EUCTR2009-014490-41-SE进行中（未招募）不适用
A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHO
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,150
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
- •- Signed informed consent prior to initiation of any study-mandated procedure.
- •- Male and female patients aged from 18 years to 75 years inclusive with symptomatic PAH.
- •- Documented hemodynamic diagnosis of PAH.
- •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
- •- Patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) within 1 month before Baseline Visit, or are
- •scheduled to receive any of these compounds during the trial.
- •- Patients with moderate or severe obstructive lung disease.
- •- Patients with moderate or severe restrictive lung disease.
- •- Patients with moderate or severe hepatic impairment (Child-Pugh B and C).
- •- Patients with documented left ventricular dysfunction.
- •- Patients with severe renal insufficiency.
- •- Patients with BMI <18.5 Kg/m2.
研究者
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已完成
3 期
A multicenter, double-blind, placebo-controlled Phase 3 study assessing the safety and efficacy of selexipag on morbidity and mortality in patients with pulmonary arterial hypertensiohypertension in lung arteries10037454Pulmonary arterial hypertensionNL-OMON39263Actelion Pharmaceuticals20