CTRI/2011/06/001842招募中3 期
A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate the efficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHO
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 670
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
入选标准
- •1. Signed informed consent prior to initiation of any study-mandated procedure.
- •2. Male and female patients aged from 18 years to 75 years inclusive with symptomatic PAH.
- •3. Documented hemodynamic diagnosis of PAH.
排除标准
- •1. 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.
- •2. Patients with moderate or severe obstructive lung disease.
- •3. Patients with moderate or severe restrictive lung disease.
- •4. Patients with moderate or severe hepatic impairment (Child-Pugh B and C).
- •5. Patients with documented left ventricular dysfunction.
- •6. Patients with severe renal insufficiency.
- •7. Patients with BMI 18.5 Kg/m2.
研究者
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