Pulmonary Arterial Hypertension Clinical Trial
— OrPHeUSOfficial title:
Multicenter, Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States
| NCT number | NCT03197688 |
| Other study ID # | AC-055-510 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 3, 2017 |
| Est. completion date | September 6, 2018 |
| Verified date | September 2018 |
| Source | Actelion |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 2200 |
| Est. completion date | September 6, 2018 |
| Est. primary completion date | September 6, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | CardioPulmonary Research Center | Guaynabo | |
| United States | Albany Medical Center | Albany | New York |
| United States | University of New Mexico | Albuquerque | New Mexico |
| United States | AnMed Health Medical Center | Anderson | South Carolina |
| United States | University of Michigan Medical Center | Ann Arbor | Michigan |
| United States | University of Colorado | Aurora | Colorado |
| United States | Piedmont Healthcare | Austell | Georgia |
| United States | Boston University Medical Center | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Tufts Medical Center | Boston | Massachusetts |
| United States | Bay Area Cardiology Associates | Brandon | Florida |
| United States | Montefiore Medical Center - Bronx | Bronx | New York |
| United States | IU Health Physicians Pulmonary & Critical Care | Carmel | Indiana |
| United States | Florida Lung, Asthma and Sleep Specialists | Celebration | Florida |
| United States | University of North Carolina Hospitals | Chapel Hill | North Carolina |
| United States | Memorial Research Center | Chattanooga | Tennessee |
| United States | Northwestern University | Chicago | Illinois |
| United States | University of Cincinnati | Cincinnati | Ohio |
| United States | CIC Associates | Clive | Iowa |
| United States | Mount Carmel Medical Group | Columbus | Ohio |
| United States | Ohio State University, Wexner Medical Center | Columbus | Ohio |
| United States | Southeastern Cardiology Associates | Columbus | Georgia |
| United States | University of Texas Southwestern Medical Center at Dallas | Dallas | Texas |
| United States | Midwest Pulmonary & Sleep Research | Dayton | Ohio |
| United States | Premier Pulmonary CC and Sleep Medicine, PA | Denison | Texas |
| United States | National Jewish Health | Denver | Colorado |
| United States | Henry Ford Health System | Detroit | Michigan |
| United States | Doylestown Health Cardiology, a division of Doylestown Health Physicians | Doylestown | Pennsylvania |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | St. Elizabeth Healthcare Clinical Research Institute | Erlanger | Kentucky |
| United States | Pulmonary Health Physicians | Fayetteville | New York |
| United States | Frank Hull, MD, PA | Fort Lauderdale | Florida |
| United States | Lutheran Hospital | Fort Wayne | Indiana |
| United States | University of Florida | Gainesville | Florida |
| United States | Indiana Internal Medicine Consultants | Greenwood | Indiana |
| United States | Stony Brook University Hospital | Hauppauge | New York |
| United States | Houston Methodist Hospital | Houston | Texas |
| United States | University of Texas Health Science Center at Houston | Houston | Texas |
| United States | West Pasco Pulmonary Associates | Hudson | Florida |
| United States | St. Vincent Medical Group, Inc. | Indianapolis | Indiana |
| United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
| United States | University of Mississippi Medical Center | Jackson | Mississippi |
| United States | Saint Vincent's Medical Center | Jacksonville | Florida |
| United States | The University of Kansas Physicians | Kansas City | Kansas |
| United States | University of California San Diego | La Jolla | California |
| United States | Sparrow Clinical Research Institute | Lansing | Michigan |
| United States | Medical Research of Central Florida | Leesburg | Florida |
| United States | Nebraska Pulmonary Specialties, LLC | Lincoln | Nebraska |
| 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 | University of Southern California | Los Angeles | California |
| United States | Kentuckiana Pulmonary Associates | Louisville | Kentucky |
| United States | Wellstar Marietta Pulmonary Medicine | Marietta | Georgia |
| United States | Independent Lung Associates | Melbourne | Florida |
| United States | Mid-South Pulmonary Specialists | Memphis | Tennessee |
| United States | University of Miami | Miami | Florida |
| United States | Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida |
| United States | Southwest General Health Center | Middleburg Heights | Ohio |
| United States | Temple University Hospital | Middletown | New York |
| United States | Aurora Health Care - Saint Luke's Medical Center | Milwaukee | Wisconsin |
| United States | Winthrop University Hospital, Clinical Trials Center | Mineola | New York |
| United States | Minneapolis Heart Institute | Minneapolis | Minnesota |
| United States | Yale University | New Haven | Connecticut |
| United States | LSU Health Sciences Center | New Orleans | Louisiana |
| United States | Ochsner Medical Center | New Orleans | Louisiana |
| United States | Mount Sinai | New York | New York |
| United States | Barnabas Health Ambulatory Care Center | Newark | New Jersey |
| United States | Christiana Care Health Services | Newark | Delaware |
| United States | Oklahoma Heart Hospital | Oklahoma City | Oklahoma |
| United States | University of Nebraska Medical Center | Omaha | Nebraska |
| United States | Central Florida Pulmonary Group, P.A. - Downtown Orlando Office | Orlando | Florida |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania Health System | Philadelphia | Pennsylvania |
| United States | Cardiovascular Consultants | Phoenix | Arizona |
| United States | Mayo Clinic - Arizona | Phoenix | Arizona |
| United States | Pulmonary Associates | Phoenix | Arizona |
| United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
| United States | Baylor Regional Medical Center at Plano | Plano | Texas |
| United States | Legacy Research Institute | Portland | Oregon |
| United States | Oregon Health & Science University | Portland | Oregon |
| United States | The Oregon Clinic | Portland | Oregon |
| United States | Carolina Cardiology Associates | Rock Hill | South Carolina |
| United States | Mercy Hospital Saint Louis | Saint Louis | Missouri |
| United States | Pulmonary Consultants Inc-St. Louis | Saint Louis | Missouri |
| United States | Saint Louis University | Saint Louis | Missouri |
| United States | Coastal Pulmonary and Critical Care | Saint Petersburg | Florida |
| United States | UCSF School of Medicine | San Francisco | California |
| United States | Paloma Medical Group | San Juan Capistrano | California |
| United States | Santa Barbara Cottage Hospital | Santa Barbara | California |
| United States | University of Washington | Seattle | Washington |
| United States | Bassetti Medical Research Inc | Sebring | Florida |
| United States | Bingham Memorial Hospital | Shelley | Idaho |
| United States | Pulmonary & Critical Care Specialists | Shreveport | Louisiana |
| United States | Sioux Falls Cardiovascular PC | Sioux Falls | South Dakota |
| United States | Cardiovascular Medicine Associates | South Miami | Florida |
| United States | Spokane Respiratory Consultants | Spokane | Washington |
| United States | Cardiac Study Center | Tacoma | Washington |
| United States | University of South Florida | Tampa | Florida |
| United States | Scott and White Memorial Hospital | Temple | Texas |
| United States | The University of Toledo Medical Center | Toledo | Ohio |
| United States | Beaumont Medical Center | Troy | Michigan |
| United States | Pulmonary and Critical Care Associates | Union | New Jersey |
| United States | MedStar Georgetown University Hospital | Washington | District of Columbia |
| United States | Cleveland Clinic Florida Hospital | Weston | Florida |
| United States | Lankenau Medical Center | Wynnewood | Pennsylvania |
| United States | Florida Medical Clinic | Zephyrhills | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Actelion |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018 | |
| Secondary | Description of demographic characteristics of patients | To describe demographic characteristics of patients treated with Opsumit at beginning and during study time period | Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018 | |
| Secondary | Description of clinical characteristics of patients | To describe clinical characteristics of patients treated with Opsumit at beginning and during study time period | Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018 |
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