A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Oxacom® in Different Dosages in Patients With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Pulmonary vascular resistance (PVR) will be measured to assess and evaluate the efficacy of study drug in comparison with placebo in patients with pulmonary arterial hypertension (PAH).
研究概览
简要总结
A multicenter, randomized, double-blind, placebo-controlled, phase II-III clinical trial to evaluate the efficacy and safety of the study drug in adult patients with pulmonary arterial hypertension (PAH).
The trial will evaluate the efficacy and safety of both single and multi-dose (seven-day) administrations of the study drug in three dosages: 0.03 mg/kg, 0.10 mg/kg, and 0.17 mg/kg.
The trial is an observer-blinded trial, since the appearance of the study drug and Placebo differs from each other. Patients included in the trial, as well as trial coordinators, investigators, and study center staff will be blinded. The only unblinded staff in the study centers will be those who preparing IP/Placebo and administering IP/Placebo to the study patients.
The trial will include 200 patients with PAH, who will be sequentially included in the trial in two stages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of PAH II or III functional class according to WHO classification
- •Symptomatic PAH group 1 according to clinical classification
- •Patients who have not previously received any PAH-specific therapy OR patients who have received endothelin receptor antagonists and/or iloprost/selexipag at stable doses for at least 3 months prior to the initial right heart catheterization.
- •Ability to perform reproducible 6-min walking test at the screening with a distance from 150 to 450 m.
排除标准
- •as per the study protocol
研究组 & 干预措施
0.030 mg\kg
干预措施: Oxacom (Drug)
0.170 mg\kg
干预措施: Oxacom (Drug)
0.100 mg\kg
干预措施: Oxacom (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pulmonary vascular resistance (PVR) will be measured to assess and evaluate the efficacy of study drug in comparison with placebo in patients with pulmonary arterial hypertension (PAH).
时间窗: 6 hours after the start of the IP administration
To evaluate the efficacy of single doses of the investigational product compared with placebo in patients with pulmonary arterial hypertension (PAH), we will measure pulmonary vascular resistance (PVR)
次要结局
未报告次要终点