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A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
Sponsor: Actelion
Summary
The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (\>=) 2 to less than (˂) 18 years of age with Pulmonary Arterial Hypertension (PAH), by investigating the PK of selexipag and its active metabolite ACT-333679 in this population.
Official title: A Prospective, Multicenter, Open Label, Single Arm, Phase 2 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Selexipag in Children With Pulmonary Arterial Hypertension
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
63
Start Date
2018-07-23
Completion Date
2026-12-31
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
selexipag (Uptravi)
Film-coated tablets for oral administration
Locations (34)
Children'S Hospital Cardiac Care Center University Of Colorado
Aurora, Colorado, United States
University of Iowa Hospital
Iowa City, Iowa, United States
Seattle Children's Hospital
Seattle, Washington, United States
State Institution Republican Scientific And Practical Center For Pediatric Surgery
Minsk, Belarus
Health Institution 4Th City Children'S Clinical Hospital
Minsk, Belarus
UZ Gent
Ghent, Belgium
Centre Hospitalier Sainte Justine
Montreal, Quebec, Canada
Beijing Anzhen Hospital
Beijing, China
Shanghai Childrens Medical Center
Shanghai, China
CHU Arnaud de Villeneuve
Montpellier, France
Hôpital Necker - Enfants Malades
Paris, France
Chu Hopital Des Enfants
Toulouse, France
Universitätsklinikum Freiburg Zentrum
Freiburg im Breisgau, Germany
Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály
Budapest, Hungary
Schneider Children's Medical Center
Petach Tikvah, Israel
Sheba Medical Center
Ramat Gan, Israel
Sarawak Heart Center
Kota Samarahan, Malaysia
Institut Jantung Negara (National Heart Institute)
Kuala Lumpur, Malaysia
Wojewodzki Szpital Specjalistyczny We Wroclawiu
Wroclaw, Poland
Kazan State Medical University
Kazan', Russia
Scientific and Research Institution of Cardiovascular Diseases Complex Problems
Kemerovo, Russia
Moscow Scientific Research Institute For Pediatrics And Childrens Surgery Of Rosmedtechnologies
Moscow, Russia
Saint Petersburg State Pediatric Medical University
Saint Petersburg, Russia
Almazov National Medical Research Center Of The Ministry Of Health Of The Russian Federation
Saint Petersburg, Russia
Samara Regional Clinical Cardiological Dispensary
Samara, Russia
Univerzitetska Dečja Klinika
Belgrade, Serbia
Institut Za Zdravstvenu Zastitu Majke I Deteta Srbije Dr Vukan Cupic
Belgrade, Serbia
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Municipal Enterprise Of The Dnipropetrovsk Regional Council
Dnipro, Ukraine
State Institution Of The Ministry Of Health Of Ukraine
Kiev, Ukraine
Lviv Regional Clinical Hospital
Lviv, Ukraine
Municipal Institution Of The Zaporizhzhya Regional Council
Zaporizhzhya, Ukraine
Great Ormond Street Hospital
London, United Kingdom