Pulmonary Arterial HypertensionADAPTNCT03045029
ADAPT - A Patient Registry of the Real-world Use of Orenitram®
An observational study of Pulmonary Arterial Hypertension, run by United Therapeutics at 41 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Oral treprostinil
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 41 sitesUnited States
- Study dates
- 18 Jul 2017to Mar 2027
- How long will I take part?
- 78 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are eligible if they have been receiving Orenitram for 182 or fewer days.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
Albany Medical College
Albany, New York, 12208
AnMed Health Pulmonary and Sleep Medicine
Anderson, South Carolina, 29621
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012
Piedmont Healthcare/Research
Austell, Georgia, 30309
Lung Associates PA
Bradenton, Florida, 34208
New York Methodist Hospital
Brooklyn, New York, 11215
Loyola University Chicago
Chicago, Illinois, 60153
Baylor University Medical Center
Dallas, Texas, 75246
Pulmonary Health Physicians, PC
Fayetteville, New York, 13066
University of California - San Francisco
Fresno, California, 94143
University of Florida Clinical Research Center
Gainesville, Florida, 32610
Houston Methodist Research Institute
Houston, Texas, 77030
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, 46260
University Of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
Stony Brook University Medical Center
Islandia, New York, 11790
St. Vincent's Lung, Sleep, and Critical Care Specialists
Jacksonville, Florida, 33204
Center for Biomedical Research
Knoxville, Tennessee, 37919
Lima Memorial Hospital
Lima, Ohio, 45804
University of Southern California - Keck Medical Center
Los Angeles, California, 90033
University of Louisville Physicians Outpatient Center
Louisville, Kentucky, 40202
Heart Care Associates, LLC
Milwaukee, Wisconsin, 53215
Northwell Health- Long Island Jewish Forest Hills
New Hyde Park, New York, 11040
Mclaren Greater Lansing
Okemos, Michigan, 48864
INTEGRIS Nazih Zuhdi Transplant Institution
Oklahoma City, Oklahoma, 73112
University of Nebraska Medical Center
Omaha, Nebraska, 68198
AdventHealth Orlando
Orlando, Florida, 32803
Central Florida Pulmonary Group, P.A.
Orlando, Florida, 32803
Pinehurst Medical Clinic, INC.
Pinehurst, North Carolina, 28374
University of Pittsburgh - Heart and Vascular Medicine Institute
Pittsburgh, Pennsylvania, 15261
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Pueblo Pulmonary Associates
Pueblo, Colorado, 81003
Carilion Clinic
Roanoke, Virginia, 24014
University of Rochester
Rochester, New York, 14623
Paloma Medical Group
San Juan Capistrano, California, 92675
Santa Barbara Pulmonary Associates
Santa Barbara, California, 93105
Chest Medicine Associates
South Portland, Maine, 04106
USF South Florida Heart Health
Tampa, Florida, 33606
Renovatio Clinical
The Woodlands, Texas, 77380
Harbor UCLA Medical Center
Torrance, California, 90502
Beaumont Hospital Troy
Troy, Michigan, 48085
Cleveland Clinic Florida
Weston, Florida, 33331
About this study
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
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Oral treprostinil
- Keywords
- PAH, Oral Treprostiinil, Orenitram
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral treprostinilDrug
Also called Treprostinil diethanolamine, Treprostinil diolamine
Sustained-release oral tablets for TID administration
| Study group | Role | What they receive |
|---|---|---|
| Oral treprostinil | Sustained-release oral tablets for three times daily (TID) administration in prostacyclin naive and prostacyclin transition patients Receives: Drug: Oral treprostinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients
Measured: Baseline to Week 78
Secondary outcomes (8)
To assess treatment-related outcomes during routine clinical care.
eg, 6-Minute Walk Distance [6MWD], World Health Organization [WHO] Functional Class [FC]
Measured: Baseline to Week 78
To observe the development, timing, severity, frequency, and treatment of prostacyclin-related adverse events (AEs) of interest
Measured: Baseline to Week 78
Use of concomitant medications
Measured: Baseline to Week 78
To evaluate information on clinical titration schedules implemented for transition to and from alternative prostacyclin-class therapies
Measured: Baseline to Week 78
Healthcare resource utilization trends
Measured: Baseline to Week 78
Health-related quality of life in PAH and treatment satisfaction
Measured: Baseline to Week 78
To evaluate reasons for discontinuation of Orenitram
Measured: Baseline to Week 78
To evaluate titration and dosing schedules of Orenitram
Measured: Baseline to Week 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start18 Jul 2017
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by United TherapeuticsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 78 Weeks
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045029
- Sponsor's protocol ID
- TDE-PH-401
- Acronym
- ADAPT
- Status last verified
- Mar 2026
- First submitted
- 2 Feb 2017
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADAPT - A Patient Registry of the Real-world Use of Orenitram®
- ClinicalTrials.gov ID
- NCT03045029
- Acronym / sponsor ID
- ADAPT / TDE-PH-401
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- PAH, Oral Treprostiinil, Orenitram
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 78 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral treprostinil | – | Drug: Oral treprostinilSustained-release oral tablets for three times daily (TID) administration in prostacyclin naive and prostacyclin transition patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are eligible if they have been receiving Orenitram for 182 or fewer days.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral treprostinilAlso: Treprostinil diethanolamine, Treprostinil diolamineSustained-release oral tablets for TID administration | Drug | Oral treprostinil |
Primary outcome
Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients
Time frame: Baseline to Week 78
8 secondary outcomes
To assess treatment-related outcomes during routine clinical care.
Time frame: 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
Use of concomitant medications
Time frame: 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
Healthcare resource utilization trends
Time frame: Baseline to Week 78
Health-related quality of life in PAH and treatment satisfaction
Time frame: Baseline to Week 78
To evaluate reasons for discontinuation of Orenitram
Time frame: Baseline to Week 78
To evaluate titration and dosing schedules of Orenitram
Time frame: Baseline to Week 78
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by United Therapeutics at 41 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients (time frame: Baseline to Week 78). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.