Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects
NCT ID: NCT03153137
Last Updated: 2025-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
142 participants
INTERVENTIONAL
2017-08-14
2021-07-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Macitentan
Macitentan 10 mg per day; film-coated tablet; oral use
Macitentan 10 mg
film-coated tablet; oral use
Placebo
film-coated tablet; oral use
Placebo
film-coated tablet; oral use
Interventions
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Macitentan 10 mg
film-coated tablet; oral use
Placebo
film-coated tablet; oral use
Eligibility Criteria
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Inclusion Criteria
* Fontan-palliated subjects with either intra-atrial lateral tunnel total cavopulmonary connection (LT-TCPC), or extra cardiac tunnel TCPC (EC-TCPC) surgery \> 1 year before Screening. Either LT- or EC-TCPC can be primary or secondary to atrio-pulmonary connection
* New York Heart Association (NYHA) functional class (FC) II or III (assessed by the investigator using the Specific Activity Scale
* Women of childbearing potential must have a negative serum pregnancy test use reliable contraception
Exclusion Criteria
* Deterioration of the Fontan-palliated condition.
* Limitations to Cardiopulmonary exercise testing (CPET)
* Peak VO2 \< 15 mL/kg/min.
* Any known factor or disease that may interfere with treatment compliance or full participation in the study
12 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Locations
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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
Queensland CHILDREN'S HOSPITAL
South Brisbane, , Australia
Westmead Hospital
Westmead, , Australia
CHU de Quebec Universite Laval
Québec, Quebec, Canada
Beijing Anzhen Hospital
Beijing, , China
Beijing Fuwai Hospital
Beijing, , China
Shanghai Childrens Medical Center
Shanghai, , China
Wuhan Asia Heart Hospital
Wuhan, , China
Fakultni nemocnice v Motole
Prague, , Czechia
Rigshospitalet Kardiologisk Klinisk
Copenhagen, , Denmark
CHU Arnaud de Villeneuve
Montpellier, , France
Hôpital Necker - Enfants Malades
Paris, , France
Hôpital Cardiologique Du Haut-Lévêque
Pessac, , France
Deutsches Herzzentrum Berlinklinik Für Angeborene Herzfehler
Berlin, , Germany
Deutsches Herzzentrum München
München, , Germany
Auckland City Hospital
Auckland, , New Zealand
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, , Poland
Krakowski Szpital Specjalityczny im Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn
Krakow, , Poland
Wojewodzki Szpital Specjalistyczny We Wroclawiu
Wroclaw, , Poland
National Taiwan University Hospital
Taipei, , Taiwan
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Birmingham Children's Hospital
Birmingham, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003320-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AC-055H301
Identifier Type: -
Identifier Source: org_study_id
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