Clinical trial NCT02126943: OPsumit USers Registry
Official title: US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Keywords: PAH
pulmonary arterial hypertension
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2014-04-30
Enrollment: 2686
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients newly treated with Opsumit

Brief summary: Prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.


Eligibility criteria: Inclusion Criteria:

Patients newly treated with Opsumit defined as a new user of therapy, initiated ≤ 30 days prior to enrollment visit.

Signed ICF

Exclusion Criteria:

Previous user of Opsumit defined as patient who initiated therapy \>30 days prior to enrollment.

Patients enrolled in any ongoing clinical trials

Primary outcomes:
measure: To estimate incidence rates for specified outcomes.
timeFrame: 1 year
Secondary outcomes:
measure: To describe demographic and clinical characteristics of patients treated with Opsumit at enrollment and during observation period.
timeFrame: 1 year
Other outcomes:
measure: To describe PAH treatment patterns at enrollment and during observation period.
timeFrame: 1 year
Locations:
city: Mobile
country: United States
facility: Investigator Site
state: Alabama
city: Phoenix
country: United States
facility: Investigator Site
state: Arizona
city: Phoenix
country: United States
facility: Investigator Site
state: Arizona
city: Phoenix
country: United States
facility: Investigator Site
state: Arizona
city: Fullerton
country: United States
facility: Investigator Site
state: California
city: La Jolla
country: United States
facility: Investigator Site
state: California
city: Loma Linda
country: United States
facility: Investigator Site
state: California
city: Los Angeles
country: United States
facility: Investigator Site
state: California
city: Los Angeles
country: United States
facility: Investigator Site
state: California
city: Los Angeles
country: United States
facility: Investigator Site
state: California
city: Moreno Valley
country: United States
facility: Investigator Site
state: California
city: San Juan Capistrano
country: United States
facility: Investigator Site
state: California
city: Santa Barbara
country: United States
facility: Investigator Site
state: California
city: Stanford
country: United States
facility: Investigator Site
state: California
city: Aurora
country: United States
facility: Investigator Site
state: Colorado
city: Denver
country: United States
facility: Investigator Site
state: Colorado
city: Greeley
country: United States
facility: Investigator Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Investigator Site
state: Colorado
city: New Haven
country: United States
facility: Investigator Site
state: Connecticut
city: Newark
country: United States
facility: Investigator Site
state: Delaware
city: Washington
country: United States
facility: Investigator Site
state: District of Columbia
city: Brandon
country: United States
facility: Investigator Site
state: Florida
city: Celebration
country: United States
facility: Investigator Site
state: Florida
city: Clermont
country: United States
facility: Investigator Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Investigator Site
state: Florida
city: Gainesville
country: United States
facility: Investigator Site
state: Florida
city: Hudson
country: United States
facility: Investigator Site
state: Florida
city: Jacksonville
country: United States
facility: Investigator Site
state: Florida
city: Jacksonville
country: United States
facility: Investigator Site
state: Florida
city: Kissimmee
country: United States
facility: Investigator Site
state: Florida
city: Leesburg
country: United States
facility: Investigator Site
state: Florida
city: Melbourne
country: United States
facility: Investigator Site
state: Florida
city: Miami Beach
country: United States
facility: Investigator Site
state: Florida
city: Miami
country: United States
facility: Investigator Site
state: Florida
city: Miami
country: United States
facility: Investigator Site
state: Florida
city: Orlando
country: United States
facility: Investigator Site
state: Florida
city: Pensacola
country: United States
facility: Investigator Site
state: Florida
city: Saint Petersburg
country: United States
facility: Investigator Site
state: Florida
city: Saint Petersburg
country: United States
facility: Investigator Site
state: Florida
city: Saint Petersburg
country: United States
facility: Investigator Site
state: Florida
city: Sebring
country: United States
facility: Investigator Site
state: Florida
city: South Miami
country: United States
facility: Investigator Site
state: Florida
city: Tampa
country: United States
facility: Investigator Site
state: Florida
city: Weston
country: United States
facility: Investigator Site
state: Florida
city: Zephyrhills
country: United States
facility: Investigator Site
state: Florida
city: Marietta
country: United States
facility: Investigator Site
state: Georgia
city: Honolulu
country: United States
facility: Investigator Site
state: Hawaii
city: Chicago
country: United States
facility: Investigator Site
state: Illinois
city: Oak Brook
country: United States
facility: Investigator Site
state: Illinois
city: Oak Brook
country: United States
facility: Investigator Site
state: Illinois
city: Carmel
country: United States
facility: Investigator Site
state: Indiana
city: Fort Wayne
country: United States
facility: Investigator Site
state: Indiana
city: Greenwood
country: United States
facility: Investigator Site
state: Indiana
city: Indianapolis
country: United States
facility: Investigator Site
state: Indiana
city: Clive
country: United States
facility: Investigator Site
state: Iowa
city: Iowa City
country: United States
facility: Investigator Site
state: Iowa
city: Kansas City
country: United States
facility: Investigator Site
state: Kansas
city: Lexington
country: United States
facility: Investigator Site
state: Kentucky
city: Louisville
country: United States
facility: Investigator Site
state: Kentucky
city: New Orleans
country: United States
facility: Investigator Site
state: Louisiana
city: New Orleans
country: United States
facility: Investigator Site
state: Louisiana
city: Shreveport
country: United States
facility: Investigator Site
state: Louisiana
city: Shreveport
country: United States
facility: Investigator Site
state: Louisiana
city: South Portland
country: United States
facility: Investigator Site
state: Maine
city: Baltimore
country: United States
facility: Investigator Site
state: Maryland
city: Boston
country: United States
facility: Investigator Site
state: Massachusetts
city: Boston
country: United States
facility: Investigator Site
state: Massachusetts
city: Boston
country: United States
facility: Investigator Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Investigator Site
state: Michigan
city: Detroit
country: United States
facility: Investigator Site
state: Michigan
city: Lansing
country: United States
facility: Investigator Site
state: Michigan
city: Troy
country: United States
facility: Investigator Site
state: Michigan
city: Minneapolis
country: United States
facility: Investigator Site
state: Minnesota
city: Rochester
country: United States
facility: Investigator Site
state: Minnesota
city: Saint Louis
country: United States
facility: Investigator Site
state: Missouri
city: Saint Louis
country: United States
facility: Investigator Site
state: Missouri
city: Lincoln
country: United States
facility: Investigator Site
state: Nebraska
city: Omaha
country: United States
facility: Investigator Site
state: Nebraska
city: Reno
country: United States
facility: Investigator Site
state: Nevada
city: Cherry Hill
country: United States
facility: Investigator Site
state: New Jersey
city: Newark
country: United States
facility: Investigator Site
state: New Jersey
city: Union
country: United States
facility: Investigator Site
state: New Jersey
city: Albuquerque
country: United States
facility: Investigator Site
state: New Mexico
city: Albany
country: United States
facility: Investigator Site
state: New York
city: Bronx
country: United States
facility: Investigator Site
state: New York
city: Brooklyn
country: United States
facility: Investigator Site
state: New York
city: Fayetteville
country: United States
facility: Investigator Site
state: New York
city: Hauppauge
country: United States
facility: Investigator Site
state: New York
city: Mineola
country: United States
facility: Investigator Site
state: New York
city: New Hyde Park
country: United States
facility: Investigator Site
state: New York
city: New York
country: United States
facility: Investigator Site
state: New York
city: New York
country: United States
facility: Investigator Site
state: New York
city: Chapel Hill
country: United States
facility: Investigator Site
state: North Carolina
city: Durham
country: United States
facility: Investigator Site
state: North Carolina
city: Greensboro
country: United States
facility: Investigator Site
state: North Carolina
city: Pinehurst
country: United States
facility: Investigator Site
state: North Carolina
city: Canton
country: United States
facility: Investigator Site
state: Ohio
city: Cincinnati
country: United States
facility: Investigator Site
state: Ohio
city: Cincinnati
country: United States
facility: Investigator Site
state: Ohio
city: Cincinnati
country: United States
facility: Investigator Site
state: Ohio
city: Cincinnati
country: United States
facility: Investigator Site
state: Ohio
city: Columbus
country: United States
facility: Investigator Site
state: Ohio
city: Columbus
country: United States
facility: Investigator Site
state: Ohio
city: Dayton
country: United States
facility: Investigator Site
state: Ohio
city: Lima
country: United States
facility: Investigator Site
state: Ohio
city: Middleburg Heights
country: United States
facility: Investigator Site
state: Ohio
city: Toledo
country: United States
facility: Investigator Site
state: Ohio
city: Wooster
country: United States
facility: Investigator Site
state: Ohio
city: Oklahoma City
country: United States
facility: Investigator Site
state: Oklahoma
city: Portland
country: United States
facility: Investigator Site
state: Oregon
city: Portland
country: United States
facility: Investigator Site
state: Oregon
city: Portland
country: United States
facility: Investigator Site
state: Oregon
city: Abington
country: United States
facility: Investigator Site
state: Pennsylvania
city: Doylestown
country: United States
facility: Investigator Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigator Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigator Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigator Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Investigator Site
state: Pennsylvania
city: Wynnewood
country: United States
facility: Investigator Site
state: Pennsylvania
city: York
country: United States
facility: Investigator Site
state: Pennsylvania
city: Anderson
country: United States
facility: Investigator Site
state: South Carolina
city: Charleston
country: United States
facility: Investigator Site
state: South Carolina
city: Columbia
country: United States
facility: Investigator Site
state: South Carolina
city: Rock Hill
country: United States
facility: Investigator Site
state: South Carolina
city: Sioux Falls
country: United States
facility: Investigator Site
state: South Dakota
city: Chattanooga
country: United States
facility: Investigator Site
state: Tennessee
city: Memphis
country: United States
facility: Investigator Site
state: Tennessee
city: Dallas
country: United States
facility: Investigator Site
state: Texas
city: Houston
country: United States
facility: Investigator Site
state: Texas
city: Plano
country: United States
facility: Investigator Site
state: Texas
city: San Antonio
country: United States
facility: Investigator Site
state: Texas
city: Sherman
country: United States
facility: Investigator Site
state: Texas
city: Temple
country: United States
facility: Investigator Site
state: Texas
city: Weslaco
country: United States
facility: Investigator Site
state: Texas
city: Charlottesville
country: United States
facility: Investigator Site
state: Virginia
city: Falls Church
country: United States
facility: Investigator Site
state: Virginia
city: Norfolk
country: United States
facility: Investigator Site
state: Virginia
city: Richmond
country: United States
facility: Investigator Site
state: Virginia
city: Seattle
country: United States
facility: Investigator Site
state: Washington
city: Spokane
country: United States
facility: Investigator Site
state: Washington
city: Tacoma
country: United States
facility: Investigator Site
state: Washington
city: Madison
country: United States
facility: Investigator Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Investigator Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Investigator Site
state: Wisconsin
city: Guaynabo
country: Puerto Rico
facility: Investigator Site
city: Ponce
country: Puerto Rico
facility: Investigator Site
Study officials:
affiliation: Chair of the OPUS scientific committee (OSC)
name: V McLaughlin, MD
role: STUDY_CHAIR
References: