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Endothelin Receptor Antagonist

High-Dose Macitentan for PAH (UNISUS Trial)

Phase 3
Recruiting
Research Sponsored by Actelion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients aged greater than or equal to 18 years or the legal age of consent in the jurisdiction
Symptomatic Pulmonary Arterial Hypertension (PAH) in World Health Organization Functional Class (WHO FC) II, III, or IV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights

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.

Who is the study for?
Adults with symptomatic Pulmonary Arterial Hypertension (PAH) in various severity classes, confirmed by specific heart and lung pressure measurements. Eligible participants include those with PAH due to different causes such as genetic factors, drug use, or associated diseases like HIV. They must be able to perform a walking test and not have severe liver issues, certain blood disorders, or significant risk factors for heart failure.Check my eligibility
What is being tested?
The trial is testing the effectiveness of a higher dose of Macitentan (75 mg) compared to the standard dose (10 mg) in delaying health deterioration or death in PAH patients. Participants will randomly receive either the high dose, standard dose, an intermediate dose (37.5 mg), or a placebo.See study design
What are the potential side effects?
Macitentan may cause side effects such as liver problems; low red blood cell counts leading to fatigue; respiratory infections; headache; dizziness; gastrointestinal symptoms like nausea and diarrhea; skin rash; and anemia.

UNISUS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have symptoms of severe lung blood pressure in classes II, III, or IV.
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I can complete a 6-minute walking test.
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I have symptoms of severe lung blood pressure in stages II, III, or IV.
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My PAH is related to a specific cause like a genetic condition, drug use, or another disease.
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My PAH is related to a specific cause like a genetic condition, drug use, or another disease.

UNISUS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Double-blind Treatment Period: Time to First Clinical Events Committee (CEC)-adjudicated Morbidity or Mortality (M/M) Events
Secondary outcome measures
Double-blind Treatment Period: Change From Baseline to Week 24 in 6MWD
Therapeutic procedure
Double-blind Treatment Period: Change From Baseline to Week 24 in PAH Symptoms Based on PAH-SYMPACT Questionnaire- Cardiovascular Symptom Domain Score
+3 more

UNISUS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Macitentan 75 mg + PlaceboExperimental Treatment4 Interventions
Run-in period:Participants who are either ERA-naive or who are receiving a daily dose of macitentan or ambrisentan <10 mg, or a daily dose of bosentan <250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated patients will bypass the run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.DBT Period: participants will receive macitentan 37.5 mg orally for 4 weeks and macitentan 75 mg thereafter up to End of DBT. To maintain the blind, participants will receive macitentan 10 mg-matching placebo up to End of DBT.Treatment Extension Period: After EDBT, participants will continue to receive macitentan 75 mg orally for 2 years. To maintain the blind, participants will receive macitentan 37.5 mg-matching placebo during the 4-week up-titration period.
Group II: Macitentan 10 milligrams (mg) + PlaceboActive Control4 Interventions
Run-in period:Participants who are either endothelin receptor antagonist (ERA)-naïve or who are receiving daily dose of macitentan or ambrisentan less (<) 10 milligrams (mg), or daily dose of bosentan <250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated participants will bypass run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.Double-blind Treatment (DBT) Period:Participants will receive macitentan 10 mg orally up to End of DBT.To maintain blind, participants will receive macitentan 37.5 mg-matching placebo for 4 weeks and macitentan 75 mg-matching placebo thereafter up to DBT.Treatment Extension Period:After EDBT, participants will receive macitentan 37.5 mg once a day (qd) orally for 4 weeks, prior to receiving open-label macitentan 75 mg qd orally for 2 years. To maintain blind, participants will receive macitentan 75 mg-matching placebo during 4-week uptitration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Macitentan 10 mg
2021
Completed Phase 3
~490
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

ActelionLead Sponsor
191 Previous Clinical Trials
34,788 Total Patients Enrolled
66 Trials studying Pulmonary Arterial Hypertension
15,080 Patients Enrolled for Pulmonary Arterial Hypertension
Actelion Clinical TrialsStudy DirectorActelion

Media Library

Macitentan (Endothelin Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04273945 — Phase 3
Pulmonary Arterial Hypertension Research Study Groups: Macitentan 75 mg + Placebo, Macitentan 10 milligrams (mg) + Placebo
Pulmonary Arterial Hypertension Clinical Trial 2023: Macitentan Highlights & Side Effects. Trial Name: NCT04273945 — Phase 3
Macitentan (Endothelin Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04273945 — Phase 3
Pulmonary Arterial Hypertension Patient Testimony for trial: Trial Name: NCT04273945 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
Mayo Clinic
University of Pennsylvania
Lankenau Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
0

Why did patients apply to this trial?

I’m currently taking all approved drug types but my condition has not improved.
PatientReceived 2+ prior treatments
I would like to try other medication or options to learn more about the condition.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Lankenau Medical Center: < 24 hours
Average response time
  • < 1 Day
~236 spots leftby Aug 2025