EUCTR2011-004106-16-NL进行中（未招募）1 期
A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent by the parents or legal representatives prior to any study mandated procedure.
- •2. Male or female = 1 year and < 17 years of age (maximum age
- •at randomization is 16 years and 9 months).
- •3. WHO functional class I–IV.
- •4. PAH diagnosed with Right Heart Catheterization (RHC).
- •5. PAH etiologies:
- •Idiopathic or heritable PAH,
- •Associated PAH persisting/recurrent for at least 6 months
- •after complete repair of a congenital heart defect,
- •CHD (PAH associated with systemic-to-pulmonary shunts
- •including Eisenmenger syndrome).
- •6. PVR > 3 Wood units for idiopathic, heritable PAH or PAH
- •persisting/recurrent after complete repaired of congenital
- •heart defect.
- •PVR > 8 Wood units for PAH associated with systemic-to-pulmonary open shunts with a ratio Qp/Qs < 2.
- •7. Body weight = 8 kg and = 95 kg.
- •8. Patients naïve to PAH-specific treatment
- •Patients already treated with PAH-specific medication at a stable dose since at least 3 months:
- •Prostanoids, PDE-5 inhibitors
- •No combination of PAH-specific therapy is allowed.
- •9. Patients naïve to PAH related, non-specific medication
- •Patients already treated with PAH related, non-specific medication, such as
- •Calcium channel blockers (stable dose since at least 3 months)
- •Anticoagulants
- •10. Females of childbearing potential must have a negative
- •pre-treatment pregnancy test and must use reliable methods of
- •contraception during the whole treatment period and for 1 month after study drug discontinuation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 105
- •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
排除标准
- •1. Non-stable disease status, e.g., history of recurrent (near-)
- •syncope or signs and symptoms of non-compensated right heart failure.
- •2. Patients with bronchopulmonary dysplasia, congenital
- •diaphragmatic hernia or other chronic lung diseases.
- •3. Need or plan to wean patient from any PAH-specific therapies
- •during the study.
- •4. Systolic blood pressure < 80% of the lower limit of normal
- •5. Aspartate aminotransferase (AST) and/or alanine
- •aminotransferase (ALT) values > 1.5 times the upper limit of
- •normal range.
- •6. Moderate or severe hepatic impairment (i.e., Child-Pugh Class
- •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 bosentan dispersible tablet.
- •9. Treatment with bosentan or any other endothelin receptor
- •antagonists within 4 months prior to randomization (including any ERA investigational drug).
- •10. Treatment with another investigational drug within 1 month
- •prior to randomization or planned treatment.
- •11. Pregnancy or breastfeeding.
- •12. Any condition that prevents compliance with the protocol or
- •adherence to therapy.
- •13. Administration of prohibited medication within 2 weeks or
- •5 times the half-life, prior to randomization, whichever is the
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