280
Participants
Start Date
May 4, 2022
Primary Completion Date
January 31, 2027
Study Completion Date
September 28, 2029
Macitentan
Adult participants will receive oral dose of macitentan 10 milligrams (mg) tablet once daily. Children greater than or equal to (\>=) 2 year to less than (\<) 18 years will be given an oral macitentan dose tailored to their body weight, ensuring an equivalent level of systemic exposure as in adults.
Selexipag
Adult Participant will receive oral dose of selexipag tablet twice daily at the dose strength corresponding to their maintenance dose at the end of their parent study. Available strengths: 200, 400, 600, 800, 1000, 1200, 1400 and 1600 micrograms (µg). Children with body weight category of \>=50 kg will use the tablets at the required dose strength as described for adults. Children with a body weight \< 50 kg will receive tablets for pediatric use (dose strengths: 100 and 150 mcg), twice daily to enable continuation of individually maximum tolerated dose of selexipag according to their body weight category.
Macitentan/Tadalafil FDC
Participants will receive oral FDC of macitentan 10 mg and tadalafil 40 mg once daily during the course of the study as already received in the parent studies.
RECRUITING
National Taiwan University Hospital, Taipei
RECRUITING
Taipei Veterans General Hospital, Taipei
RECRUITING
Chang-Gung Memorial Hospital, LinKou Branch, Taoyuan District
RECRUITING
National Cheng Kung University Hospital, Tainan City
RECRUITING
Kaohsiung Veterans General Hospital, Kaohsiung City
RECRUITING
Gottsegen György Országos Kardiológiai Intézet, Budapest
RECRUITING
University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD, Sofia
RECRUITING
Dr Kalla, Lenasia
COMPLETED
UZ Leuven, Leuven
COMPLETED
Abdullah, IA, Durban
RECRUITING
Gachon University Gil Medical Center, Incheon
RECRUITING
Chungnam National University Hospital, Daejeon
RECRUITING
Maharaj Nakorn Chiang Mai hospital Faculty of Medicine, Chiang Mai
RECRUITING
Beijing Anzhen Hospital, Beijing
COMPLETED
Federal State Budgetary Institution, Saint Petersburg
RECRUITING
Childrens Hospital of Shanghai, Shanghai
RECRUITING
The Republican Scientific-Practical Center ''Cardiology'', Minsk
RECRUITING
Qingdao Women and Children's Hospital, Qingdao
RECRUITING
The Second Xiangya Hospital of Central South Hospital, Changsha
RECRUITING
Regional Clinical Hospital No1, Tyumen
RECRUITING
E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation, Novosibirsk
RECRUITING
Institute of Cardiology of Tomsk National Research Medical Center of Rus Academy of Sciences, Tomsk
RECRUITING
Scientific and Research Institution of Cardiovascular Diseases Complex Problems, Kemerovo
RECRUITING
The First Affiliated Hospital of Xian Jiaotong University, Xi'an
RECRUITING
Minsk Regional Clinical Hospital Of The Red Banner Of Labor, Minsk
RECRUITING
Jiangsu Province Hospital, Nanjing
RECRUITING
Municipal Inst. Of Dnipropetrovsk Region. Council, Dnipro
RECRUITING
Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku, Bialystok
COMPLETED
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii, Bydgoszcz
RECRUITING
SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca, Katowice
RECRUITING
Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego, Lodz
RECRUITING
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ, Lublin
RECRUITING
SPSK2 PUM Klinika Kardiologii, Szczecin
RECRUITING
Wojewodzki Szpital Specjalist Osrodek Badawczo Rozwojowy, Wroclaw
RECRUITING
Wojewodzki Szpital Specjalistyczny we Wroclawiu, Wroclaw
RECRUITING
Seoul National University Hospital, Seoul
RECRUITING
Asan Medical Center, Seoul
RECRUITING
Samsung Medical Center, Seoul
RECRUITING
The Catholic University of Korea Seoul St Marys Hospital, Seoul
COMPLETED
State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine, Kyiv
Lead Sponsor
Actelion
INDUSTRY