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

March 27, 2026 updated by: United Therapeutics
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 94143
        • University of California - San Francisco
      • Los Angeles, California, United States, 90033
        • University of Southern California - Keck Medical Center
      • San Juan Capistrano, California, United States, 92675
        • Paloma Medical Group
      • Santa Barbara, California, United States, 93105
        • Santa Barbara Pulmonary Associates
      • Torrance, California, United States, 90502
        • Harbor UCLA Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Aurora Denver Cardiology Associates
      • Pueblo, Colorado, United States, 81003
        • Pueblo Pulmonary Associates
    • Florida
      • Bradenton, Florida, United States, 34208
        • Lung Associates PA
      • Gainesville, Florida, United States, 32610
        • University of Florida Clinical Research Center
      • Jacksonville, Florida, United States, 33204
        • St. Vincent's Lung, Sleep, and Critical Care Specialists
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando
      • Orlando, Florida, United States, 32803
        • Central Florida Pulmonary Group, P.A.
      • Tampa, Florida, United States, 33606
        • USF South Florida Heart Health
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Georgia
      • Austell, Georgia, United States, 30309
        • Piedmont Healthcare/Research
    • Illinois
      • Chicago, Illinois, United States, 60153
        • Loyola University Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Saint Vincent Hospital and Health Services
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital and Clinics
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Physicians Outpatient Center
    • Maine
      • South Portland, Maine, United States, 04106
        • Chest Medicine Associates
    • Michigan
      • Okemos, Michigan, United States, 48864
        • McLaren Greater Lansing
      • Troy, Michigan, United States, 48085
        • Beaumont Hospital Troy
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • Brooklyn, New York, United States, 11215
        • New York Methodist Hospital
      • Fayetteville, New York, United States, 13066
        • Pulmonary Health Physicians, PC
      • Islandia, New York, United States, 11790
        • Stony Brook University Medical Center
      • New Hyde Park, New York, United States, 11040
        • Northwell Health- Long Island Jewish Forest Hills
      • Rochester, New York, United States, 14623
        • University of Rochester
    • North Carolina
      • Pinehurst, North Carolina, United States, 28374
        • Pinehurst Medical Clinic, INC.
    • Ohio
      • Lima, Ohio, United States, 45804
        • Lima Memorial Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • INTEGRIS Nazih Zuhdi Transplant Institution
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University (OHSU)
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh - Heart and Vascular Medicine Institute
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Pulmonary and Sleep Medicine
    • Tennessee
      • Knoxville, Tennessee, United States, 37919
        • Center for Biomedical Research
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Houston, Texas, United States, 77030
        • Houston Methodist Research Institute
      • The Woodlands, Texas, United States, 77380
        • Renovatio Clinical
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Carilion Clinic
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Heart Care Associates, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Oral treprostinil
Sustained-release oral tablets for three times daily (TID) administration in prostacyclin naive and prostacyclin transition patients
Drug: Oral treprostinil
Sustained-release oral tablets for TID administration
Other Names:
  • Treprostinil diethanolamine
  • Treprostinil diolamine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients
Time Frame: Baseline to Week 78
Baseline to Week 78

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess treatment-related outcomes during routine clinical care.
Time Frame: Baseline to Week 78
eg, 6-Minute Walk Distance [6MWD], World Health Organization [WHO] Functional Class [FC]
Baseline to Week 78
To observe the development, timing, severity, frequency, and treatment of prostacyclin-related adverse events (AEs) of interest
Time Frame: Baseline to Week 78
Baseline to Week 78
Use of concomitant medications
Time Frame: Baseline to Week 78
Baseline to Week 78
To evaluate information on clinical titration schedules implemented for transition to and from alternative prostacyclin-class therapies
Time Frame: Baseline to Week 78
Baseline to Week 78
Healthcare resource utilization trends
Time Frame: Baseline to Week 78
Baseline to Week 78
Health-related quality of life in PAH and treatment satisfaction
Time Frame: Baseline to Week 78
Baseline to Week 78
To evaluate reasons for discontinuation of Orenitram
Time Frame: Baseline to Week 78
Baseline to Week 78
To evaluate titration and dosing schedules of Orenitram
Time Frame: Baseline to Week 78
Baseline to Week 78

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
United Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2017

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TDE-PH-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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