[Translation] IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose-Ranging Exploring and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH)
本研究的目的是主要根据PVR变化(经右心导管插入术评估)以及本研究2b期部分的AV-101安全性和耐受性评估来确定最佳剂量。研究的3期部分将采用最佳剂量,该阶段将使用24周治疗后经安慰剂校正的6MWD变化作为主要终点。
[Translation] The aim of this study was to determine the optimal dose primarily based on changes in PVR (assessed by right heart catheterization) and AV-101 safety and tolerability assessments in the phase 2b portion of this study. The optimal dose will be used in the Phase 3 portion of the study, which will use the placebo-adjusted change in 6MWD after 24 weeks of treatment as the primary endpoint.