Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument
Public ClinicalTrials.gov record NCT01841762. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
SYMPHONY is prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study of the PAH-SYMPACT, a new quality of life questionnaire for patients with pulmonary arterial hypertension. Patients will be in the study for 5 1/2 months, 4 months of which they will receive macitentan, 10 mg, once daily. The primary objectives are to demonstrate the final content validity of the PAH SYMPACT instrument, to demonstrate the psychometric characteristics of reliability and construct validity of the PAH-SYMPACT instrument, and to demonstrate the ability of the PAH SYMPACT instrument to detect change. The secondary objective is to assess the safety of macitentan in patients with pulmonary arterial hypertension. The exploratory objective is to explore the effects of macitentan on PAH symptoms and their impact (as measured by the PAH-SYMPACT) in patients with pulmonary arterial hypertension.
Study identification
- NCT ID
- NCT01841762
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 284 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 1, 2013 (Actual)
- Primary completion
- Nov 1, 2015 (Actual)
- Completion
- Nov 1, 2015 (Actual)
- Last update posted
- Feb 26, 2019
2013 – 2015
United States locations
- U.S. sites
- 81
- U.S. states
- 29
- U.S. cities
- 60
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cardiovascular Associates of the Southeast, LLC | Birmingham | Alabama | 35243 | — |
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Pulmonary Associates, PA | Phoenix | Arizona | 85006-2611 | — |
| Mayo Clinic Arizona | Phoenix | Arizona | 85054-4502 | — |
| Cedars-Sinai Medical Center | Beverly Hills | California | 90211 | — |
| UCSF Fresno | Fresno | California | 93701 | — |
| UCSD Medical Center, Pulmonary Department | La Jolla | California | 92093 | — |
| VAGLAHS, VA Greater LA Healthcare System | Los Angeles | California | 90073 | — |
| University of California Los Angeles | Los Angeles | California | 90095 | — |
| University of California San Francisco Medical Center | San Francisco | California | 94143 | — |
| Stanford University | Stanford | California | 94305-2200 | — |
| Los Angeles Biomedical Research Institute | Torrance | California | 90502 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Bay Area Cardiology Associates, P.A. | Brandon | Florida | 33511 | — |
| University of Florida Academic Health Center | Gainesville | Florida | 32610 | — |
| University of Florida College of Medicine, Jacksonville | Jacksonville | Florida | 32209 | — |
| Mayo Clinic | Jacksonville | Florida | 32224-1865 | — |
| Cleveland Clinic Florida | Weston | Florida | 33331-3609 | — |
| Georgia Regents University | Augusta | Georgia | 30912 | — |
| Georgia Clinical Research | Austell | Georgia | 30106 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Chicago Medical | Chicago | Illinois | 60637 | — |
| Advocate Health and Hospitals Corporation | Oakbrook Terrace | Illinois | 60181 | — |
| Chest Infectious Diseases and Critical Care Associates, PC | Des Moines | Iowa | 50325-7046 | — |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | — |
| Iowa City Heart Center | Iowa City | Iowa | 52245 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160-0001 | — |
| Veritas Clinical Specialties | Topeka | Kansas | 66606 | — |
| Kentuckiana Pulmonary Associates | Louisville | Kentucky | 40202 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Johns Hopkins University | Baltimore | Maryland | 21205 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Boston University Medical Center | Boston | Massachusetts | 02118 | — |
| University of Michigan | Ann Arbor | Michigan | 48109-5644 | — |
| Beaumont Hospital | Troy | Michigan | 48085 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Midwest Pulmonary Consultants | Kansas City | Missouri | 64111 | — |
| Ferrell-Duncan Clinic | Springfield | Missouri | 65807 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Mercy Clinic Pulmonology | St Louis | Missouri | 63141 | — |
| Clayton Sleep Institute | St Louis | Missouri | 63143 | — |
| Nebraska Pulmonary Specialties | Lincoln | Nebraska | 68506 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Pulmonary and Critical Care Associates | Union | New Jersey | 07083 | — |
| Buffalo General Medical Center | Buffalo | New York | 14203 | — |
| Winthrop University Hospital | Mineola | New York | 11501 | — |
| North Shore-LIJ/Advance Lung Disease Clinic | New Hyde Park | New York | 11040 | — |
| Beth Israel Medical Center | New York | New York | 10003 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Montefiore Medical Center, Weiler Division | The Bronx | New York | 10461 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Novant Health Pulmonary and Critical Care | Matthews | North Carolina | 28105 | — |
| The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| UC Health/University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Cleveland Clinic | Cleveland | Ohio | 45219 | — |
| Davis Heart & Lung Research Institute | Columbus | Ohio | 43210-1252 | — |
| The Ohio State University | Columbus | Ohio | 43221 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| The Oregon Clinic | Portland | Oregon | 97220 | — |
| CDA for Oregon Pulmonary Associate | Portland | Oregon | 97225 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Thomas Jefferson University, Division on Pulmonary and Critical Care | Philadelphia | Pennsylvania | 19107-5109 | — |
| Temple Lung Center | Philadelphia | Pennsylvania | 19140 | — |
| UPMC | Pittsburgh | Pennsylvania | 15123 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212-4756 | — |
| Berks Schuylkill Respiratory Specialists, Ltd. | Wyomissing | Pennsylvania | 19610 | — |
| Wellspan Lung, Sleep and Critical Care | York | Pennsylvania | 17402-8200 | — |
| Sioux Falls Cardiovascular, PC | Sioux Falls | South Dakota | 57108 | — |
| Baylor Research Institute (BRI) | Dallas | Texas | 75204 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390-8550 | — |
| Baylor College of Medicine | Houston | Texas | 77030-2348 | — |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| Scott & White Memorial Hospital | Temple | Texas | 76508 | — |
| Inova Heart and Vascular Institue / Inova Fairfax Hospital | Falls Church | Virginia | 22042-3307 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| Pulmonary & Sleep Research | Spokane | Washington | 99204 | — |
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53792 | — |
| Aurora Cardiovascular Services | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01841762, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 26, 2019 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01841762 live on ClinicalTrials.gov.