Clinical trial NCT03197688: Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States
Official title: Multicenter, Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2017-06-23
Enrollment: 2200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Estimation of incidence rates of adverse events
timeFrame: Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018
Secondary outcomes:
measure: Description of demographic characteristics of patients
timeFrame: Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018
measure: Description of clinical characteristics of patients
timeFrame: Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
city: Phoenix
country: United States
facility: Cardiovascular Consultants
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic - Arizona
state: Arizona
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at University of California Los Angeles
state: California
city: San Francisco
country: United States
facility: UCSF School of Medicine
state: California
city: San Juan Capistrano
country: United States
facility: Paloma Medical Group
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Brandon
country: United States
facility: Bay Area Cardiology Associates
state: Florida
city: Celebration
country: United States
facility: Florida Lung, Asthma and Sleep Specialists
state: Florida
city: Fort Lauderdale
country: United States
facility: Frank Hull, MD, PA
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Hudson
country: United States
facility: West Pasco Pulmonary Associates
state: Florida
city: Jacksonville
country: United States
facility: Saint Vincent's Medical Center
state: Florida
city: Leesburg
country: United States
facility: Medical Research of Central Florida
state: Florida
city: Melbourne
country: United States
facility: Independent Lung Associates
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group, P.A. - Downtown Orlando Office
state: Florida
city: Saint Petersburg
country: United States
facility: Coastal Pulmonary and Critical Care
state: Florida
city: Sebring
country: United States
facility: Bassetti Medical Research Inc
state: Florida
city: South Miami
country: United States
facility: Cardiovascular Medicine Associates
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida Hospital
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic
state: Florida
city: Austell
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Columbus
country: United States
facility: Southeastern Cardiology Associates
state: Georgia
city: Marietta
country: United States
facility: Wellstar Marietta Pulmonary Medicine
state: Georgia
city: Shelley
country: United States
facility: Bingham Memorial Hospital
state: Idaho
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Carmel
country: United States
facility: IU Health Physicians Pulmonary & Critical Care
state: Indiana
city: Fort Wayne
country: United States
facility: Lutheran Hospital
state: Indiana
city: Greenwood
country: United States
facility: Indiana Internal Medicine Consultants
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Medical Group, Inc.
state: Indiana
city: Clive
country: United States
facility: CIC Associates
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: The University of Kansas Physicians
state: Kansas
city: Erlanger
country: United States
facility: St. Elizabeth Healthcare Clinical Research Institute
state: Kentucky
city: Louisville
country: United States
facility: Kentuckiana Pulmonary Associates
state: Kentucky
city: New Orleans
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: Pulmonary & Critical Care Specialists
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Troy
country: United States
facility: Beaumont Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Saint Louis
country: United States
facility: Pulmonary Consultants Inc-St. Louis
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital Saint Louis
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Pulmonary Specialties, LLC
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Newark
country: United States
facility: Barnabas Health Ambulatory Care Center
state: New Jersey
city: Union
country: United States
facility: Pulmonary and Critical Care Associates
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center - Bronx
state: New York
city: Fayetteville
country: United States
facility: Pulmonary Health Physicians
state: New York
city: Hauppauge
country: United States
facility: Stony Brook University Hospital
state: New York
city: Middletown
country: United States
facility: Temple University Hospital
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital, Clinical Trials Center
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Ohio State University, Wexner Medical Center
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel Medical Group
state: Ohio
city: Dayton
country: United States
facility: Midwest Pulmonary & Sleep Research
state: Ohio
city: Middleburg Heights
country: United States
facility: Southwest General Health Center
state: Ohio
city: Toledo
country: United States
facility: The University of Toledo Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Portland
country: United States
facility: Legacy Research Institute
state: Oregon
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Doylestown
country: United States
facility: Doylestown Health Cardiology, a division of Doylestown Health Physicians
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health Medical Center
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Cardiology Associates
state: South Carolina
city: Sioux Falls
country: United States
facility: Sioux Falls Cardiovascular PC
state: South Dakota
city: Chattanooga
country: United States
facility: Memorial Research Center
state: Tennessee
city: Memphis
country: United States
facility: Mid-South Pulmonary Specialists
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Denison
country: United States
facility: Premier Pulmonary CC and Sleep Medicine, PA
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Plano
country: United States
facility: Baylor Regional Medical Center at Plano
state: Texas
city: Temple
country: United States
facility: Scott and White Memorial Hospital
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Spokane
country: United States
facility: Spokane Respiratory Consultants
state: Washington
city: Tacoma
country: United States
facility: Cardiac Study Center
state: Washington
city: Milwaukee
country: United States
facility: Aurora Health Care - Saint Luke's Medical Center
state: Wisconsin
city: Guaynabo
country: Puerto Rico
facility: CardioPulmonary Research Center
Study officials:
References: