A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients

Therapeutic confirmatory (phase III)

The primary efficacy endpoint is TTCW.The events that will comprise this endpoint include the following:All-cause death,Non-planned PAH-related hospitalization of ≥24 hours in duration,Atrial septostomy,Lung transplant. Deterioration in performance in exercise testing due to PAH,and at least 1 of the following:Worsening of WHO FC from baseline,Signs/symptoms of increased right heart failure.Addition of a background PAH therapy or change in the background PAH therapy delivery route to parenteral, Cont. Translation- German (AT), Cont. Translation- Croatian, Cont. Translation- French, Cont. Translation- Dutch, Cont. Translation- Portuguese

Multicomponent improvement endpoint: Measure of participants achieving improvement in 6MWD, NT-proBNP, and WHO FC at Week 24. achieving low-risk category in REVEAL Lite 2 risk score; using simplified French Risk score calculator; change in NT-proBNP levels; maintaining or improving WHO FC at 24 weeks; change in 6MWD; and changes in the Physical Impacts, Cardiopulmonary Symptoms, and Cognitive/Emotional Impacts domain scores of PAH-SYMPACT® at Week 24 versus baseline., Cont. Translation- German (AT), Cont. Translation- Croatian, Cont. Translation- France, Cont. Translation- Dutch, Cont. Translation- Portuguese

No related papers found yet.

Austria, Belgium, Croatia, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Spain