EUCTR2007-002440-14-NL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
- •1.Signed informed consent prior to initiation of any study mandated procedure.
- •2.Patients with symptomatic pulmonary arterial hypertension (PAH) in modified WHO functional class II to IV.
- •3.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; or
- •iv.Drugs and toxins.
- •4.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 left ventricular end diastolic pressure (LVEDP) < 15 mmHg; and
- •c.Pulmonary vascular resistance (PVR) at rest >= 240 dyn*sec/cm5.
- •?For patients who participate in the pharmacokinetic/ pharmacodynamic substudy, hemodynamic evaluation must have been performed within 3 months prior to randomization.
- •?For all other patients, hemodynamic evaluation must have been performed within 1 year prior to randomization.
- •5.6-minute walk distance (6MWD) >= 50 m and = 475 m.
- •6.Men or women >= 12 years of age (women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception).
- •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
- •1.PAH associated with portal hypertension, thyroid disorders, glycogen storage disease, Gaucher’s disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders and splenectomy.
- •2.PAH associated with non corrected simple congenital systemic-to-pulmonary shunts, and combined and complex systemic-to-pulmonary shunts, corrected or non corrected.
- •3.PAH associated with significant venous or capillary involvement (PCWP > 15 mmHg), known pulmonary veno-occlusive disease, and pulmonary capillary hemangiomatosis.
- •4.Persistent pulmonary hypertension of the newborn.
- •5.Pulmonary Hypertension belonging to groups 2 to 5 of the Venice classification.
- •6.Moderate to severe obstructive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 65% of predicted value after bronchodilator administration.
- •7.Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted value.
- •8.Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
- •9.Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal.
- •10.Hemoglobin < 75% of the lower limit of the normal range.
- •11.Systolic blood pressure < 100 mmHg.
- •12.Acute or chronic physical impairment (other than dyspnea), limiting the ability to comply with study requirements.
- •13.Pregnant or breast-feeding.
- •14.Known concomitant life-threatening disease with a life expectancy < 12 months.
- •15.Body weight < 40 kg.
- •16.Any condition that prevents compliance with the protocol or adherence to therapy.
- •17.Recently started (< 8 weeks prior to randomization) or planned cardio-pulmonary rehabilitation program based on exercise.
- •18.Treatment with endothelin receptor antagonists (ERAs) within 3 months prior to randomization.
- •19.Systemic treatment within 1 week prior to randomization with cyclosporine A or tacrolimus, everolimus, sirolimus (calcineurin or mTOR inhibitors).
- •20.Known hypersensitivity to drugs of the same class as the study drug, or any of their excipients.
- •21.Planned treatment, or treatment, with another investigational drug within 1 month prior to randomization.
研究者
相似试验
招募中
4 期
The clinic research for Liu Shen capsule in the treatment of seasonal influenzaITMCTR1900002746The First Affiliated Hospital of Guangzhou Medical University
进行中（未招募）
1 期
A multicenter, double-blind, randomized, placebo-controlled, 4 parallel groups, dose-ranging trial evaluating the efficacy and safety of ucb 34714 used as adjunctive treatment at doses of 50, 150 and 400 mg/day in b.i.d. administration (oral capsules of 25 or 50 mg) for a maximum of 13 weeks in subjects from 16 to 65 years with refractory epilepsy suffering from partial onset seizures whether or not secondarily generalized - ucb 34714 dose-rangingEpilepsy - Refractory Partial Onset Seizure wheter or not secondarily generalized.MedDRA version: 7.1Level: LLTClassification code 10061334EUCTR2004-001856-35-BECB S.A. Pharma Sector245
进行中（未招募）
不适用
Clinical trial in children from 2 to 11 years with either allergic rhinonconjuctivitis or chronic urticaria in order to evaluate the safety and tolerability of 10 mg once daily bilastineEUCTR2012-003506-27-PTFAES FARMA, S.A.504
进行中（未招募）
1 期
A multicenter, double-blind, randomized, placebo-controlled, parallel-group, dose-response study of the safety and efficacy of a single treatment of BOTOX® (botulinum toxin type A) purified neurotoxin complex in patients with idiopathic overactive bladder with urinary urge incontinence.Idiopathic overactive bladder (symptoms of frequency and urgency) with urinary incontinence.MedDRA version: 7.1 Level: LLT Classification code 10059617EUCTR2005-001936-59-GBALLERGAN LTD270
已完成
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 hypertensio-I270 Primary pulmonary hypertensionPrimary pulmonary hypertensionI270PER-057-08Actelion Pharmaceuticals Ltd,7