PER-064-10已完成未知
A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY TO DEMONSTRATE THE EFFICACY AND SAFETY OF ACT-293987 IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSIO
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 15
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 75（—）
- 性别
- All
入选标准
- •Male and female patients 18-75 years old, with symptomatic PAH
- •PAH belonging to the following subgroups of the updated Dana Point Clinical Classification Group 1 (Idiopathic, or Heritable, or Drug or toxin induced, or Associated (APAH) with Connective tissue disease, Congenital heart disease with simple systemic-to-pulmonary shunt at least 1 year after surgical repair, or HIV infection)
- •Documented hemodynamic diagnosis of PAH by right heart catheterization, performed at any time prior to Screening
- •Six minute walk distance (6MWD) between 50 and 450 m at Screening within 2 weeks prior to the Baseline Visit
- •Signed informed consent
排除标准
- •Patients with pulmonary hypertension (PH) in the Updated Dana Point Classification Groups 2-5, and PAH Group 1 subgroups that are not covered by the inclusion criteria
- •Patients who have received prostacyclin or its analogs 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
- •Patients who are receiving or have been receiving any investigational drugs within 1 month before the Baseline Visit
- •Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements, in particular with 6MWT
- •Recently conducted or planned cardio-pulmonary rehabilitation program based on exercise training
- •Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements
- •Life expectancy less than 12 months
- •Females who are lactating or pregnant or plan to become pregnant during the study
- •Known hypersensitivity to any of the excipients of the drug formulations
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