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

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: Active, not recruiting
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Drug: Oral treprostinil

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients	Baseline to Week 78

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess treatment-related outcomes during routine clinical care.	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		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
Health-related quality of life in PAH and treatment satisfaction		Baseline to Week 78
To evaluate reasons for discontinuation of Orenitram		Baseline to Week 78
To evaluate titration and dosing schedules of Orenitram		Baseline to Week 78

Collaborators and Investigators

• Sponsor: United Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2017
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 6, 2017
• First Posted (Estimated): February 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: PAH; Orenitram; Oral Treprostiinil
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Antihypertensive Agents; treprostinil
• Other Study ID 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