NCT02558231

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Macitentan	Used open-label in both arms, 10 mg tablet, 1 tablet u.i.d.
DRUG	Tadalafil	Used open-label in both arms, 20 mg tablet, 1-2 tablets u.i.d.
DRUG	Selexipag	Used double-blind in the triple oral treatment arm, 200 microgram tablet, 1-8 tablets b.i.d.

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-08-29
• Completion: 2020-04-20
• First posted: 2015-09-23
• Last updated: 2025-03-30
• Results posted: 2020-09-11

Locations

58 sites across 15 countries: United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom