CTRI/2011/06/001843已完成3 期
An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety & efficacy of the pediatric formulation of Bosentan twice versus three times a day in children with pulmonary arterial hypertension - FUTURE 3
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 ≥ 2 years 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.
排除标准
- •1. PAH etiologies other than listed above
- •2. Non-stable disease status, e.g., history of recurrent (near-) syncope or signs and symptoms of noncompensated right heart failure.
- •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
研究者
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