CompletedPhase 3

FUTURE 3 Study Extension

United States, Australia, Belarus58 participantsStarted 2011-03-08

Plain-language 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).

Who can participate

Age range

3 Months – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Up to 62 weeks in average

Trial details

NCT IDNCT01338415

SponsorActelion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-08-13

Results submitted2017-09-20

View on ClinicalTrials.gov More Pulmonary Arterial Hypertension trials