CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 89 enrolled
Drug / intervention
Macitentandrug
Likely dose
Macitentan 10mgfrom 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/NCT02310672
NCT02310672Phase 4Completed
CompareCT.gov

A Prospective, Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Effects of Macitentan on Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension Assessed by Cardiac Magnetic Resonance Imaging

Actelion·interventional·Posted Dec 8, 2014·Updated Mar 30, 2025

In Brief

A Phase 4 clinical trial evaluating Macitentan for Pulmonary Arterial Hypertension. Completed, enrolled 89 participants across 41 sites in 12 countries.

Detailed Summary

The study evaluates the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension. Patients are treated with macitentan for 1 year. Patients undergo right heart catheterization (RHC) at baseline and Week 26. They also undergo cardiac magnetic resonance imaging (MRI) at baseline, Week 26 and Week 52. Safety is monitored throughout the study. The study has three stub-studies. Each patient can participate in no sub-study or in one sub-study. The sub-studies are: (1) metabolism sub-study (with PET-MR scans); (2) biopsy sub-study (biopsies taken during the RHC); (3) Echo sub-study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesAustralia, France, Germany, Hong Kong, Israel, Italy, Malaysia, Netherlands, Russia, Singapore, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 8, 2014
Enrollment StartJun 1, 2015
Primary CompletionSep 10, 2019
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 11.6 years ago

Interventions

Macitentandrug

All patients take open-label macitentan 10mg o.d.