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

a study on High Blood Pressure Pulmonary Arterial Hypertension

Summary

for people ages 18 years and up (full criteria)
at UCSF
study started
estimated completion
Vijay Balasubramanian, MD (ucsf)

Description

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

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

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.

You CAN'T join if...

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

Locations

  • University of California - San Francisco accepting new patients
    Fresno California 94143 United States
  • University of Southern California - Keck Medical Center accepting new patients
    Los Angeles California 90033 United States

Lead Scientist

  • Vijay Balasubramanian, MD (ucsf)
    Vijay Balasubramanian, M.D. Clinical Professor, UCSF Medical Director of Pulmonary Hypertension-Community Regional Medical Center Vijay Balasubramanian, M.D., specializes in pulmonary disease. He is board certified in Internal Medicine. His residency and fellowship training were completed at the Medical College of Wisconsin.

Details

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