FUTURE 3 Study Extension
- Registration Number
- NCT01338415
- Lead Sponsor
- Actelion
- Brief Summary
The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- Patients who completed the FUTURE 3 core study (AC-052-373) or prematurely discontinued due to PAH-progression, if bosentan was not permanently discontinued
- 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)
- Signed informed consent by the parents or the legal representatives prior to any study-mandated procedure.
- Known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible bosentan tablet
- Any clinically significant laboratory abnormality that precludes continuation of bosentan 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description bosentan 2mg/kg b.i.d. Bosentan 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 2mg/kg t.i.d. Bosentan 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
- Primary Outcome Measures
Name Time Method Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation Up to 62 weeks in average This is the total number of subjects with at least one adverse event (serious or not serious) whether or not causally related to the study drug and presented cumulatively in the FUTURE 3 and FUTURE 3 Extension study. NOTE: FUTURE 3 extension study was exploratory and no primary efficacy and safety endpoints were defined in the protocol. So, this safety outcome measure was selected and reported as primary endpoint here.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (72)
CARE Hospitals, Cardiology Dep. Hyderabad - Site 5302
🇮🇳Hyderabad, India
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
The Republican Scientific-Practical Center "Cardiology" - Site 3001
🇧🇾Minsk, Belarus
Shanghai Children's Medical Center - Site 5102
🇨🇳Shanghai, China
CHU de Toulouse - Hôpital des Enfants, Service de Cardiologie Pédiatrique - Site 2202
🇫🇷Toulouse, France
Fakultní nemocnice v Motole, dětské kardiocentrum - Site 3301
🇨🇿Prague, Czechia
Gover INS - Scientific Practical Cardiovascular Pediatric Center - MOH Ukraine - Site 4102
🇺🇦Kiev, Ukraine
Instituto Nacional de Cardiologia (INC) Ignacio Chavez - Site 8401
🇲🇽Mexico City, Mexico
Moscow Scientific Research Institute for Pediatrics and Childrens Surgery of Rosmedtechnologies - Site 3804
🇷🇺Moscow, Russian Federation
Federal State Institution "Federal center of Heart, Blood and Endocrinology named after V.A.Almazov Rosmedtekhnologies" - Site 3802
🇷🇺St. Petersberg, Russian Federation
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
Cardiovascular Institute and Fuwai Hospital
🇨🇳Beijing, China
Hopital Necker-Enfants Malades, Service de Cardiologie Pédiatrique - Site 2201
🇫🇷Paris, France
The Children's Hospital - Site 9102
🇺🇸Aurora, Colorado, United States
Children's National Medical Center - Site 9104
🇺🇸Washington, 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
Justus-Liebig-Universität Giessen, Kinderherzzentrum - Site 1403
🇩🇪Giessen, Germany
Università Degli Studi di Padova - Dipartimento di Pediatria - Servizio di Cardiologia Pediatrica - Site 1501
🇮🇹Padova, Italy
Deutsches Herzzentrum Kinderkardiologie - Site 1401
🇩🇪Berlin, Germany
Universitätsklinikum Bonn Abteilung für Kinderkardiologie - Site 1404
🇩🇪Bonn, Germany
Schneider Children's Medical Center- Institute of pediatric cardiology - Site 7101
🇮🇱Petach Tikvah, Israel
Uniwersyteckie Centrum Kliniczne Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca - Site 3604
🇵🇱Gdansk, Poland
Ospedale Pediatrico "Bambino Gesù" - Dipartimento Medico Chirurgico di Cardiologia Pediatrica - Site 1502
🇮🇹Rome, Italy
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, Russian Federation
Scientific Center of Cardiovascular Surgery named after A.N.Bakulev of the RAMS - Site 3803
🇷🇺Moscow, Russian Federation
State Educational Institution of Higher Professional Education "Saint Petersburg State Pediatric Medical Academy of Roszdrav" - Site 3801
🇷🇺St. Petersburg, Russian Federation
Univerzitetska dečja klinika, Služba za kardiologiju - Site 3901
🇷🇸Belgrade, Serbia
Department of Paediatric Cardiology University of the Free State - Site 6001
🇿🇦Bloemfontein, South Africa
Clinical Diagnostic Center - Pediatric Cardiovascular and ANES and Intensive Care Department - Site 4103
🇺🇦Dnepropetrovsk, Ukraine
Gusak Ins Urgent and Recovery SUR AMS - Cardiovascular Rehabilitation Pediatric Department - Site 4101
🇺🇦Donetsk, Ukraine
Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, Gyermekgyógyászati Klinika és Gyermekegészségügyi Központ - Site 3402
🇭🇺Szeged, Hungary
Gottsegen György Országos Kardiológiai Intézet, Gyermekszív Központ, Gyermek Kardiológiai osztály - Site 3401
🇭🇺Budapest, Hungary
The Children's Hospital - Site 9102
🇺🇸Aurora, Colorado, United States
Children's National Medical Center - Site 9104
🇺🇸Washington, 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
🇮🇹Padova, 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, Russian Federation
Scientific Center of Cardiovascular Surgery named after A.N.Bakulev of the RAMS - Site 3803
🇷🇺Moscow, Russian Federation
Moscow Scientific Research Institute for Pediatrics and Childrens Surgery of Rosmedtechnologies - Site 3804
🇷🇺Moscow, Russian Federation
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
Clinical Diagnostic Center - Pediatric Cardiovascular and ANES and Intensive Care Department - Site 4103
🇺🇦Dnepropetrovsk, Ukraine
Federal State Institution "Federal center of Heart, Blood and Endocrinology named after V.A.Almazov Rosmedtekhnologies" - Site 3802
🇷🇺St. Petersberg, Russian Federation
State Educational Institution of Higher Professional Education "Saint Petersburg State Pediatric Medical Academy of Roszdrav" - Site 3801
🇷🇺St. Petersburg, Russian Federation
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
Hospital Universitario La Paz - Paediatric Cardiology Department - Site 1906
🇪🇸Madrid, Spain
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