Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
58 participants
INTERVENTIONAL
2011-03-08
2020-05-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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bosentan 2mg/kg b.i.d.
Patients who received 2 mg/kg bosentan twcie daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
Bosentan
Oral dispersible tablet administered as 2mg/kg two (b.i.d.) or three (t.i.d.) times per day
bosentan 2mg/kg t.i.d.
Patients who received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
Bosentan
Oral dispersible tablet administered as 2mg/kg two (b.i.d.) or three (t.i.d.) times per day
Interventions
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Bosentan
Oral dispersible tablet administered as 2mg/kg two (b.i.d.) or three (t.i.d.) times per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients who tolerated bosentan pediatric formulation and for whom bosentan is considered beneficial at the end of the FUTURE 3 core study (AC-052-373)
3. Signed informed consent by the parents or the legal representatives prior to any study-mandated procedure.
Exclusion Criteria
2. Any clinically significant laboratory abnormality that precludes continuation of bosentan therapy
3. Pregnancy
4. AST and/or ALT values \> 3 times the upper limit of normal range (ULN)
5. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
6. Premature and permanent study drug discontinuation during the FUTURE 3 core study (AC-052-373)
7. Any major violation of the FUTURE 3 core study (AC-052-373) protocol.
3 Months
12 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Locations
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The Children's Hospital - Site 9102
Aurora, Colorado, United States
Children's National Medical Center - Site 9104
Washington D.C., District of Columbia, United States
Columbia University Medical Center Children's Hospital of New York Presbyterian - Site 9101
New York, New York, United States
Royal Children's Hospital Melbourne, Cardiology - Site 5001
Parkville, , Australia
The Republican Scientific-Practical Center "Cardiology" - Site 3001
Minsk, , Belarus
Cardiovascular Institute and Fuwai Hospital
Beijing, , China
Shanghai Children's Medical Center - Site 5102
Shanghai, , China
Fakultní nemocnice v Motole, dětské kardiocentrum - Site 3301
Prague, , Czechia
Hopital Necker-Enfants Malades, Service de Cardiologie Pédiatrique - Site 2201
Paris, , France
CHU de Toulouse - Hôpital des Enfants, Service de Cardiologie Pédiatrique - Site 2202
Toulouse, , France
Deutsches Herzzentrum Kinderkardiologie - Site 1401
Berlin, , Germany
Universitätsklinikum Bonn Abteilung für Kinderkardiologie - Site 1404
Bonn, , Germany
Justus-Liebig-Universität Giessen, Kinderherzzentrum - Site 1403
Giessen, , Germany
Gottsegen György Országos Kardiológiai Intézet, Gyermekszív Központ, Gyermek Kardiológiai osztály - Site 3401
Budapest, , Hungary
Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, Gyermekgyógyászati Klinika és Gyermekegészségügyi Központ - Site 3402
Szeged, , Hungary
CARE Hospitals, Cardiology Dep. Hyderabad - Site 5302
Hyderabad, , India
Schneider Children's Medical Center- Institute of pediatric cardiology - Site 7101
Petach Tikvah, , Israel
Università Degli Studi di Padova - Dipartimento di Pediatria - Servizio di Cardiologia Pediatrica - Site 1501
Padua, , Italy
Ospedale Pediatrico "Bambino Gesù" - Dipartimento Medico Chirurgico di Cardiologia Pediatrica - Site 1502
Rome, , Italy
Instituto Nacional de Cardiologia (INC) Ignacio Chavez - Site 8401
Mexico City, , Mexico
Uniwersyteckie Centrum Kliniczne Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca - Site 3604
Gdansk, , Poland
Wojewódzki Szpital Specjalistyczny we Wrocławiu Oddział Kardiologii Dziecięcej z pododdziałem Intensywnego Nadzoru Kardiologicznego - Site 3605
Wroclaw, , Poland
RAMS Institution, Research Institute for complex issues of cardiovascular diseases, Siberian branch of the Russian Academy of Medical Sciences - Site 3805
Kemerovo, , Russia
Scientific Center of Cardiovascular Surgery named after A.N.Bakulev of the RAMS - Site 3803
Moscow, , Russia
Moscow Scientific Research Institute for Pediatrics and Childrens Surgery of Rosmedtechnologies - Site 3804
Moscow, , Russia
Federal State Institution "Federal center of Heart, Blood and Endocrinology named after V.A.Almazov Rosmedtekhnologies" - Site 3802
Saint Petersberg, , Russia
State Educational Institution of Higher Professional Education "Saint Petersburg State Pediatric Medical Academy of Roszdrav" - Site 3801
Saint Petersburg, , Russia
Univerzitetska dečja klinika, Služba za kardiologiju - Site 3901
Belgrade, , Serbia
Institut za zdravstvenu zaštitu majke i deteta Srbije "Dr Vukan Čupić", Služba za ispitivanje i lečenje bolesti srca i krvnih sudova - Site 3902
Belgrade, , Serbia
Department of Paediatric Cardiology University of the Free State - Site 6001
Bloemfontein, , South Africa
Division of Paediatric Cardiology, Steve Biko Academic Hospital - Site 6002
Pretoria, , South Africa
Hospital Universitatario Vall d'Hebron, Neumologia - Site 1907
Barcelona, , Spain
Hospital Universitario La Paz - Paediatric Cardiology Department - Site 1906
Madrid, , Spain
Clinical Diagnostic Center - Pediatric Cardiovascular and ANES and Intensive Care Department - Site 4103
Dnipro, , Ukraine
Gusak Ins Urgent and Recovery SUR AMS - Cardiovascular Rehabilitation Pediatric Department - Site 4101
Donetsk, , Ukraine
Gover INS - Scientific Practical Cardiovascular Pediatric Center - MOH Ukraine - Site 4102
Kiev, , Ukraine
Countries
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Other Identifiers
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2010-021793-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AC-052-374
Identifier Type: -
Identifier Source: org_study_id
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