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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 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.

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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.

Conditions Studied

Pulmonary Arterial Hypertension

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

504 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, categorized as Phase 4. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (92% lower). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.