Phase 3 Completed N=64 Treatment

FUTURE 3 Study Extension

Source: ClinicalTrials.gov NCT01338415 ↗

Enrolled (actual)

Serious AEs

43.2%

Results posted

Dec 2017

Primary outcomePrimary: Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation — 29; 26 Participants

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation	29; 26	—

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01338415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.