Phase
Condition
Williams Syndrome
Pulmonary Arterial Hypertension
Stress
Treatment
Macitentan/Tadalafil FDC
Macitentan
Selexipag
Clinical Study ID
Ages > 2 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must sign an informed consent form (ICF) (or their legally designatedrepresentative must sign) indicating that participant understands the purpose of,and procedures required for, the study and is willing to participate in the study
Participant treated with oral macitentan or selexipag or fixed dose combination (FDC) of macitentan 10 milligrams (mg) and tadalafil 40 mg at the end of a sponsorparent study and: a) the indication of the parent study is included in theintervention-specific appendices (ISA) (pulmonary arterial hypertension [PAH]; b)participant has completed the parent study; c) no alternative means of access tostudy intervention (or equivalent approved therapy) have been identified; d)participant may continue to benefit from treatment with the study intervention; e)Participant is at least 18 years old for macitentan/tadalafil FDC, and at least 2years old for macitentan or selexipag
A female participant of childbearing potential must: a) have a negative urine orserum pregnancy test prior to first intake of study intervention; b) agree toperform monthly urine pregnancy test up to the end of the safety follow-up period;c) If heterosexually active, agree to follow contraceptive methods until 30 daysafter the last intake of the study intervention. For pediatric female participants:It is the responsibility of the investigator to ensure appropriate counselling,including consultation with a specialist (if needed), to the participant and/orparent(s)/ legally designated representative (LDR)(s) on the acceptable method ofcontraception
Exclusion
Exclusion Criteria:
General:
Participants prematurely discontinued from the study intervention in their parentstudy
Female participant being pregnant, or breastfeeding, or planning to become pregnantwhile enrolled in this study
Planned or current treatment with another investigational treatment
Macitentan-specific:
Known allergies, hypersensitivity, or intolerance to macitentan or its excipients
Hemoglobin less than (<) 80 grams per liter (g/L)
Serum aspartate (AST) and/or alanine aminotransferases (ALT) greater than (>) 3*upper limit of normal (ULN)
Known and documented severe hepatic impairment that is, Child-Pugh Class C. Forparticipants with hepatic impairment, Child-Pugh Class (Child-Pugh score) should befully assessed and documented in the source documents at screening
Selexipag-specific:
Known allergies, hypersensitivity, or intolerance to selexipag or its excipients
Suspected or known pulmonary veno-occlusive disease (PVOD)
Uncontrolled thyroid disease
Severe coronary heart disease or unstable angina, myocardial infarction within thelast 6 months, decompensated cardiac failure (if not under close medicalsupervision), severe arrhythmia, cerebrovascular events (for example, transientischemic attack, stroke) within the last 3 months, or congenital or acquiredvalvular defects with clinically relevant myocardial function disorders not relatedto pulmonary hypertension (PH)
Known and documented severe hepatic impairment that is, Child-Pugh Class C. Forparticipants with hepatic impairment, Child-Pugh Class (Child-Pugh score) should befully assessed and documented in the source documents at screening
Children only: (a) Current suspicion of intussusception or ileus or gastrointestinalobstruction, per the investigator's judgment; (b) hemoglobin or hematocrit <75percent (%) of the lower limit of normal range
Macitentan/tadalafil FDC-specific:
Known allergies, hypersensitivity, or intolerance to macitentan or tadalafil ortheir excipients
Hemoglobin <80 g/L
Serum aspartate (AST) and/or alanine aminotransferases (ALT) >3* ULN range
Known and documented severe hepatic impairment that is, Child-Pugh Class C. Forparticipants with hepatic impairment, Child-Pugh Class should be fully assessed anddocumented in the source documents at screening
Severe renal impairment (estimated glomerular filtration rate [eGF]/creatinineclearance <30 milliliter per minute [mL/min])
Study Design
Connect with a study center
Minsk Regional Clinical Hospital Of The Red Banner Of Labor
Minsk,
BelarusActive - Recruiting
The Republican Scientific-Practical Center ''Cardiology''
Minsk, 220036
BelarusActive - Recruiting
Minsk Regional Clinical Hospital Of The Red Banner Of Labor
Minsk 625144,
BelarusActive - Recruiting
The Republican Scientific-Practical Center ''Cardiology''
Minsk 625144, 220036
BelarusSite Not Available
UZ Leuven
Leuven, 3000
BelgiumCompleted
UZ Leuven
Leuven 2792482, 3000
BelgiumSite Not Available
University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
Sofia, 1750
BulgariaActive - Recruiting
University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
Sofia 727011, 1750
BulgariaSite Not Available
Beijing Anzhen Hospital
Beijing, 100029
ChinaActive - Recruiting
Beijing Anzhen Hospital
Beijing 1816670, 100029
ChinaSite Not Available
The Second Xiangya Hospital of Central South Hospital
Changsha, 410011
ChinaActive - Recruiting
The Second Xiangya Hospital of Central South Hospital
Changsha 1815577, 410011
ChinaSite Not Available
Jiangsu Province Hospital
Nanjing,
ChinaActive - Recruiting
Jiangsu Province Hospital
Nanjing 1799962,
ChinaSite Not Available
Qingdao Women and Children's Hospital
Qingdao, 266035
ChinaActive - Recruiting
Qingdao Women and Children's Hospital
Qingdao 1797929, 266035
ChinaSite Not Available
Childrens Hospital of Shanghai
Shanghai, 200062
ChinaActive - Recruiting
Childrens Hospital of Shanghai
Shanghai 1796236, 200062
ChinaSite Not Available
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061
ChinaActive - Recruiting
The First Affiliated Hospital of Xian Jiaotong University
Xi'an 1790630, 710061
ChinaSite Not Available
CHRU Besançon -Hôpital Jean Minjoz
Besançon, 25030
FranceSite Not Available
CHU de Bordeaux - Hospital Haut-Leveque
Bordeaux (Pessac), 33604
FranceSite Not Available
GH est - Hôpital Cardiovasculaire et Pneumologie Louis Pradel
Bron Cedex, 69677
FranceSite Not Available
Hôpital Côte de Nacre
Caen Cedex,
FranceSite Not Available
CHU Dijon
Dijon Cedex, 21079
FranceSite Not Available
CHU Grenoble
Grenoble, 38700
FranceSite Not Available
Hopital Bicêtre - Aphp Hôpitaux Universitaires Paris-Sud
Le Kremlin Bicetre cedex, 94275
FranceSite Not Available
Hôpital Cardiologique - Chru Lille
Lille Cedex, 59037
FranceSite Not Available
CHU de Limoges
Limoges Cedex, 87042
FranceSite Not Available
CHU de la Timone
Marseille cedex 5, 13385
FranceSite Not Available
CHU de Montpellier - Arnaud de Villeneuve
Montpellier, 34295
FranceSite Not Available
CHU Nantes - Hopital Nord Laënnec
Nantes Cedex 1, 44093
FranceSite Not Available
Centre Hospitalier Universitaire - de Nice - Hopital Pasteur
Nice, 06001
FranceSite Not Available
Hôpital Européen Georges Pompidou
Paris Cedex 15, 75908
FranceSite Not Available
CHU de Reims
Reims, 51100
FranceSite Not Available
Chu Rennes - Hopital Pontchaillou
Rennes, 35033
FranceSite Not Available
CHU Rouen - Hopital Charles Nicolle
Rouen, 76031
FranceSite Not Available
CHU Saint-Etienne - Hôpital Nord
St Priest en Jarez Cedex, 42277
FranceSite Not Available
Nouvel Hôpital Civil
Strasbourg, 67091
FranceSite Not Available
Hopital Larrey CHU de Toulouse
Toulouse Cedex 9,
FranceSite Not Available
CHU de Nancy - Hôpital de Brabois
Vandoeuvre les Nancy Cedex, 54511
FranceSite Not Available
Gottsegen György Országos Kardiológiai Intézet
Budapest, 1096
HungaryActive - Recruiting
Gottsegen György Országos Kardiológiai Intézet
Budapest 3054643, 1096
HungarySite Not Available
Sanjivani Hospitals
Ahmedabad, 380015
IndiaSite Not Available
Apollo Hospitals
Chennai, 600006
IndiaSite Not Available
Chungnam National University Hospital
Daejeon, 35015
Korea, Republic ofSite Not Available
Gachon University Gil Medical Center
Incheon, 21565
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591
Korea, Republic ofSite Not Available
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591
Korea, Republic ofActive - Recruiting
Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku
Bialystok, 15 276
PolandActive - Recruiting
Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku
Bialystok 776069, 15 276
PolandSite Not Available
Klinika Kardiologii z Oddzialem Intensywnego Nadzoru Kardiologicznego, UM w Białymstoku
Białystok, 15-276
PolandSite Not Available
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii
Bydgoszcz, 85-168
PolandCompleted
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii
Bydgoszcz 3102014, 85-168
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
PolandSite Not Available
SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca
Katowice, 40 635
PolandActive - Recruiting
SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im. Prof. Leszka Gieca
Katowice, 40-635
PolandActive - Recruiting
SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca
Katowice 3096472, 40 635
PolandSite Not Available
Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego
Lodz, 91 347
PolandActive - Recruiting
Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im. W.Bieganskiego
Lodz, 91-347
PolandActive - Recruiting
Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego
Lodz 3093133, 91 347
PolandSite Not Available
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ
Lublin, 20 718
PolandActive - Recruiting
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ
Lublin, 20-718
PolandActive - Recruiting
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ
Lublin 765876, 20 718
PolandSite Not Available
ECZ Otwock Klinika Kardiologii, Klinika Krążenia Płucnego Chorób Zakrzepowo-Zatorowych i Kardiologii
Otwock, 05-400
PolandSite Not Available
SPSK2 PUM Klinika Kardiologii
Szczecin, 70 111
PolandActive - Recruiting
SPSK2 PUM, Klinika Kardiologii
Szczecin, 70-111
PolandActive - Recruiting
SPSK2 PUM Klinika Kardiologii
Szczecin 3083829, 70 111
PolandSite Not Available
Wojewodzki Szpital Specjalist Osrodek Badawczo Rozwojowy
Wroclaw, 51 124
PolandCompleted
Wojewodzki Szpital Specjalist, Osrodek Badawczo-Rozwojowy
Wroclaw, 51-124
PolandActive - Recruiting
Wojewodzki Szpital Specjalistyczny we Wroclawiu
Wroclaw, 51 124
PolandActive - Recruiting
Wojewodzki Szpital Specjalist Osrodek Badawczo Rozwojowy
Wroclaw 3081368, 51 124
PolandSite Not Available
Wojewodzki Szpital Specjalistyczny we Wroclawiu
Wroclaw 3081368, 51 124
PolandActive - Recruiting
Wojewodzki Szpital Specjalistyczny, Oddzial Kardiologiczny
Wrocław, 51-124
PolandSite Not Available
Institutul de pneumoftiziologie Marius Nasta
Bucuresti, 050152
RomaniaSite Not Available
Scientific and Research Institution of Cardiovascular Diseases Complex Problems
Kemerovo, 650002
RussiaCompleted
Scientific and Research Institution of Cardiovascular Diseases Complex Problems
Kemerovo 1503901, 650002
RussiaSite Not Available
E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
Novosibirsk, 630055
RussiaActive - Recruiting
E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
Novosibirsk 1496747, 630055
RussiaSite Not Available
Federal State Budgetary Institution
Saint Petersburg, 197341
RussiaCompleted
Federal State Budgetary Institution
Saint Petersburg 498817, 197341
RussiaSite Not Available
Institute of Cardiology of Tomsk National Research Medical Center of Rus Academy of Sciences
Tomsk, 634012
RussiaCompleted
Institute of Cardiology of Tomsk National Research Medical Center of Rus Academy of Sciences
Tomsk 1489425, 634012
RussiaSite Not Available
Regional Clinical Hospital No1
Tyumen, 625000
RussiaActive - Recruiting
Regional Clinical Hospital No1
Tyumen 1488754, 625000
RussiaSite Not Available
Altay Regional Cardiological Dispensary
Barnaul, 656055
Russian FederationSite Not Available
Scientific and Research Institution of Cardiovascular Diseases Complex Problems
Kemerovo, 650002
Russian FederationSite Not Available
National Medical Research Center of Cardiology of MoH of Russian Federation
Moscow, 121552
Russian FederationSite Not Available
E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
Novosibirsk, 630055
Russian FederationSite Not Available
Federal State Budgetary Institution Of Ministry Of Health Of Russian Federation
Novosibirsk, 630055
Russian FederationSite Not Available
Samara Regional Clinical Cardiological Dispensary
Samara, 443070
Russian FederationSite Not Available
Federal State Budgetary Institution
St Petersburg, 197341
Russian FederationSite Not Available
Institute of Cardiology of Tomsk National Research Medical Center of Rus Academy of Sciences
Tomsk, 634012
Russian FederationSite Not Available
Regional Clinical Hospital No1
Tyumen, 625000
Russian FederationSite Not Available
Abdullah, IA
Durban, 4001
South AfricaCompleted
Abdullah, IA
Durban 1007311, 4001
South AfricaSite Not Available
Dr Kalla
Lenasia, 1820
South AfricaActive - Recruiting
Dr Kalla
Lenasia 983199, 1820
South AfricaSite Not Available
Chungnam National University Hospital
Daejeon, 35015
South KoreaActive - Recruiting
Chungnam National University Hospital
Daejeon 1835235, 35015
South KoreaSite Not Available
Gachon University Gil Medical Center
Incheon, 21565
South KoreaActive - Recruiting
Gachon University Gil Medical Center
Incheon 1843564, 21565
South KoreaSite Not Available
Asan Medical Center
Seoul, 05505
South KoreaActive - Recruiting
Samsung Medical Center
Seoul, 06351
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul, 03080
South KoreaActive - Recruiting
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591
South KoreaActive - Recruiting
Asan Medical Center
Seoul 1835848, 05505
South KoreaSite Not Available
Samsung Medical Center
Seoul 1835848, 06351
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul 1835848, 03080
South KoreaActive - Recruiting
The Catholic University of Korea Seoul St Marys Hospital
Seoul 1835848, 06591
South KoreaActive - Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung, 813
TaiwanSite Not Available
Kaohsiung Veterans General Hospital
Kaohsiung City, 813
TaiwanActive - Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City 1673820, 813
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan, 704
TaiwanActive - Recruiting
National Cheng Kung University Hospital
Tainan 1668355, 704
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan City 1668355, 704
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 100
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei, 112
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei 1668341, 100
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei 1668341, 112
TaiwanSite Not Available
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan, 333
TaiwanSite Not Available
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan District, 333
TaiwanActive - Recruiting
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan District 1667905, 333
TaiwanSite Not Available
Maharaj Nakorn Chiang Mai hospital Faculty of Medicine
Chiang Mai, 50200
ThailandActive - Recruiting
Maharaj Nakorn Chiang Mai hospital Faculty of Medicine
Chiang Mai 1153671, 50200
ThailandSite Not Available
Istanbul University Istanbul Medical Faculty
Capa_Istanbul, 34093
TurkeySite Not Available
Municipal Inst. Of Dnipropetrovsk Region. Council
Dnipro,
UkraineActive - Recruiting
Municipal Inst. Of Dnipropetrovsk Region. Council
Dnipro 709930,
UkraineSite Not Available
Health Care Municipal Institution City Clinical Hospital #13
Kharkiv,
UkraineSite Not Available
State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
Kyiv, 03680
UkraineCompleted
State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
Kyiv 703448, 03680
UkraineSite Not Available
Lviv Regional Clinical Hospital
Lviv, 79000
UkraineSite Not Available
Hanoi Heart Hospital
Hanoi,
VietnamActive - Recruiting
Hanoi Medical University Hospital
Hanoi,
VietnamActive - Recruiting
Hanoi Heart Hospital
Hanoi 1581130,
VietnamSite Not Available
Hanoi Medical University Hospital
Hanoi 1581130,
VietnamActive - Recruiting
Children's Hospital 1
Ho Chi Minh City,
VietnamActive - Recruiting
Children's Hospital 1
Ho Chi Minh City 1566083,
VietnamSite Not Available

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