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 range3 Months – 12 Years

SexALL

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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.

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