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

Completed

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT03197688

Run by

Actelion

People needed

2200

Starts

2017-08-03

Expected to finish

2018-09-06

Last updated by the study team

2025-03-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Cardiovascular Consultants — Phoenix, Arizona, United States
• Mayo Clinic - Arizona — Phoenix, Arizona, United States
• University of California San Diego — La Jolla, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• University of Southern California — Los Angeles, 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
• Paloma Medical Group — San Juan Capistrano, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• University of Colorado — Aurora, Colorado, United States
• National Jewish Health — Denver, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Christiana Care Health Services — Newark, Delaware, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Bay Area Cardiology Associates — Brandon, Florida, United States
• Florida Lung, Asthma and Sleep Specialists — Celebration, Florida, United States
• Frank Hull, MD, PA — Fort Lauderdale, Florida, United States
• University of Florida — Gainesville, Florida, United States
• West Pasco Pulmonary Associates — Hudson, 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
• University of Miami — Miami, Florida, United States
• Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
• Pulmonary Associates — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.