FUTURE 3 Study Extension

Completed · Phase 3

Conditions studied: Pulmonary Arterial Hypertension

In brief

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).

Key facts

Study ID

NCT01338415

Run by

Actelion

People needed

58

Starts

2011-03-08

Expected to finish

2020-05-29

Last updated by the study team

2025-03-30

Who can join

Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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 — 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, 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

Full record on ClinicalTrials.gov

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