NL-OMON54353招募中3 期
A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg - UNISUS
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 12
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
- •- Target population: greater than or equal to (><=) 18 (or the legal age of
- •consent in the jurisdiction in which the study is taking place) years of age
- •- Target population: Symptomatic Pulmonary Arterial Hypertension (PAH) in World
- •Health Organization,Functional Class (WHO FC) II, III, or IV
- •- Target population: PAH subtype falling in one of the below classifications:
- •Idiopathic; Heritable; Drug- or toxininduced; Related to: Connective tissue
- •disease, HIV infection, Portal hypertension, and Congenital heart disease with
- •small/coincidental cardiac defect with systemic-to-pulmonary shunt (for example
- •atrial septal defect, ventricular septal defect, patent ductus arteriosus,
- •atrioventricular septal defect) which does not account for the elevated
- •pulmonary vascular resistance (PVR) or persistent PAH documented by an Right
- •heart catheterization (RHC) ><= 1 year after simple systemic-to pulmonary shunt
- •- PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior
- •to screening: Mean pulmonary artery pressure (mPAP) greater than (>) 20
- •millimeters of mercury (mm Hg), and; Pulmonary artery wedge pressure (PAWP) or
- •left ventricular end diastolic pressure (LVEDP) less than or equal to (<<=) 15
- •mm Hg, and PVR ><= 3 Wood Units (that is, ><= 240 dyn*sec/cm^5)
- •- Able to perform the 6-minute walking test (6MWT) with a minimum distance of
- •50 meters (m) and maximum distance of 440m at screening. Participants able to
- •walk more than 440m at screening are eligible if they are in WHO FC III or IV
- •and n-terminal prohormone of brain natriuretic peptide or n-terminal pro B-type
- •natriuretic peptide (NT-proBNP) level is ><=300 nanograms per liter (ng/L) at
- •screening, based on central laboratory results
排除标准
- •- Known presence of three or more of the following risk factors for heart
- •failure with preserved ejection fraction at screening, based on records that
- •confirm documented medical history: Body mass index (BMI) > 30 kilograms per
- •meter square (kg/m^2), Diabetes mellitus of any type, Essential hypertension
- •(even if well controlled); Coronary artery disease, that is, any of the
- •following: history of stable angina, or known more than 50 percent (%) stenosis
- •in a coronary artery, or history of myocardial infarction, or history of or
- •planned coronary artery bypass grafting and/or coronary artery stenting
- •- Presence of moderate or severe obstructive lung disease (forced expiratory
- •volume in 1 second [FEV1] / forced vital capacity [FVC] < 70%; and FEV1 < 60%
- •of predicted after bronchodilator administration) ) in participants with a
- •known or suspected history of significant lung disease as documented by a
- •spirometry test performed within 1 year prior to screening
- •- Known moderate to severe hepatic impairment, defined as Child-Pugh Class B or
- •C, based on records that confirm documented medical history
- •- Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)
- •> 1.5*upper limit of normal (ULN) at screening
- •- Hemoglobin < 100 gram per liter (g/L) (< 10 gram per deciliter [g/dL]) at
研究者
相似试验
进行中（未招募）
1 期
A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersPulmonary arterial hypertensionEUCTR2019-002533-11-HUACTELION Pharmacteuticals Ltd.900
进行中（未招募）
1 期
A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersPulmonary arterial hypertensionEUCTR2019-002533-11-DEACTELION Pharmacteuticals Ltd.900
进行中（未招募）
1 期
A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.Pulmonary arterial hypertensionEUCTR2019-002533-11-PTACTELION Pharmacteuticals Ltd.900
进行中（未招募）
1 期
A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersPulmonary arterial hypertensionEUCTR2019-002533-11-SEACTELION Pharmacteuticals Ltd.900
进行中（未招募）
1 期
A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.Pulmonary arterial hypertensionEUCTR2019-002533-11-NOACTELION Pharmacteuticals Ltd.900