We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03045029
Recruitment Status : Active, not recruiting
First Posted : February 7, 2017
Last Update Posted : September 21, 2022
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Drug: Oral treprostinil

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 78 Weeks
Official Title: ADAPT - A Patient Registry of the Real-world Use of Orenitram®
Actual Study Start Date : July 18, 2017
Actual Primary Completion Date : April 7, 2022
Estimated Study Completion Date : December 2022

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients [ Time Frame: Baseline to Week 78 ]

Secondary Outcome Measures :
  1. 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]

  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 ]

Biospecimen Retention:   Samples With DNA
  1. Optional evaluation of biomarkers
  2. Optional evaluation of pharmacogenomics

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.


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.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045029

Show Show 41 study locations
Sponsors and Collaborators
United Therapeutics
Additional Information:

Layout table for additonal information
Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT03045029    
Other Study ID Numbers: TDE-PH-401
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by United Therapeutics:
Oral Treprostiinil
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Arterial Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Antihypertensive Agents