Pulmonary Arterial Hypertension Clinical Trial
— OPUSOfficial title:
US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice
| NCT number | NCT02126943 |
| Other study ID # | AC-055-503 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 30, 2014 |
| Est. completion date | April 24, 2020 |
| Verified date | August 2020 |
| Source | Actelion |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.
| Status | Completed |
| Enrollment | 2686 |
| Est. completion date | April 24, 2020 |
| Est. primary completion date | April 24, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: Patients newly treated with Opsumit defined as a new user of therapy, initiated = 30 days prior to enrollment visit. Signed ICF Exclusion Criteria: Previous user of Opsumit defined as patient who initiated therapy >30 days prior to enrollment. Patients enrolled in any ongoing clinical trials |
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Investigator Site | Guaynabo | |
| Puerto Rico | Investigator Site | Ponce | |
| United States | Investigator Site | Abington | Pennsylvania |
| United States | Investigator Site | Albany | New York |
| United States | Investigator Site | Albuquerque | New Mexico |
| United States | Investigator Site | Anderson | South Carolina |
| United States | Investigator Site | Ann Arbor | Michigan |
| United States | Investigator Site | Aurora | Colorado |
| United States | Investigator Site | Baltimore | Maryland |
| United States | Investigator Site | Boston | Massachusetts |
| United States | Investigator Site | Boston | Massachusetts |
| United States | Investigator Site | Boston | Massachusetts |
| United States | Investigator Site | Brandon | Florida |
| United States | Investigator Site | Bronx | New York |
| United States | Investigator Site | Brooklyn | New York |
| United States | Investigator Site | Canton | Ohio |
| United States | Investigator Site | Carmel | Indiana |
| United States | Investigator Site | Celebration | Florida |
| United States | Investigator Site | Chapel Hill | North Carolina |
| United States | Investigator Site | Charleston | South Carolina |
| United States | Investigator Site | Charlottesville | Virginia |
| United States | Investigator Site | Chattanooga | Tennessee |
| United States | Investigator Site | Cherry Hill | New Jersey |
| United States | Investigator Site | Chicago | Illinois |
| United States | Investigator Site | Cincinnati | Ohio |
| United States | Investigator Site | Cincinnati | Ohio |
| United States | Investigator Site | Cincinnati | Ohio |
| United States | Investigator Site | Cincinnati | Ohio |
| United States | Investigator Site | Clermont | Florida |
| United States | Investigator Site | Clive | Iowa |
| United States | Investigator Site | Columbia | South Carolina |
| United States | Investigator Site | Columbus | Ohio |
| United States | Investigator Site | Columbus | Ohio |
| United States | Investigator Site | Dallas | Texas |
| United States | Investigator Site | Dayton | Ohio |
| United States | Investigator Site | Denver | Colorado |
| United States | Investigator Site | Detroit | Michigan |
| United States | Investigator Site | Doylestown | Pennsylvania |
| United States | Investigator Site | Durham | North Carolina |
| United States | Investigator Site | Falls Church | Virginia |
| United States | Investigator Site | Fayetteville | New York |
| United States | Investigator Site | Fort Lauderdale | Florida |
| United States | Investigator Site | Fort Wayne | Indiana |
| United States | Investigator Site | Fullerton | California |
| United States | Investigator Site | Gainesville | Florida |
| United States | Investigator Site | Greeley | Colorado |
| United States | Investigator Site | Greensboro | North Carolina |
| United States | Investigator Site | Greenwood | Indiana |
| United States | Investigator Site | Hauppauge | New York |
| United States | Investigator Site | Honolulu | Hawaii |
| United States | Investigator Site | Houston | Texas |
| United States | Investigator Site | Hudson | Florida |
| United States | Investigator Site | Indianapolis | Indiana |
| United States | Investigator Site | Iowa City | Iowa |
| United States | Investigator Site | Jacksonville | Florida |
| United States | Investigator Site | Jacksonville | Florida |
| United States | Investigator Site | Kansas City | Kansas |
| United States | Investigator Site | Kissimmee | Florida |
| United States | Investigator Site | La Jolla | California |
| United States | Investigator Site | Lansing | Michigan |
| United States | Investigator Site | Leesburg | Florida |
| United States | Investigator Site | Lexington | Kentucky |
| United States | Investigator Site | Lima | Ohio |
| United States | Investigator Site | Lincoln | Nebraska |
| United States | Investigator Site | Loma Linda | California |
| United States | Investigator Site | Los Angeles | California |
| United States | Investigator Site | Los Angeles | California |
| United States | Investigator Site | Los Angeles | California |
| United States | Investigator Site | Louisville | Kentucky |
| United States | Investigator Site | Madison | Wisconsin |
| United States | Investigator Site | Marietta | Georgia |
| United States | Investigator Site | Melbourne | Florida |
| United States | Investigator Site | Memphis | Tennessee |
| United States | Investigator Site | Miami | Florida |
| United States | Investigator Site | Miami | Florida |
| United States | Investigator Site | Miami Beach | Florida |
| United States | Investigator Site | Middleburg Heights | Ohio |
| United States | Investigator Site | Milwaukee | Wisconsin |
| United States | Investigator Site | Milwaukee | Wisconsin |
| United States | Investigator Site | Mineola | New York |
| United States | Investigator Site | Minneapolis | Minnesota |
| United States | Investigator Site | Mobile | Alabama |
| United States | Investigator Site | Moreno Valley | California |
| United States | Investigator Site | New Haven | Connecticut |
| United States | Investigator Site | New Hyde Park | New York |
| United States | Investigator Site | New Orleans | Louisiana |
| United States | Investigator Site | New Orleans | Louisiana |
| United States | Investigator Site | New York | New York |
| United States | Investigator Site | New York | New York |
| United States | Investigator Site | Newark | New Jersey |
| United States | Investigator Site | Newark | Delaware |
| United States | Investigator Site | Norfolk | Virginia |
| United States | Investigator Site | Oakbrook Terrace | Illinois |
| United States | Investigator Site | Oakbrook Terrace | Illinois |
| United States | Investigator Site | Oklahoma City | Oklahoma |
| United States | Investigator Site | Omaha | Nebraska |
| United States | Investigator Site | Orlando | Florida |
| United States | Investigator Site | Pensacola | Florida |
| United States | Investigator Site | Philadelphia | Pennsylvania |
| United States | Investigator Site | Philadelphia | Pennsylvania |
| United States | Investigator Site | Philadelphia | Pennsylvania |
| United States | Investigator Site | Phoenix | Arizona |
| United States | Investigator Site | Phoenix | Arizona |
| United States | Investigator Site | Phoenix | Arizona |
| United States | Investigator Site | Pinehurst | North Carolina |
| United States | Investigator Site | Pittsburgh | Pennsylvania |
| United States | Investigator Site | Plano | Texas |
| United States | Investigator Site | Portland | Oregon |
| United States | Investigator Site | Portland | Oregon |
| United States | Investigator Site | Portland | Oregon |
| United States | Investigator Site | Reno | Nevada |
| United States | Investigator Site | Richmond | Virginia |
| United States | Investigator Site | Rochester | Minnesota |
| United States | Investigator Site | Rock Hill | South Carolina |
| United States | Investigator Site | Saint Louis | Missouri |
| United States | Investigator Site | Saint Louis | Missouri |
| United States | Investigator Site | Saint Petersburg | Florida |
| United States | Investigator Site | Saint Petersburg | Florida |
| United States | Investigator Site | Saint Petersburg | Florida |
| United States | Investigator Site | San Antonio | Texas |
| United States | Investigator Site | San Juan Capistrano | California |
| United States | Investigator Site | Santa Barbara | California |
| United States | Investigator Site | Seattle | Washington |
| United States | Investigator Site | Sebring | Florida |
| United States | Investigator Site | Sherman | Texas |
| United States | Investigator Site | Shreveport | Louisiana |
| United States | Investigator Site | Shreveport | Louisiana |
| United States | Investigator Site | Sioux Falls | South Dakota |
| United States | Investigator Site | South Miami | Florida |
| United States | Investigator Site | South Portland | Maine |
| United States | Investigator Site | Spokane | Washington |
| United States | Investigator Site | Stanford | California |
| United States | Investigator Site | Tacoma | Washington |
| United States | Investigator Site | Tampa | Florida |
| United States | Investigator Site | Temple | Texas |
| United States | Investigator Site | Toledo | Ohio |
| United States | Investigator Site | Troy | Michigan |
| United States | Investigator Site | Union | New Jersey |
| United States | Investigator Site | Washington | District of Columbia |
| United States | Investigator Site | Weslaco | Texas |
| United States | Investigator Site | Weston | Florida |
| United States | Investigator Site | Wheat Ridge | Colorado |
| United States | Investigator Site | Wooster | Ohio |
| United States | Investigator Site | Wynnewood | Pennsylvania |
| United States | Investigator Site | York | Pennsylvania |
| United States | Investigator Site | Zephyrhills | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Actelion |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | To describe PAH treatment patterns at enrollment and during observation period. | 1 year | ||
| Primary | To estimate incidence rates for specified outcomes. | Liver test abnormalities/ Occurrence of Hepatic Adverse Events (HAEs)/ Occurrence of any other AEs/ Discontinuation of Opsumit and reason for stopping therapy/ Hospitalization and death. | 1 year | |
| Secondary | To describe demographic and clinical characteristics of patients treated with Opsumit at enrollment and during observation period. | 1 year |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04076241 -
Effects of Adding Yoga Respiratory Training to Osteopathic Manipulative Treatment in Pulmonary Arterial Hypertension
|
N/A | |
| Completed |
NCT05521113 -
Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension
|
||
| Recruiting |
NCT04972656 -
Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension
|
N/A | |
| Completed |
NCT04908397 -
Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension
|
Phase 1 | |
| Active, not recruiting |
NCT03288025 -
Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE)
|
N/A | |
| Completed |
NCT01959815 -
Novel Screening Strategies for Scleroderma PAH
|
||
| Recruiting |
NCT04266197 -
Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study
|
Phase 2 | |
| Active, not recruiting |
NCT06092424 -
High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA)
|
N/A | |
| Enrolling by invitation |
NCT03683186 -
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
|
Phase 3 | |
| Terminated |
NCT02060487 -
Effects of Oral Sildenafil on Mortality in Adults With PAH
|
Phase 4 | |
| Terminated |
NCT02253394 -
The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study
|
Phase 4 | |
| Withdrawn |
NCT02958358 -
FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan
|
N/A | |
| Terminated |
NCT01953965 -
Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI.
|
Phase 2 | |
| Withdrawn |
NCT01723371 -
Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children
|
Phase 1/Phase 2 | |
| Unknown status |
NCT01712997 -
Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients
|
Phase 3 | |
| Not yet recruiting |
NCT01649739 -
Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost
|
Phase 4 | |
| Completed |
NCT01548950 -
Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension
|
N/A | |
| Completed |
NCT01165047 -
Nitric Oxide, GeNO Nitrosyl Delivery System
|
Phase 2 | |
| Completed |
NCT00942708 -
Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension
|
Phase 2 | |
| Completed |
NCT00902174 -
Imatinib (QTI571) in Pulmonary Arterial Hypertension
|
Phase 3 |