ADAPT - A Patient Registry of the Real-world Use of Orenitram®
ADAPT
1 other identifier
observational
300
1 country
41
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2017
Longer than P75 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2017
CompletedFirst Posted
Study publicly available on registry
February 7, 2017
CompletedStudy Start
First participant enrolled
July 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
April 2, 2026
March 1, 2026
9.6 years
February 2, 2017
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients
Baseline to Week 78
Secondary Outcomes (8)
To assess treatment-related outcomes during routine clinical care.
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
Use of concomitant medications
Baseline to Week 78
To evaluate information on clinical titration schedules implemented for transition to and from alternative prostacyclin-class therapies
Baseline to Week 78
Healthcare resource utilization trends
Baseline to Week 78
- +3 more secondary outcomes
Study Arms (1)
Oral treprostinil
Sustained-release oral tablets for three times daily (TID) administration in prostacyclin naive and prostacyclin transition patients
Interventions
Sustained-release oral tablets for TID administration
Eligibility Criteria
Patients are eligible if they have been receiving Orenitram for 182 or fewer days.
You may qualify if:
- Patients are eligible for the registry if:
- The patient voluntarily gives informed consent to participate in the study.
- The patient must be at least 18 years of age or older.
- 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.
- 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.
- The patient has the ability to answer surveys and use the diary in English.
- The patient must have an email address and be willing to access the PRO Portal.
You may not qualify if:
- Patients are ineligible for the registry if:
- The patient has previously received Orenitram for more than 182 days.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
University of California - San Francisco
Fresno, California, 94143, United States
University of Southern California - Keck Medical Center
Los Angeles, California, 90033, United States
Paloma Medical Group
San Juan Capistrano, California, 92675, United States
Santa Barbara Pulmonary Associates
Santa Barbara, California, 93105, United States
Harbor UCLA Medical Center
Torrance, California, 90502, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012, United States
Pueblo Pulmonary Associates
Pueblo, Colorado, 81003, United States
Lung Associates PA
Bradenton, Florida, 34208, United States
University of Florida Clinical Research Center
Gainesville, Florida, 32610, United States
St. Vincent's Lung, Sleep, and Critical Care Specialists
Jacksonville, Florida, 33204, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Central Florida Pulmonary Group, P.A.
Orlando, Florida, 32803, United States
USF South Florida Heart Health
Tampa, Florida, 33606, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Piedmont Healthcare/Research
Austell, Georgia, 30309, United States
Loyola University Chicago
Chicago, Illinois, 60153, United States
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, 46260, United States
University Of Iowa Hospital and Clinics
Iowa City, Iowa, 52242, United States
University of Louisville Physicians Outpatient Center
Louisville, Kentucky, 40202, United States
Chest Medicine Associates
South Portland, Maine, 04106, United States
Mclaren Greater Lansing
Okemos, Michigan, 48864, United States
Beaumont Hospital Troy
Troy, Michigan, 48085, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Albany Medical College
Albany, New York, 12208, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
Pulmonary Health Physicians, PC
Fayetteville, New York, 13066, United States
Stony Brook University Medical Center
Islandia, New York, 11790, United States
Northwell Health- Long Island Jewish Forest Hills
New Hyde Park, New York, 11040, United States
University of Rochester
Rochester, New York, 14623, United States
Pinehurst Medical Clinic, INC.
Pinehurst, North Carolina, 28374, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
INTEGRIS Nazih Zuhdi Transplant Institution
Oklahoma City, Oklahoma, 73112, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239, United States
University of Pittsburgh - Heart and Vascular Medicine Institute
Pittsburgh, Pennsylvania, 15261, United States
AnMed Health Pulmonary and Sleep Medicine
Anderson, South Carolina, 29621, United States
Center for Biomedical Research
Knoxville, Tennessee, 37919, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Houston Methodist Research Institute
Houston, Texas, 77030, United States
Renovatio Clinical
The Woodlands, Texas, 77380, United States
Carilion Clinic
Roanoke, Virginia, 24014, United States
Heart Care Associates, LLC
Milwaukee, Wisconsin, 53215, United States
Biospecimen
1. Optional evaluation of biomarkers 2. Optional evaluation of pharmacogenomics
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 78 Weeks
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2017
First Posted
February 7, 2017
Study Start
July 18, 2017
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
April 2, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share