Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome

Summary

Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects with Eisenmenger Syndrome.

Timeline

Start

2013-05-21

Primary completion

2016-12-01

Completion

2016-12-01

Outcome

Missed primary endpoint

registry analysis (superiority test); Macitentan vs Placebo; p = 0.6120; least-square (LS) mean difference -4.7 (95% CI -22.8 to 13.5) NCT01743001 ↗

paper CONCLUSIONS: Macitentan did not show superiority over placebo on the primary end point PMID 30586694 ↗

Publications

• Gatzoulis MA, Landzberg M, Beghetti M, Berger RM, Efficace M, Gesang S, He J, Papadakis K, Pulido T, Galie N; MAESTRO Study Investigators. Evaluation of Macitentan in Patients With Eisenmenger Syndrome. Circulation. 2019 Jan 2;139(1):51-63. doi: 10.1161/CIRCULATIONAHA.118.033575.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Macitentan	Other / unclassified	10 mg	Oral

Indications