NCT03045029

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

Study Contact:

Study Phase:

Recruitment Status:

ACTIVE_NOT_RECRUITING

NCT ID:

NCT03045029

Principal Investigator:

Study Type:

OBSERVATIONAL

Official Title:

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

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

Eligibility

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

Disease(s) and\or Condition(s)

Pulmonary Arterial Hypertension

Primary Purpose

Intervention/Treatment

- Type: DRUG
- Name: Oral treprostinil
- Description: Sustained-release oral tablets for TID administration
- Arm Group Labels: Oral treprostinil

Sponsor

United Therapeutics