NCT00780728撤回3 期
Addition of Sildenafil to Bosentan Monotherapy in Patients With Pulmonary Arterial Hypertension (PAH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
研究概览
简要总结
This study will examine the effects of add-on sildenafil to bosentan monotherapy in patients with Pulmonary Arterial Hypertension. Patients on bosentan monotherapy will be followed every 6 months to assess if they have met the pre-defined treatment goals. If a patient fails to achieve these treatment goals or fails to maintain them, sildenafil will be added to their existing bosentan monotherapy. Patients will be assessed 6 months after start of combination therapy for changes in 6MWT, Borg dyspnea scale, WHO functional class, quality of life.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sildenafil
Active Comparator
干预措施: Sildenafil (Drug)
研究者
相似试验
已完成
3 期
Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers SyndromeEisenmenger SyndromeNCT00303004Rigshospitalet, Denmark20
尚未招募
2 期
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 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