drugset / Trial / NCT06968962
Comparison of Sequential to Initial Combination Therapy in PAH
Recruiting
376 enrolled
Second Affiliated Hospital, School of Medicine, Zhejiang University
Affiliated Hospital of Jiaxing University · collabFirst Affiliated Hospital of Ningbo University · collabFirst Affiliated Hospital of Wenzhou Medical University · collabGuangdong Provincial People's Hospital · collabHuzhou Central Hospital · collabNingbo Medical Center Lihuili Hospital · collabNingbo No.2 Hospital · collabShanghai Pulmonary Hospital, Shanghai, China · collabTaizhou Hospital · collabThe Second Affiliated Hospital of Jiaxing University · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2025-05-14
- Primary completion
- 2028-05
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ambrisentan | Small molecule | 10 mg | — |
| Subject | Tadalafil | Small molecule | 40 mg | — |