Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New study tracks Long-Term safety of two common PH drugs

NCT ID NCT05179876

Disease control Sponsor: Actelion Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This study follows 280 adults and children with pulmonary hypertension who are already taking macitentan or selexipag in a previous trial. The goal is to monitor long-term safety, including side effects and serious events, while allowing continued access to the medication. Participants receive their usual dose, with children getting a weight-adjusted version of macitentan.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
macitentan and selexipag
What this could lead to
If successful, this study could confirm that long-term use of these drugs is safe for managing pulmonary hypertension.
What could go wrong
This is an open-label extension study focused on safety, not on proving new benefits. Results may not apply to all patients, and side effects are still possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant must sign an informed consent form (ICF) (or their legally designated representative must sign) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study * Participant treated with oral macitentan or selexipag or fixed dose combination (FDC) of macitentan 10 milligrams (mg) and tadalafil 40 mg at the end of a sponsor parent study and: a) the indication of the parent study is included in the intervention-specific appendices (ISA) (pulmonary arterial hypertension \[PAH\]; b) participant has completed the parent study; c) no alternative means of access to study intervention (or equivalent approved therapy) have been identified; d) participant may continue to benefit from treatment with the study intervention; e) Participant is at least 18 years old for macitentan/tadalafil FDC, and at least 2 years old for macitentan or selexipag * A female participant of childbearing potential must: a) have a negative urine or serum pregnancy test prior to first intake of study intervention; b) agree to perform monthly urine pregnancy test up to the end of the safety follow-up period; c) If heterosexually active, agree to follow contraceptive methods until 30 days after the last intake of the study intervention. For pediatric female participants: It is the responsibility of the investigator to ensure appropriate counselling, including consultation with a specialist (if needed), to the participant and/or parent(s)/ legally designated representative (LDR)(s) on the acceptable method of contraception Exclusion Criteria: General: * Participants prematurely discontinued from the study intervention in their parent study * Female participant being pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study * Planned or current treatment with another investigational treatment Macitentan-specific: * Known allergies, hypersensitivity, or intolerance to macitentan or its excipients * Hemoglobin less than (\<) 80 grams per liter (g/L) * Serum aspartate (AST) and/or alanine aminotransferases (ALT) greater than (\>) 3\* upper limit of normal (ULN) * Known and documented severe hepatic impairment that is, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class (Child-Pugh score) should be fully assessed and documented in the source documents at screening Selexipag-specific: * Known allergies, hypersensitivity, or intolerance to selexipag or its excipients * Suspected or known pulmonary veno-occlusive disease (PVOD) * Uncontrolled thyroid disease * Severe coronary heart disease or unstable angina, myocardial infarction within the last 6 months, decompensated cardiac failure (if not under close medical supervision), severe arrhythmia, cerebrovascular events (for example, transient ischemic attack, stroke) within the last 3 months, or congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension (PH) * Known and documented severe hepatic impairment that is, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class (Child-Pugh score) should be fully assessed and documented in the source documents at screening * Children only: (a) Current suspicion of intussusception or ileus or gastrointestinal obstruction, per the investigator's judgment; (b) hemoglobin or hematocrit \<75 percent (%) of the lower limit of normal range Macitentan/tadalafil FDC-specific: * Known allergies, hypersensitivity, or intolerance to macitentan or tadalafil or their excipients * Hemoglobin \<80 g/L * Serum aspartate (AST) and/or alanine aminotransferases (ALT) \>3\* ULN range * Known and documented severe hepatic impairment that is, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class should be fully assessed and documented in the source documents at screening * Severe renal impairment (estimated glomerular filtration rate \[eGF\]/creatinine clearance \<30 milliliter per minute \[mL/min\])

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hypertension, pulmonary are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension pulmonary hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension, pulmonary

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    31 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Abdullah, IA

    COMPLETED

    Durban, 4001, South Africa

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Beijing Anzhen Hospital

    RECRUITING

    Beijing, 100029, China

  • Beijing Anzhen Hospital 1

    RECRUITING

    Beijing, 100029, China

  • Chang-Gung Memorial Hospital, LinKou Branch

    RECRUITING

    Taoyuan, 333, Taiwan

  • Children's Hospital 1

    RECRUITING

    Ho Chi Minh City, Vietnam

  • Childrens Hospital of Shanghai

    RECRUITING

    Shanghai, 200062, China

  • Chungnam National University Hospital

    RECRUITING

    Daejeon, 35015, South Korea

  • Dr Kalla

    RECRUITING

    Lenasia, 1820, South Africa

  • E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation

    RECRUITING

    Novosibirsk, 630055, Russia

  • Federal State Budgetary Institution

    COMPLETED

    Saint Petersburg, 197341, Russia

  • Gachon University Gil Medical Center

    RECRUITING

    Incheon, 21565, South Korea

  • Gottsegen György Országos Kardiológiai Intézet

    RECRUITING

    Budapest, 1096, Hungary

  • Hanoi Heart Hospital

    RECRUITING

    Hanoi, Vietnam

  • Hanoi Medical University Hospital

    RECRUITING

    Hanoi, Vietnam

  • Institute of Cardiology of Tomsk National Research Medical Center of Rus Academy of Sciences

    COMPLETED

    Tomsk, 634012, Russia

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, China

  • Kaohsiung Veterans General Hospital

    RECRUITING

    Kaohsiung City, 813, Taiwan

  • Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku

    RECRUITING

    Bialystok, 15 276, Poland

  • Maharaj Nakorn Chiang Mai hospital Faculty of Medicine

    RECRUITING

    Chiang Mai, 50200, Thailand

  • Minsk Regional Clinical Hospital Of The Red Banner Of Labor

    COMPLETED

    Minsk, Belarus

  • Municipal Inst. Of Dnipropetrovsk Region. Council

    COMPLETED

    Dnipro, Ukraine

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100, Taiwan

  • Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego

    COMPLETED

    Lodz, 91 347, Poland

  • Qingdao Women and Children's Hospital

    RECRUITING

    Qingdao, 266035, China

  • Regional Clinical Hospital No1

    RECRUITING

    Tyumen, 625000, Russia

  • SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca

    RECRUITING

    Katowice, 40 635, Poland

  • SPSK2 PUM Klinika Kardiologii

    COMPLETED

    Szczecin, 70 111, Poland

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Scientific and Research Institution of Cardiovascular Diseases Complex Problems

    COMPLETED

    Kemerovo, 650002, Russia

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Seoul National University Hospital 1

    RECRUITING

    Seoul, 03080, South Korea

  • State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine

    COMPLETED

    Kyiv, 03680, Ukraine

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii

    COMPLETED

    Bydgoszcz, 85-168, Poland

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 112, Taiwan

  • The Catholic University of Korea Seoul St Marys Hospital

    COMPLETED

    Seoul, 06591, South Korea

  • The First Affiliated Hospital of Xian Jiaotong University

    RECRUITING

    Xi'an, 710061, China

  • The Republican Scientific-Practical Center ''Cardiology''

    RECRUITING

    Minsk, 220036, Belarus

  • The Second Xiangya Hospital of Central South Hospital

    RECRUITING

    Changsha, 410011, China

  • UZ Leuven

    COMPLETED

    Leuven, 3000, Belgium

  • University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD

    RECRUITING

    Sofia, 1750, Bulgaria

  • Wojewodzki Szpital Specjalist Osrodek Badawczo Rozwojowy

    COMPLETED

    Wroclaw, 51 124, Poland

  • Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ

    COMPLETED

    Lublin, 20 718, Poland

  • Wojewodzki Szpital Specjalistyczny we Wroclawiu

    RECRUITING

    Wroclaw, 51 124, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.