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

Status: Unknown
Location: See all (41) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
California
University of California - San Francisco
Fresno
University of Southern California - Keck Medical Center
Los Angeles
Paloma Medical Group
San Juan Capistrano
Santa Barbara Pulmonary Associates
Santa Barbara
Harbor UCLA Medical Center
Torrance
Colorado
Aurora Denver Cardiology Associates
Aurora
Pueblo Pulmonary Associates
Pueblo
Florida
Lung Associates PA
Bradenton
University of Florida Clinical Research Center
Gainesville
St. Vincent's Lung, Sleep, and Critical Care Specialists
Jacksonville
AdventHealth Orlando
Orlando
Central Florida Pulmonary Group, P.A.
Orlando
USF South Florida Heart Health
Tampa
Cleveland Clinic Florida
Weston
Georgia
Piedmont Healthcare/Research
Austell
Iowa
University Of Iowa Hospital and Clinics
Iowa City
Illinois
Loyola University Chicago
Chicago
Indiana
Saint Vincent Hospital and Health Services
Indianapolis
Kentucky
University of Louisville Physicians Outpatient Center
Louisville
Maine
Chest Medicine Associates
South Portland
Michigan
Mclaren Greater Lansing
Okemos
Beaumont Hospital Troy
Troy
North Carolina
Pinehurst Medical Clinic, INC.
Pinehurst
Nebraska
University of Nebraska Medical Center
Omaha
New York
Albany Medical College
Albany
New York Methodist Hospital
Brooklyn
Pulmonary Health Physicians, PC
Fayetteville
Stony Brook University Medical Center
Islandia
Northwell Health- Long Island Jewish Forest Hills
New Hyde Park
University of Rochester
Rochester
Ohio
Lima Memorial Hospital
Lima
Oklahoma
INTEGRIS Nazih Zuhdi Transplant Institution
Oklahoma City
Oregon
Oregon Health & Science University (OHSU)
Portland
Pennsylvania
University of Pittsburgh - Heart and Vascular Medicine Institute
Pittsburgh
South Carolina
AnMed Health Pulmonary and Sleep Medicine
Anderson
Tennessee
Center for Biomedical Research
Knoxville
Texas
Baylor University Medical Center
Dallas
Houston Methodist Research Institute
Houston
Renovatio Clinical
The Woodlands
Virginia
Carilion Clinic
Roanoke
Wisconsin
Heart Care Associates, LLC
Milwaukee
Time Frame
Start Date: 2017-07-18
Completion Date: 2023-12
Participants
Target number of participants: 300
Treatments
Oral treprostinil
Sustained-release oral tablets for three times daily (TID) administration in prostacyclin naive and prostacyclin transition patients
Related Therapeutic Areas
Sponsors
Leads: United Therapeutics

This content was sourced from clinicaltrials.gov