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ClinicalTrials.gov record
Completed No phase listed Observational

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

ClinicalTrials.gov ID: NCT03197688

Public ClinicalTrials.gov record NCT03197688. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 1:32 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03197688
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Actelion
Industry
Enrollment
2,200 participants

Conditions and interventions

Interventions

Other

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 3, 2017 (Actual)
Primary completion
Sep 6, 2018 (Actual)
Completion
Sep 6, 2018 (Actual)
Last update posted
Mar 30, 2025

2017 – 2018

United States locations

U.S. sites
105
U.S. states
35
U.S. cities
92
Facility City State ZIP Site status
Pulmonary Associates Phoenix Arizona 85006 —
Cardiovascular Consultants Phoenix Arizona 85032 —
Mayo Clinic - Arizona Phoenix Arizona 85054 —
University of California San Diego La Jolla California 93093 —
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 —
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 Colorado Aurora Colorado 80045 —
National Jewish Health Denver Colorado 80206 —
Yale University New Haven Connecticut 06520 —
Christiana Care Health Services Newark Delaware 19718 —
MedStar Georgetown University Hospital Washington D.C. District of Columbia 20007 —
Bay Area Cardiology Associates Brandon Florida 33511 —
Florida Lung, Asthma and Sleep Specialists Celebration Florida 34747 —
Frank Hull, MD, PA Fort Lauderdale Florida 33316 —
University of Florida Gainesville Florida 32610 —
West Pasco Pulmonary Associates Hudson Florida 34667 —
Saint Vincent's Medical Center Jacksonville Florida 32209 —
Medical Research of Central Florida Leesburg Florida 34748 —
Independent Lung Associates Melbourne Florida 32901 —
University of Miami Miami Florida 33136 —
Mount Sinai Comprehensive Cancer Center Miami Beach Florida 33140 —
Central Florida Pulmonary Group, P.A. - Downtown Orlando Office Orlando Florida 32803 —
Bassetti Medical Research Inc Sebring Florida 33870 —
Cardiovascular Medicine Associates South Miami Florida 33143 —
Coastal Pulmonary and Critical Care St. Petersburg Florida 33704 —
University of South Florida Tampa Florida 33606 —
Cleveland Clinic Florida Hospital Weston Florida 33331 —
Florida Medical Clinic Zephyrhills Florida 33542 —
Piedmont Healthcare Austell Georgia 30106 —
Southeastern Cardiology Associates Columbus Georgia 31904 —
Wellstar Marietta Pulmonary Medicine Marietta Georgia 30060 —
Bingham Memorial Hospital Shelley Idaho 83274 —
Northwestern University Chicago Illinois 60611 —
IU Health Physicians Pulmonary & Critical Care Carmel Indiana 46032 —
Lutheran Hospital Fort Wayne Indiana 46804 —
Indiana Internal Medicine Consultants Greenwood Indiana 46143 —
St. Vincent Medical Group, Inc. Indianapolis Indiana 46260 —
CIC Associates Clive Iowa 50325 —
University of Iowa Hospitals and Clinics Iowa City Iowa 52242 —
The University of Kansas Physicians Kansas City Kansas 66160 —
St. Elizabeth Healthcare Clinical Research Institute Erlanger Kentucky 41018 —
Kentuckiana Pulmonary Associates Louisville Kentucky 40202 —
LSU Health Sciences Center New Orleans Louisiana 70112 —
Ochsner Medical Center New Orleans Louisiana 70121 —
Pulmonary & Critical Care Specialists Shreveport Louisiana 71105 —
Tufts Medical Center Boston Massachusetts 02111 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Boston University Medical Center Boston Massachusetts 02118 —
University of Michigan Medical Center Ann Arbor Michigan 48109 —
Henry Ford Health System Detroit Michigan 48202 —
Sparrow Clinical Research Institute Lansing Michigan 48912 —
Beaumont Medical Center Troy Michigan 48085 —
Minneapolis Heart Institute Minneapolis Minnesota 55407-3799 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
Saint Louis University St Louis Missouri 63104 —
Pulmonary Consultants Inc-St. Louis St Louis Missouri 63136 —
Mercy Hospital Saint Louis St Louis Missouri 63141 —
Nebraska Pulmonary Specialties, LLC Lincoln Nebraska 68506 —
University of Nebraska Medical Center Omaha Nebraska 68198-5990 —
Barnabas Health Ambulatory Care Center Newark New Jersey 07112 —
Pulmonary and Critical Care Associates Union New Jersey 07083 —
University of New Mexico Albuquerque New Mexico 87131-0001 —
Albany Medical Center Albany New York 12208 —
Pulmonary Health Physicians Fayetteville New York 13066 —
Stony Brook University Hospital Hauppauge New York 11788 —
Temple University Hospital Middletown New York 10941 —
Winthrop University Hospital, Clinical Trials Center Mineola New York 11501 —
Mount Sinai New York New York 10029 —
Montefiore Medical Center - Bronx The Bronx New York 10467 —
University of North Carolina Hospitals Chapel Hill North Carolina 27599 —
Duke University Medical Center Durham North Carolina 27710 —
University of Cincinnati Cincinnati Ohio 45242 —
Ohio State University, Wexner Medical Center Columbus Ohio 43210 —
Mount Carmel Medical Group Columbus Ohio 43213 —
Midwest Pulmonary & Sleep Research Dayton Ohio 45459 —
Southwest General Health Center Middleburg Heights Ohio 44130 —
The University of Toledo Medical Center Toledo Ohio 43614 —
Oklahoma Heart Hospital Oklahoma City Oklahoma 73120 —
Oregon Health & Science University Portland Oregon 97201-3098 —
Legacy Research Institute Portland Oregon 97210 —
The Oregon Clinic Portland Oregon 97225 —
Doylestown Health Cardiology, a division of Doylestown Health Physicians Doylestown Pennsylvania 18907 —
University of Pennsylvania Health System Philadelphia Pennsylvania 19104 —
Thomas Jefferson University Philadelphia Pennsylvania 19107 —
Allegheny General Hospital Pittsburgh Pennsylvania 15212 —
Lankenau Medical Center Wynnewood Pennsylvania 19096 —
AnMed Health Medical Center Anderson South Carolina 29621 —
Carolina Cardiology Associates Rock Hill South Carolina 29732 —
Sioux Falls Cardiovascular PC Sioux Falls South Dakota 57108 —
Memorial Research Center Chattanooga Tennessee 37404 —
Mid-South Pulmonary Specialists Memphis Tennessee 38157 —
University of Texas Southwestern Medical Center at Dallas Dallas Texas 75390-8550 —
Premier Pulmonary CC and Sleep Medicine, PA Denison Texas 75020 —
Houston Methodist Hospital Houston Texas 77030 —
University of Texas Health Science Center at Houston Houston Texas 77030 —
Baylor Regional Medical Center at Plano Plano Texas 75093 —
Scott and White Memorial Hospital Temple Texas 76508-0001 —
University of Washington Seattle Washington 98195 —
Spokane Respiratory Consultants Spokane Washington 99204-4800 —
Cardiac Study Center Tacoma Washington 98405 —
Aurora Health Care - Saint Luke's Medical Center Milwaukee Wisconsin 53215 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03197688, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 30, 2025 · Synced Oct 21, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03197688 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →