FUTURE 3 Study Extension

Last updated: March 28, 2025
Sponsor: Actelion
Overall Status: Completed

Phase

3

Condition

Circulation Disorders

Williams Syndrome

Pulmonary Arterial Hypertension

Treatment

Bosentan

Clinical Study ID

NCT01338415
AC-052-374
2010-021793-12
  • Ages 3-12
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who completed the FUTURE 3 core study (AC-052-373) or prematurelydiscontinued due to PAH-progression, if bosentan was not permanently discontinued

  2. Patients who tolerated bosentan pediatric formulation and for whom bosentan isconsidered 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 anystudy-mandated procedure.

Exclusion

Exclusion Criteria:

  1. Known intolerance or hypersensitivity to bosentan or any of the excipients of thedispersible bosentan tablet

  2. Any clinically significant laboratory abnormality that precludes continuation ofbosentan 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.

Study Design

Total Participants: 58
Treatment Group(s): 1
Primary Treatment: Bosentan
Phase: 3
Study Start date:
March 08, 2011
Estimated Completion Date:
May 29, 2020

Connect with a study center

  • Royal Children's Hospital Melbourne, Cardiology - Site 5001

    Parkville, 3052
    Australia

    Site Not Available

  • The Republican Scientific-Practical Center "Cardiology" - Site 3001

    Minsk, 220036
    Belarus

    Site Not Available

  • Cardiovascular Institute and Fuwai Hospital

    Beijing, 100037
    China

    Site Not Available

  • West China 2nd university Hospital-Center of interventional diagnosis and therapy for Children's cardiovascular disease - Site 5104

    Chengdu, 610041
    China

    Site Not Available

  • Shanghai Children's Medical Center - Site 5102

    Shanghai, 200127
    China

    Site Not Available

  • Fakultní nemocnice v Motole, dětské kardiocentrum - Site 3301

    Prague, 150 06
    Czechia

    Site Not Available

  • Hopital Necker-Enfants Malades, Service de Cardiologie Pédiatrique - Site 2201

    Paris, 75743
    France

    Site Not Available

  • CHU de Toulouse - Hôpital des Enfants, Service de Cardiologie Pédiatrique - Site 2202

    Toulouse, 31059
    France

    Site Not Available

  • Deutsches Herzzentrum Kinderkardiologie - Site 1401

    Berlin, 13353
    Germany

    Site Not Available

  • Universitätsklinikum Bonn Abteilung für Kinderkardiologie - Site 1404

    Bonn, 53113
    Germany

    Site Not Available

  • Justus-Liebig-Universität Giessen, Kinderherzzentrum - Site 1403

    Giessen, 35392
    Germany

    Site Not Available

  • Gottsegen György Országos Kardiológiai Intézet, Gyermekszív Központ, Gyermek Kardiológiai osztály - Site 3401

    Budapest, 1096
    Hungary

    Site Not Available

  • Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, Gyermekgyógyászati Klinika és Gyermekegészségügyi Központ - Site 3402

    Szeged, 6720
    Hungary

    Site Not Available

  • CARE Hospitals, Cardiology Dep. Hyderabad - Site 5302

    Hyderabad, 500001
    India

    Site Not Available

  • Indraprashta Apollo Hospitals, Pediatric Cardiology - Site 5303

    New Dehli, 110076
    India

    Site Not Available

  • Indraprashta Apollo Hospitals, Pediatric Cardiology - Site 5303

    New Delhi, 110076
    India

    Site Not Available

  • Schneider Children's Medical Center- Institute of pediatric cardiology - Site 7101

    Petach Tikvah, 49202
    Israel

    Site Not Available

  • Università Degli Studi di Padova - Dipartimento di Pediatria - Servizio di Cardiologia Pediatrica - Site 1501

    Padova, 35128
    Italy

    Site Not Available

  • Ospedale Pediatrico "Bambino Gesù" - Dipartimento Medico Chirurgico di Cardiologia Pediatrica - Site 1502

    Rome, 00193
    Italy

    Site Not Available

  • Instituto Nacional de Cardiologia (INC) Ignacio Chavez - Site 8401

    Mexico City, 14080
    Mexico

    Site Not Available

  • Unidad de Investigacion Clinica en Medicina, SC (UDICEM) - Site 8402

    Monterrey, 64710
    Mexico

    Site Not Available

  • Universitair Medish Centrum Groningen, Kindercardiologie - Site 1601

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca - Site 3604

    Gdansk, 80-952
    Poland

    Site Not Available

  • Instytut Centrum Zdrowia Matki Polki Klinika Kardiologii ICMP w Lodz - Site 3602

    Lodz, 93-336
    Poland

    Site Not Available

  • Instytut Pomnik - Centrum Zdrowia Dziecka Klinika Kardiologii Dziecięcej - Site 3601

    Warszawa, 04-730
    Poland

    Site Not Available

  • Wojewódzki Szpital Specjalistyczny we Wrocławiu Oddział Kardiologii Dziecięcej z pododdziałem Intensywnego Nadzoru Kardiologicznego - Site 3605

    Wroclaw, 51-124
    Poland

    Site 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 Federation

    Site Not Available

  • Moscow Scientific Research Institute for Pediatrics and Childrens Surgery of Rosmedtechnologies - Site 3804

    Moscow, 125412
    Russian Federation

    Site Not Available

  • Scientific Center of Cardiovascular Surgery named after A.N.Bakulev of the RAMS - Site 3803

    Moscow, 121552
    Russian Federation

    Site Not Available

  • Federal State Institution "Federal center of Heart, Blood and Endocrinology named after V.A.Almazov Rosmedtekhnologies" - Site 3802

    St. Petersberg, 197341
    Russian Federation

    Site Not Available

  • State Educational Institution of Higher Professional Education "Saint Petersburg State Pediatric Medical Academy of Roszdrav" - Site 3801

    St. Petersburg, 194100
    Russian Federation

    Site 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
    Serbia

    Site Not Available

  • Univerzitetska dečja klinika, Služba za kardiologiju - Site 3901

    Belgrade, 11000
    Serbia

    Site Not Available

  • Department of Paediatric Cardiology University of the Free State - Site 6001

    Bloemfontein, 9300
    South Africa

    Site Not Available

  • Paediatric Cardiology Albert Luthuli Central Hospital - Site 6003

    Durban, 4001
    South Africa

    Site Not Available

  • Division of Paediatric Cardiology, Steve Biko Academic Hospital - Site 6002

    Pretoria, 0001
    South Africa

    Site Not Available

  • Hospital Universitatario Vall d'Hebron, Neumologia - Site 1907

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario La Paz - Paediatric Cardiology Department - Site 1906

    Madrid, 28046
    Spain

    Site Not Available

  • Clinical Diagnostic Center - Pediatric Cardiovascular and ANES and Intensive Care Department - Site 4103

    Dnepropetrovsk, 49060
    Ukraine

    Site Not Available

  • Gusak Ins Urgent and Recovery SUR AMS - Cardiovascular Rehabilitation Pediatric Department - Site 4101

    Donetsk, 83045
    Ukraine

    Site Not Available

  • Gover INS - Scientific Practical Cardiovascular Pediatric Center - MOH Ukraine - Site 4102

    Kiev, 01135
    Ukraine

    Site Not Available

  • The Children's Hospital - Site 9102

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Children's National Medical Center - Site 9104

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Children's National Medical Center - Site 9104

    Washington, D.C., District of Columbia 20010
    United States

    Site Not Available

  • Columbia University Medical Center Children's Hospital of New York Presbyterian - Site 9101

    New York, New York 10032
    United States

    Site Not Available

  • Texas Children's Hospital - Department of Cardiology - Site 9107

    Houston, Texas 77030
    United States

    Site Not Available

  • Seattle Children's Hospital - Site 9106

    Seattle, Washington 98105
    United States

    Site Not Available

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