Comparison of Sequential to Initial Combination Therapy in PAH

This is a multicenter, randomized, controlled, double-blind, and non-inferiority clinical trial to compare the efficacy of sequential to initial combination therapy in patients with pulmonary arterial hypertension (PAH). Ambrisentan and Tadalafil will be used in the study. Our research hypothesis is that the efficacy of sequential combination therapy in PAH patients is not inferior to the initial combination therapy as the primary efficacy endpoint is the change in 6MWD at month 12 from baseline.

NCT Number	NCT06968962
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University Collaborators: Huzhou Central Hospital, Ningbo Medical Center Lihuili Hospital, First Affiliated Hospital of Ningbo University, Ningbo No.2 Hospital, Affiliated Hospital of Jiaxing University, The Second Affiliated Hospital of Jiaxing University, First Affiliated Hospital of Wenzhou Medical University, Shanghai Pulmonary Hospital, Shanghai, China, Taizhou Hospital, Guangdong Provincial People's Hospital
Conditions	Pulmonary Arterial Hypertension (PAH)
Enrollment	376 participants
Start Date	2025-05-14
Primary Completion	2028-05 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2025-07-29