Trial intelligence / Profile preview

Macitentan in Fontan-palliated Subjects (RUBATO OL)

NCT03775421Phase 3Terminated

Sponsor
Actelion Pharmaceuticals Ltd
Start
Apr 2019
Primary completion
Jan 2022
Modality
Small Molecules
Countries
11
01

Overview

Phase 3, open-label, single-arm trial of macitentan in congenital heart disease (CHD), sponsored by Actelion Pharmaceuticals Ltd. Primary endpoints: Number of Participants With Treatment-emergent Adverse Events up to 133 weeks, Number of Participants With Treatment-emergent Serious AEs up to 133 weeks and 1 more. Started Apr 2019; status: terminated.

02

Drugs

macitentan
03

Conditions

congenital heart disease (CHD)

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