drugset

drugset / Trial / NCT05437224

Efficacy and Safety Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension

NCT05437224 ↗

Phase 3 Completed 80 enrolled RenJi Hospital First Affiliated Hospital of Chongqing Medical University · collab Shanghai Pulmonary Hospital, Shanghai, China · collab Shanghai Zhongshan Hospital · collab The Affiliated Hospital of Qingdao University · collab The First Affiliated Hospital with Nanjing Medical University · collab Wuhan Asia Heart Hospital · collab Xinqiao Hospital of Chongqing · collab

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2018-12-18
Primary completion: 2022-01-09
Completion: 2022-02-06

Publications

Wang A, Chen M, Zhuang Q, Guan L, Xie W, Wang L, Huang W, Cheng Z, Yu S, Zhou H, Shen J. Time to clinical improvement: an appropriate surrogate endpoint for pulmonary arterial hypertension medication trials. Front Cardiovasc Med. 2023 Jun 12;10:1142721. doi: 10.3389/fcvm.2023.1142721. eCollection 2023.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ambrisentan	Small molecule	5 mg	Oral
Subject	Ambrisentan	Small molecule	10 mg	Oral

Indications