NL-OMON39263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 hypertension - GRIPHON (Prostacyclin (PGI2) Receptor agonist In PAH)
Actelion Pharmaceuticals0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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.
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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