EUCTR2007-002440-14-DE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
- 700
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
- •Eligible patients must meet all of the following inclusion criteria:
- •1. Signed informed consent prior to 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),
- •c. Related to:
- •i. Collagen vascular disease
- •ii. Simple (atrial septal defect, ventricular septal defect, patent ductus
- •arterious) congenital systemic to pulmonary shunts at least 1 year
- •post surgical repair
- •iii. HIV infection
- •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 mm Hg
- •b. Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic
- •pressure (LVEDP) = 15 mmHg
- •c. Pulmonary vascular resistance (PVR) at rest = 320 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 at screening and randomization
- •The 6MWT performed at screening and randomization must satisfy the following
- •requirements:
- •6MWT distance must be > 50 m or patient cannot be included in the study.
- •6MWT #2 (at Randomization) distance should be within 10% of 6MWT #1
- •distance (at Screening) or a third test is required (6MWT #3).
- •6MWT #3 (at Randomization) distance should be within 10% of 6MWT #2
- •distance or the patient cannot be included in the study.
- •6. Men or women = 12 years of age:
- •Only sites that have adequate pediatric pulmonary experience are allowed to enroll
- •patients between 12 and 17 year of age.
- •Women of childbearing potential* with a negative serum pre-treatment pregnancy test and who
- •consistently and correctly use (from screening and up to 28 days after study treatment
- •discontinuation) a reliable method of contraception with a Pearl index of < 1% (oral hormonal
- •contraceptive, implant, vaginal hormone ring, or intrauterine system [IUS]). During the entire
- •study duration and for at least 1 month after last study drug intake, their partner, if not
- •vasectomised, must use a condom in addition.
- •*A woman is considered to have childbearing potential unless she meets at least one of the
- •following criteria:
- •previous bilateral salpingo-oophorectomy or hysterectomy
- •premature ovarian failure confirmed by a specialist gynaecologist
- •pre-pubescence, XY genotype, Turner syndrome, uterine agenesis
- •age > 50 years and not treated with any kind of HRT for at least 2 years prior to
- •screening, with amenorrhea for at least 24 consecutive months prior to screening, and a
- 另有 7 项未显示
排除标准
- •1.PAH associated with portal hypertension, thyroid disorders, glycogen storage disease, Gaucher’s disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders or 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. Estimated Creatinine clearance <30mL/min
- •10.Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal.
- •11.Hemoglobin < 75% of the lower limit of the normal range.
- •12.Systolic blood pressure < 100 mmHg.
- •13.Acute or chronic physical impairment (other than dyspnea), limiting the ability to comply with study requirements.
- •14.Pregnant or breast-feeding.
- •15.Known concomitant life-threatening disease with a life expectancy < 12 months.
- •16.Body weight < 40 kg.
- •17.Any condition that prevents compliance with the protocol or adherence to therapy.
- •18.Recently started (< 8 weeks prior to randomization) or planned cardio-pulmonary rehabilitation program based on exercise.
- •19.Treatment with endothelin receptor antagonists (ERAs) within 3 months prior to randomization.
- •20.Systemic treatment within 4 weeks prior to randomization with cyclosporine A or tacrolimus, everolimus, sirolimus (calcineurin or mTOR inhibitors).
- •21. Treatment with CYP3A inducers within 4 weeks prior to randomization.
- •22.Known hypersensitivity to drugs of the same class as the study drug, or any of their excipients.
- •23.Planned treatment, or treatment, with another investigational drug within 1 month prior to randomization.
研究者
相似试验
进行中（未招募）
1 期
Efficacy and Safety of apraglutide in short bowel syndrome and intestinal failureEUCTR2020-001202-32-NOVectivBio AG164
进行中（未招募）
1 期
A research study to study the effects of a new oral drug called lucerastat in adults with Fabry diseaseFabry diseaseMedDRA version: 20.0Level: PTClassification code 10016016Term: Fabry's diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2017-003369-85-NLIdorsia Pharmaceuticals Ltd99
进行中（未招募）
不适用
A multicenter, double-blind, randomized, placebo-controlled, two-arm parallel-group study of BGG492 as monotherapy in individuals with refractory partial seizures undergoing inpatient evaluation for epilepsy surgeryMedDRA version: 9.1Level: LLTClassification code 10061334Term: Partial seizuresEpilepsyEUCTR2008-005065-64-DEovartis Pharma Services AG
进行中（未招募）
1 期
A research study to study the effects of a new oral drug called lucerastat in adults with Fabry diseaseFabry diseaseMedDRA version: 20.0Level: PTClassification code 10016016Term: Fabry's diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2017-003369-85-GBIdorsia Pharmaceuticals Ltd99
进行中（未招募）
不适用
A multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety and tolerability of AVE5530 when added to ongoing stable statin therapy at high doses in patients with severe primary hypercholesterolemiaPrimary HypercholesterolemiaMedDRA version: 11.0Level: LLTClassification code 10060375Term: <Manually entered code. Term in E.1.1>EUCTR2008-002849-23-BESanofi-Aventis Recherche & Développement668