EUCTR2005-005068-97-SE进行中（未招募）不适用
Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2
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
- 350
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) Males or females >= 18 years of age
- •Women of childbearing potential must have a negative pre-treatment pregnancy test and must use reliable methods of contraception.
- •Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea for at least 1 year), or documented surgically or naturally sterile.
- •3) Patients with symptomatic PAH
- •4) Patients with the following types of PAH belonging to WHO Group I:
- •a. Idiopathic (IPAH)
- •b. Familial (FPAH)
- •c. Associated with (APAH):
- •i. Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%)
- •ii. Congenital systemic-to-pulmonary shunts at least 2 years post surgical repair
- •iii. Drugs and toxins
- •5) PAH diagnosed by right heart catheter showing:
- •a. Mean pulmonary arterial pressure
- •(mPAP) >=25 mmHg
- •b. Pulmonary capillary wedge pressure
- •(PCWP) <= 15 mmHg or left ventricular end diastolic pressure (LVEDP) <= 15 mmHg
- •If both PCWP and LVEDP are available then the LVEDP value is retained for inclusion
- •6) Treatment with a stable dose of sildenafil equal to or greater than 20 mg t.i.d. for at least 12 weeks prior to randomization (no sildenafil dosage adjustment should occur in this period)
- •7) 150 m <= 6MWT <= 480 m
- •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 belonging to WHO group II-V
- •2) PAH associated with portal hypertension and HIV infection
- •3) PAH associated with thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders and splenectomy
- •4) PAH associated with significant venous or capillary involvement (PCWP > 15 mmHg): pulmonary veno-occlusive disease and pulmonary capillary hemangiomatosis
- •5) Persistent pulmonary hypertension of the newborn
- •6) Significant valvular disease with valvular lesions to be excluded by echocardiogram within 2 years prior to randomization (i.e., patients with tricuspid or pulmonary insufficiency secondary to PAH can be included)
- •7) Restrictive lung disease: total lung capacity (TLC) < 60% of normal predicted value
- •8) Obstructive lung disease: forced expiratory volume/ forced vital capacity (FEV1/FVC) < 0.5
- •9) Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
- •10) Known HIV infection
- •11) Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements or that may interfere with the safety or the evaluation of the study, such as chronic infection, chronic renal failure etc.
- •12) Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements
- •13) Pregnancy or breast-feeding
- •14) Condition that prevents compliance with the protocol or adherence to therapy
- •15) Systolic blood pressure < 85 mmHg
- •16) Body weight < 40 kg
- •17) Hemoglobin < 75% of the lower limit of the normal range
- •18) Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal ranges
- •19) Known hypersensitivity or history of drug-related adverse events with bosentan (e.g., increase in liver function test results [LFTs]), or any of the excipients of its formulation
- •20) Receipt of an investigational product other than sildenafil within 3 months prior to randomization
- •21) Treatment with endothelin receptor antagonists (ERAs), prostanoids or phosphodiesterase (PDE) 5 inhibitors other than sildenafil within 3 months prior to randomization
- •22) Concomitant systemic treatment within 1 week prior to randomization with
- •calcineurin inhibitors (e.g., cyclosporine A and tacrolimus), sirolimus and everolimus
- •glibenclamide (glyburide)
- •inhibitors of both CYP2C9 and CYP3A4 (e.g., fluconazole, amiodarone, voriconazole)
- •combination of drugs that inhibit CYP2C9 and CYP3A4
- •23) Treatment with nitrates and alpha-blockers at time of randomization
- •24) In the opinion of the investigator – patients in need for treatment with any prostanoid up to Visit 4
- •25) Significant left ventricular dysfunction
研究者
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