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New registry follows PAH patients on orenitram in Real-World settings

NCT ID NCT03045029

Disease control Sponsor: United Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is a patient registry that follows 300 adults with pulmonary arterial hypertension (PAH) who are starting or recently started Orenitram. Researchers will track how well patients tolerate the drug and how it affects their daily function and symptoms over 78 weeks. The goal is to understand real-world use and side effects, not to test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2017

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients are eligible if they have been receiving Orenitram for 182 or fewer days.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA Patients are eligible for the registry if: 1. The patient voluntarily gives informed consent to participate in the study. 2. The patient must be at least 18 years of age or older. 3. The patient is prescribed Orenitram (per the package insert indication), and plans to initiate therapy with this medication or has been receiving Orenitram for 182 or fewer days. 4. The patient agrees to dosing, prostacyclin-related AE of interest record keeping, survey participation during designated time periods, and recording any medication changes, use, for the duration of the study. 5. The patient has the ability to answer surveys and use the diary in English. 6. The patient must have an email address and be willing to access the PRO Portal. EXCLUSION CRITERIA Patients are ineligible for the registry if: 1. The patient has previously received Orenitram for more than 182 days. 2. The patient is currently participating in an investigational drug or device study or has participated in a clinical study with an investigational product other than Orenitram in PAH within

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary arterial hypertension

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Albany Medical College

    Albany, New York, 12208, United States

  • AnMed Health Pulmonary and Sleep Medicine

    Anderson, South Carolina, 29621, United States

  • Aurora Denver Cardiology Associates

    Aurora, Colorado, 80012, United States

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

  • Beaumont Hospital Troy

    Troy, Michigan, 48085, United States

  • Carilion Clinic

    Roanoke, Virginia, 24014, United States

  • Center for Biomedical Research

    Knoxville, Tennessee, 37919, United States

  • Central Florida Pulmonary Group, P.A.

    Orlando, Florida, 32803, United States

  • Chest Medicine Associates

    South Portland, Maine, 04106, United States

  • Cleveland Clinic Florida

    Weston, Florida, 33331, United States

  • Harbor UCLA Medical Center

    Torrance, California, 90502, United States

  • Heart Care Associates, LLC

    Milwaukee, Wisconsin, 53215, United States

  • Houston Methodist Research Institute

    Houston, Texas, 77030, United States

  • INTEGRIS Nazih Zuhdi Transplant Institution

    Oklahoma City, Oklahoma, 73112, United States

  • Lima Memorial Hospital

    Lima, Ohio, 45804, United States

  • Loyola University Chicago

    Chicago, Illinois, 60153, United States

  • Lung Associates PA

    Bradenton, Florida, 34208, United States

  • Mclaren Greater Lansing

    Okemos, Michigan, 48864, United States

  • New York Methodist Hospital

    Brooklyn, New York, 11215, United States

  • Northwell Health- Long Island Jewish Forest Hills

    New Hyde Park, New York, 11040, United States

  • Oregon Health & Science University (OHSU)

    Portland, Oregon, 97239, United States

  • Paloma Medical Group

    San Juan Capistrano, California, 92675, United States

  • Piedmont Healthcare/Research

    Austell, Georgia, 30309, United States

  • Pinehurst Medical Clinic, INC.

    Pinehurst, North Carolina, 28374, United States

  • Pueblo Pulmonary Associates

    Pueblo, Colorado, 81003, United States

  • Pulmonary Health Physicians, PC

    Fayetteville, New York, 13066, United States

  • Renovatio Clinical

    The Woodlands, Texas, 77380, United States

  • Saint Vincent Hospital and Health Services

    Indianapolis, Indiana, 46260, United States

  • Santa Barbara Pulmonary Associates

    Santa Barbara, California, 93105, United States

  • St. Vincent's Lung, Sleep, and Critical Care Specialists

    Jacksonville, Florida, 33204, United States

  • Stony Brook University Medical Center

    Islandia, New York, 11790, United States

  • USF South Florida Heart Health

    Tampa, Florida, 33606, United States

  • University Of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242, United States

  • University of California - San Francisco

    Fresno, California, 94143, United States

  • University of Florida Clinical Research Center

    Gainesville, Florida, 32610, United States

  • University of Louisville Physicians Outpatient Center

    Louisville, Kentucky, 40202, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Pittsburgh - Heart and Vascular Medicine Institute

    Pittsburgh, Pennsylvania, 15261, United States

  • University of Rochester

    Rochester, New York, 14623, United States

  • University of Southern California - Keck Medical Center

    Los Angeles, California, 90033, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.