Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral treprostinil | Sustained-release oral tablets for three times daily (TID) administration in prostacyclin naive and prostacyclin transition patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral treprostinil | Drug | Sustained-release oral tablets for TID administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients | Baseline to Week 78 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess treatment-related outcomes during routine clinical care. | eg, 6-Minute Walk Distance [6MWD], World Health Organization [WHO] Functional Class [FC] | Baseline to Week 78 |
| To observe the development, timing, severity, frequency, and treatment of prostacyclin-related adverse events (AEs) of interest |
Not provided
INCLUSION CRITERIA
Patients are eligible for the registry if:
EXCLUSION CRITERIA
Patients are ineligible for the registry if:
Not provided
Not provided
Not provided
Patients are eligible if they have been receiving Orenitram for 182 or fewer days.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - San Francisco | Fresno | California | 94143 | United States | ||
| University of Southern California - Keck Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline to Week 78 |
| Use of concomitant medications | Baseline to Week 78 |
| To evaluate information on clinical titration schedules implemented for transition to and from alternative prostacyclin-class therapies | Baseline to Week 78 |
| Healthcare resource utilization trends | Baseline to Week 78 |
| Health-related quality of life in PAH and treatment satisfaction | Baseline to Week 78 |
| To evaluate reasons for discontinuation of Orenitram | Baseline to Week 78 |
| To evaluate titration and dosing schedules of Orenitram | Baseline to Week 78 |
| Los Angeles |
| California |
| 90033 |
| United States |
| Paloma Medical Group | San Juan Capistrano | California | 92675 | United States |
| Santa Barbara Pulmonary Associates | Santa Barbara | California | 93105 | United States |
| Harbor UCLA Medical Center | Torrance | California | 90502 | United States |
| Aurora Denver Cardiology Associates | Aurora | Colorado | 80012 | United States |
| Pueblo Pulmonary Associates | Pueblo | Colorado | 81003 | United States |
| Lung Associates PA | Bradenton | Florida | 34208 | United States |
| University of Florida Clinical Research Center | Gainesville | Florida | 32610 | United States |
| St. Vincent's Lung, Sleep, and Critical Care Specialists | Jacksonville | Florida | 33204 | United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| Central Florida Pulmonary Group, P.A. | Orlando | Florida | 32803 | United States |
| USF South Florida Heart Health | Tampa | Florida | 33606 | United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| Piedmont Healthcare/Research | Austell | Georgia | 30309 | United States |
| Loyola University Chicago | Chicago | Illinois | 60153 | United States |
| Saint Vincent Hospital and Health Services | Indianapolis | Indiana | 46260 | United States |
| University Of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Louisville Physicians Outpatient Center | Louisville | Kentucky | 40202 | United States |
| Chest Medicine Associates | South Portland | Maine | 04106 | United States |
| Mclaren Greater Lansing | Okemos | Michigan | 48864 | United States |
| Beaumont Hospital Troy | Troy | Michigan | 48085 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| New York Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Pulmonary Health Physicians, PC | Fayetteville | New York | 13066 | United States |
| Stony Brook University Medical Center | Islandia | New York | 11790 | United States |
| Northwell Health- Long Island Jewish Forest Hills | New Hyde Park | New York | 11040 | United States |
| University of Rochester | Rochester | New York | 14623 | United States |
| Pinehurst Medical Clinic, INC. | Pinehurst | North Carolina | 28374 | United States |
| Lima Memorial Hospital | Lima | Ohio | 45804 | United States |
| INTEGRIS Nazih Zuhdi Transplant Institution | Oklahoma City | Oklahoma | 73112 | United States |
| Oregon Health & Science University (OHSU) | Portland | Oregon | 97239 | United States |
| University of Pittsburgh - Heart and Vascular Medicine Institute | Pittsburgh | Pennsylvania | 15261 | United States |
| AnMed Health Pulmonary and Sleep Medicine | Anderson | South Carolina | 29621 | United States |
| Center for Biomedical Research | Knoxville | Tennessee | 37919 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Houston Methodist Research Institute | Houston | Texas | 77030 | United States |
| Renovatio Clinical | The Woodlands | Texas | 77380 | United States |
| Carilion Clinic | Roanoke | Virginia | 24014 | United States |
| Heart Care Associates, LLC | Milwaukee | Wisconsin | 53215 | United States |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C427248 | treprostinil |
Not provided
Not provided
Not provided