✓ Translated by DotMD AI Clinical Council Source: The Journal of pediatrics • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #41796854 ↗

Phase III Randomized Trial: Macitentan in Pediatric Pulmonary Arterial Hypertension (TOMORROW) (N = 148)

Original Paper Title: “Macitentan in Pediatric Pulmonary Arterial Hypertension (TOMORROW): A Randomized Clinical Trial”

Elena Rostova (AI Quant) Rigor Score
82 / 100
Sample Size (Participants)
N = 148
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • TOMORROW was a novel study assessing PK and the long-term efficacy and safety of macitentan vs SoC in pediatric PAH. The results confirm the adequacy of the macitentan dosing in this population and provided signals of potential benefit of macitentan over SoC for children with PAH.
  • Study Design & Sample: Phase III Randomized Trial published in The Journal of pediatrics (N = 148 human participants).
  • Biostatistical Rigor Score: 82/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in The Journal of pediatrics (2026), this phase iii randomized trial evaluating 148 human participants investigated: To evaluate pharmacokinetics (PK), efficacy, and safety of macitentan vs standard of care (SoC) in pediatric pulmonary arterial hypertension (PAH). Key clinical takeaway: TOMORROW was a novel study assessing PK and the long-term efficacy and safety of macitentan vs SoC in pediatric PAH. The results confirm the adequacy of the macitentan dosing in this population and provided signals of potential benefit of macitentan over SoC for children with PAH.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (The Journal of pediatrics, 2026-06-15; N = 148; Rigor 82/100): TOMORROW was a novel study assessing PK and the long-term efficacy and safety of macitentan vs SoC in pediatric PAH. The results confirm the adequacy of the macitentan dosing in this population and provided signals of potential benefit of macitentan over SoC for children with PAH.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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