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
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
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
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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
: Oral treprostinil
Sustained-release oral tablets for three times daily (TID) administration in prostacyclin naive and prostacyclin transition patients
Drug: - Oral treprostinil
Sustained-release oral tablets for TID administration
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
University of California - San Francisco
Fresno, California, 94143
University of Southern California - Keck Medical Center
Los Angeles, California, 90033
Paloma Medical Group
San Juan Capistrano, California, 92675
Santa Barbara Pulmonary Associates
Santa Barbara, California, 93105
Harbor UCLA Medical Center
Torrance, California, 90502
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012
Pueblo Pulmonary Associates
Pueblo, Colorado, 81003
Lung Associates PA
Bradenton, Florida, 34208
University of Florida Clinical Research Center
Gainesville, Florida, 32610
St. Vincent's Lung, Sleep, and Critical Care Specialists
Jacksonville, Florida, 33204
Iris Orengo, RN
Orlando, Florida, 32803
Central Florida Pulmonary Group, P.A.
USF South Florida Heart Health
Tampa, Florida, 33606
Cleveland Clinic Florida
Weston, Florida, 33331
Norma Jean Barton
Austell, Georgia, 30309
Loyola University Chicago
Chicago, Illinois, 60153
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, 46260
University Of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
University of Louisville Physicians Outpatient Center
Louisville, Kentucky, 40202
Chest Medicine Associates
South Portland, Maine, 04106
Mclaren Greater Lansing
Okemos, Michigan, 48864
Katie Wray Esckilsen
Beaumont Hospital Troy
Troy, Michigan, 48085
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Albany Medical College
Albany, New York, 12208
New York Methodist Hospital
Brooklyn, New York, 11215
Pulmonary Health Physicians, PC
Fayetteville, New York, 13066
Stony Brook University Medical Center
Islandia, New York, 11790
Northwell Health- Long Island Jewish Forest Hills
New Hyde Park, New York, 11040
University of Rochester
Rochester, New York, 14623
Pinehurst Medical Clinic, INC.
Pinehurst, North Carolina, 28374
Lima Memorial Hospital
Lima, Ohio, 45804
INTEGRIS Nazih Zuhdi Transplant Institution
Oklahoma City, Oklahoma, 73112
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
University of Pittsburgh - Heart and Vascular Medicine Institute
Pittsburgh, Pennsylvania, 15261
Yasmin Al Aaraj
AnMed Health Pulmonary and Sleep Medicine
Anderson, South Carolina, 29621
Center for Biomedical Research
Knoxville, Tennessee, 37919
Baylor University Medical Center
Dallas, Texas, 75246
Houston Methodist Research Institute
Houston, Texas, 77030
The Woodlands, Texas, 77380
Roanoke, Virginia, 24014
Heart Care Associates, LLC
Milwaukee, Wisconsin, 53215