EUCTR2010-018322-40-BE进行中（未招募）1 期
A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •1. Male or female aged 18 years and above
- •2. Patients with the following types of pulmonary arterial hypertension (PAH) belonging to WHO Group I:
- •Idiopathic (IPAH)
- •Heritable (HPAH)
- •Associated (APAH) with
- •o Connective tissue diseases
- •o Drugs and toxins
- •3. Patients treated with Flolan® for at least 12 months and on a stable dose for at least 3 month prior to enrollment
- •4. Patients who are currently treated with concomitant PAH therapy listed below must have been treated for at least 90 days and on a stable dose for 30 days prior to enrollment:
- •Ambrisentan
- •Sitaxsentan
- •Sildenafil
- •Tadalafil
- •5. Women of childbearing potential must use a reliable method of contraception
- •6. Signed informed consent prior to initiation of any study mandated procedure
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with respiratory and/or cardiovascular distress in need of emergency care
- •2. Known or suspicion of pulmonary veno-occlusive disease (PVOD)
- •3. Current use of IV inotropic agents
- •4. Current use of any prostacyclin or prostacyclin analog other than Flolan®
- •5. Tachycardia with heart rate > 120 beats/min at rest
- •6. PAH related to any condition other than those specified in the inclusion criteria
- •7. Known hypersensitivity to the formulations of EFI or any of its excipients, and Flolan® or any of its excipients
- •8. Cerebrovascular events (e.g., transient ischemic attack or stroke) within 6 months of screening
- •9. History of myocardial infarction
- •10. History of left-sided heart disease, including any of the following:
- •hemodynamically significant aortic or mitral valve disease
- •restrictive or congestive cardiomyopathy
- •left ventricular ejection fraction < 40% by multigated radionucleotide angiogram (MUGA), angiography, or echocardiography
- •unstable angina pectoris
- •life-threatening cardiac arrhythmias
- •11. Chronic bleeding disorders
- •12. Central venous line infection within 90 days prior to screening and/or a history of recurring line infections
- •13. Women who are pregnant or breast-feeding
- •14. Participation in another clinical trial, except observational, or receipt of an investigational product within 30 days prior to enrollment
- •15. Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease
- •16. Known concomitant life-threatening disease other than PAH with a life expectancy < 12 months
研究者
相似试验
进行中（未招募）
1 期
A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2Pulmonary Arterial HypertensionEUCTR2010-018322-40-FRACTELION Pharmaceuticals Ltd41
进行中（未招募）
不适用
A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2Pulmonary Arterial HypertensionMedDRA version: 12.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertensionEUCTR2010-018322-40-NLACTELION Pharmaceuticals Ltd35
已完成
3 期
A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertensio10037454Pulmonary arterial hypertensionNL-OMON36699Actelion Pharmaceuticals5
进行中（未招募）
1 期
Ph 3b, BIC/FTC/TAF to DTG/3TC FDC, 96 Week switch, efficacy, safety, and tolerability study in ART-experienced older adults living with HIV with virologic suppressioCTIS2022-503137-66-00Viiv Healthcare UK Limited200
进行中（未招募）
不适用
Study of the drug macitentan in patients with pulmonary arterial hypertension in order to test the French, Italian, and Spanish translations of a patient questionnaire called PAH-SYMPACT.Pulmonary arterial hypertensionHipertensión arterial pulmonarMedDRA version: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2013-003462-14-ESACTELION Pharmaceuticals Ltd.160