drugset / Trial / NCT02558231

The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension

NCT02558231

Phase 3 Completed 247 enrolled Actelion
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2016-05-01
Primary completion
2019-08-29
Completion
2020-04-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Selexipag Small molecule 200 ug Oral
Background Macitentan Other / unclassified 10 mg Oral
Background Tadalafil Small molecule 20 mg Oral