A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

Phase 3 Terminated 127 enrolled Actelion

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).

Timeline

Start: 2020-07-07
Primary completion: 2023-12-21
Completion: 2023-12-21

Outcome

Missed primary endpoint

Stopped: “The Sponsor decided to stop the study for futility based on a recommendation by the IDMC following a pre-planned interim analysis”

registry analysis (superiority test); Double Blind (DB) Period: Macitentan vs DB Period: Placebo; p = 0.974; Least square mean -16.1 (95% CI -32.34 to 0.16); MMRM NCT04271475 ↗

Publications

Inacio Cazeiro D, Azaredo Raposo M, Guimaraes T, Lousada N, Jenkins D, R Inacio J, Moreira S, Mineiro A, Freitas C, Martins S, Ferreira R, Luis R, Cardim N, Pinto FJ, Placido R. Chronic thromboembolic pulmonary hypertension: A comprehensive review of pathogenesis, diagnosis, and treatment strategies. Rev Port Cardiol. 2025 Feb;44(2):121-137. doi: 10.1016/j.repc.2024.04.006. Epub 2024 Jun 28. English, Portuguese.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Macitentan	Other / unclassified	75 mg	Oral