FUTURE 3 Study Extension

NCT01338415 | Completed Phase 3 Results

• 2 other identifiers: AC-052-3742010-021793-12
• Study Type: interventional
• Target: 58
• Locations: 18 countries
• Sites: 36

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).

Conditions

Pulmonary Arterial Hypertension

Keywords

pediatric; pulmonary arterial hypertension; bosentan; Tracleer

Outcome Measures

Primary Outcomes (1)

• Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation

  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.

  Up to 62 weeks in average

Other Outcomes (16)

• Change From Baseline up to 12 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC)

  At Month 12

• Change From Baseline up to 18 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC)

  At Month 18

• Change From Baseline up to 12 Months of Study Treatment in the Global Clinical Impression Scale (GCIS)

  At Month 12

Study Arms (2)

bosentan 2mg/kg b.i.d.

EXPERIMENTAL

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

Drug: Bosentan

bosentan 2mg/kg t.i.d.

EXPERIMENTAL

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

Drug: Bosentan

Interventions

Bosentan DRUG

Oral dispersible tablet administered as 2mg/kg two (b.i.d.) or three (t.i.d.) times per day

Also known as: ACT-050088

bosentan 2mg/kg b.i.d.; bosentan 2mg/kg t.i.d.

Eligibility Criteria

• Age: 3 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Actelion: lead

Study Sites (36)

The Children's Hospital - Site 9102

Aurora, Colorado, 80045, United States

Location

Children's National Medical Center - Site 9104

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

Location

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

New York, New York, 10032, United States

Location

Royal Children's Hospital Melbourne, Cardiology - Site 5001

Parkville, 3052, Australia

Location

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

Minsk, 220036, Belarus

Location

Cardiovascular Institute and Fuwai Hospital

Beijing, 100037, China

Location

Shanghai Children's Medical Center - Site 5102

Shanghai, 200127, China

Location

Fakultní nemocnice v Motole, dětské kardiocentrum - Site 3301

Prague, 150 06, Czechia

Location

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

Paris, 75743, France

Location

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

Toulouse, 31059, France

Location

Deutsches Herzzentrum Kinderkardiologie - Site 1401

Berlin, 13353, Germany

Location

Universitätsklinikum Bonn Abteilung für Kinderkardiologie - Site 1404

Bonn, 53113, Germany

Location

Justus-Liebig-Universität Giessen, Kinderherzzentrum - Site 1403

Giessen, 35392, Germany

Location

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

Budapest, 1096, Hungary

Location

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

Szeged, 6720, Hungary

Location

CARE Hospitals, Cardiology Dep. Hyderabad - Site 5302

Hyderabad, 500001, India

Location

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

Petach Tikvah, 49202, Israel

Location

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

Padua, 35128, Italy

Location

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

Rome, 00193, Italy

Location

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

Mexico City, 14080, Mexico

Location

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

Gdansk, 80-952, Poland

Location

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

Wroclaw, 51-124, Poland

Location

RAMS Institution, Research Institute for complex issues of cardiovascular diseases, Siberian branch of the Russian Academy of Medical Sciences - Site 3805

Kemerovo, 650002, Russia

Location

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

Moscow, 121552, Russia

Location

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

Moscow, 125412, Russia

Location

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

Saint Petersberg, 197341, Russia

Location

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

Saint Petersburg, 194100, Russia

Location

Univerzitetska dečja klinika, Služba za kardiologiju - Site 3901

Belgrade, 11000, Serbia

Location

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

Location

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

Bloemfontein, 9300, South Africa

Location

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

Pretoria, 0001, South Africa

Location

Hospital Universitatario Vall d'Hebron, Neumologia - Site 1907

Barcelona, 08035, Spain

Location

Hospital Universitario La Paz - Paediatric Cardiology Department - Site 1906

Madrid, 28046, Spain

Location

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

Dnipro, 49060, Ukraine

Location

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

Donetsk, 83045, Ukraine

Location

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

Kiev, 01135, Ukraine

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was uncontrolled and exploratory. The main purpose of exceptional use treatment period of FUTURE 3 extension was to provide participants with bosentan beyond 12-month treatment period of FUTURE 3 extension. Providing bosentan as a study treatment required monitoring safety on an individual participant-level. No formal hypothesis was formulated, therefore results were exploratory.

Results Point of Contact

• Title: Principal Clinical Scientist
• Organization: Actelion Pharmaceuticals Ltd

ClinicalTrialDisclosure@its.jnj.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 19, 2011
• Study Start: March 8, 2011
• Primary Completion: August 13, 2014
• Study Completion: May 29, 2020
• Last Updated: March 30, 2025
• Results First Posted: December 11, 2017

Record last verified: 2025-03

Locations

IN (1); CN (2); ME (1); ES (2); RU (5); ZA (2); AU (1); IT (2); US (3); DE (3); FR (2); PL (2); IL (1); UA (3); CZ (1); SE (2); BE (1); HU (2)