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NCT03422328CompletedPhase 3

A Clinical Study to Investigate the Long-term Safety of the Drug Macitentan in Patients With Pulmonary Hypertension Who Were Previously Treated With Macitentan in Clinical Studies.

mUlticenter, Single-arM, Open-laBel, Long-teRm Safety Study With macitEntan in Patients With puLmonary Arterial Hypertension previousLy Treated With mAcitentan in Clinical Studies

Source: ClinicalTrials.gov · Last updated 27 Apr 2025

Brief summary (registry, in English)

The aim of the trial is to study the long-term safety of macitentan and to provide continued treatment with macitentan to patients with pulmonary arterial hypertension (PAH) and Chronic thromboembolic pulmonary hypertension (CTEPH) who were previously treated with macitentan in clinical studies.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
151 (actual)
First submitted
30 Jan 2018
Start date
5 Apr 2018
Primary completion date
27 Dec 2023
Lead sponsor
Actelion
NCT number
NCT03422328
EudraCT number
2017-003934-10

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 151
  • From 5 Apr 2018 to the primary completion date, 27 Dec 2023
  • 34 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Planned or current treatment with another investigational treatment up to 3 months prior to Enrollment
  • Treatment with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir)

Other illness

  • Known and documented history of severe hepatic impairment that is Child-Pugh Class C.
  • Known hypersensitivity to macitentan, its excipients, or drugs of the same class
  • Any known factor or disease that may interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease

Lab values

  • Hemoglobin less than 80 gram per liter (g/L)
  • Serum Aspartate aminotransferase (AST) and/or alanine aminotransferases (ALT) more than three times the upper limit of normal range

Other

  • Pregnant, planning to become pregnant, or breastfeeding

Who the study is looking for

  • Signed informed consent to take part in the study before any study mandated procedure.
  • Participants from one of the parent studies and: a) the sponsor has decided to terminate the parent study in that country and b) the participant has completed the end of treatment (EOT) Visit of the parent study
  • Women of childbearing potential are able to take part in the study if the following applies: a) Urine pregnancy test is negative at Enrollment; b) Agreement to perform monthly urine or serum pregnancy tests during the study and up to at least 30 days after the study treatment discontinuation; and c) Agreement to adhere to the planned contraception scheme from Enrollment up to at least 30 days after study treatment discontinuation

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (34)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UZ Leuven
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LeuvenBelgiumUnknown status
The Republican Scientific-Practical Center ''Cardiology''
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MinskBelarusUnknown status
CHRU Besançon - Hôpital Jean Minjoz
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BesançonFranceUnknown status
CHU de Bordeaux - Hospital Haut-Leveque
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Bordeaux (Pessac)FranceUnknown status
CHU de la Cavale Blanche
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BrestFranceUnknown status
GH est - Hôpital Cardiovasculaire et Pneumologie Louis Pradel
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BronFranceUnknown status
Hôpital Côte De Nacre
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CaenFranceUnknown status
CHU Dijon
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DijonFranceUnknown status
Chu Grenoble
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GrenobleFranceUnknown status
Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud
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Le Kremlin-BicêtreFranceUnknown status
Hôpital Cardiologique - Chru Lille
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LilleFranceUnknown status
CHU de Limoges
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LimogesFranceUnknown status
CHU de la Timone
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MarseilleFranceUnknown status
CHU de Montpellier - Arnaud de Villeneuve
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MontpellierFranceUnknown status
CHU Nantes - Hopital Nord Laënnec
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NantesFranceUnknown status
Centre Hospitalier Universitaire de Nice - Hopital Pasteur
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NiceFranceUnknown status
Hôpital Européen Georges Pompidou
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ParisFranceUnknown status
CHU de Reims
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ReimsFranceUnknown status
CHU Rennes - Hopital Pontchaillou
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RennesFranceUnknown status
CHU Rouen Hopital Charles Nicolle
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RouenFranceUnknown status
CHU Saint-Etienne - Hopital Nord
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Saint-Priest-en-JarezFranceUnknown status
Nouvel Hôpital Civil
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StrasbourgFranceUnknown status
Hôpital Larrey - CHU de Toulouse
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ToulouseFranceUnknown status
CHU de Nancy - Hopital de Brabois
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Vandœuvre-lès-NancyFranceUnknown status
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ
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LublinPolandUnknown status
Wojewodzki Szpital Specjalistyczny Oddzial Kardiologiczny
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WroclawPolandUnknown status
Cardiovascular Pathology Research Institute of Siberian Branch of RAMS
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KemerovoRussiaUnknown status
National Medical Research Center of Cardiology of MoH of Russian Federation
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MoscowRussiaUnknown status
Federal State Budgetary Institution Of Ministry Of Health Of Russian Federation
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NovosibirskRussiaUnknown status
Federal North-West Medical Research Centre
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Saint PetersburgRussiaUnknown status
Federal State Budget Scientific Institution
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TomskRussiaUnknown status
CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'
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DniproUkraineUnknown status
Lviv Regional Clinical Hospital
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LvivUkraineUnknown status
Istanbul University Istanbul Medical Faculty
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Capa_IstanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.