An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3

Actelion Pharmaceuticals Ltd.0 个研究点目标入组 64 人开始时间: 2010年12月3日最近更新: 2014年3月10日

适应症

试验速览

暂无简介。

•1. PAH diagnosis confirmed with RHC:
•- Idiopathic or heritable PAH, or
•- Associated PAH persisting after complete repair of a congenital heart defect (PAH has to be persistent for at least 6 months after surgery)
•2. WHO Functional Class I, II or III
•3. Male or female = 3 months and < 12 years of age (maximum age at randomization is 11.5 years)
•4. Body weight =3,5 kg
•5. Peripheral oxygen saturation (SpO2) = 88% (at rest, on room air)
•6. Baseline PAH-therapy (calcium channel blocker, bosentan, intravenous or inhaled prostanoid, oral PDE-5 inhibitor) if present, has to be stable for at least 3 months prior to screening.
•During the study, all background treatments should remain stable.
•7. Signed informed consent by the parents or legal representatives
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 64
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. PAH etiologies other than listed above
•2. Non-stable disease status
•3. Need or plan to wean patient from intravenous epoprostenol or intravenous or inhaled iloprost.
•4. Systolic blood pressure < 80% of the lower limit of normal range.
•5. AST and/or ALT values > 1.5 times the upper limit of normal range.
•6. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
•7. Hemoglobin and/or hematocrit levels < 75% of the lower limit of normal range.
•8. Known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible Tracleer tablet.
•9. Treatment with forbidden medication within 2 weeks or at least 5 times the half-life prior to randomization, whichever is the longest:
•-Glibenclamide (glyburide)
•-Cyclosporin A
•-Sirolimus
•-Tacrolimus
•-Fluconazole
•-Rifampicin (rifampin)
•-Ritonavir
•-Co-administration of CYP2C9 inhibitors (e.g., amiodarone, voriconazole) and moderate/strong CYP3A4 inhibitors (e.g., amprenavir, erythromycin, ketoconazole, diltiazem, itraconazole)
•-Endothelin receptor antagonists (ERAs) other than bosentan
•10. Treatment with another investigational drug within 1 month prior to randomization or planned treatment.

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