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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
The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.
Age
12 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Alabama at Birmingham
Birmingham, Alabama, United States
UCLA
Los Angeles, California, United States
Massachusetts General Hospital Heart Center
Boston, Massachusetts, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Texas Children's Hospital
Houston, Texas, United States
Providence Medical Research Providence Health Care
Spokane, Washington, United States
Royal Adelaide Hospital
Adelaide, Australia
Royal Prince Alfred Hospital
Camperdown, Australia
The Prince Charles Hospital, Adult Congenital Heart Disease Unit
Chermside, Australia
Royal Children's Hospital
Parkville, Australia
Start Date
August 14, 2017
Primary Completion Date
June 30, 2021
Completion Date
July 26, 2021
Last Updated
March 30, 2025
142
ACTUAL participants
Macitentan 10 mg
DRUG
Placebo
DRUG
Lead Sponsor
Actelion
NCT05647213
NCT07042334
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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