NL-OMON36699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 Hypertension - EPITOME-2
Actelion Pharmaceuticals0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
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
- 18 至 99（—）
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 months 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:
- •* Bosentan
- •* 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
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 Epoprostenol for injection 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
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