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Active, not recruitingNCT03045029ADAPTUpdated Apr 2, 2026

ADAPT - A Patient Registry of the Real-world Use of Orenitram®

An observational study in Pulmonary Arterial Hypertension, sponsored by United Therapeutics. Active, not recruiting at 41 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by United Therapeutics · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Pulmonary Arterial Hypertension

Keywords

  • PAH
  • Oral Treprostiinil
  • Orenitram
03

In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

This study's planned enrollment of 300 is above the median of 100 across 197 observational studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

United Therapeutics is the lead sponsor of 81 studies on the registry; 6 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 14 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients are eligible if they have been receiving Orenitram for 182 or fewer days.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
78 Weeks
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Oral treprostinil

    Sustained-release oral tablets for three times daily (TID) administration in prostacyclin naive and prostacyclin transition patients

    Drug: Oral treprostinil

Interventions

  • DrugOral treprostinil

    Sustained-release oral tablets for TID administration

    Also known as: Treprostinil diethanolamine, Treprostinil diolamine

06

What researchers measure

Primary outcomes

  1. Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients

    Time frame: Baseline to Week 78

Secondary outcomes

  1. To assess treatment-related outcomes during routine clinical care.

    eg, 6-Minute Walk Distance \[6MWD\], World Health Organization \[WHO\] Functional Class \[FC\]

    Time frame: Baseline to Week 78

  2. To observe the development, timing, severity, frequency, and treatment of prostacyclin-related adverse events (AEs) of interest

    Time frame: Baseline to Week 78

  3. Use of concomitant medications

    Time frame: Baseline to Week 78

  4. To evaluate information on clinical titration schedules implemented for transition to and from alternative prostacyclin-class therapies

    Time frame: Baseline to Week 78

  5. Healthcare resource utilization trends

    Time frame: Baseline to Week 78

  6. Health-related quality of life in PAH and treatment satisfaction

    Time frame: Baseline to Week 78

  7. To evaluate reasons for discontinuation of Orenitram

    Time frame: Baseline to Week 78

  8. To evaluate titration and dosing schedules of Orenitram

    Time frame: Baseline to Week 78

07

Study locations

41 sites
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03045029
Lead sponsor
United Therapeutics
Responsible party
Sponsor
First posted
Feb 7, 2017
Start date
Jul 18, 2017
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Apr 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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