Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/28/2018 |
| Start Date: | August 3, 2017 |
| End Date: | September 6, 2018 |
Multicenter, Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States
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.
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.
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
We found this trial at
106
sites
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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University of Southern California The University of Southern California is one of the world’s leading...
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University of Miami A private research university with more than 15,000 students from around the...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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University of South Florida The University of South Florida is a high-impact, global research university...
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University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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1 Boston Medical Center Place
Boston, Massachusetts 02118
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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595 West State Street
Doylestown, Pennsylvania 18901
Doylestown, Pennsylvania 18901
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Los Angeles, California 90095
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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1115 East Ridgewood Street
Orlando, Florida 32803
Orlando, Florida 32803
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Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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2639 Doctor Martin Luther King Junior Street North
Saint Petersburg, Florida 33704
Saint Petersburg, Florida 33704
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Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
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