CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 247 enrolled
Drug / intervention
Macitentan +2 moredrug
Likely dose
Macitentan 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02558231
NCT02558231Phase 3Completed
CompareCT.gov

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

Actelion·interventional·Posted Sep 23, 2015·Updated Mar 30, 2025

In Brief

A Phase 3 clinical trial evaluating Macitentan, Tadalafil, and 1 other intervention for Pulmonary Arterial Hypertension. Completed, enrolled 247 participants across 58 sites in 15 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesAustralia, Austria, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 23, 2015
Enrollment StartMay 1, 2016
Primary CompletionAug 29, 2019
Study CompletionApr 20, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.8 years ago

Interventions

Macitentandrug

Used open-label in both arms, 10 mg tablet, 1 tablet u.i.d.

Tadalafildrug

Used open-label in both arms, 20 mg tablet, 1-2 tablets u.i.d.

Selexipagdrug

Used double-blind in the triple oral treatment arm, 200 microgram tablet, 1-8 tablets b.i.d.