Table 7: Paediatric studies included in the submission PK topic Age group Study ID Synopsis Intrinsic factor Children An open label, multicentre study to PK study assess the PK, tolerability, and safety reports FUTURE-1 of a paediatric formulation of bosentan in children with idiopathic or familial PAH. Population PK PopPK of bosentan in children with analyses PAH FUTURE-3 Uncontrolled Children An open label, long term, safety, and clinical studies tolerability extension study using FUTURE-2 the paediatric formulation of bosentan in the treatment of children with idiopathic or familial PAH who completed FUTURE-1. An open label, randomised, multicentre, multiple dose to FUTURE-3 evaluate the PK, tolerability, safety and efficacy of the paediatric formulation of bosentan BD versus TDS in children from 3 months to less than 12 years of age with PAH. A prospective multicentre, open extension of Future 3 to assess the FUTURE-3 safety, tolerability and efficacy of the extension paediatric formulation of bosentan BD versus TDS in children with PAH. Reports of This document is a compilation of analyses of data appendices referred to in the from more than FUTURE-2 Summary of Clinical Efficacy. one study FUTURE-3 FUTURE-4 This document provides an analysis of the pooled long term safety data FUTURE-1 from the FUTURE Study series 1 to 4 Extension. FUTURE-2 FUTURE-3
Table 7: Paediatric studies included in the submission PK topic Age group Study ID Synopsis Intrinsic factor PK study reports Children FUTURE-1 An open label, multicentre study to assess the PK, tolerability, and safety of a paediatric formulation of bosentan in children with idiopathic or familial PAH. Population PK analyses FUTURE-3 PopPK of bosentan in children with PAH Uncontrolled clinical studies Children FUTURE-2 An open label, long term, safety, and tolerability extension study using the paediatric formulation of bosentan in the treatment of children with idiopathic or familial PAH who completed FUTURE-1. FUTURE-3 An open label, randomised, multicentre, multiple dose to evaluate the PK, tolerability, safety and efficacy of the paediatric formulation of bosentan BD versus TDS in children from 3 months to less than 12 years of age with PAH. FUTURE-3 extension A prospective multicentre, open extension of Future 3 to assess the safety, tolerability and efficacy of the paediatric formulation of bosentan BD versus TDS in children with PAH. Reports of analyses of data from more than one study FUTURE-2 FUTURE-3 FUTURE-4 This document is a compilation of appendices referred to in the Summary of Clinical Efficacy. FUTURE-1 FUTURE-2 FUTURE-3 This document provides an analysis of the pooled long term safety data from the FUTURE Study series 1 to 4 Extension.
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