Summary

for people ages 18 years and up (full criteria)
at Fresno, California and other locations
study started
estimated completion:

Description

Summary

This is a prospective, observational, multicenter, patient registry to observe and assess the real-world use and tolerability of Orenitram (treprostinil). Patients who are newly initiated on Orenitram for the treatment of pulmonary arterial hypertension (PAH) or who transition from another prostacyclin therapy will be evaluated for 52 weeks to observe dosing regimens, titration schedules, prostacyclin-related adverse events (AEs), and clinical outcomes of interest.

Keywords

Pulmonary Arterial Hypertension PAH Oral Treprostiinil Orenitram Hypertension Familial Primary Pulmonary Hypertension Treprostinil Oral treprostinil

Eligibility

You can join if…

Open to people ages 18 years and up

  1. The patient is newly prescribed on Orenitram, per the package insert indication, and plans to initiate therapy with this medication, or has been receiving Orenitram for 21 or fewer days.
  2. The patient agrees to dosing, prostacyclin-related AE of interest record keeping,survey participation during designated time periods, and recording any medication changes and use for the duration of the study.
  3. The patient has the ability to answer surveys, use the diary in English, and has access to the internet.

You CAN'T join if...

  1. The patient has previously received Orenitram for more than 21 days.
  2. The patient is currently receiving epoprostenol therapy or has received epoprostenol within 30 days of enrollment (except if received during acute vasodilator testing).
  3. The patient is currently participating in an investigational drug or device study within 30 days of enrollment. Co-enrollment in other noninterventional studies is allowed.

Locations

  • University of California - San Francisco accepting new patients
    Fresno California 94143 United States
  • Santa Barbara Cottage Hospital accepting new patients
    Santa Barbara California 93105 United States
  • University of Southern California - Keck Medical Center accepting new patients
    Los Angeles California 90033 United States
  • Paloma Medical Group accepting new patients
    San Juan Capistrano California 92675 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
United Therapeutics
ID
NCT03045029
Study Type
Observational [Patient Registry]
Last Updated
June 21, 2018