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A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension
Sponsor: Actelion
Summary
The purpose of this study is to evaluate whether the addition of selexipag to standard of care treatment delays disease progression in children with Pulmonary Arterial Hypertension (PAH) in comparison to placebo.
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged >=2 to <18 Years With Pulmonary Arterial Hypertension
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
138
Start Date
2020-01-16
Completion Date
2027-10-01
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Selexipag
Selexipag tablet will be administered orally.
Placebo
Matching placebo tablets will be administered orally.
Standard of Care (SOC): Endothelin receptor antagonist
ERAs will be administered as SOC therapy.
SOC: Phosphodiesterase type 5 (PDE-5) inhibitor
PDE-5 inhibitor will be administered as SOC therapy.
SOC: Soluble guanylate cyclase stimulator
Soluble guanylate cyclase stimulator will be administered as SOC therapy.
Locations (116)
Phoenix Children's Hospital
Phoenix, Arizona, United States
UCLA Medical Center
Los Angeles, California, United States
UCSF
San Francisco, California, United States
Childrens Hospital Colorado
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Congenital Heart Center of the University of Florida
Gainesville, Florida, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Detroit Medical Center
Detroit, Michigan, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Childrens Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States
Texas Children's Hospital
Houston, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
University of Virginia Division of Pediatric Cardiology
Charlottesville, Virginia, United States
Queensland CHILDREN'S HOSPITAL
South Brisbane, Australia
State Institution Republican Scientific And Practical Center For Pediatric Surgery
Minsk, Belarus
Health Institution 4Th City Children'S Clinical Hospital
Minsk, Belarus
ULB Hôpital Erasme
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
Complexo de Prevencao,Diagnostico,Terapia e Reabilitacao Respiratoria LTDA Hospital Dia do Pulmao
Blumenau, Brazil
Fundacao Universitaria de Cardiologia - Instituto de Cardiologia e Transplantes do DF
Brasília, Brazil
Hospital Pequeno Principe
Curitiba, Brazil
Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes
Fortaleza, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
Fundacao Universitaria de Cardiologia
Porto Alegre, Brazil
Irmandade Santa Casa de Misericordia de Sao Paulo
São Paulo, Brazil
SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
São Paulo, Brazil
Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead
Sofia, Bulgaria
Stollery Children's Hospital
Edmonton, Alberta, Canada
Hospital For Sick Children
Toronto, Ontario, Canada
Beijing Anzhen Hospital
Beijing, China
Guangzhou Women And Children's Medical Center
Guangzhou, China
Qingdao Women and Children's Hospital 1
Qingdao, China
Qingdao Women and Children's Hospital
Qingdao, China
Shanghai Childrens Medical Center
Shanghai, China
Children's Hospital of Fudan University
Shanghai, China
The General Hospital of Northern Theater Command
Shenyang, China
Clinica San Rafael
Bogotá, Colombia
Fundacion Neumologica Colombiana
Bogotá, Colombia
Fundacion Santa Fe de Bogota
Bogotá, Colombia
Clínica Imbanaco S.A.S.
Cali, Colombia
Fundacion Cardiovascular de Colombia
Piedecuesta, Colombia
Hospital Universidad del Norte
Soledad, Colombia
New Children's Hospital of the Helsinki University Hospital (HUS)
Helsinki, Finland
Hôpital Cardiologique - Chru Lille
Lille, France
Hopital de la Timone
Marseille, France
CHU Arnaud de Villeneuve
Montpellier, France
Hôpital Necker - Enfants Malades
Paris, France
Hôpital Cardiologique Du Haut-Lévêque
Pessac, France
Chu Hopital Des Enfants
Toulouse, France
Universitätsklinikum Freiburg Zentrum
Freiburg im Breisgau, Germany
Universitaetsklinikum Heidelberg
Heidelberg, Germany
Herzzentrum Leipzig GmbH
Leipzig, Germany
Klinikum der Universitaet Muenchen
München, Germany
Gottsegen György Országos Kardiológiai Intézet
Budapest, Hungary
Our Lady's Children's Hospital
Dublin, Ireland
Rambam Medical Center
Haifa, Israel
Sheba Medical Center
Ramat Gan, Israel
Azienda Ospedaliera Policlinico S. Orsola-Malpighi
Bologna, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Universta Degli Studi Di Padova
Padova, Italy
Ospedale Pediatrico Bambin Gesù
Roma, Italy
IRCCS Policlinico San Donato
S. Donato Milanese, Italy
AOU Città della Salute e della Scienza di Torino, Presidio Ospedale Infantile Regina Margherita
Torino, Italy
Vilnius University Hospital Santariskiu Clinics
Vilnius, Lithuania
National Heart Institute
Kuala Lumpur, Malaysia
CICUM San Miguel
Guadalajara, Mexico
Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas
México, Mexico
Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)
Monterrey, Mexico
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, Poland
Szpital Kliniczny im Karola Jonschera
Poznan, Poland
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Poland
Wojewodzki Szpital Specjalistyczny we Wroclawiu
Wroclaw, Poland
Slaskie Centrum Chorob Serca
Zabrze, Poland
Uls Sao Jose - Hosp. Santa Marta
Lisbon, Portugal
Uls Sao Joao - Hosp. Sao Joao
Porto, Portugal
Kazan State Medical University
Kazan', Russia
Kazan State Medical University 1
Kazan', Russia
Scientific and Research Institution of Cardiovascular Diseases Complex Problems
Kemerovo, Russia
Childrens City Clinical Hospital n.a. Bashlyaeva
Moscow, Russia
Veltischev Research and Clinical Institute for Pediatrics of the Pirogov RNRMU
Moscow, Russia
Samara Regional Clinical Cardiological Dispensary
Samara, Russia
Univerzitetska Dečja Klinika
Belgrade, Serbia
Seoul National University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Severance Hospital Yonsei University Health System
Seoul, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
Hosp Univ A Coruna
A Coruña, Spain
Hosp Univ Vall D Hebron
Barcelona, Spain
Hosp. Sant Joan de Deu
Esplugues de Llobregat, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain
Hosp. Univ. La Paz
Madrid, Spain
Hosp. Virgen Del Rocio
Seville, Spain
Drottning Silvias barn- och ungdomssjukhus
Gothenburg, Sweden
Skanes universitetssjukhus
Lund, Sweden
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, Switzerland
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chiang Mai University Hospital
Chiang Mai, Thailand
Songklanagarind hospital
Songkhla, Thailand
Cukurova Balcali Hospital Application and Research Center
Adana, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye)
CAPA Istanbul University Medical Faculty
Istanbul, Turkey (Türkiye)
Mehmet Akif Ersoy Training and Research Hospital
Istanbul, Turkey (Türkiye)
Izmir Tepecik Training and Research Hospital
Izmir, Turkey (Türkiye)
Behcet Uz Pediatric Diseases and Surgery Training and Research Hospital
Izmir, Turkey (Türkiye)
Dnipropetrovsk clinical medical center of Mother and Child after prof. Rudnev
Dnipro, Ukraine
MI 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery'
Dnipro, Ukraine
Scientific Practical Medical Center for Pediatric Cardiology and Cardio Surgery of the MOH
Kyiv, Ukraine
MI Zaporizhzhia Regional Clinical Childrens Hospital of Zaporizhzhia Regional Council
Zaporizhzhya, Ukraine
Hanoi Medical University Hospital
Hanoi, Vietnam
Tam Anh Hospital
Ho Chi Minh City, Vietnam
University Medical Center Ho Chi Minh city
Ho Chi Minh City, Vietnam
Children's Hospital 1
Ho Chi Minh City, Vietnam