Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1)
Public ClinicalTrials.gov record NCT00617305. 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
An Open-label, Multicenter Study of Ambrisentan and a Phosphodiesterase Type-5 Inhibitor Combination Therapy in Subjects With Pulmonary Arterial Hypertension Who Have Demonstrated a Sub-Optimal Response to a Phosphodiesterase Type-5 Inhibitor
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To evaluate the change from baseline in pulmonary vascular resistance (PVR), and other hemodynamic parameters, following the addition of ambrisentan to background phosphodiesterase type-5 inhibitor (PDE-5i) therapy in subjects with pulmonary arterial hypertension (PAH) who have demonstrated a sub-optimal response to PDE-5i monotherapy. The study was originally designed as a 2-arm, double-blind, randomized study in which patients received ambrisentan or placebo for 24 weeks, and then received ambrisentan blinded to dose for 24 weeks. With Protocol Amendment 2 (12 June, 2009), the study was switched to single-arm, open-label treatment, and all patients remaining in the placebo arm were switched to open-label ambrisentan treatment. Patients who enrolled after Amendment 2 all received open-label ambrisentan.
Study identification
- NCT ID
- NCT00617305
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 38 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years to 75 Years
- 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 2008 (Type not available)
- Primary completion
- Feb 2011 (Actual)
- Completion
- Jul 2011 (Actual)
- Last update posted
- Jul 30, 2012
2008 – 2011
United States locations
- U.S. sites
- 30
- U.S. states
- 17
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36617 | — |
| Arizona Pulmonary Specialists | Phoenix | Arizona | 85013 | — |
| West Los Angeles Healthcare Center | Los Angeles | California | 90073 | — |
| Harbor - UCLA | Torrance | California | 90502 | — |
| Cleveland Clinic | Fort Lauderdale | Florida | 33331 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | — |
| Orlando Heart Center | Orlando | Florida | 32806 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Atlanta Institute for Medical Research | Decatur | Georgia | 30030 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| BACH Cardiology | Boston | Massachusetts | 02115 | — |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Weill Cornell Medical Center | New York | New York | 10021 | — |
| Asheville Cardiology Associates | Asheville | North Carolina | 28803 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| The Lindner Clinical Trial Center | Cincinnati | Ohio | 45219 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75235 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Scott & White Memorial Hospital | Temple | Texas | 76508 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
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 NCT00617305, 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 Jul 30, 2012 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00617305 live on ClinicalTrials.gov.