AzTrials
AzTrials

Pulmonary Arterial HypertensionOrPHeUSNCT03197688

Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States

An observational study of Pulmonary Arterial Hypertension, run by Actelion at 106 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The Opsumit Users registry (OPUS; NCT02126943) was developed to characterize the safety profile of Opsumit and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting. Read more about this study

Who is it for?
Any age
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
Notapplicable
How many people
2,200 participants
Where
106 sitesin 2 countries
Study dates
3 Aug 2017to 6 Sep 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients who initiated Opsumit for the first time between 19 October 2013 and 31 December 2016 (inclusive) are eligible for OrPHeUS (i.e., eligibility period).

Who may be able to join

  • Patients who initiated Opsumit for the first time between 19 October 2013 and 31 December 2016 (inclusive)
  • Patients whose medical charts are available for data collection

Who cannot join

  • Patient participation in the OPUS registry
  • Patient participation in any clinical trial involving Opsumit treatment or macitentan investigational product

Trial locations and contacts

106 sites in 2 countries.

106 sites in 2 countries

United States105 sites

  • Albany Medical Center

    Albany, New York, 12208

  • University of New Mexico

    Albuquerque, New Mexico, 87131-0001

  • AnMed Health Medical Center

    Anderson, South Carolina, 29621

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

  • University of Colorado

    Aurora, Colorado, 80045

  • Piedmont Healthcare

    Austell, Georgia, 30106

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • Bay Area Cardiology Associates

    Brandon, Florida, 33511

  • IU Health Physicians Pulmonary & Critical Care

    Carmel, Indiana, 46032

  • Florida Lung, Asthma and Sleep Specialists

    Celebration, Florida, 34747

  • University of North Carolina Hospitals

    Chapel Hill, North Carolina, 27599

  • Memorial Research Center

    Chattanooga, Tennessee, 37404

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Cincinnati

    Cincinnati, Ohio, 45242

  • CIC Associates

    Clive, Iowa, 50325

  • Southeastern Cardiology Associates

    Columbus, Georgia, 31904

  • Ohio State University, Wexner Medical Center

    Columbus, Ohio, 43210

  • Mount Carmel Medical Group

    Columbus, Ohio, 43213

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390-8550

  • Midwest Pulmonary & Sleep Research

    Dayton, Ohio, 45459

  • Premier Pulmonary CC and Sleep Medicine, PA

    Denison, Texas, 75020

  • National Jewish Health

    Denver, Colorado, 80206

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Doylestown Health Cardiology, a division of Doylestown Health Physicians

    Doylestown, Pennsylvania, 18907

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • St. Elizabeth Healthcare Clinical Research Institute

    Erlanger, Kentucky, 41018

  • Pulmonary Health Physicians

    Fayetteville, New York, 13066

  • Frank Hull, MD, PA

    Fort Lauderdale, Florida, 33316

  • Lutheran Hospital

    Fort Wayne, Indiana, 46804

  • University of Florida

    Gainesville, Florida, 32610

  • Indiana Internal Medicine Consultants

    Greenwood, Indiana, 46143

  • Stony Brook University Hospital

    Hauppauge, New York, 11788

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • West Pasco Pulmonary Associates

    Hudson, Florida, 34667

  • St. Vincent Medical Group, Inc.

    Indianapolis, Indiana, 46260

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Saint Vincent's Medical Center

    Jacksonville, Florida, 32209

  • The University of Kansas Physicians

    Kansas City, Kansas, 66160

  • University of California San Diego

    La Jolla, California, 93093

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912

  • Medical Research of Central Florida

    Leesburg, Florida, 34748

  • Nebraska Pulmonary Specialties, LLC

    Lincoln, Nebraska, 68506

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • University of Southern California

    Los Angeles, California, 90033

  • David Geffen School of Medicine at University of California Los Angeles

    Los Angeles, California, 90095-1690

  • Kentuckiana Pulmonary Associates

    Louisville, Kentucky, 40202

  • Wellstar Marietta Pulmonary Medicine

    Marietta, Georgia, 30060

  • Independent Lung Associates

    Melbourne, Florida, 32901

  • Mid-South Pulmonary Specialists

    Memphis, Tennessee, 38157

  • University of Miami

    Miami, Florida, 33136

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Southwest General Health Center

    Middleburg Heights, Ohio, 44130

  • Temple University Hospital

    Middletown, New York, 10941

  • Aurora Health Care - Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Winthrop University Hospital, Clinical Trials Center

    Mineola, New York, 11501

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407-3799

  • Yale University

    New Haven, Connecticut, 06520

  • LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Mount Sinai

    New York, New York, 10029

  • Christiana Care Health Services

    Newark, Delaware, 19718

  • Barnabas Health Ambulatory Care Center

    Newark, New Jersey, 07112

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-5990

  • Central Florida Pulmonary Group, P.A. - Downtown Orlando Office

    Orlando, Florida, 32803

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Pulmonary Associates

    Phoenix, Arizona, 85006

  • Cardiovascular Consultants

    Phoenix, Arizona, 85032

  • Mayo Clinic - Arizona

    Phoenix, Arizona, 85054

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Baylor Regional Medical Center at Plano

    Plano, Texas, 75093

  • Oregon Health & Science University

    Portland, Oregon, 97201-3098

  • Legacy Research Institute

    Portland, Oregon, 97210

  • The Oregon Clinic

    Portland, Oregon, 97225

  • Carolina Cardiology Associates

    Rock Hill, South Carolina, 29732

  • UCSF School of Medicine

    San Francisco, California, 94143

  • Paloma Medical Group

    San Juan Capistrano, California, 92675

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93105

  • University of Washington

    Seattle, Washington, 98195

  • Bassetti Medical Research Inc

    Sebring, Florida, 33870

  • Bingham Memorial Hospital

    Shelley, Idaho, 83274

  • Pulmonary & Critical Care Specialists

    Shreveport, Louisiana, 71105

  • Sioux Falls Cardiovascular PC

    Sioux Falls, South Dakota, 57108

  • Cardiovascular Medicine Associates

    South Miami, Florida, 33143

  • Spokane Respiratory Consultants

    Spokane, Washington, 99204-4800

  • Saint Louis University

    St Louis, Missouri, 63104

  • Pulmonary Consultants Inc-St. Louis

    St Louis, Missouri, 63136

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Coastal Pulmonary and Critical Care

    St. Petersburg, Florida, 33704

  • Cardiac Study Center

    Tacoma, Washington, 98405

  • University of South Florida

    Tampa, Florida, 33606

  • Scott and White Memorial Hospital

    Temple, Texas, 76508-0001

  • Montefiore Medical Center - Bronx

    The Bronx, New York, 10467

  • The University of Toledo Medical Center

    Toledo, Ohio, 43614

  • Beaumont Medical Center

    Troy, Michigan, 48085

  • Pulmonary and Critical Care Associates

    Union, New Jersey, 07083

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Cleveland Clinic Florida Hospital

    Weston, Florida, 33331

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • Florida Medical Clinic

    Zephyrhills, Florida, 33542

Other trials in United States

Puerto Rico1 site

  • CardioPulmonary Research Center

    Guaynabo, 00968

Other trials in Puerto Rico

About this study

Official title: Multicenter, Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States

The Opsumit Users registry (OPUS; NCT02126943) was developed to characterize the safety profile of Opsumit and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting. It is expected that the recruitment target of the OPUS registry cannot be achieved within the planned time period (5000 Opsumit new users by October 2018). The OrPHeUS study is designed to supplement the OPUS registry with retrospectively identified first-time Opsumit users in order to achieve the desired sample size.

Being tested
Notapplicable
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NotapplicableOther

    Not applicable as non-interventional study

Study groups in NCT03197688
Study groupRoleWhat they receive
NotapplicableNot applicable as non-interventional study
Receives: Other: Notapplicable

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimation of incidence rates of adverse events

    Incidence rates of liver test abnormalities, Occurrence of Hepatic Adverse Events (HAEs), Occurrence of any other Adverse Event (AE), Occurrence and reason for discontinuation of Opsumit treatment, hospitalization and death

    Measured: Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018

Secondary outcomes (2)

  1. Description of demographic characteristics of patients

    To describe demographic characteristics of patients treated with Opsumit at beginning and during study time period

    Measured: Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018

  2. Description of clinical characteristics of patients

    To describe clinical characteristics of patients treated with Opsumit at beginning and during study time period

    Measured: Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2017
  2. Study start3 Aug 2017
  3. Primary completion6 Sep 2018
  4. Study completion6 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
2,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03197688
Sponsor's protocol ID
AC-055-510
Acronym
OrPHeUS
Status last verified
Mar 2025
First submitted
12 May 2017
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Melendres-Groves LD, Channick RN, Chin KM, McLaughlin VV, MacDonald G, Martin N, Ong R, Sandros M, Kim NH. Characteristics, Treatment Patterns and Outcomes of Patients with Pulmonary Arterial Hypertension by Race and Ethnicity Using Real-World Data from the Combined OPUS/OrPHeUS Studies. Adv Ther. 2026 Jan;43(1):231-254. doi: 10.1007/s12325-025-03403-4. Epub 2025 Nov 19.

    PubMed 41258625

  • Kim NH, Chin KM, McLaughlin VV, Ong R, MacDonald G, Martin N, Senatore A, Channick R. Macitentan and Tadalafil Combination Therapy in Patients with Pulmonary Arterial Hypertension and Cardiovascular Comorbidities: Real-World Evidence from OPUS and OrPHeUS. Adv Ther. 2025 Jul;42(7):3306-3333. doi: 10.1007/s12325-025-03180-0. Epub 2025 May 19.

    PubMed 40388087

  • Chin KM, Channick R, Kim NH, Ong R, Turricchia S, Martin N, Mitchell L, McLaughlin VV. Macitentan in Pulmonary Arterial Hypertension Due to Congenital Heart Disease (CHD-PAH): Real-World Evidence from the OPUS/OrPHeUS Studies. Cardiol Ther. 2024 Dec;13(4):775-796. doi: 10.1007/s40119-024-00386-1. Epub 2024 Nov 25.

    PubMed 39585521

  • Channick R, Chin KM, McLaughlin VV, Lammi MR, Zamanian RT, Turricchia S, Ong R, Mitchell L, Kim NH. Macitentan in Pulmonary Arterial Hypertension Associated with Connective Tissue Disease (CTD-PAH): Real-World Evidence from the Combined OPUS/OrPHeUS Dataset. Cardiol Ther. 2024 Jun;13(2):315-339. doi: 10.1007/s40119-024-00361-w. Epub 2024 Mar 7.

    PubMed 38451426

  • Kim NH, Chin KM, McLaughlin VV, DuBrock H, Restrepo-Jaramillo R, Safdar Z, MacDonald G, Martin N, Rosenberg D, Solonets M, Channick R. Safety of Macitentan for the Treatment of Portopulmonary Hypertension: Real-World Evidence from the Combined OPUS/OrPHeUS Studies. Pulm Ther. 2024 Mar;10(1):85-107. doi: 10.1007/s41030-023-00251-x. Epub 2024 Jan 7.

    PubMed 38184507

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Arterial Hypertension, run by Actelion at 106 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimation of incidence rates of adverse events (time frame: Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03197688, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in