EUCTR2009-014490-41-FR进行中（未招募）不适用
A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate theefficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON 2
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 272
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 18 years of age or older 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 (e.g., treprostinil, iloprost) 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: FEV1/FVC < 70% or FEV1 < 65% of predicted value after bronchodilator administration.
- •- Patients with moderate or severe restrictive lung disease:
- •Total Lung Capacity < 60% of predicted value.
- •- Patients with moderate or severe hepatic impairment (Child-Pugh B and C).
- •- Patients with clinically-relevant left ventricular dysfunction.
- •- Patients with clinically-significant chronic renal insufficiency (estimated creatinine clearance < 30 mL/min, or serum creatinine > 2.5 mg/dL).
- •- Patients with body weight < 40 kg.
研究者
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已完成
3 期
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