CTIS2023-508734-34-00进行中（未招募）1 期
IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH) - AV-101-002
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 462
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Male or female between 18 and 75 years of age inclusive at the Screening Visit, A diagnosis of PAH belonging to one of the subgroups of the NICE classification of Group 1*: a. I/HPAH, PAH-CTD, b. PAH due to drugs and/or toxins/chemicals (having been in the care of the investigator for at least one year with no relapses of drug or toxin/chemical abuse), c. HIV associated or d. PAH due to repaired congenital heart disease (at least 1 year since repair). *Excluding patients with Portopulmonary Hypertension, World Health Organization (WHO) Functional Class II, III or IV symptoms, Must be able to walk a distance of at least 100 m but no more than 475 m during the screening 6-minute walk test.
排除标准
- •Pulmonary hypertension (PH) belonging to Groups 2 to 5 of the 2018 NICE classification and Group 1 diagnosed with Portopulmonary Hypertension., A history of left ventricular ejection fraction (LVEF) = 40% on echocardiogram within 12 months of screening, or clinically significant ischemic, mitral or aortic valve disease, or constrictive heart disease, in the opinion of the Investigator, Pregnant or breast-feeding females
研究者
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