FUTURE-2: Results from an open-label, long-term safety and tolerability extension study using the pediatric FormUlation of bosenTan in pUlmonary arterial hypeRtEnsion

Berger, Rolf M F; Haworth, Sheila G; Bonnet, Damien; Dulac, Yves; Fraisse, Alain; Galiè, Nazzareno; Ivy, D Dunbar; Jaïs, Xavier; Miera, Oliver; Rosenzweig, Erika B; Efficace, Michela; Kusic-Pajic, Andjela; Beghetti, Maurice

doi:10.1016/j.ijcard.2015.08.080

Scientific article

English

FUTURE-2: Results from an open-label, long-term safety and tolerability extension study using the pediatric FormUlation of bosenTan in pUlmonary arterial hypeRtEnsion

ContributorsBerger, Rolf M F; Haworth, Sheila G; Bonnet, Damien; Dulac, Yves; Fraisse, Alain; Galiè, Nazzareno; Ivy, D Dunbar; Jaïs, Xavier; Miera, Oliver; Rosenzweig, Erika B; Efficace, Michela; Kusic-Pajic, Andjela; Beghetti, Maurice

Published inInternational Journal of Cardiology, vol. 202, p. 52-58

Publication date2016

Abstract

A novel formulation of bosentan was evaluated in children with pulmonary arterial hypertension (PAH) in FUTURE-1, which characterized its pharmacokinetic and clinical profile. The subsequent phase III, open-label, long-term extension study, FUTURE-2, aimed to provide long-term tolerability, safety and exploratory efficacy data.

Keywords

Administration, Oral
Adult
Biomarkers, Pharmacological/metabolism
Dose-Response Relationship, Drug
Drug Tolerance
Endothelin Receptor Antagonists/administration & dosage/pharmacokinetics
Familial Primary Pulmonary Hypertension/drug therapy/metabolism/mortality
Female
Follow-Up Studies
Global Health
Humans
Male
Sulfonamides/administration & dosage/pharmacokinetics
Survival Rate/trends
Time Factors
Treatment Outcome

Affiliation entities

Faculté de médecine / Section de médecine clinique / Département de pédiatrie, gynécologie et obstétrique

Research groups

L'hypertension pulmonaire (pédiatrie) (228)

Citation (ISO format)

BERGER, Rolf M F et al. FUTURE-2: Results from an open-label, long-term safety and tolerability extension study using the pediatric FormUlation of bosenTan in pUlmonary arterial hypeRtEnsion. In: International Journal of Cardiology, 2016, vol. 202, p. 52–58. doi: 10.1016/j.ijcard.2015.08.080

Article (Published version)

Identifiers

PID : unige:96702
DOI : 10.1016/j.ijcard.2015.08.080
PMID : 26386921

Journal ISSN0167-5273

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FUTURE-2: Results from an open-label, long-term safety and tolerability extension study using the pediatric FormUlation of bosenTan in pUlmonary arterial hypeRtEnsion

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