ARIES 1 and ARIES 2: Ambrisentan in PAH - A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 46
- 主要终点
- Change from baseline at Week 12 of six minute walk distance
研究概览
简要总结
The primary objective is to determine the effect of ambrisentan on exercise capacity in subjects with PAH.
详细描述
ARIES-1 in North America and Australia
ARIES-2 in Western and Eastern Europe, South America and Israel
Subjects in these randomized studies will receive one of two doses of ambrisentan or placebo. Inclusion is not based on a specified WHO functional classification. Rather, subjects with WHO Class I-IV symptoms are eligible if their 6-minute walk distance is 150-450 meters and they meet the study-specified hemodynamic criteria. Subjects with anorexigen or HIV infection related PAH are eligible but subjects with congenital heart disease and pediatric subjects are excluded. The study requires a historical cardiac catheterization and other diagnostic procedures.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic PAH (formally known as PPH), or PAH associated with collagen vascular disease, anorexigen use, or HIV infection;
- •Historical cardiac catheterization with the following hemodynamic criteria:
- •Mean pulmonary artery pressure greater than or equal to 25 mmHg; Pulmonary vascular resistance greater than 3 mmHg/L/min; Pulmonary capillary wedge pressure or left ventricular end diastolic pressure less than 15 mmHg;
- •6-minute walk distance of at least 150 meters, but no more than 450 meters;
- •Total lung capacity greater than or equal to 70% and FEV1 greater than or equal to 65% of predicted normal;
排除标准
- •Portopulmonary hypertension;
- •Subjects with PAH due to or associated with coronary artery disease, left heart disease, interstitial lung disease, chronic obstructive pulmonary disease, veno-occlusive disease, chronic thromboembolic disease, or sleep apnea;
- •Bosentan (Tracleer®), sildenafil (Viagra®), or chronic prostanoid therapy within 4 weeks of screening;
- •Serum ALT or AST lab value that is greater than 1.5 times the upper limit of normal;
- •Contraindication to treatment with an endothelin receptor antagonist;
- •Subject with cardiovascular, hepatic, renal, hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that may adversely affect the safety of the subject;
- •Participation in a clinical study involving another investigational drug within 4 weeks of screening.
结局指标
主要结局
Change from baseline at Week 12 of six minute walk distance
次要结局
- Change from baseline at Week 12 of:
- Borg Dsypnea Index
- WHO Functional Classification
- SF-36
- Time to Clinical Worsening