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ACTIVE NOT RECRUITING Phase 3

Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension

NCT04273945 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.

Interventions

  • DRUG Placebo
  • DRUG Macitentan 10 mg
  • DRUG Macitentan 37.5 mg
  • DRUG Macitentan 75 mg

Study Locations (20)

California

  • Scripps Memorial Hospital — La Jolla
  • USC Keck — Los Angeles
  • Jeffrey S. Sager, MD Medical Corporation — Santa Barbara
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance

Arizona

  • Mayo Clinic — Phoenix
  • Arizona Pulmonary Specialists, Ltd — Scottsdale

Georgia

  • Piedmont Healthcare — Atlanta
  • Northside Hospital — Atlanta

Indiana

  • Indiana University — Indianapolis
  • St. Vincent Medical Group, Inc. — Indianapolis

Michigan

  • University of Michigan — Ann Arbor
  • Troy Beaumont — Troy

Missouri

  • Washington University School Of Medicine — St Louis
  • Saint Louis University Academic Pavillion — St Louis

Colorado

  • National Jewish Health — Denver

Florida

  • Cleveland Clinic — Weston

Trial Details

FieldValue
Enrollment Target 935 participants
Start Date 2020-06-30
Est. Completion 2029-02-20
Phase Phase 3

Sponsor

Actelion

14 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04273945

The ClinicalTrials.gov registry entry for NCT04273945 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 935 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actelion, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 4 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04273945 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Arizona, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04273945 about?

NCT04273945 is a clinical study titled "Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension". The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10...

What is the current status of trial NCT04273945?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 935 participants. The study started on 2020-06-30. Estimated completion is 2029-02-20.

What conditions does trial NCT04273945 study?

This clinical trial studies the following conditions: Pulmonary Arterial Hypertension. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04273945?

The interventions under investigation include: Placebo (DRUG), Macitentan 10 mg (DRUG), Macitentan 37.5 mg (DRUG), Macitentan 75 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04273945?

This trial is sponsored by Actelion, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04273945 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial