EUCTR2007-002440-14-IT进行中（未招募）不适用
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel group, Event driven, Phase III study to assess the effects of ACT-064992 on Morbidity and Mortality in patients with Symptomatic Pulmonary Arterial Hypertension - SERAPHI
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 525
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
- •Signed informed consent prior to initiation of any study mandated procedure.Patients with symptomatic pulmonary arterial hypertension (PAH) in modified WHO functional class II to IV.Patients with the following types of PAH belonging to groups 1.1 to 1.3 of the Venice classification:a. Idiopathic (IPAH); b. Familial (FPAH); or c. Related to: i. Collagen vascular disease;ii. Simple, congenital systemic-to-pulmonary shunts at least 1 year post surgical repair;iii. HIV infection; oriv. Drugs and toxins.PAH diagnosis confirmed by hemodynamic evaluation performed prior to randomization and showing all of the following: a. Mean pulmonary artery pressure (mPAP) = 25 mmHg at rest,b. Pulmonary capillary wedge pressure (PCWP) or leftventricular end diastolic pressure (LVEDP) < 15 mmHg,andc. Pulmonary vascular resistance (PVR) at rest= 240 dyn·sec/cm5.
- •Are the trial subjects under 18? yes
- •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
- •PAH associated with portal hypertension, thyroid disorders, glycogen storage disease, Gaucher??s disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders and splenectomy.PAH associated with non corrected simple congenital systemic-to-pulmonary shunts, and combined and complex systemic-to-pulmonary shunts, corrected or non corrected.PAH Associated with significant venous or capillaryinvolvement (PCWP > 15 mmHg), Pulmonary veno-occlusive disease and Pulmonary capillary hemangiomatosis.Persistent pulmonary hypertension of the newborn.Pulmonary Hypertension belonging to groups 2 to 5 of the Venice classification.Pulmonary hypertension associated with moderate to severe obstructive lung disease: forced expiratory volume in one second/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 65% of predicted value after bronchodilator administration.Pulmonary hypertension associated with moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted value.Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal.Hemoglobin < 75% of the lower limit of the normal range.Systolic blood pressure < 100 mmHg.Acute or chronic physical impairment (other than dyspnea), limiting the ability to comply with study requirements.Pregnant or breast-feeding.Known concomitant life-threatening disease with a lifeexpectancy < 12 months.Body weight < 40 kg.Any condition that prevents compliance with the protocol or adherence to therapy.Recently started (< 8 weeks prior to randomization) or planned cardio-pulmonary rehabilitation program based on exercise.Treatment with endothelin receptor antagonists (ERAs) within 3 months prior to randomization.Systemic treatment within 1 week prior to randomization with cyclosporine A or tacrolimus, everolimus, sirolimus (calcineurin or mTOR inhibitors).Known hypersensitivity to drugs of the same class as the study drug, or any of their excipients.Planned treatment, or treatment, with another investigational drug within 1 month prior to randomization.
研究者
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