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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03683186
Other study ID # ROR-PH-303
Secondary ID APD811-303
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date September 23, 2019
Est. completion date September 2024

Study information

Verified date May 2024
Source United Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.


Description:

Study ROR-PH-303 is a multicenter, open-label extension (OLE) study for subjects with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag and who qualify for entry based upon participation in the prior study. Subjects who discontinue participation in a prior study due to safety issues related to study medication or who fail to complete study procedures will not be eligible to enter Study ROR-PH-303. Subjects who meet all OLE entry criteria will be enrolled and will receive ralinepag in addition to their pre-existing PAH disease-specific background therapy. For subjects who are enrolled from an ongoing double-blind Phase 2 or Phase 3 ralinepag study, a 16-week blinded Dose Titration Period will be completed following enrollment into the OLE. Subjects previously on ralinepag will continue on the same dose during the Dose Titration Period as received in the original study and will also initiate placebo treatment in the OLE. Subjects who are enrolled from a non-blinded study or another OLE will not participate in the blinded Dose Titration Period in Study ROR-PH-303 but will be enrolled directly into the Treatment Period and continue on the dose of ralinepag received in the original study. All subjects will receive ralinepag in the OLE study until premature discontinuation of ralinepag due to an AE/serious adverse event (SAE) or other reason, marketing approval of ralinepag is granted in the region in which the study is conducted, or the study is discontinued by the Sponsor.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1000
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures. 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Completed the protocol-defined Study Drug Termination Visit or End of Study Visit procedures in the preceding ralinepag study. 4. Both male and female subjects agree to use a medically acceptable method of contraception throughout the entire study period from informed consent through the 30 day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process (i.e., actively attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 30 days after the last dose of ralinepag. Exclusion Criteria: 1. Subjects who prematurely discontinued investigational medicinal product (IMP) due to a drug-related AE/SAE or tolerability issue in the preceding ralinepag study in which they were enrolled, or subjects who did not complete all protocol defined study procedures at a Study Drug Termination Visit or End of Study Visit in the preceding ralinepag study. 2. Subjects who withdrew consent during participation in another ralinepag study. 3. Female subjects who wish to become pregnant or who have a positive pregnancy test on Day 1 (OLE Entry Visit), or are lactating or breastfeeding. 4. Subjects who have undergone lung or heart/lung transplant or the initiation of long-term parenteral or inhaled therapy with a prostacyclin during the time since participation in their original ralinepag study. 5. Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3 study.

Study Design


Intervention

Drug:
Ralinepag
Active

Locations

Country Name City State
Argentina Sanatorio de la Trinidad Mitre Buenos Aires
Argentina Cardiologia Palmero Caba
Argentina Fundacion Favaloro Ciudad Autonoma Buenos Aires
Argentina Fundacion Respirar Ciudad Autonoma Buenos Aires
Argentina Hospital Britanico de Buenos Aires Ciudad Autonoma Buenos Aires
Argentina Hospital Italiano Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina Hospital Privado Centro Medico de Cordoba S.A Cordoba
Argentina Hospital Italiano de Cordoba Córdoba
Argentina Instituto de Cardiologia de Corrientes Corrientes
Argentina Instituto de Investigaciones Clinicas Mar Del Plata
Argentina Sanatorio Parque S.A. Rosario Santa Fe
Argentina Hospital PROVINCIAL "Dr. Jose Maria Cullen" Santa Fe Santa Fe De La Vera Cruz
Australia Royal Prince Alfred Hospital Camperdown New South Wales
Australia The Prince Charles Hospital Chermside Queensland
Australia St Vincent's Hospital Sydney Darlinghurst New South Wales
Australia St Vincent's Hospital Melbourne Fitzroy Victoria
Australia Royal Hobart Hospital Hobart Tasmania
Australia The Alfred Hospital Melbourne Victoria
Australia Fiona Stanley Hospital Perth Western Australia
Australia Macquarie University Sydney New South Wales
Australia Nepean Hospital Sydney New South Wales
Australia Westmead Hospital Sydney New South Wales
Australia Princess Alexandra Hospital Woolloongabba Queensland
Austria Medizinische Universität Innsbruck Innsbruck
Austria Ordensklinikum Linz GmbH - Elisabethinen, Fadingerstrasse 1 Linz
Austria AKH Wien, Innere Med. II, Kardiologie, Währingergürtel 18-20 Wien
Belgium Cliniques Universitaires de Bruxelles Hopital Erasme Bruxelles
Belgium UZ Leuven, UZ Leuven Campus Gasthuisberg, Herestraat 49 Leuven
Brazil Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa Belo Horizonte MG
Brazil UNESP-Faculdade de Medicina da Universidade Estadual Paulista Campus Botucatu Botucatu Sao Paulo
Brazil HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás Goiânia Goias
Brazil Hospital Sao Lucas da PUC-RS Porto Alegre R.S
Brazil Irmandade da Santa Casa de Misericórdia de Porto Alegre Porto Alegre RS
Brazil Hospital Sao Paulo Sao Paulo SP
Brazil Instituto do Coracao Sao Paulo SP
Bulgaria MHAT "Sveta Anna" Sofia AD Sofia
Bulgaria MHAT - "National Heart Hospital" EAD, 65, Konyovitza Str. Sofia
Canada Peter Lougheed Centre Calgary Alberta
Canada University of Alberta Hospital Edmonton Alberta
Canada LHSC - Victoria Hospital London Ontario
Canada SMBD Jewish General Hospital d/b/a Jewish General Hospital Montreal Quebec
Canada Institut Universitaire de Cardiologie et de Pneumologie de Quebec Québec Quebec
Canada University Health Network-Toronto General Hospital Toronto Ontario
Chile Instiuto Nacional del Torax Providencia Santiago De Chile
China Beijing Shijitan Hospital, Capital Medical University Beijing Beijing
China Fuwai Hospital, Chinese Academy of Medical Sciences Beijing
China Xiangya Hospital Central South University Changsha Hunan
China Guangdong Provincial People's Hospital Guangzhou Guangdong
China Shanghai Pulmonary Hospital Shanghai Shanghai
Croatia Clinical Hospital Dubrava Zagreb, Avenija G.Šuška 6 Zagreb
Croatia University Clinic for Pulmonary Diseases, Jordanovac 104 Zagreb
Czechia Vseobecna fakultni nemocnice v Praze, II. interni klinika kardiologie a angiologie VFN a 1. LF UK, U nemocnice 2 Praha 2
Denmark Århus Universitetshospital Århus
Denmark Copenhagen University Hospital (Rigshospitalet) Copenhagen
France CHU Besançon - Hôpital Jean Minjoz Besançon Cedex
France CHU de Brest - Hôpital de la Cavale Blanche Brest cedex 2
France CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel, Service de Pneumologie, 59 Boulevard Pinel Bron cedex Rhone
France CHU de Grenoble - Hôpital Albert Michallon, Clinique de Cardiologie, Boulevrad de la Chantourne Grenoble Isere
France Groupement Hospitalier Sud - Hôpital Bicêtre, Service de Pneumologie, 78 Avenue du General Leclerc Le Kremlin-Bicêtre Val De Marne
France CHRU de Lille - Hopital Cardiologique Lille Cedex
France Hôpital Nord - CHU Marseille Marseille
France CHU de Rouen - Hôpital Charles Nicolle Rouen cedex Seine Maritime
France CHU de Saint-Etienne - Hopital Nord, Service de Medecine vasculaire et therapeutique, 81 Avenue A. Raimond Saint-Étienne Loire
France CHU de Strasbourg - Nouvel Hôpital Civil, Ctre de competence Hypertension Arterielle Pulmona, 1 place de l Hopital Strasbourg Bas Rhin
France CHU Nancy - Hôpital de Brabois Adultes, Pneumologie- Oncologie Médicale, Rue du Morvan Vandoeuvre les Nancy Meurthe Et Moselle
Germany Schwarzwald-Baar Klinikum Donaueschingen
Germany Universitaetsklinikum Carl Gustav Carus TU Dresden Dresden
Germany Universitätsmedizin Greifswald Greifswald Mecklenburg-Vorpommern
Germany Universitaetsklinikum Hamburg-Eppendorf Hamburg
Germany Thoraxklinik-Heidelberg Zentrum für Pulmonale Hypertonie Heidelberg Baden-Württemberg
Germany Universitaetsklinikum des Saarlandes, Innere Medizin V, IMED, Kirrberger Strasse 100, Gebäude 41 Homburg Saarland
Germany Universitätsklinikum Leipzig, Medizinische Klinik II, Pneumologie Leipzig Sachsen
Germany Universitaetsmedizin der Johannes-Gutenberg-Universitaet Mainz, Zentrum für Kardiologie I, Centrum für Thrombose und Hämostase (CTH), Langenbeckstrasse 1 Mainz Rheinland Pfalz
Greece University General Hospital of Alexandroupolis Alexandroupolis
Greece "Onasseio" Cardiosurgery Hospital, Hemodynamic Research and Interventional Cardiology Dept., 356, Syggrou Avenue Athens
Greece University General Hospital Attikon Chaidari
Greece AHEPA General Hospital of Thessaloniki, A' Cardiology Clinic, 1 St. Kyriakidi Street Thessaloniki
Hungary Gottsegen György Országos Kardiovaszkuláris Intézet Budapest
Hungary Pecsi Tudomanyegyetem, Szivgyogyaszati Klinika, Ifjusag u. 13. Pecs
Israel The Lady Davis Carmel Medical Center, 7 Michal st. Haifa
Israel Hadassah Ein Kerem Medical Center, Kiryat Hadassah Jerusalem
Israel Meir Medical Center, 59 Tshernichovski st. Kfar- Sava
Israel Rabin Medical Center-Beilinson Campus, Pulmonary Institute, 39 Jabotinsky St Ground floor Petach Tikva
Israel Tel Aviv Sourasky Medical Center, 6 Weizmann St. Tel Aviv
Italy Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, S.C. di Cardiologia, Viale Luigi Pinto, 1 Foggia
Italy IRCC Ospedale Policlinico San Martino Genova
Italy Centro Cardiologico Monzino, IRCCS U.O. Scompenso Milan
Italy Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35 Milano
Italy Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo) Monza
Italy Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT) Palermo PA
Italy Fondazione IRCCS Policlinico San Matteo Pavia
Italy Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, Viale del Policlinico, 155 Roma
Korea, Republic of Gachon University Hospital Gil Medical Center Incheon Namdong-gu
Korea, Republic of Samsung Medical Center Seoul Gangnam-gu
Korea, Republic of Seoul National University Hospital Seoul Jongno-gu
Mexico CICUM San Miguel Guadalajara Jalisco
Mexico Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera Mexico Distrito Federal
Mexico Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran Mexico Distrito Federal
Mexico Unidad de Investigacion Clinica en Medicina, S.C. Monterrey N.l.
Netherlands VU Medisch Centrum, De Boelelaan 1117 Amsterdam
Poland Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Kardiologii z Oddzialem Intensywnego Nazdoru Kardiologicznego, M. Sklodowskiej 24a Bialystok
Poland Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddzial Kliniczny Chorób Serca i Naczyn z Pododdzialem Intensywnego Nadzoru Kardiologicznego, Pradnicka 80 Krakow
Poland NZOZ Europejskie Centrum Zdrowia, ul. Borowa 14/18 Otwock
Poland Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Oddzial Kardiologii - F, ul. Dluga 1/2 Poznan
Poland Premium Clinic Wroclaw CM, Podwale 83/17 Wroclaw
Portugal Hospital Garcia de Orta, E.P.E Almada
Portugal Centro Hospitalar e Universitário de Coimbra, E.P.E. Coimbra
Portugal Centro Hospitalar Universitário Lisboa Norte, E.P.E. Hospital Pulido Valente Lisboa
Portugal Centro Hospitalar de Santo António, E.P.E. Porto
Romania Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Sos. Fundeni nr. 258 Bucharest
Romania Institutul de Pneumoftiziologie "Marius Nasta", Sos. Viilor nr. 90, Sector 5 Bucuresti
Romania Institutul Inimii "Niculae Stancioiu" Cluj-Napoca, Cardiologie, Str. Motilor nr. 19-21 Cluj-Napoca
Romania Spitalul Clinic de Boli Infectioase si Pneumoftiziologie "Dr. Victor Babes" Timisoara, Str. Gheorghe Adam nr. 13 Timisoara
Serbia Clinical Center of Serbia, Koste Todorovica 8 Belgrade
Serbia Clinical Center Zemun. Clinic for internal medicine, Department of Cardiology Belgrade
Serbia Institute for Pulmonary Diseases of Vojvodina, Put Dr Goldmana 4 Sremska Kamenica
Singapore National Heart Centre Singapore
Singapore National University Hospital Singapore
Spain Hospital Clinic de Barcelona, C/ Villarroel, 170 Barcelona
Spain Hospital Universitari Vall d'Hebron, Respiratory Dept., Passeig Vall d'Hebron,119-129, Neumologia Barcelona
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitari i Politecnic La Fe Valencia
Sweden Sahlgrenska Universitetssjukhuset Göteborg
Sweden Linköping Universitetssjukhuset Linköping
Sweden Norrlands Universitetssjukhus, Hjärtcentrum Umeå
Taiwan National Cheng Kung University Hospital Tainan
Taiwan National Taiwan University Hospital Taipei
Turkey Balcali, Çukurova Üniversitesi Kardiyoloji ABD Adana Saricam
Turkey Gazi University Medical Faculty Hospital Ankara
Turkey Uludag Universitesi Tip Fakültesi, Gorukle Kampusu Bursa
Turkey Osmangazi Uni Medical Faculty Eskisehir Odumpazari
Turkey Marmara Universitesi Istanbul Pendik Egitim ve Arastirma Hastanesi, Fevzi Cakmak Mahallesi Muhsin Yazicioglu Cad. No: 10 Istanbul
Turkey Dokuz Eylul Universitesi Tip Fakultesi, Mithatpasa caddesi Inciralti Balcova Izmir
Turkey Mersin Üniversitesi Tip Fakültesi Ciftlikköy Kampüsü Mersin Yenisehir
Ukraine CE Dniprop RCC&C Center of Dniprop RC Dept of Card SI DMA of MOHU, Chair of Internal Medicine 3, 28, Knyazya Volodymyra Velykogo St. Dnipro
Ukraine SI F.H.Yanovskyi National Institute of Phthisiology and Pulmonology of NAMSU, Clinical and Functional Dept, 10, Amosova St. Kyiv
Ukraine Communal Noncommercial Enterprise of Lviv Regional Council Lviv Clinical Hospital, Dept of Cardiology, D.Halytskyi Lviv NMU, Ch of Internal Medicine #1, 7, Chernihivska str. Lviv
United Kingdom Golden Jubilee National Hospital Glasgow West Dunbartonshire
United Kingdom Hammersmith Hospital London
United Kingdom Royal Brompton Hospital London Greater London
United Kingdom Royal Free London NHS Foundation Trust, Pond Street London Greater London
United Kingdom The Newcastle upon Tyne Hospitals NHS Foundation Trust, Sir William Leech Lung Research Centre, Freeman Hospital Newcastle upon Tyne Tyne & Wear
United States University of New Mexico Albuquerque New Mexico
United States Emory University Hospital Atlanta Georgia
United States University of Colorado Hospital Aurora Colorado
United States Piedmont Healthcare Pulmonary and Critical Care Research Austell Georgia
United States Ascension Texas Cardiovascular Austin Texas
United States University of Maryland Medical Center Baltimore Maryland
United States University of Alabama at Birmingham Birmingham Alabama
United States Boston University Medical Center Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States Vermont Lung Center Burlington Vermont
United States University of Virginia Medical Center Charlottesville Virginia
United States University of Chicago Medical Center Chicago Illinois
United States University of Cincinnati-Medical Science Building Cincinnati Ohio
United States Cleveland Clinic Cleveland Ohio
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States UT Southwestern Medical Center Dallas Texas
United States National Jewish Health Denver Colorado
United States Duke University Medical Center Durham North Carolina
United States Ascension Alexian Brothers Elk Grove Village Illinois
United States University of Florida Gainesville Florida
United States Spectrum Health Medical Group Grand Rapids Michigan
United States East Carolina University Greenville North Carolina
United States Memorial Hermann Hospital Houston Texas
United States The Methodist Hospital Research Institute Houston Texas
United States Community Heart and Vascular Hospital Indianapolis Indiana
United States Indiana University School of Medicine Indianapolis Indiana
United States St. Vincent Medical Group, Inc. Indianapolis Indiana
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States StatCare Pulmonary Consultants Knoxville Tennessee
United States UCSD Health Sciences La Jolla California
United States Loma Linda University Medical Center Loma Linda California
United States Cedars-Sinai Medical Center Los Angeles California
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Keck Hospital of USC Los Angeles California
United States Ronald Reagan UCLA Medical Center Los Angeles California
United States VA Greater Los Angeles Healthcare System Los Angeles California
United States Kentuckiana Pulmonary Research Center Louisville Kentucky
United States University of Miami Miami Florida
United States Medical College of Wisconsin/Froedtert Hospital Milwaukee Wisconsin
United States Winthrop Hospital Mineola New York
United States Ochsner Medical Center New Orleans Louisiana
United States Mount Sinai School of Medicine New York New York
United States NYU Langone Medical Center New York New York
United States Weill-Cornell-New York Presbyterian Hospital New York New York
United States Sentara Cardiovascular Research Institute Norfolk Virginia
United States Integris Baptist Medical Center Oklahoma City Oklahoma
United States Nebraska Medical Center Omaha Nebraska
United States University of California, Irvine Orange California
United States Central Florida Pulmonary Group Orlando Florida
United States Investigational Drug Services, AdventHealth Orlando (Drug Shipment Address) Orlando Florida
United States Temple University Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania
United States St. Joseph's Hospital and Medical Center-Norton Thoracic Institute Phoenix Arizona
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States Oregon Clinic-Pulmonary West Portland Oregon
United States Oregon Health & Science University Portland Oregon
United States Carilion Clinic Pulmonary and Sleep Medicine Roanoke Virginia
United States University of Rochester Rochester New York
United States University of California Davis Medical Center Sacramento California
United States Washington University School of Medicine Saint Louis Missouri
United States Santa Barbara Cottage Hospital Santa Barbara California
United States Chest Medicine Associates South Portland Maine
United States Stanford University Medical Center Stanford California
United States University of Arizona Tucson Arizona
United States Cleveland Clinic Florida Weston Florida

Sponsors (1)

Lead Sponsor Collaborator
United Therapeutics

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Croatia,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Romania,  Serbia,  Singapore,  Spain,  Sweden,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of subjects with treatment-emergent adverse events [Safety and Tolerability] The safety and tolerability of ralinepag will be evaluated by the Number of subjects with treatment-emergent adverse events Up to 6 years
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