Study Comparing the Effectiveness and Safety of Macitentan 75 mg and 10 mg for Patients with Pulmonary Arterial Hypertension

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What is this study about?

This clinical trial is focused on studying a condition known as Pulmonary Arterial Hypertension (PAH). PAH is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. The study is testing a medication called Macitentan, which is already used in a 10 mg dose, and comparing it to a higher dose of 75 mg. The purpose of the study is to see if the higher dose of Macitentan is more effective in delaying the time to the first serious health event related to PAH.

Participants in the study will be randomly assigned to receive either the 10 mg or 75 mg dose of Macitentan. Some participants may receive a placebo, which looks like the medication but does not contain the active ingredient. The study will be conducted in a way that neither the participants nor the researchers know who is receiving which treatment, to ensure unbiased results. After the initial phase, all participants will have the opportunity to receive the 75 mg dose of Macitentan in an open-label period, meaning everyone will know they are receiving the active medication.

The study will last for a period of up to 72 weeks, during which participants will be monitored for any changes in their condition and any side effects they may experience. The goal is to determine if the higher dose of Macitentan can better manage the symptoms of PAH and improve the quality of life for those affected by this condition. Participants will be required to visit the study site regularly for check-ups and assessments throughout the study period.

1 randomization

Upon joining the study, participants are randomly assigned to one of two groups. One group receives macitentan 75 mg, and the other group receives macitentan 10 mg. This process is double-blind, meaning neither the participants nor the researchers know which dosage each participant receives.

2 double-blind treatment period

Participants take their assigned dosage of macitentan orally once daily. This phase continues until a specific number of health events occur among participants, as determined by the study’s design.

3 open-label treatment period

After the double-blind period, all participants receive macitentan 75 mg. This phase allows researchers to gather additional data on the long-term effects of the higher dosage.

4 monitoring and assessments

Throughout the study, participants undergo regular health assessments to monitor the effects of the medication. These assessments include physical exams, blood tests, and other evaluations to ensure safety and effectiveness.

5 completion

The study concludes when the predetermined number of health events has been reached, and all data has been collected and analyzed. Participants may receive follow-up care as needed.

Who Can Join the Study?

  • Participants must be 18 years or older or the legal age of consent in the area where the study is conducted.
  • Female participants who can have children must have a negative pregnancy test before starting the study.
  • Female participants must use a highly effective method of birth control during the study and for 30 days after the last dose of the study medication.
  • Participants must be willing and able to follow the lifestyle rules specified in the study.
  • Participants must have symptomatic pulmonary arterial hypertension (PAH) in WHO Functional Class II, III, or IV. This means they have symptoms that affect their daily activities.
  • Participants must understand and agree to the study’s purpose and procedures by signing a consent form.
  • Participants must have a specific type of PAH, such as idiopathic (unknown cause), heritable (runs in families), drug- or toxin-induced, or related to other conditions like connective tissue disease or HIV infection.
  • Participants must have a confirmed PAH diagnosis through specific heart and lung tests done at rest before the study.
  • Participants with idiopathic, heritable, or drug/toxin-induced PAH must have a negative vasoreactivity test or a confirmed PAH diagnosis if already on PAH treatment for more than 3 months.
  • Participants must be able to walk a distance of at least 50 meters but not more than 440 meters during a walking test at the start of the study. If they can walk more than 440 meters, they must meet additional criteria.
  • Participants already on PAH treatments must have been on a stable treatment plan for at least 3 months before the study and follow specific guidelines regarding their current medications.
  • Participants must sign a separate consent form if they agree to provide optional samples for biomarker research. Not agreeing to this does not exclude them from the study.

Who Cannot Join the Study?

  • Patients who have a different condition than pulmonary arterial hypertension (a type of high blood pressure that affects the arteries in the lungs and the right side of the heart) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have any other medical condition that might interfere with the study or its results cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria
Hospital Universitario De Salamanca Salamanca Spain
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Medizinische Hochschule Hannover Hanover Germany
Katholieke Universiteit te Leuven Leuven Belgium
Oncopole Claudius Regaud Toulouse France
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

Site Name City Country Status
General University Hospital Of Larissa Larissa Greece
Národny ustav srdcovych a cievnych chorob a.s. Bratislava Slovakia
MHAT National Heart Hospital EAD Sofia Bulgaria
Universitaetsklinikum Regensburg AöR Regensburg Germany
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Alexandra Hospital Athens Greece
Fondazione Toscana Gabriele Monasterio Pisa Italy
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Gornoslaskie Centrum Mwdyczne Katowice Poland
Semmelweis University Budapest Hungary
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Stichting Radboud University Medical Center Nijmegen The Netherlands
Centre Hospitalier Universitaire De Nice Nice France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Of Pecs Pecs Hungary
Hopital Beaujon Clichy France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
University Of Szeged Szeged Hungary
Hospital Costa del Sol Marbella Spain
Vychodoslovensky Ustav Srdcovych A Cievnych Chorob a.s. Kosice Slovakia
Aevswmeil Ujd Amsterdam The Netherlands
Pbcxaupso Iupjztaj Mzqhatdv Mbdrvyyeglul Sfmoq Wxwnzrpdjtnp I Abgqttcpwbwuu Warsaw Poland
Kynuwsus dfl Ujpwyindpxlh Mlyaxizc Acy Munich Germany
Uijsbkcnehdkht Cfidfur Kiablgryd Gdansk Poland
Oemedclmioxttt Lnab Gfpl Linz Austria
Unpyncxgtuvwd Sikhnly Kxznkiwqt Ni 2 Pgq W Svgztqcczt Szczecin Poland
Mvcigwd Uahpxjurra Or Gxgc Graz Austria
Fijjyngbz Pllt Lw Icoebzmhsfpup Bbjpubihd Dwb Hfkcagtw Uqtqifitifmlx Lh Pyq Madrid Spain
Drsncosihe Cmsegbhpmgmz Cpuxtr (wgcu &hrojfohbtrr Ajmlvjkcyuf Eshw Sofia Bulgaria
Auumbl Uxkzankvwf Hcnergfi Aarhus Denmark
Ivpbolaw dm Cegqmxicnxoe Hqgblzojmnd Uogzapkxmpnko dt Saqzu Ekhvccx (rasvxbq Saint Priest En Jarez France
Kcjjcfucn Sbjevlv Sslketktncarexj ib Jzwa Pafpv It Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
15.01.2020
Belgium Belgium
Not recruiting
15.01.2020
Bulgaria Bulgaria
Not recruiting
15.01.2020
Czechia Czechia
Not recruiting
15.01.2020
Denmark Denmark
Not recruiting
15.01.2020
France France
Not recruiting
15.01.2020
Germany Germany
Not recruiting
15.01.2020
Greece Greece
Not recruiting
15.01.2020
Hungary Hungary
Not recruiting
15.01.2020
Italy Italy
Not recruiting
15.01.2020
Poland Poland
Not recruiting
15.01.2020
Portugal Portugal
Not recruiting
15.01.2020
Slovakia Slovakia
Not recruiting
15.01.2020
Spain Spain
Not recruiting
15.01.2020
Sweden Sweden
Not recruiting
15.01.2020
The Netherlands The Netherlands
Not recruiting
15.01.2020

Trial locations

Investigated drugs:

Macitentan: This medication is used to treat pulmonary arterial hypertension (PAH), a condition where there is high blood pressure in the arteries that go from the heart to the lungs. The trial is comparing two different doses of macitentan to see which is more effective in delaying the worsening of the disease or preventing death. Macitentan works by relaxing and widening the blood vessels, which helps to lower blood pressure and improve blood flow.

Investigated diseases:

Pulmonary arterial hypertension – This is a condition characterized by high blood pressure in the arteries that supply the lungs. It occurs when the small arteries in the lungs become narrowed or blocked, making it harder for blood to flow through them. As a result, the heart has to work harder to pump blood through these arteries, which can lead to heart strain and eventually heart failure. Symptoms often include shortness of breath, fatigue, dizziness, and swelling in the ankles or legs. Over time, the condition can progress, leading to more severe symptoms and complications. It is considered a rare disease and can significantly impact a person’s quality of life.

Trial ID:
2024-515669-32-00
Protocol code:
AC-055-315
Trial Phase:
Therapeutic confirmatory (Phase III)

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