to screening visit and planned to be: - If on ERA therapy: discontinued at randomization or start of run-in (ie, last dose of ERA taken the day before initiating study intervention), - If on PAH therapy other than ERA: maintained on top of the study intervention.\n- Must sign a separate informed consent form (or their legallyacceptable representative must sign) if he or she agrees to provide optional samples for biomarker research (where local regulations permit). Refusal to give consent for the optional biomarker research samples does not exclude a participant from participation in the study."}
Exclusion criteria
- {"criterion_text":"- Treatment with a strong CYP3A4 inducer (eg, rifabutin, rifampin, rifampicin, rifapentin, carbamazepine, phenobarbital, phenytoin, St. John's Wort) within 1 month prior to randomization or start of run-in, if applicable.\n- Treatment with a strong CYP3A4 inhibitor or a moderate dual CYP3A4/CYP2C9 inhibitor, or co-administration of a combination of moderate CYP3A4 and moderate CYP2C9 inhibitors in the 1-month period prior to randomization, or start of run-in, if applicable. External use (cream, shampoo, etc) per approved label is permitted.\n- Known moderate to severe hepatic impairment, defined as Child- Pugh Class B or C (see Appendix 5), based on records that confirm documented medical history.\n- Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)> 1.5 X upper limit of normal (ULN) at Screening.\n- Hemoglobin < 100 g/L (< 10 g/dL) at Screening.\n- Severe renal impairment as defined with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 (Chronic Kidney Disease Epidemiology Collaboration [CKD EPI] 2009 equation) at screening\n- Systemic hypotension (systolic blood pressure [SBP] < 90 or diastolic blood pressure [DBP] < 50 mm Hg) at Screening.\n- For selected sites taking part to the cardiac MRI sub-study only: participants must not be considered for this sub-study in case of MRIincompatible permanent cardiac pacemaker, automatic internal cardioverter, metallic implant (eg, defibrillator, neurostimulator, hearing aid, permanent use of infusion device), multiple premature ventricular or atrial contractions, or any other condition that may confound cardiac MRI assessment or for which, in the opinion of the investigator, participation would not be in the best interests of the participant (eg, compromise well-being).\n- For participants involved in the cardiac remodeling and/or hemodynamic substudies only: Diuretic treatment initiated or dose changed within 1 week prior to the MRI or RHC assessment.\n- Known presence of three or more of the following risk factors for heart failure with preserved ejection fraction at Screening, based on records that confirm documented medical history: - Body mass index (BMI) > 30 kg/m2, - Diabetes mellitus of any type, - Essential hypertension (even if well controlled), - Coronary artery disease, ie, any of the following: *History of stable angina, or *Known more than 50% stenosis in a coronary artery, or *History of myocardial infarction, or *History of or planned coronary artery bypass grafting and/or coronary artery stenting.\n- Presence of moderate or severe obstructive lung disease (forced expiratory volume in 1 second [FEV1] / forced vital capacity [FVC] < 70%; and FEV1 < 60% of predicted after bronchodilator administration) in participants with a known or suspected history of significant lung disease, as documented by a spirometry test performed within 1 year prior to Screening.\n- Presence of moderate or severe restrictive lung disease (eg, total lung capacity [TLC] or FVC < 60% of normal predicted value) in participants with a known or suspected history of significant lung disease, as documented by a spirometry test performed within 1 year prior to Screening.\n- Significant unrepaired structural left heart valvular disease (ie, moderate or severe aortic or mitral stenosis or regurgitation); pericardial constriction; restrictive or congestive left-sided cardiomyopathy; life-threatening cardiac arrhythmias; significant left ventricular dysfunction; or left ventricular outflow obstruction.\n- Permanent atrial fibrillation or atrial flutter, in the opinion of the investigator.\n- Known or suspected pulmonary veno-occlusive disease (PVOD)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Time to first CEC-adjudicated M/M event on-treatment (ie, up to 7 days after the last dose of double-blind (DB) study intervention)","definition_or_measurement_approach":"Time-to-event measure: time from randomization (or start of on-treatment period) to the first morbidity or mortality (M/M) event adjudicated by the Clinical Events Committee (CEC) while on-treatment; events counted up to 7 days after the last dose of the double-blind study intervention."}
Recruitment
- Planned Sample Size
- 790
- Recruitment Window Months
- 109
- Consent Approach
- Participants (≥18 years) must provide written informed consent; if unable to consent a legally acceptable representative may sign ("Must sign an ICF (or their legally acceptable representative must sign)"). Separate informed consent is required for optional biomarker/sample collection and for optional substudies; refusal to consent to optional samples does not exclude participation. Country/language-specific subject information sheets and ICFs are provided (multiple translated ICFs and country addenda listed in the trial documents).
Geography
- Total Number Of Sites
- 44
- Total Number Of Participants
- 110
Belgium
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 663
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- UZ Leuven
- Department Name
- Pneumology
- Principal Investigator Name
- Marion Delcroix
- Principal Investigator Email
- marion.delcroix@uzleuven.be
- Contact Person Name
- Marion Delcroix
- Contact Person Email
- marion.delcroix@uzleuven.be
France
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 664
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pneumology Department
- Principal Investigator Name
- Olivier SITBON
- Principal Investigator Email
- olivier.sitbon@u-psud.fr
- Contact Person Name
- Olivier SITBON
- Contact Person Email
- olivier.sitbon@u-psud.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Vascular Medecine Department
- Principal Investigator Name
- Laurent BERTOLETTI
- Principal Investigator Email
- laurent.bertoletti@chu-st-etienne.fr
- Contact Person Name
- Laurent BERTOLETTI
- Contact Person Email
- laurent.bertoletti@chu-st-etienne.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Pneumology Department
- Principal Investigator Name
- Grégoire PREVOT
- Principal Investigator Email
- prevot.g@chu-toulouse.fr
- Contact Person Name
- Grégoire PREVOT
- Contact Person Email
- prevot.g@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Cardiology Department
- Principal Investigator Name
- Delphine BAUDOUY
- Principal Investigator Email
- baudouy.d@chu-nice.fr
- Contact Person Name
- Delphine BAUDOUY
- Contact Person Email
- baudouy.d@chu-nice.fr
Poland
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 660
- Number Of Sites
- 6
- Number Of Participants
- 16
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny W Bialymstoku
- Department Name
- Klinika Kardiologii z Oddzialem Intensywnego Nadzoru Kardiologicznego
- Principal Investigator Name
- Karol Kamiński
- Principal Investigator Email
- kardio@uskwb.pl
- Contact Person Name
- Karol Kamiński
- Contact Person Email
- kardio@uskwb.pl
- Site Name
- Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
- Department Name
- I Katedra i Klinika Kardiologii SUM I Oddział Kardiologii
- Principal Investigator Name
- Katarzyna Mizia-Stec
- Principal Investigator Email
- badania.gcm@gmail.com
- Contact Person Name
- Katarzyna Mizia-Stec
- Contact Person Email
- badania.gcm@gmail.com
- Site Name
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
- Department Name
- Klinika Kardiologii Inwazyjnej
- Principal Investigator Name
- Agnieszka Pawlak
- Principal Investigator Email
- kardiologia@cskmswia.gov.pl
- Contact Person Name
- Agnieszka Pawlak
- Contact Person Email
- kardiologia@cskmswia.gov.pl
- Site Name
- Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
- Department Name
- Oddzial Kliniczny Chorob Serca i Naczyn z Pododdziałem Intensywnego Nadzoru Kardiologicznego
- Principal Investigator Name
- Grzegorz Kopeć
- Principal Investigator Email
- sekr_kard@szpitaljp2.krakow.pl
- Contact Person Name
- Grzegorz Kopeć
- Contact Person Email
- sekr_kard@szpitaljp2.krakow.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie
- Department Name
- Klinika Kardiologii z Intensywnym Nadzorem Kardiologicznym
- Principal Investigator Name
- Małgorzata Peregud-Pogorzelska
- Principal Investigator Email
- kardiologia@spsk2-szczecin.pl
- Contact Person Name
- Małgorzata Peregud-Pogorzelska
- Contact Person Email
- kardiologia@spsk2-szczecin.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- I Klinik Kardiologii Oddzial Intensywnej Terapii Kardiologicznej
- Principal Investigator Name
- Wiesław Puchalski
- Principal Investigator Email
- puchalski@uck.gda.pl
- Contact Person Name
- Wiesław Puchalski
- Contact Person Email
- puchalski@uck.gda.pl
Germany
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 660
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- Klinik und Poliklinik für Innere Medizin II
- Principal Investigator Name
- Stefan Stadler
- Principal Investigator Email
- Stefan.Stadler@klinik.uni-regensburg.de
- Contact Person Name
- Stefan Stadler
- Contact Person Email
- Stefan.Stadler@klinik.uni-regensburg.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Abt. für Pulmonologie
- Principal Investigator Name
- Karen Olsson
- Principal Investigator Email
- Olsson.karen@mh-hannover.de
- Contact Person Name
- Karen Olsson
- Contact Person Email
- Olsson.karen@mh-hannover.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Medizinische Klinik und Poliklinik V (Pneumologie)
- Principal Investigator Name
- Katrin Milger-Kneidinger
- Principal Investigator Email
- Katrin.Milger@med.uni-muenchen.de
- Contact Person Name
- Katrin Milger-Kneidinger
- Contact Person Email
- Katrin.Milger@med.uni-muenchen.de
Denmark
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 07-05-2026
- Processing Time Days
- 659
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Aarhus Universitetshospital
- Department Name
- Afdeling B for Hjertesygdomme
- Principal Investigator Name
- Soren Mellemkjaer
- Principal Investigator Email
- Soren.Mellemkjaer@rm.dk
- Contact Person Name
- Soren Mellemkjaer
- Contact Person Email
- Soren.Mellemkjaer@rm.dk
Czechia
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 663
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- 2. interni klinika
- Principal Investigator Name
- Pavel Jansa
- Principal Investigator Email
- pavel.jansa@vfn.cz
- Contact Person Name
- Pavel Jansa
- Contact Person Email
- pavel.jansa@vfn.cz
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 663
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- University Hospital St. Anna
- Department Name
- Clinic of cardiology
- Principal Investigator Name
- Sarkis Kalustian
- Principal Investigator Email
- d_rkalustian@abv.bg
- Contact Person Name
- Sarkis Kalustian
- Contact Person Email
- d_rkalustian@abv.bg
- Site Name
- MHAT National Heart Hospital EAD
- Department Name
- Clinic of cardiology
- Principal Investigator Name
- Danail Avramov
- Principal Investigator Email
- dungobest@hotmail.com
- Contact Person Name
- Danail Avramov
- Contact Person Email
- dungobest@hotmail.com
Austria
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 663
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- University Hospital Graz
- Department Name
- Universitätsklinik für Innere Medizin, klinische Abteilung für Pulmonologie
- Principal Investigator Name
- Gabor Kovacs
- Principal Investigator Email
- gabor.kovacs@uniklinikum.kages.at
- Contact Person Name
- Gabor Kovacs
- Contact Person Email
- gabor.kovacs@uniklinikum.kages.at
- Site Name
- Medical University Of Vienna
- Department Name
- Universitätsklinik für Innere Medizin II, Klinische Abteilung für Kardiologie
- Principal Investigator Name
- Irene Marthe Lang
- Principal Investigator Email
- irene.lang@meduniwien.ac.at
- Contact Person Name
- Irene Marthe Lang
- Contact Person Email
- irene.lang@meduniwien.ac.at
- Site Name
- Ordensklinikum Linz GmbH
- Principal Investigator Name
- Regina Steringer-Mascherbauer
- Principal Investigator Email
- regina.steringer-mascherbauer@ordensklinikum.at
- Contact Person Name
- Regina Steringer-Mascherbauer
- Contact Person Email
- regina.steringer-mascherbauer@ordensklinikum.at
Greece
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 07-05-2026
- Processing Time Days
- 659
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Alexandra Hospital
- Department Name
- Heart Failure and Cardio-oncology Clinic/ Therapeutic Clinic
- Principal Investigator Name
- Alexandros Briasoulis
- Principal Investigator Email
- abriasoulis@med.uoa.gr
- Contact Person Name
- Alexandros Briasoulis
- Contact Person Email
- abriasoulis@med.uoa.gr
- Site Name
- University General Hospital Of Thessaloniki Ahepa
- Department Name
- Cardiology Clinic, Congenital Heart diseases and Pulmonary Arterial Hypertension
- Principal Investigator Name
- Georgios Giannakoulas
- Principal Investigator Email
- g.giannakoulas@gmail.com
- Contact Person Name
- Georgios Giannakoulas
- Contact Person Email
- g.giannakoulas@gmail.com
- Site Name
- General University Hospital Of Larissa
- Department Name
- University Cardiology Clinic
- Principal Investigator Name
- Ioannnis Skoularingis
- Principal Investigator Email
- iskoular@med.uth.gr
- Contact Person Name
- Ioannnis Skoularingis
- Contact Person Email
- iskoular@med.uth.gr
Sweden
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 07-05-2026
- Processing Time Days
- 659
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Kardiologens forskningsenhet
- Principal Investigator Name
- Sven-Erik Bartfay
- Principal Investigator Email
- sven-erik.bartfay@vgregion.se
- Contact Person Name
- Sven-Erik Bartfay
- Contact Person Email
- sven-erik.bartfay@vgregion.se
Portugal
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 663
- Number Of Sites
- 2
- Number Of Participants
- 15
Sites
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- Departamento de Coracao e Vasos
- Principal Investigator Name
- Rui Plácido
- Principal Investigator Email
- 20808@chln.min-saude.pt
- Contact Person Name
- Rui Plácido
- Contact Person Email
- 20808@chln.min-saude.pt
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- Serviço de Cardiologia - Departamento Coracao e Vasos
- Principal Investigator Name
- Maria da Graca Castro
- Principal Investigator Email
- castro2406@gmail.com
- Contact Person Name
- Maria da Graca Castro
- Contact Person Email
- castro2406@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 660
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- U.O. Cardiologia
- Principal Investigator Name
- Stefano Ghio
- Principal Investigator Email
- s.ghio@smatteo.pv.it
- Contact Person Name
- Stefano Ghio
- Contact Person Email
- s.ghio@smatteo.pv.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- U.O.C. Pneumologia
- Principal Investigator Name
- Fabiana Baldi
- Principal Investigator Email
- fabiana.baldi@policlinicogemelli.it
- Contact Person Name
- Fabiana Baldi
- Contact Person Email
- fabiana.baldi@policlinicogemelli.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Cardiologia 2 - Insufficienza Cardiaca e Trapianti
- Principal Investigator Name
- Andrea Garascia
- Principal Investigator Email
- andrea.garascia@ospedaleniguarda.it
- Contact Person Name
- Andrea Garascia
- Contact Person Email
- andrea.garascia@ospedaleniguarda.it
- Site Name
- Fondazione Toscana Gabriele Monasterio
- Department Name
- Dipartimento Cardiotoracico U.O.S.V.D. Pneumologia
- Principal Investigator Name
- Edoardo Airò
- Principal Investigator Email
- edoardo.airo@ftgm.it
- Contact Person Name
- Edoardo Airò
- Contact Person Email
- edoardo.airo@ftgm.it
Spain
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 663
- Number Of Sites
- 5
- Number Of Participants
- 12
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Cardiology
- Principal Investigator Name
- Pilar Escribano
- Principal Investigator Email
- hipertensionpulmonar.hdoc@salud.madrid.org
- Contact Person Name
- Pilar Escribano
- Contact Person Email
- hipertensionpulmonar.hdoc@salud.madrid.org
- Site Name
- Hospital Costa Del Sol
- Department Name
- Cardiology
- Principal Investigator Name
- Rafael Bravo Marques
- Principal Investigator Email
- rafael.bravo.sspa@juntadeandalucia.es
- Contact Person Name
- Rafael Bravo Marques
- Contact Person Email
- rafael.bravo.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Cardiology
- Principal Investigator Name
- Javier Segovia Cubero
- Principal Investigator Email
- jsecu@telefonica.net
- Contact Person Name
- Javier Segovia Cubero
- Contact Person Email
- jsecu@telefonica.net
- Site Name
- Hospital Universitario La Paz
- Department Name
- Pneumology
- Principal Investigator Name
- Sergio Alcolea
- Principal Investigator Email
- alcobatres@yahoo.es
- Contact Person Name
- Sergio Alcolea
- Contact Person Email
- alcobatres@yahoo.es
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Pneumology
- Principal Investigator Name
- Sergio Cadenas
- Principal Investigator Email
- sercam.2007@gmail.com
- Contact Person Name
- Sergio Cadenas
- Contact Person Email
- sercam.2007@gmail.com
Hungary
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 663
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- University Of Pecs
- Principal Investigator Name
- Réka Faludi
- Principal Investigator Email
- faludi.reka@pte.hu
- Contact Person Name
- Réka Faludi
- Contact Person Email
- faludi.reka@pte.hu
- Site Name
- Clinic Of Pulmonology Semmelweis University
- Principal Investigator Name
- Kristóf Karlócai
- Principal Investigator Email
- kristof@karlocai.hu
- Contact Person Name
- Kristóf Karlócai
- Contact Person Email
- kristof@karlocai.hu
- Site Name
- University Of Szeged
- Principal Investigator Name
- Albert Varga
- Principal Investigator Email
- varga.albert@med.u-szeged.hu
- Contact Person Name
- Albert Varga
- Contact Person Email
- varga.albert@med.u-szeged.hu
Netherlands
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 07-05-2026
- Processing Time Days
- 659
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Sint Antonius Ziekenhuis Stichting
- Department Name
- Cardiology
- Principal Investigator Name
- Marco Post
- Principal Investigator Email
- m.post@antoniusziekenhuis.nl
- Contact Person Name
- Marco Post
- Contact Person Email
- m.post@antoniusziekenhuis.nl
- Site Name
- Stichting Amsterdam UMC
- Department Name
- Pneumology
- Principal Investigator Name
- Harm Jan Bogaard
- Principal Investigator Email
- hj.bogaard@amsterdamumc.nl
- Contact Person Name
- Harm Jan Bogaard
- Contact Person Email
- hj.bogaard@amsterdamumc.nl
- Site Name
- Stichting Radboud universitair medisch centrum
- Department Name
- Cardiology
- Principal Investigator Name
- Arie van Dijk
- Principal Investigator Email
- Arie.vanDijk@radboudumc.nl
- Contact Person Name
- Arie van Dijk
- Contact Person Email
- Arie.vanDijk@radboudumc.nl
Slovakia
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 658
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Národny ustav srdcovych a cievnych chorob a.s.
- Department Name
- Oddelenie zlyhávania a transplantácie
- Principal Investigator Name
- Eva Goncalvesová
- Principal Investigator Email
- EVA.GONCALVESOVA@nusch.sk
- Contact Person Name
- Eva Goncalvesová
- Contact Person Email
- EVA.GONCALVESOVA@nusch.sk
- Site Name
- Vychodoslovensky Ustav Srdcovych A Cievnych Chorob a.s.
- Department Name
- Oddelenie kardiológie
- Principal Investigator Name
- Bibiana Kafková
- Principal Investigator Email
- bibakafkova@gmail.com
- Contact Person Name
- Bibiana Kafková
- Contact Person Email
- bibakafkova@gmail.com
Sponsor
Primary sponsor
- Full Name
- Actelion Pharmaceuticals Ltd.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Iqvia Inc.
- Responsibilities
- Country & Site Management
- Name
- Perceptive Informatics Inc.
- Responsibilities
- cMRI Central reading
- Name
- Pharmaceutical Research Associates Group B.V.
- Responsibilities
- PK analysis, ET-1
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- Central laboratory services: Glomerular Filtration Rate, NT-proBNP
- Name
- Eresearchtechnology Inc.
- Responsibilities
- central ECG reading, ePRO
- Name
- WCG Clinical Inc.
- Responsibilities
- Central Adjudication of Event
Third parties
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"cMRI Central reading","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Country & Site Management","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"central ECG reading, ePRO","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"IVRS – treatment randomisation","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Frontier Science & Technology Research Foundation Inc.","duties_or_roles":"interaction with IDMC","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Glomerular Filtration Rate, NT-proBNP","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"Biostorage service for optional biomarker research","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Central Adjudication of Event","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Pharmaceutical Research Associates Group B.V.","duties_or_roles":"PK analysis, ET-1","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- JNJ 67896062 (macitentan 75 mg film-coated tablet)
- Active Substance
- MACITENTAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Dose Levels
- 75 mg
- Maximum Dose
- 75 mg
- Investigational Product Name
- JNJ 67896062 (macitentan 37 mg film-coated tablet)
- Active Substance
- MACITENTAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Dose Levels
- 37 mg
- Maximum Dose
- 37 mg
- Investigational Product Name
- Opsumit 10 mg film-coated tablets
- Active Substance
- MACITENTAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Marketing authorisation EU/1/13/893/001
- Orphan Designation
- Yes
- Starting Dose
- 10 mg
- Dose Levels
- 10 mg
- Maximum Dose
- 10 mg
- Investigational Product Name
- Matching Placebo for Macitentan 75 mg
- Modality
- Other
- Investigational Product Name
- Matching Placebo for Macitentan 37.5 mg
- Modality
- Other
- Investigational Product Name
- Matching Placebo for Macitentan 10 mg
- Modality
- Other
- Combination Treatment
- Yes
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