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NCT00617305 · ClinicalTrials.gov registry record · Phase 4
Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1)
A Phase 4 study of Pulmonary Arterial Hypertension, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
- 20
- Study locations
NCT00617305: Completed Phase 4 study of Pulmonary Arterial Hypertension, sponsored by Gilead Sciences.
NCT00617305 is a Phase 4 study of Pulmonary Arterial Hypertension that has completed, run by Gilead Sciences. The registered enrollment target is 38 participants, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00617305, a Phase 4 study of Pulmonary Arterial Hypertension, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The primary objective of this study is to evaluate the change from baseline in PVR, and other hemodynamic parameters, following the addition of ambrisentan to background PDE-5i therapy in subjects with PAH who have demonstrated a sub-optimal response to PDE-5i monotherapy. A decrease in measurement value (dynes sec/cm\^5) indicates improvement for this patient population.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sildenafil
- DRUG Tadalafil
- DRUG Ambrisentan
Study Locations (20)
Florida
- Cleveland Clinic - Fort Lauderdale
- University of Florida - Gainesville
- Mount Sinai Medical Center - Miami Beach
- Orlando Heart Center - Orlando
California
- West Los Angeles Healthcare Center - Los Angeles
- Harbor - UCLA - Torrance
Georgia
- Emory University - Atlanta
- Atlanta Institute for Medical Research - Decatur
Massachusetts
- BACH Cardiology - Boston
- Brigham & Women's Hospital - Boston
North Carolina
- Asheville Cardiology Associates - Asheville
- University of North Carolina at Chapel Hill - Chapel Hill
Alabama
- University of South Alabama - Mobile
Arizona
- Arizona Pulmonary Specialists - Phoenix
Iowa
- University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2008-04 |
| Est. Completion | 2011-07 |
| Phase | Phase 4 |
What the finished NCT00617305 record still lists
NCT00617305 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT00617305 names 20 study sites across 13 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT00617305 about?
NCT00617305 is a clinical study titled "Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1)". 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-op...
What is the current status of trial NCT00617305?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2008-04. Estimated completion is 2011-07.
What conditions does trial NCT00617305 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.
What interventions are being tested in trial NCT00617305?
The interventions under investigation include: Placebo (DRUG), Sildenafil (DRUG), Tadalafil (DRUG), Ambrisentan (DRUG).
Who is sponsoring clinical trial NCT00617305?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00617305 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00617305's enrollment target sits among peer trials
38 35th of 63 higher than 29 of 63 other Pulmonary Arterial Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Arterial Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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