EUCTR2013-003462-14-IT进行中（未招募）1 期
A multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
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. Patients with symptomatic PAH in WHO Functional Class (FC) II or III.
- •3. Patients with PAH belonging to one of the following subgroups of the Dana Point Clinical Classification Group 1:
- •a. Idiopathic, or,
- •b. Heritable, or,
- •c. Drug or toxin induced, or,
- •d. Associated with one of the following:
- •i. Connective tissue disease,
- •ii. Congenital heart disease with simple systemic-to-pulmonary shunt at least 1 year after surgical repair,
- •iii. HIV infection.
- •4. Documented hemodynamic diagnosis of PAH by right heart catheterization – performed at any time prior to Screening showing:
- •a. Resting mean pulmonary arterial pressure (mPAP) = 25 mmHg and,
- •b. Resting pulmonary vascular resistance (PVR) > 240 dyn·s·cm-5 and,
- •c. Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) = 15 mmHg.
- •5. 6-minute walk distance (6MWD) = 150 m at Screening.
- •6. Able to fluently speak and read the local language.
- •7. Men or women aged 18–80; women of childbearing potential must:
- •a. have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to perform monthly serum pregnancy tests, and,
- •b. agree to use two reliable methods of contraception in parallel, from Screening Visit 1 until 1 month after study drug discontinuation.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Known moderate-to-severe obstructive lung disease (i.e., forced expiratory volume in one second [FEV1] < 80% of predicted, with FEV1 / forced vital capacity [FVC] < 70%) or known significant chronic lung disease diagnosed by chest imaging (e.g., interstitial lung disease, emphysema).
- •2. Known moderate-to-severe restrictive lung disease (i.e., total lung capacity [TLC] < 60% of predicted value).
- •3. Hemoglobin < 100g/L at Screening.
- •4. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 X the upper limit of the normal range (ULN) at Screening.
- •5. Patients undergoing dialysis.
- •6. Systolic blood pressure (SBP) < 90 mmHg at Screening.
- •7. Body weight < 40 kg at Screening.
- •8. Known concomitant life-threatening diseases with a life expectancy of < 12 months.
- •9. Treatment with endothelin receptor antagonists (ERAs) within 3 months prior to Visit 2, or scheduled to receive any of these compounds, other than macitentan, during the trial.
- •10. Treatment with intravenous or subcutaneous prostacyclin or prostacyclin analogs within 3 months prior to Visit 2, or scheduled to receive any of these compounds during the trial.
- •11. Treatment with soluble guanylate cyclase stimulator (riociguat) within 3 months prior to Visit 2, or scheduled to receive riociguat during the trial.
- •12. Patients who changed the dose of or discontinued phosphodiesterase type-5 inhibitors (PDE5i), inhaled prostacyclin analogues, or calcium channel blockers within 3 months prior to Visit 2.
- •13. Initiation of diuretics within 1 week prior to the Baseline period.
- •14. Patients on oral diuretics in whom the dose has not been stable for at least 1 week prior to the Baseline period.
- •15. Treatment with cytochrome P450 (CYP) 3A inducers within 4 weeks prior to Visit 2.
- •16. Recently started (< 8 weeks prior to Visit 2) or planned cardio-pulmonary rehabilitation program based on exercise.
- •17. Females who are lactating or pregnant (positive Screening or Baseline pregnancy test) or plan to become pregnant during the study.
- •18. Known hypersensitivity to macitentan or its excipients or drugs of the same class.
- •19. Treatment with another investigational drug within 3 months prior to Visit 2.
- •20. Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.
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