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NCT Number: NCT03045029

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California - San Francisco, Fresno, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Oral Treprostinil

Drug

Sustained-release oral tablets for TID administration

Other names: Treprostinil diethanolamine, Treprostinil diolamine

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.

    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

Sponsors and collaborators

Lead sponsor

United Therapeutics

Industry

Registry information

Acronym: ADAPT

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Feb 7, 2017
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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