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Macitentan for Pulmonary Hypertension (TOMORROW Trial)
TOMORROW Trial Summary
This trial will test the effects of macitentan in children with pulmonary arterial hypertension. The trial will see if the medication is safe and effective in this population.
TOMORROW Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTOMORROW Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 4 trial • 89 Patients • NCT02310672TOMORROW Trial Design
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Who is running the clinical trial?
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- I am under 18 years old.I haven't taken IV or SC prostanoids in the last 4 weeks, except for a specific test.I am currently on more than two treatments for pulmonary arterial hypertension.I have PAH linked to Eisenmenger syndrome or significant heart defects.My liver is not working well (severe issues).Your hemoglobin or hematocrit levels are very low.Your blood test shows that your AST and/or ALT levels are more than three times the normal range.I have been diagnosed with PAH confirmed by a heart catheter test.I have low blood pressure that makes starting PAH treatment risky.I have been diagnosed with PAH confirmed by a heart catheter test.I am under 18 years old.My kidneys are not working well (severe renal insufficiency).My PAH is classified under Group 1 and may be related to a specific cause like heart disease or HIV.I have been diagnosed with bronchopulmonary dysplasia.I am not pregnant, will test monthly, and will use birth control until the study ends.My PAH is caused by portal hypertension, schistosomiasis, or specific lung diseases.My body weight is at least 3.5 kg.
- Group 1: Macitentan
- Group 2: Standard-of-care
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Please let me know how many hospitals are currently testing this new treatment.
"There are a total of 18 sites running this trial currently. To help reduce burdening enrollees with travel, the sites are located in major cities such as Boston, Indianapolis and Aurora."
What is the novel aspect of this research?
"There are 8 ongoing trials for Macitentan in 88 cities and 46 countries. The first study began in 2017 and completed Phase 3 in the same year. This was a 300-patient trial sponsored by Actelion. There have been 34 completed trials since then."
Might I be a candidate to participate in this research project?
"Eligible patients for this trial must have pulmonary arterial hypertension and be between the ages of 1 month to 17 years old. This study plans to enroll around 300 individuals."
Are there similar therapies to compare this drug to?
"8 clinical trials are currently testing the efficacy of Macitentan. Of these 8 studies, 1 is in Phase 3. It's worth mentioning that while several studies are taking place in Durham, North carolina, there are 818 total locations running Macitentan trials."
Is there a risk of long-term side effects from taking Macitentan?
"There is some clinical data supporting the efficacy of Macitentan, and as it is a Phase 3 trial, it received a score of 3 for safety."
Which goals does this test hope to achieve?
"The primary objective of this study, as measured over Week 12, is to establish the observed steady-state trough plasma concentration of macitentan and its active metabolite ACT-132577 in participants aged 2 years or younger. Secondary objectives include determining the percentage of participants with WHO functional class I or II versus III or IV, measuring the time to CEC-confirmed death due to PAH, and assessing the change from baseline to Week 24 in PedsQL 4.0 Generic Core Scales Short Form (SF-15) scores."
Do elderly individuals qualify for this experiment?
"This clinical trial is enrolling patients that are infants up to seventeen years old. Out of the 756 total studies, 58 are for patients under eighteen and 698 are for patients over the age of sixty-five."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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