Pulmonary Arterial HypertensionPhase 3FUTURE 3 ExtNCT01338415

FUTURE 3 Study Extension

A Phase 3 study testing Bosentan in people with Pulmonary Arterial Hypertension, run by Actelion at 36 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 3 months to 12 years
Conditions the study is for: Pulmonary Arterial Hypertension
What is being tested?: Bosentan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 36 sitesin 18 countries
Study dates: 8 Mar 2011to 29 May 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 months to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

36 sites in 18 countries.

Country

City, postcode or hospital

36 sites in 18 countries

Russia5 sites

RAMS Institution, Research Institute for complex issues of cardiovascular diseases, Siberian branch of the Russian Academy of Medical Sciences - Site 3805
Kemerovo, 650002
Scientific Center of Cardiovascular Surgery named after A.N.Bakulev of the RAMS - Site 3803
Moscow, 121552
Moscow Scientific Research Institute for Pediatrics and Childrens Surgery of Rosmedtechnologies - Site 3804
Moscow, 125412
Federal State Institution "Federal center of Heart, Blood and Endocrinology named after V.A.Almazov Rosmedtekhnologies" - Site 3802
Saint Petersberg, 197341
State Educational Institution of Higher Professional Education "Saint Petersburg State Pediatric Medical Academy of Roszdrav" - Site 3801
Saint Petersburg, 194100

Other trials in Russia

United States3 sites

The Children's Hospital - Site 9102
Aurora, Colorado, 80045
Columbia University Medical Center Children's Hospital of New York Presbyterian - Site 9101
New York, New York, 10032
Children's National Medical Center - Site 9104
Washington D.C., District of Columbia, 20010

Other trials in United States

Germany3 sites

Deutsches Herzzentrum Kinderkardiologie - Site 1401
Berlin, 13353
Universitätsklinikum Bonn Abteilung für Kinderkardiologie - Site 1404
Bonn, 53113
Justus-Liebig-Universität Giessen, Kinderherzzentrum - Site 1403
Giessen, 35392

Other trials in Germany

Ukraine3 sites

Clinical Diagnostic Center - Pediatric Cardiovascular and ANES and Intensive Care Department - Site 4103
Dnipro, 49060
Gusak Ins Urgent and Recovery SUR AMS - Cardiovascular Rehabilitation Pediatric Department - Site 4101
Donetsk, 83045
Gover INS - Scientific Practical Cardiovascular Pediatric Center - MOH Ukraine - Site 4102
Kiev, 01135

Other trials in Ukraine

China2 sites

Cardiovascular Institute and Fuwai Hospital
Beijing, 100037
Shanghai Children's Medical Center - Site 5102
Shanghai, 200127

Other trials in China

France2 sites

Hopital Necker-Enfants Malades, Service de Cardiologie Pédiatrique - Site 2201
Paris, 75743
CHU de Toulouse - Hôpital des Enfants, Service de Cardiologie Pédiatrique - Site 2202
Toulouse, 31059

Other trials in France

Hungary2 sites

Gottsegen György Országos Kardiológiai Intézet, Gyermekszív Központ, Gyermek Kardiológiai osztály - Site 3401
Budapest, 1096
Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, Gyermekgyógyászati Klinika és Gyermekegészségügyi Központ - Site 3402
Szeged, 6720

Other trials in Hungary

Italy2 sites

Università Degli Studi di Padova - Dipartimento di Pediatria - Servizio di Cardiologia Pediatrica - Site 1501
Padova, 35128
Ospedale Pediatrico "Bambino Gesù" - Dipartimento Medico Chirurgico di Cardiologia Pediatrica - Site 1502
Rome, 00193

Other trials in Italy

Poland2 sites

Uniwersyteckie Centrum Kliniczne Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca - Site 3604
Gdansk, 80-952
Wojewódzki Szpital Specjalistyczny we Wrocławiu Oddział Kardiologii Dziecięcej z pododdziałem Intensywnego Nadzoru Kardiologicznego - Site 3605
Wroclaw, 51-124

Other trials in Poland

Serbia2 sites

Univerzitetska dečja klinika, Služba za kardiologiju - Site 3901
Belgrade, 11000
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

Other trials in Serbia

South Africa2 sites

Department of Paediatric Cardiology University of the Free State - Site 6001
Bloemfontein, 9300
Division of Paediatric Cardiology, Steve Biko Academic Hospital - Site 6002
Pretoria, 0001

Other trials in South Africa

Spain2 sites

Hospital Universitatario Vall d'Hebron, Neumologia - Site 1907
Barcelona, 08035
Hospital Universitario La Paz - Paediatric Cardiology Department - Site 1906
Madrid, 28046

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Australia1 site

Royal Children's Hospital Melbourne, Cardiology - Site 5001
Parkville, 3052

Other trials in Australia

Belarus1 site

The Republican Scientific-Practical Center "Cardiology" - Site 3001
Minsk, 220036

Other trials in Belarus

Czechia1 site

Fakultní nemocnice v Motole, dětské kardiocentrum - Site 3301
Prague, 150 06

Other trials in Czechia

India1 site

CARE Hospitals, Cardiology Dep. Hyderabad - Site 5302
Hyderabad, 500001

Other trials in India

Israel1 site

Schneider Children's Medical Center- Institute of pediatric cardiology - Site 7101
Petach Tikvah, 49202

Other trials in Israel

Mexico1 site

Instituto Nacional de Cardiologia (INC) Ignacio Chavez - Site 8401
Mexico City, 14080

Other trials in Mexico

About this study

Official title: A Prospective, Multicenter, Open-label Extension of FUTURE 3 to Assess the Safety, Tolerability and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension

Conditions: Pulmonary Arterial Hypertension
Being tested: Bosentan
Keywords: pediatric, pulmonary arterial hypertension, bosentan, Tracleer
Medical subject headings: Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BosentanDrug
Also called ACT-050088
Oral dispersible tablet administered as 2mg/kg two (b.i.d.) or three (t.i.d.) times per day

Study groups in NCT01338415
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: Bosentan

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 62 weeks in average

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Mar 201129 May 2020

First posted19 Apr 2011 (estimated)
Study start8 Mar 2011
Primary completion13 Aug 2014
Study completion29 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01338415
Sponsor's protocol ID: AC-052-374
Other IDs: 2010-021793-12
Acronym: FUTURE 3 Ext
Status last verified: Mar 2025
First submitted: 15 Apr 2011
Last updated: 30 Mar 2025
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Asthma and Primary Arterial Hypertension: an Inflammatory Link?
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HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
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RecruitingPhase 2
Spironolactone for Pulmonary Arterial Hypertension
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RecruitingPhase 1/2
A Study of HS235 for Treatment of Pulmonary Arterial Hypertension (PAH) in Adults
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Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
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All Pulmonary Arterial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Open-label Extension of FUTURE 3 to Assess the Safety, Tolerability and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension
ClinicalTrials.gov ID: NCT01338415
Acronym / sponsor ID: FUTURE 3 Ext / AC-052-374
Conditions: Pulmonary Arterial Hypertension
Keywords: pediatric, pulmonary arterial hypertension, bosentan, Tracleer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: ActelionIndustry (pharma, biotech, devices)
Study start: 8 Mar 2011 (actual)
Primary completion: 13 Aug 2014 (actual)
Study completion: 29 May 2020 (actual)
First posted: 19 Apr 2011 (estimated)
Results: Posted 11 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
bosentan 2mg/kg b.i.d.	Experimental	Drug: BosentanPatients 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.	Experimental	Drug: BosentanPatients 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

Who may qualify

Ages: 3 months to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BosentanAlso: ACT-050088Oral dispersible tablet administered as 2mg/kg two (b.i.d.) or three (t.i.d.) times per day	Drug	bosentan 2mg/kg b.i.d., bosentan 2mg/kg t.i.d.

Primary outcome

Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation
Time frame: 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.

Results and safety

Results posted to the registry on 11 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bosentan 2mg/kg b.i.d.	33	23
Bosentan 2mg/kg t.i.d.	31	22
Bosentan 2mg/kg b.i.d or t.i.d. During EUTP	0	0

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

Time frame: Up to 62 weeks in average. Count of participants. Unit: Participants

Measure	Bosentan 2mg/kg b.i.d. n = 33	Bosentan 2mg/kg t.i.d. n = 31
Value	29	26

Population analysed: The analysis was performed on the Safety population analysis set, including all patients who received at least one dose of study treatment and evaluated according to the study treatment that they received.

Adverse events

Time frame: From baseline up to end of treatment (and up to additional 60 days for serious adverse events and deaths), i.e. an average of 62 weeks and for EUTP: up to 7 days after discontinuation of study drug (approximately 3 years and 4 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bosentan 2mg/kg b.i.d.	15 of 33 (45.5%)	24 of 33 (72.7%)	8 of 33
Bosentan 2mg/kg t.i.d	13 of 31 (41.9%)	23 of 31 (74.2%)	4 of 31
Bosentan 2mg/kg b.i.d or t.i.d. During EUTP	4 of 10 (40%)	8 of 10 (80%)	1 of 10

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pulmonary Arterial Hypertension

RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
RecruitingPhase 2
Spironolactone for Pulmonary Arterial Hypertension
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A Study of HS235 for Treatment of Pulmonary Arterial Hypertension (PAH) in Adults
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Active, not recruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

36 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bosentan in people with Pulmonary Arterial Hypertension, run by Actelion at 36 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Russia, United States, Germany, Ukraine, China and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation (time frame: Up to 62 weeks in average). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01338415.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.