The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension: A Multi-center, Double-blind, Placebo-controlled, Phase 3b Study

Triton [NCT02558231]

Description: The objective of this clinical trial is to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension.

Drug: Macitentan; Drug: Tadalafill; Drug: Selexipag

Primary Investigator: Engel

Drug/Device Information
Efficacy and safety study comparing a triple oral regimen (macitentan, tadalafil, selexipag) with a dual oral regimen (macitentan, tadalafil, placebo)
Newly diagnosed, treatment-naïve subjects with PAH
Selexipag is an orally available non-prostanoid prostacyclin receptor agonist
Randomized in a 1: 1 ratio to macitentan, tadalafil, selexipag vs. macitentan, tadalafil, placebo