Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Other: Notapplicable
- Registration Number
- NCT03197688
- Lead Sponsor
- Actelion
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2200
- 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
- Patient participation in the OPUS registry
- Patient participation in any clinical trial involving Opsumit treatment or macitentan investigational product
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Notapplicable Notapplicable Not applicable as non-interventional study
- Primary Outcome Measures
Name Time Method Estimation of incidence rates of adverse events Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018 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
- Secondary Outcome Measures
Name Time Method Description of clinical characteristics of patients Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018 To describe clinical characteristics of patients treated with Opsumit at beginning and during study time period
Description of demographic characteristics of patients Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018 To describe demographic characteristics of patients treated with Opsumit at beginning and during study time period
Trial Locations
- Locations (106)
University of Southern California
🇺🇸Los Angeles, California, United States
Pulmonary & Critical Care Specialists
🇺🇸Shreveport, Louisiana, United States
Sparrow Clinical Research Institute
🇺🇸Lansing, Michigan, United States
Mount Carmel Medical Group
🇺🇸Columbus, Ohio, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Boston University Medical Center
🇺🇸Boston, Massachusetts, United States
St. Vincent Medical Group, Inc.
🇺🇸Indianapolis, Indiana, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Pulmonary and Critical Care Associates
🇺🇸Union, New Jersey, United States
Memorial Research Center
🇺🇸Chattanooga, Tennessee, United States
CardioPulmonary Research Center
🇵🇷Guaynabo, Puerto Rico
Mid-South Pulmonary Specialists
🇺🇸Memphis, Tennessee, United States
University of Washington
🇺🇸Seattle, Washington, United States
University of Miami
🇺🇸Miami, Florida, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Sioux Falls Cardiovascular PC
🇺🇸Sioux Falls, South Dakota, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Nebraska Pulmonary Specialties, LLC
🇺🇸Lincoln, Nebraska, United States
Barnabas Health Ambulatory Care Center
🇺🇸Newark, New Jersey, United States
MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Pulmonary Associates
🇺🇸Phoenix, Arizona, United States
Cardiovascular Consultants
🇺🇸Phoenix, Arizona, United States
Mayo Clinic - Arizona
🇺🇸Phoenix, Arizona, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Southwest General Health Center
🇺🇸Middleburg Heights, Ohio, United States
Midwest Pulmonary & Sleep Research
🇺🇸Dayton, Ohio, United States
The University of Toledo Medical Center
🇺🇸Toledo, Ohio, United States
Oklahoma Heart Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Doylestown Health Cardiology, a division of Doylestown Health Physicians
🇺🇸Doylestown, Pennsylvania, United States
Carolina Cardiology Associates
🇺🇸Rock Hill, South Carolina, United States
Premier Pulmonary CC and Sleep Medicine, PA
🇺🇸Denison, Texas, United States
Cardiac Study Center
🇺🇸Tacoma, Washington, United States
Wellstar Marietta Pulmonary Medicine
🇺🇸Marietta, Georgia, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Lutheran Hospital
🇺🇸Fort Wayne, Indiana, United States
Cleveland Clinic Florida Hospital
🇺🇸Weston, Florida, United States
Coastal Pulmonary and Critical Care
🇺🇸Saint Petersburg, Florida, United States
Bay Area Cardiology Associates
🇺🇸Brandon, Florida, United States
Bassetti Medical Research Inc
🇺🇸Sebring, Florida, United States
Cardiovascular Medicine Associates
🇺🇸South Miami, Florida, United States
The University of Kansas Physicians
🇺🇸Kansas City, Kansas, United States
Florida Medical Clinic
🇺🇸Zephyrhills, Florida, United States
Piedmont Healthcare
🇺🇸Austell, Georgia, United States
Bingham Memorial Hospital
🇺🇸Shelley, Idaho, United States
Southeastern Cardiology Associates
🇺🇸Columbus, Georgia, United States
CIC Associates
🇺🇸Clive, Iowa, United States
Indiana Internal Medicine Consultants
🇺🇸Greenwood, Indiana, United States
IU Health Physicians Pulmonary & Critical Care
🇺🇸Carmel, Indiana, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
Ohio State University, Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Pulmonary Consultants Inc-St. Louis
🇺🇸Saint Louis, Missouri, United States
Mercy Hospital Saint Louis
🇺🇸Saint Louis, Missouri, United States
Temple University Hospital
🇺🇸Middletown, New York, United States
Winthrop University Hospital, Clinical Trials Center
🇺🇸Mineola, New York, United States
Mount Sinai
🇺🇸New York, New York, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
St. Elizabeth Healthcare Clinical Research Institute
🇺🇸Erlanger, Kentucky, United States
Baylor Regional Medical Center at Plano
🇺🇸Plano, Texas, United States
Paloma Medical Group
🇺🇸San Juan Capistrano, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
David Geffen School of Medicine at University of California Los Angeles
🇺🇸Los Angeles, California, United States
UCSF School of Medicine
🇺🇸San Francisco, California, United States
Santa Barbara Cottage Hospital
🇺🇸Santa Barbara, California, United States
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Frank Hull, MD, PA
🇺🇸Fort Lauderdale, Florida, United States
West Pasco Pulmonary Associates
🇺🇸Hudson, Florida, United States
Florida Lung, Asthma and Sleep Specialists
🇺🇸Celebration, Florida, United States
Saint Vincent's Medical Center
🇺🇸Jacksonville, Florida, United States
Medical Research of Central Florida
🇺🇸Leesburg, Florida, United States
Independent Lung Associates
🇺🇸Melbourne, Florida, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Beaumont Medical Center
🇺🇸Troy, Michigan, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Pulmonary Health Physicians
🇺🇸Fayetteville, New York, United States
Stony Brook University Hospital
🇺🇸Hauppauge, New York, United States
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
AnMed Health Medical Center
🇺🇸Anderson, South Carolina, United States
Scott and White Memorial Hospital
🇺🇸Temple, Texas, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Spokane Respiratory Consultants
🇺🇸Spokane, Washington, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Yale University
🇺🇸New Haven, Connecticut, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Central Florida Pulmonary Group, P.A. - Downtown Orlando Office
🇺🇸Orlando, Florida, United States
Kentuckiana Pulmonary Associates
🇺🇸Louisville, Kentucky, United States
LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Montefiore Medical Center - Bronx
🇺🇸Bronx, New York, United States
University of North Carolina Hospitals
🇺🇸Chapel Hill, North Carolina, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Legacy Research Institute
🇺🇸Portland, Oregon, United States
The Oregon Clinic
🇺🇸Portland, Oregon, United States
Aurora Health Care - Saint Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States