ADAPT - A Patient Registry of the Real-world Use of Orenitram®
- Registration Number
- NCT03045029
- Lead Sponsor
- United Therapeutics
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Oral treprostinil Oral treprostinil Sustained-release oral tablets for three times daily (TID) administration in prostacyclin naive and prostacyclin transition patients
- Primary Outcome Measures
Name Time Method Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients Baseline to Week 78
- Secondary Outcome Measures
Name Time Method To assess treatment-related outcomes during routine clinical care. Baseline to Week 78 eg, 6-Minute Walk Distance \[6MWD\], World Health Organization \[WHO\] Functional Class \[FC\]
To evaluate information on clinical titration schedules implemented for transition to and from alternative prostacyclin-class therapies Baseline to Week 78 Health-related quality of life in PAH and treatment satisfaction Baseline to Week 78 To observe the development, timing, severity, frequency, and treatment of prostacyclin-related adverse events (AEs) of interest Baseline to Week 78 Healthcare resource utilization trends Baseline to Week 78 To evaluate reasons for discontinuation of Orenitram Baseline to Week 78 To evaluate titration and dosing schedules of Orenitram Baseline to Week 78 Use of concomitant medications Baseline to Week 78
Trial Locations
- Locations (41)
University of Pittsburgh - Heart and Vascular Medicine Institute
🇺🇸Pittsburgh, Pennsylvania, United States
University of Southern California - Keck Medical Center
🇺🇸Los Angeles, California, United States
Saint Vincent Hospital and Health Services
🇺🇸Indianapolis, Indiana, United States
Houston Methodist Research Institute
🇺🇸Houston, Texas, United States
Aurora Denver Cardiology Associates
🇺🇸Aurora, Colorado, United States
Center for Biomedical Research
🇺🇸Knoxville, Tennessee, United States
Mclaren Greater Lansing
🇺🇸Okemos, Michigan, United States
Carilion Clinic
🇺🇸Roanoke, Virginia, United States
Pulmonary Health Physicians, PC
🇺🇸Fayetteville, New York, United States
University of California - San Francisco
🇺🇸Fresno, California, United States
Pueblo Pulmonary Associates
🇺🇸Pueblo, Colorado, United States
Pinehurst Medical Clinic, INC.
🇺🇸Pinehurst, North Carolina, United States
Santa Barbara Pulmonary Associates
🇺🇸Santa Barbara, California, United States
University of Louisville Physicians Outpatient Center
🇺🇸Louisville, Kentucky, United States
Beaumont Hospital Troy
🇺🇸Troy, Michigan, United States
Stony Brook University Medical Center
🇺🇸Islandia, New York, United States
Loyola University Chicago
🇺🇸Chicago, Illinois, United States
Harbor UCLA Medical Center
🇺🇸Torrance, California, United States
Central Florida Pulmonary Group, P.A.
🇺🇸Orlando, Florida, United States
Paloma Medical Group
🇺🇸San Juan Capistrano, California, United States
Chest Medicine Associates
🇺🇸South Portland, Maine, United States
University of Florida Clinical Research Center
🇺🇸Gainesville, Florida, United States
Lung Associates PA
🇺🇸Bradenton, Florida, United States
St. Vincent's Lung, Sleep, and Critical Care Specialists
🇺🇸Jacksonville, Florida, United States
Piedmont Healthcare/Research
🇺🇸Austell, Georgia, United States
University Of Iowa Hospital and Clinics
🇺🇸Iowa City, Iowa, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
University of Rochester
🇺🇸Rochester, New York, United States
USF South Florida Heart Health
🇺🇸Tampa, Florida, United States
AnMed Health Pulmonary and Sleep Medicine
🇺🇸Anderson, South Carolina, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Northwell Health- Long Island Jewish Forest Hills
🇺🇸New Hyde Park, New York, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
Albany Medical College
🇺🇸Albany, New York, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Renovatio Clinical
🇺🇸The Woodlands, Texas, United States
Heart Care Associates, LLC
🇺🇸Milwaukee, Wisconsin, United States
INTEGRIS Nazih Zuhdi Transplant Institution
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Health & Science University (OHSU)
🇺🇸Portland, Oregon, United States