deltatrials
Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm NCT04273945

Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension (UNISUS)

A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg

Sponsor: Actelion

Conditions Pulmonary Arterial Hypertension
Interventions Macitentan 10 mg Macitentan 37.5 mg Macitentan 75 mg Placebo
Last updated: Mar 12, 2026 Started: Jun 30, 2020 Primary completion: Oct 7, 2025 Completion: Feb 20, 2029
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Pulmonary Arterial Hypertension, this trial is ongoing. The trial is conducted by Actelion and has accumulated 0 data snapshots since 2020. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.

Change History

No change history available.

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Actelion
Data source: Actelion

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aarhus, Denmark , Adana, Turkey (Türkiye) , Ahmedabad, India , Alexandroupoli, Greece , Amsterdam, Netherlands , Anderson, United States , Ankara, Turkey (Türkiye) , Ann Arbor, United States , Antalya, Turkey (Türkiye) , Athens, Greece and 212 more locations