EUCTR2006-000021-57-DK进行中（未招募）不适用
Bosentan and Sildenfil for patients with Eisenmenger syndrome
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- •Eisenmenger Syndrome
- •Al least 18 years old
- •Negative pregnancy test
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Raised liver enzymes to more than 3 times normal values.
- •Recently stroke or myocardial infarction(3 months)
- •Allergy to medication
研究者
相似试验
已完成
不适用
Bosentan, an endothelin-receptor antagonist, in the treatment of pulmonary hypertension in severe chronic obstructive pulmonary disease: a prospective, double-blind, placebo-controlled trialChronic obstructive pulmonary diseaseRespiratoryISRCTN98252311niversity Hospital Basel (USB) (Switzerland)24
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