Trial Profile

Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Adult and Adolescent Subjects

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 02 Apr 2025

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At a glance

01 Feb 2025 Results assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent patients, published in the Journal of Thoracic and Cardiovascular Surgery
29 Aug 2022 Primary endpoint (Change in peak VO2 (oxygen uptake)) has not been met, as per results presented at the ESC Congress 2022 - Annual Congress of the European Society of Cardiology.
29 Aug 2022 Results (n=137) assessing the efficacy and safety of macitentan in Fontan-palliated patients over 52 weeks, presented at the ESC Congress 2022 - Annual Congress of the European Society of Cardiology.

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