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COMPLETED Phase 4

Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1)

NCT00617305 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 38 participants
Start Date 2008-04
Est. Completion 2011-07
Phase Phase 4

Sponsor

Gilead Sciences

190 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00617305

The ClinicalTrials.gov registry entry for NCT00617305 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00617305 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00617305?

The interventions under investigation include: Placebo (DRUG), Sildenafil (DRUG), Tadalafil (DRUG), Ambrisentan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00617305?

This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial