Phase
Condition
Circulation Disorders
Williams Syndrome
Pulmonary Arterial Hypertension
Treatment
Bosentan
Clinical Study ID
Ages 3-12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients who completed the FUTURE 3 core study (AC-052-373) or prematurelydiscontinued due to PAH-progression, if bosentan was not permanently discontinued
Patients who tolerated bosentan pediatric formulation and for whom bosentan isconsidered beneficial at the end of the FUTURE 3 core study (AC-052-373)
Signed informed consent by the parents or the legal representatives prior to anystudy-mandated procedure.
Exclusion
Exclusion Criteria:
Known intolerance or hypersensitivity to bosentan or any of the excipients of thedispersible bosentan tablet
Any clinically significant laboratory abnormality that precludes continuation ofbosentan therapy
Pregnancy
AST and/or ALT values > 3 times the upper limit of normal range (ULN)
Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
Premature and permanent study drug discontinuation during the FUTURE 3 core study (AC-052-373)
Any major violation of the FUTURE 3 core study (AC-052-373) protocol.
Study Design
Connect with a study center
Royal Children's Hospital Melbourne, Cardiology - Site 5001
Parkville, 3052
AustraliaSite Not Available
The Republican Scientific-Practical Center "Cardiology" - Site 3001
Minsk, 220036
BelarusSite Not Available
Cardiovascular Institute and Fuwai Hospital
Beijing, 100037
ChinaSite Not Available
West China 2nd university Hospital-Center of interventional diagnosis and therapy for Children's cardiovascular disease - Site 5104
Chengdu, 610041
ChinaSite Not Available
Shanghai Children's Medical Center - Site 5102
Shanghai, 200127
ChinaSite Not Available
Fakultní nemocnice v Motole, dětské kardiocentrum - Site 3301
Prague, 150 06
CzechiaSite Not Available
Hopital Necker-Enfants Malades, Service de Cardiologie Pédiatrique - Site 2201
Paris, 75743
FranceSite Not Available
CHU de Toulouse - Hôpital des Enfants, Service de Cardiologie Pédiatrique - Site 2202
Toulouse, 31059
FranceSite Not Available
Deutsches Herzzentrum Kinderkardiologie - Site 1401
Berlin, 13353
GermanySite Not Available
Universitätsklinikum Bonn Abteilung für Kinderkardiologie - Site 1404
Bonn, 53113
GermanySite Not Available
Justus-Liebig-Universität Giessen, Kinderherzzentrum - Site 1403
Giessen, 35392
GermanySite Not Available
Gottsegen György Országos Kardiológiai Intézet, Gyermekszív Központ, Gyermek Kardiológiai osztály - Site 3401
Budapest, 1096
HungarySite Not Available
Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, Gyermekgyógyászati Klinika és Gyermekegészségügyi Központ - Site 3402
Szeged, 6720
HungarySite Not Available
CARE Hospitals, Cardiology Dep. Hyderabad - Site 5302
Hyderabad, 500001
IndiaSite Not Available
Indraprashta Apollo Hospitals, Pediatric Cardiology - Site 5303
New Dehli, 110076
IndiaSite Not Available
Indraprashta Apollo Hospitals, Pediatric Cardiology - Site 5303
New Delhi, 110076
IndiaSite Not Available
Schneider Children's Medical Center- Institute of pediatric cardiology - Site 7101
Petach Tikvah, 49202
IsraelSite Not Available
Università Degli Studi di Padova - Dipartimento di Pediatria - Servizio di Cardiologia Pediatrica - Site 1501
Padova, 35128
ItalySite Not Available
Ospedale Pediatrico "Bambino Gesù" - Dipartimento Medico Chirurgico di Cardiologia Pediatrica - Site 1502
Rome, 00193
ItalySite Not Available
Instituto Nacional de Cardiologia (INC) Ignacio Chavez - Site 8401
Mexico City, 14080
MexicoSite Not Available
Unidad de Investigacion Clinica en Medicina, SC (UDICEM) - Site 8402
Monterrey, 64710
MexicoSite Not Available
Universitair Medish Centrum Groningen, Kindercardiologie - Site 1601
Groningen, 9713 GZ
NetherlandsSite Not Available
Uniwersyteckie Centrum Kliniczne Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca - Site 3604
Gdansk, 80-952
PolandSite Not Available
Instytut Centrum Zdrowia Matki Polki Klinika Kardiologii ICMP w Lodz - Site 3602
Lodz, 93-336
PolandSite Not Available
Instytut Pomnik - Centrum Zdrowia Dziecka Klinika Kardiologii Dziecięcej - Site 3601
Warszawa, 04-730
PolandSite Not Available
Wojewódzki Szpital Specjalistyczny we Wrocławiu Oddział Kardiologii Dziecięcej z pododdziałem Intensywnego Nadzoru Kardiologicznego - Site 3605
Wroclaw, 51-124
PolandSite Not Available
RAMS Institution, Research Institute for complex issues of cardiovascular diseases, Siberian branch of the Russian Academy of Medical Sciences - Site 3805
Kemerovo, 650002
Russian FederationSite Not Available
Moscow Scientific Research Institute for Pediatrics and Childrens Surgery of Rosmedtechnologies - Site 3804
Moscow, 125412
Russian FederationSite Not Available
Scientific Center of Cardiovascular Surgery named after A.N.Bakulev of the RAMS - Site 3803
Moscow, 121552
Russian FederationSite Not Available
Federal State Institution "Federal center of Heart, Blood and Endocrinology named after V.A.Almazov Rosmedtekhnologies" - Site 3802
St. Petersberg, 197341
Russian FederationSite Not Available
State Educational Institution of Higher Professional Education "Saint Petersburg State Pediatric Medical Academy of Roszdrav" - Site 3801
St. Petersburg, 194100
Russian FederationSite Not Available
Institut za zdravstvenu zaštitu majke i deteta Srbije "Dr Vukan Čupić", Služba za ispitivanje i lečenje bolesti srca i krvnih sudova - Site 3902
Belgrade, 11070
SerbiaSite Not Available
Univerzitetska dečja klinika, Služba za kardiologiju - Site 3901
Belgrade, 11000
SerbiaSite Not Available
Department of Paediatric Cardiology University of the Free State - Site 6001
Bloemfontein, 9300
South AfricaSite Not Available
Paediatric Cardiology Albert Luthuli Central Hospital - Site 6003
Durban, 4001
South AfricaSite Not Available
Division of Paediatric Cardiology, Steve Biko Academic Hospital - Site 6002
Pretoria, 0001
South AfricaSite Not Available
Hospital Universitatario Vall d'Hebron, Neumologia - Site 1907
Barcelona, 08035
SpainSite Not Available
Hospital Universitario La Paz - Paediatric Cardiology Department - Site 1906
Madrid, 28046
SpainSite Not Available
Clinical Diagnostic Center - Pediatric Cardiovascular and ANES and Intensive Care Department - Site 4103
Dnepropetrovsk, 49060
UkraineSite Not Available
Gusak Ins Urgent and Recovery SUR AMS - Cardiovascular Rehabilitation Pediatric Department - Site 4101
Donetsk, 83045
UkraineSite Not Available
Gover INS - Scientific Practical Cardiovascular Pediatric Center - MOH Ukraine - Site 4102
Kiev, 01135
UkraineSite Not Available
The Children's Hospital - Site 9102
Aurora, Colorado 80045
United StatesSite Not Available
Children's National Medical Center - Site 9104
Washington, District of Columbia 20010
United StatesSite Not Available
Children's National Medical Center - Site 9104
Washington, D.C., District of Columbia 20010
United StatesSite Not Available
Columbia University Medical Center Children's Hospital of New York Presbyterian - Site 9101
New York, New York 10032
United StatesSite Not Available
Texas Children's Hospital - Department of Cardiology - Site 9107
Houston, Texas 77030
United StatesSite Not Available
Seattle Children's Hospital - Site 9106
Seattle, Washington 98105
United StatesSite Not Available
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