EUCTR2015-002078-19-FR进行中（未招募）1 期
Prospective, multicenter, open-label study evaluating the effects of first-line oral combination therapy of macitentan and tadalafil in patients with newly diagnosed pulmonary arterial hypertension. - OPTIMA
ACTELION Pharmaceuticals France0 个研究点目标入组 46 人开始时间: 2015年8月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
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
入选标准
- •1.Signed informed consent prior to any study-mandated procedure.
- •2.Male or female = 18 and = 75 years of age at screening.
- •3.Initial PAH diagnosis < 6 months prior to Day 1.
- •4.Right heart catheterization (RHC) performed between Day -28 and Day 1 (RHC data obtained at the study site within this time frame, but before the study, i.e., before signed informed consent, are acceptable), meeting all the following criteria:
- •Resting mean pulmonary arterial pressure (mPAP) = 25 mmHg.
- •Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) = 15 mmHg.
- •PVR = 400 dyn·sec/cm5 (= 5 Wood units) if PCWP < 12 mmHg OR PVR = 500 dyn·sec/cm5 (= 6.25 Wood units) if PCWP in [12-15] mmHg.
- •Negative vasoreactivity test mandatory in idiopathic PAH (at this or a previous RHC).
- •5.World Health Organization (WHO) Functional Class (FC) II to III.
- •6.PAH etiology belonging to one of the following groups:
- •Idiopathic.
- •Heritable.
- •Anorexigens induced.
- •Associated with one of the following:
- •o Connective tissue disease
- •o Congenital heart disease with simple systemic-to-pulmonary shunt (atrial septal defect, ventricular septal defect, patent ductus arteriosus) = 1 year after surgical repair
- •o HIV infection
- •7.6MWD = 50 m at screening.
- •8.Women of childbearing potential [defined in Section 4.5.1] must:
- •Have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the Day 1 visit, and
- •Agree to perform monthly pregnancy tests up to 30 days after EOT2, and
- •Agree to use reliable contraception [defined in Section 4.5.2] from screening up to 30 days after EOT2. Reliable contraception must be started at least 11 days prior to Day 1.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Any PAH-specific drug therapy [e. g. any endothelin receptor antagonist, phosphodiesterase-5 inhibitors (PDE-5i), soluble guanylate cyclase stimulator, prostacyclin, prostacyclin analog, or prostacyclin receptor agonist] at any time prior to Day 1 (single-dose administration for vasoreactivity testing is permitted; previous iloprost used intermittently for the treatment of digital ulcers or Raynaud’s phenomenon is permitted if stopped > 6 months prior to Day 1).
- •2.Subjects who changed the dose or discontinued calcium channel blockers within 3 months prior to Day 1.
- •3.Initiation of diuretics within 1 week prior to RHC.
- •4.Subjects on oral diuretics in whom the dose has not been stable for at least 1 week prior to RHC.
- •5.Treatment with other PDE-5i for erectile dysfunction.
- •6.Treatment with strong inducers of CYP3A4 (e.g., carbamazepine, rifampin, rifampicin, rifabutin, rifapentin, phenobarbital, phenytoin, and St. John’s wort) = 28 days prior to Day 1.
- •7.Treatment with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, boceprevir, telaprevir, saquinavir, lopinavir, fosamprenavir, darunavir, tipranavir, atazanavir, nelfinavir, amprenavir, indinavir) = 28 days prior to Day 1.
- •8.History of priapism.
- •9.Significant aortic and mitral valve disease.
- •10.Pericardial constriction.
- •11.Significant left ventricular dysfunction in the opinion of the investigator.
- •12.Life-threatening arrhythmia.
- •13.Uncontrolled hypertension.
- •14.Symptomatic coronary artery disease.
- •15.Cardio-pulmonary rehabilitation program based on exercise (planned, or started = 12 weeks prior to Day 1).
- •16.Body mass index (BMI) > 40 kg/m2 at screening.
- •17.Acute myocardial infarction = 12 weeks prior to Day 1.
- •18.Known permanent atrial fibrillation.
- •19.Low blood pressure < 90/50 mmHg at screening or Day 1.
- •20.Ongoing or planned treatment with nitrates and/or doxazosin.
- •21.Presence of = 1 of the following signs of relevant lung disease at any time prior to Day 1:
- •DLCO < 40% of predicted value;
- •FEV1/FVC < 70% and FEV1 < 65% of predicted after bronchodilator administration;
- •Total Lung Capacity (TLC) < 60% of predicted.
- •22.Known or suspicion of pulmonary veno-occlusive disease (PVOD).
- •23.Severe renal insufficiency (estimated creatinine clearance = 30 mL/min/1.73m²) assessed by central laboratory at screening
- •24.Ongoing or planned dialysis.
- •25.Documented severe hepatic impairment (with or without cirrhosis) according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin > 3 x ULN accompanied by AST > ULN (assessed by central laboratory at screening); and/or Child Pugh Class C.
- •26.Serum AST and/or ALT > 3 x ULN (assessed by central laboratory at screening).
- •27.Porto-pulmonary hypertension.
- •28.Hemoglobin < 100 g/L assessed by central laboratory at screening.
- •29.Hypersensitivity to any active substance or excipient of macitentan or tad
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