Comparison of Sequential to Initial Combination Therapy in PAH
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
Second Affiliated Hospital, School of Medicine, Zhejiang University
376 participants
May 14, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
Target dose 40 mg OD
Target dose 10 mg OD
Ambrisentan mimic will switch to Ambrisentan if low risk status was not achived at month 4, or 8, or 12.
Tadalafil mimic will switch to Tadalafil if low risk status was not achived at month 4, or 8, or 12.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06968962