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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 August 2023
• Main ID: NCT03045029
• Date of registration: 02/02/2017
• Prospective Registration: Yes
• Primary sponsor: United Therapeutics
• Public title: ADAPT - A Patient Registry of the Real-world Use of Orenitram® ADAPT
• Scientific title: ADAPT - A Patient Registry of the Real-world Use of Orenitram®
• Date of first enrolment: July 18, 2017
• Target sample size: 300
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03045029
• Study type: Observational [Patient Registry]

Countries of recruitment

United States

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Oral treprostinil

Primary Outcome(s)

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

Secondary Outcome(s)

To assess treatment-related outcomes during routine clinical care. [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]

Healthcare resource utilization trends [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]

To observe the development, timing, severity, frequency, and treatment of prostacyclin-related adverse events (AEs) of interest [Time Frame: Baseline to Week 78]

Health-related quality of life in PAH and treatment satisfaction [Time Frame: Baseline to Week 78]

Use of concomitant medications [Time Frame: Baseline to Week 78]

Secondary ID(s)

TDE-PH-401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors