Clinical trial NCT03045029: ADAPT - A Patient Registry of the Real-world Use of Orenitram®
Official title: ADAPT - A Patient Registry of the Real-world Use of Orenitram®
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pulmonary Arterial Hypertension
Keywords: PAH
Oral Treprostiinil
Orenitram
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-02-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are eligible if they have been receiving Orenitram for 182 or fewer days.

Brief summary: This prospective, observational, multicenter, patient registry will follow patients who are receiving treatment with Orenitram for the treatment of PAH for up to 78 weeks from Orenitram initiation


Eligibility criteria: INCLUSION CRITERIA

Patients are eligible for the registry if:

1. The patient voluntarily gives informed consent to participate in the study.
2. The patient must be at least 18 years of age or older.
3. The patient is prescribed Orenitram (per the package insert indication), and plans to initiate therapy with this medication or has been receiving Orenitram for 182 or fewer days.
4. The patient agrees to dosing, prostacyclin-related AE of interest record keeping, survey participation during designated time periods, and recording any medication changes, use, for the duration of the study.
5. The patient has the ability to answer surveys and use the diary in English.
6. The patient must have an email address and be willing to access the PRO Portal.

EXCLUSION CRITERIA

Patients are ineligible for the registry if:

1. The patient has previously received Orenitram for more than 182 days.
2. The patient is currently participating in an investigational drug or device study or has participated in a clinical study with an investigational product other than Orenitram in PAH within

Primary outcomes:
measure: Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients
timeFrame: Baseline to Week 78
Secondary outcomes:
measure: To assess treatment-related outcomes during routine clinical care.
timeFrame: Baseline to Week 78
measure: To observe the development, timing, severity, frequency, and treatment of prostacyclin-related adverse events (AEs) of interest
timeFrame: Baseline to Week 78
measure: Use of concomitant medications
timeFrame: Baseline to Week 78
measure: To evaluate information on clinical titration schedules implemented for transition to and from alternative prostacyclin-class therapies
timeFrame: Baseline to Week 78
measure: Healthcare resource utilization trends
timeFrame: Baseline to Week 78
measure: Health-related quality of life in PAH and treatment satisfaction
timeFrame: Baseline to Week 78
measure: To evaluate reasons for discontinuation of Orenitram
timeFrame: Baseline to Week 78
measure: To evaluate titration and dosing schedules of Orenitram
timeFrame: Baseline to Week 78
Other outcomes:
Locations:
city: Fresno
country: United States
facility: University of California - San Francisco
state: California
city: Los Angeles
country: United States
facility: University of Southern California - Keck Medical Center
state: California
city: San Juan Capistrano
country: United States
facility: Paloma Medical Group
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Pulmonary Associates
state: California
city: Torrance
country: United States
facility: Harbor UCLA Medical Center
state: California
city: Aurora
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Pueblo
country: United States
facility: Pueblo Pulmonary Associates
state: Colorado
city: Bradenton
country: United States
facility: Lung Associates PA
state: Florida
city: Gainesville
country: United States
facility: University of Florida Clinical Research Center
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's Lung, Sleep, and Critical Care Specialists
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group, P.A.
state: Florida
city: Tampa
country: United States
facility: USF South Florida Heart Health
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Austell
country: United States
facility: Piedmont Healthcare/Research
state: Georgia
city: Chicago
country: United States
facility: Loyola University Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Saint Vincent Hospital and Health Services
state: Indiana
city: Iowa City
country: United States
facility: University Of Iowa Hospital and Clinics
state: Iowa
city: Louisville
country: United States
facility: University of Louisville Physicians Outpatient Center
state: Kentucky
city: South Portland
country: United States
facility: Chest Medicine Associates
state: Maine
city: Okemos
country: United States
facility: Mclaren Greater Lansing
state: Michigan
city: Troy
country: United States
facility: Beaumont Hospital Troy
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Fayetteville
country: United States
facility: Pulmonary Health Physicians, PC
state: New York
city: Islandia
country: United States
facility: Stony Brook University Medical Center
state: New York
city: New Hyde Park
country: United States
facility: Northwell Health- Long Island Jewish Forest Hills
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Pinehurst
country: United States
facility: Pinehurst Medical Clinic, INC.
state: North Carolina
city: Lima
country: United States
facility: Lima Memorial Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: INTEGRIS Nazih Zuhdi Transplant Institution
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University (OHSU)
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh - Heart and Vascular Medicine Institute
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health Pulmonary and Sleep Medicine
state: South Carolina
city: Knoxville
country: United States
facility: Center for Biomedical Research
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical
state: Texas
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Milwaukee
country: United States
facility: Heart Care Associates, LLC
state: Wisconsin
Study officials:
References: