EUCTR2021-001910-13-IE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). - IMPAHCT
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
- 性别
- All
入选标准
- •Key Inclusion Criteria:
- •1. Male or female adults (between 18 and 75 years) at the Screening
- •Visit within 28 days prior to Day 1
- •2. Subjects with a diagnosis of PAH belong to one of the subgroups of the NICE classification of Group 1:
- •- a. I/HPAH, PAH-CTD
- •- b. PAH due to drugs and toxins (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
- •3. World Health Organization (WHO) Functional Class II, III or IV
- •4. 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 323
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 139
排除标准
- •Key Exclusion Criteria:
- •1. PH belonging to Groups 2 to 5 of the 2018 NICE classification and Group 1 diagnosed with Portopulmonary Hypertension
- •2. A history of 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
- •3. Pregnant or breast-feeding females
研究者
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