EUCTR2004-000478-30-DK进行中（未招募）不适用
Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 170
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
- •a)Men or women aged 12 years of age and over (except for countries where this age limit is contrary to specific regulatory requirements).
- •Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception during study treatment and for at least 3 months after study treatment termination.
- •–Reliable method of contraception are:
- •Barrier type devices (e.g., female condom, diaphragm, contraceptive sponge) only in combination with a spermicide.
- •Intra-uterine devices.
- •Oral, injectable or implantable contraceptives only in combination with a barrier method.
- •–Hormone-based contraceptives alone, regardless of the route of administration, are not considered as reliable methods of contraception.
- •–Abstention, rhythm method, and contraception by the partner alone are not acceptable methods of contraception.
- •Women not of childbearing potential are defined as prepubescent, postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile.
- •b)PAH in modified NYHA functional class II due to:
- •1.PAH idiopathic (Primary Pulmonary Hypertension)
- •2.PAH secondary to human immunodeficiency virus (HIV)
- •3.PAH secondary to anorexigens
- •4.PAH secondary to atrial septum defect (ASD) < 2 cm, ventricular septum defect (VSD) < 1 cm or patent ductus arteriosus (PAD)
- •5.PAH secondary to connective tissue or auto-immune diseases
- •c)6-minute walk test (6MWT) distance < 80% of normal predicted value (see Appendix 3 in protocol)
- •d)Mean pulmonary arterial pressure (mPAP) 25 mmHg and over, pulmonary capillary wedge pressure (PCWP) < 15 mmHg, and pulmonary vascular resistance (PVR) at rest 500 dyn.sec.cm-5 and over
- •e)Signed informed consent prior to initiation of any study-mandated procedure.
- •Are the trial subjects under 18? no
- •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 conditions other than those mentioned above, e.g., PAH secondary to portal hypertension, complex congenital heart disease or reverse shunt
- •2)Severe obstructive lung disease: FEV1/FVC < 0.5
- •3)Total lung capacity (TLC) < 80% of normal predicted value (see Appendix 4 in protocol)
- •4)Significant vasoreactivity during right heart catheterization: i.e., a fall in mPAP to < 40 mmHg with a decrease of 10 mmHg and over and with a normal cardiac index ( 2.5 l/min.m2 and over)
- •5)Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements (in particular with 6MWT)
- •6)Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements
- •7)Symptomatic lower limb vascular disease
- •8)HIV patient with opportunistic infection
- •9)Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
- •10)Aminotransferases, i.e., aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT) > 3 times the upper limit of the normal (ULN) range
- •11)Hemoglobin concentration < 75% of the lower limit of the normal range
- •12)Systolic blood pressure (BP) < 85 mmHg
- •13)Pregnancy or breast-feeding
- •14)Recently started (< 8 weeks prior to randomization) or planned cardio-pulmonary rehabilitation program based on exercise
- •15)Treatment or planned treatment with another investigational drug within 3 months of randomization.
- •16)Treatment with an endothelin receptor antagonist or with prostanoids (excluding acute administration during a catheterization procedure to test vascular reactivity) within 3 months of randomization.
- •17)Treatment for PAH within one month of randomization, excluding calcium channel blockers (if present for at least 1 month before randomization) and anticoagulants.
- •18)Treatment with calcineurin-inhibitors (e.g., cyclosporine A, tacrolimus), fluconazole, glibenclamide (glyburide) within 1 week of randomization.
- •19)Known hypersensitivity to bosentan or any of the excipients
研究者
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