TCTR20230816006招募中1 期
comparative efficacy of sildenafil and bosentan in newborn with persistent pulmonary hypertension
self0 个研究点目标入组 84 人开始时间: 2023年8月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 84
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
- 年龄范围
- 1 Days 至 10 Days（—）
- 性别
- All
入选标准
- •1. less than 10 days of age of either gender greater than 34 weeks of gestational age
- •echocardiographic findings according to operational definations
- •2. new born with sign and symptoms of PPHN not related to any secondary cause
排除标准
- •1. babies with congenital heart disease except atrieal septal defect
- •other cyanosis diseases and PPHN caused by pneumonia or meconium aspiration
- •ventriculo septal defect
- •2. babies with active seiures pneumothorax and other congenital anomalies
研究者
相似试验
尚未招募
不适用
To compare oral Sildenafil and Bosentan in the treatment of pulmonary hypertension in neonatesCTRI/2022/06/043328Department of Neonatology
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 10064910Term: Familial (FPAH)MedDRA version: 9.1Level: LLTClassification code 10064909Term: Idiopathic (IPAH)EUCTR2005-005068-97-CZActelion 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
进行中（未招募）
1 期
A clinical trial to investigate the safety and effectiveness of the combination of bosentan and sildenafil to treat patients with symptomatic pulmonary arterial hypertension in comparison to treatment with sildenafil on its owPatients 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: 14.1Level: LLTClassification code 10064910Term: Familial (FPAH)System Organ Class: 100000004855MedDRA version: 14.1Level: LLTClassification code 10064909Term: Idiopathic (IPAH)System Organ Class: 100000004855MedDRA version: 14.1Level: LLTClassification code 10064908Term: Associated with (APAH)System Organ Class: 100000004855EUCTR2005-005068-97-SKActelion Pharmaceuticals Ltd.350