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High-Dose Macitentan for PAH (UNISUS Trial)
UNISUS Trial Summary
This trial is testing if a higher dose of macitentan will help people with PAH by prolonging the time to first adjudicated morbidity or mortality event.
UNISUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowUNISUS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.UNISUS Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.You have three or more factors that increase your risk of heart failure with preserved ejection fraction.I am 18 years old or older, or at the legal age of consent where I live.I can complete a 6-minute walking test.Your hemoglobin level is less than 100 grams per liter at the time of screening.I have a known liver condition that is moderate to severe.I have symptoms of severe lung blood pressure in classes II, III, or IV.You have been diagnosed with pulmonary arterial hypertension (PAH) based on specific measurements of your heart and lung pressures.I have symptoms of severe lung blood pressure in stages II, III, or IV.My PAH is related to a specific cause like a genetic condition, drug use, or another disease.Your blood test shows that the levels of AST and/or ALT are higher than what is considered normal.I have severe breathing problems due to lung blockage.My PAH is related to a specific cause like a genetic condition, drug use, or another disease.
- Group 1: Macitentan 75 mg + Placebo
- Group 2: Macitentan 10 milligrams (mg) + Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA cleared Macitentan for use at the 75 mg dosage?
"Macitentan 75 mg is a Phase 3 medication, which means that it has undergone multiple rounds of testing and has been proven to be safe and effective."
How many people are receiving the treatment being studied?
"The total number of patients required to run this study is 900. The sponsor, Actelion, is conducting the trial at various sites, such as Sanford Health in Sioux Falls, South dakota and Allegheny General Hospital of Research in Pittsburgh, Pennsylvania."
are patients able to participate in this experiment at multiple hospitals?
"There are 51 sites running this study, including Sanford Health in Sioux Falls, Allegheny General Hospital of Research in Pittsburgh, and San Antonio Methodist/TX Transplant Physicians Group in San Antonio."
Could you provide a summary of research completed on Macitentan 75 mg thus far?
"There are 8 ongoing clinical trials researching Macitentan 75 mg with 8 trials in Phase 3. The majority of the trials for Macitentan 75 mg are based in Nagasaki, Vermont, however, there are 808 locations running clinical trials for Macitentan 75 mg."
Does this research project explore novel territory?
"There have been 8 clinical trials involving the drug Macitentan 75 mg. These studies have taken place in 88 cities, across 45 countries and the first one was conducted in 2017. The 300 person Phase 3 trial, sponsored by Actelion, completed its drug approval stage that year. To date, 18261 studies have been conducted."
How can patients sign up for this research project?
"Yes, that is accurate. The clinical trial is presently recruiting candidates, as is stated on clinicaltrials.gov. This study was initially posted on 6/30/2020, as seen on the website, and was most recently updated on 10/11/2022. The clinical trial is searching for 900 participants at 51 locations, which is also detailed on the website."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Lankenau Medical Center: < 24 hours
Average response time
- < 1 Day
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