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
Sites (34)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| The Republican Scientific-Practical Center ''Cardiology'' Coordinator of this site? Confirm its status | Minsk | Belarus | Unknown status |
| CHRU Besançon - Hôpital Jean Minjoz Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| CHU de Bordeaux - Hospital Haut-Leveque Coordinator of this site? Confirm its status | Bordeaux (Pessac) | France | Unknown status |
| CHU de la Cavale Blanche Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| GH est - Hôpital Cardiovasculaire et Pneumologie Louis Pradel Coordinator of this site? Confirm its status | Bron | France | Unknown status |
| Hôpital Côte De Nacre Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| CHU Dijon Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Chu Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Unknown status |
| Hôpital Cardiologique - Chru Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| CHU de Limoges Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| CHU de la Timone Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| CHU de Montpellier - Arnaud de Villeneuve Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CHU Nantes - Hopital Nord Laënnec Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Centre Hospitalier Universitaire de Nice - Hopital Pasteur Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU de Reims Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| CHU Rennes - Hopital Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| CHU Rouen Hopital Charles Nicolle Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| CHU Saint-Etienne - Hopital Nord Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Unknown status |
| Nouvel Hôpital Civil Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| Hôpital Larrey - CHU de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| CHU de Nancy - Hopital de Brabois Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
| Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Wojewodzki Szpital Specjalistyczny Oddzial Kardiologiczny Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| Cardiovascular Pathology Research Institute of Siberian Branch of RAMS Coordinator of this site? Confirm its status | Kemerovo | Russia | Unknown status |
| National Medical Research Center of Cardiology of MoH of Russian Federation Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Federal State Budgetary Institution Of Ministry Of Health Of Russian Federation Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
| Federal North-West Medical Research Centre Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Federal State Budget Scientific Institution Coordinator of this site? Confirm its status | Tomsk | Russia | Unknown status |
| CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery' Coordinator of this site? Confirm its status | Dnipro | Ukraine | Unknown status |
| Lviv Regional Clinical Hospital Coordinator of this site? Confirm its status | Lviv | Ukraine | Unknown status |
| Istanbul University Istanbul Medical Faculty Coordinator of this site? Confirm its status | Capa_Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.