CTRI/2022/06/043328尚未招募未知
Comparison of oral Sildenafil and Bosentan in the treatment of persistent pulmonary arterial hypertension in neonates
Department of Neonatology0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
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
- •Neonates with 34 weeks of completed gestational age who are echocardiographically diagnosed to have Persistent pulmonary hypertension of the newborn defined as
- •1.PASP of more than 35 mm of Hg calculation by TR peak jet velocity and Fio2 requirement > 21%
排除标准
- •1. Congenital heart disease (Except patent ductus arteriosus, atrial septal defect ( <6mm), or a single, small muscular ventricular septal defect ( <4 mm)
- •2. Congenital diaphragmatic hernia
- •3. Lethal congenital anomaly
- •4. Babies with severe PPHN with Oxygenation index (OI) > 15 and directly started on inhaled nitric oxide (iNO) on diagnosis.
研究者
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Sildenafil alone versus Bosentan as an Add-on for treatment of respiratory problem due to persistent fetal circulation among newbornsCTRI/2024/04/065318All India Institute of Medical Sciences AIIMS Rishikesh
进行中（未招募）
不适用
Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxinsMedDRA version: 9.1Level: LLTClassification code 10064908Term: Associated with (APAH)MedDRA version: 9.1Level: LLTClassification code 10064909Term: Idiopathic (IPAH)MedDRA version: 9.1Level: LLTClassification code 10064910Term: Familial (FPAH)EUCTR2005-005068-97-DKActelion Pharmaceuticals Ltd.350
进行中（未招募）
不适用
Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxinsMedDRA version: 9.1Level: LLTClassification code 10064908Term: Associated with (APAH)MedDRA version: 9.1Level: LLTClassification code 10064909Term: Idiopathic (IPAH)MedDRA version: 9.1Level: LLTClassification code 10064910Term: Familial (FPAH)EUCTR2005-005068-97-SEActelion Pharmaceuticals Ltd.350