A Multicenter Open Label Study to Evaluate Efficacy and Safety of China Made Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change From Baseline to 12 weeks and 24weeks in 6-minute Walk Distance
研究概览
简要总结
This multicenter, open label, single-arm study is aim at investigating the the efficacy and safety of china made ambrisentan in Chinese subjects with PAH.
详细描述
Pulmonary arterial hypertension is a hemodynamic and pathophysiological state, which can cause progressive hyperplasia of pulmonary vascular walls and elevated pulmonary arterial pressure for various reasons. Ambrisentan is a selective endothelin-A (ETA) receptor antagonist with vasodilatory, antiproliferative and vascular remodeling effects at a dose of 5 mg or 10 mg once daily, oral. A number of international clinical studies have shown that ambrisentan can improve the hemodynamic parameters, WHO functional classification and exercise tolerance of PAH patients, and improve the survival rate. The domestic Ambrisentan tablet is produced by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. under the trade name of "Pu Nuo An". It has been developed and completed according to the consistency evaluation standard after the bioequivalence test, and is currently listed in mainland China. In view of the low price of the domestic ambrisentan, in order to verify its efficacy and safety in the real world, this post-marketing multicenter clinical study was carried out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old and ≤75 years old, regardless of gender;
- •patients weighing ≥ 40 kg;
- •Patients diagnosed with PAH in Group 1 of the WHO Updated Clinical Classification of Pulmonary Hypertension (WHO functional class II or III);
- •6 min walk test (6MWT), walking distance ≥ 50 m;
- •Right heart catheterization performed within 6 months prior to screening and meeting the following hemodynamic criteria:
- •mean pulmonary artery pressure ≥ 25 mm Hg；
- •Pulmonary vascular resistance ≥ 240 dyn·s·cm-5;
- •Pulmonary artery wedge pressure or left ventricular end-diastolic pressure ≤ 15 mmHg;
- •Subject receiving calcium channel blocker (CCB) drugs, only those whose doses have been stabilized for more than 4 weeks at the time of screening are allowed to be included in the study;
- •Pulmonary function testing performed within 6 months prior to screening and meeting the following criteria：
- •Total lung capacity ≥ 60% of normal predicted value;
- •Forced expiratory volume in one second (FEV1) ≥ 55% of normal expected value;
- •Female subjects of childbearing potential must have a negative pregnancy test at the Screening Visit and Day 0;
- •Females subjects of childbearing potential must use a medically acceptable method of contraception (eg, hormone therapy, IUD, barrier methods such as condoms or cervical caps) during the study;
- •Sign written informed consent
排除标准
- •Patients diagnosed with WHO updated PH clinical classification of group 2, 3, 4, 5;
- •Endothelin receptor antagonist therapy (eg, bosentan) has been discontinued prior to enrollment due to safety or tolerability concerns (non-drug-induced liver function abnormalities);
- •Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 2 times ULN;
- •Serum bilirubin level > 1.5 times ULN;
- •severe hepatic insufficiency (Child-Pugh class C);
- •severe renal insufficiency (creatinine clearance <30 mL/min);
- •Hemoglobin concentration < 10 g/dL or hematocrit < 30%;
- •Contraindications to treatment identified by laboratory tests, physical examination, medical history, or other investigations
- •severe hypotension (diastolic < 50 mm Hg or systolic < 90 mm Hg);
- •Clinically significant aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, fatal arrhythmias, LV ejection fraction < 45%, LV outflow tract obstruction, symptomatic coronary heart disease, spontaneously low blood pressure;
- •A history of malignancy within 5 years prior to enrollment, except for basal cell carcinoma of the skin and carcinoma in situ of the cervix;
- •Subject taking endothelin receptor antagonists such as ambrisentan, bosentan and macitentan within 4 weeks prior to enrollment;
- •pregnant and lactating women;
- •Subject deemed unsuitable for participation in this study by other investigators
研究组 & 干预措施
ambrisentan
Open Label
干预措施: Ambrisentan (Drug)
结局指标
主要结局
Change From Baseline to 12 weeks and 24weeks in 6-minute Walk Distance
时间窗: Baseline, week 12 and week 24
The 6-minute walk test (6MWT) is a non-encouraged test, performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. These guidelines were provided to all sites. For patients who had never performed a 6MWT previously, a training test was required before the qualifying tests for inclusion were performed.
次要结局
- Number of participants with a change from baseline to week 12 and 24 in WHO functional class(Baseline, week 12 and week 24)
- Changes from baseline to week 12 and 24 in BNP plasma levels(Baseline, week 12 and week 24)
- Number and severity of Participants With Any Adverse Events(From Baseline to week 24)
- Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) up to Week 24, Assessed as the First Occurrence of a Clinical Worsening Events(From Baseline to week 24)
- Change from baseline to week 12 and 24 in Borg Dyspnea Index (BDI) sores(Baseline, week 12 and week 24)