Ignite Creation Date:
2024-05-05 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00617305
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
2008-02-06
Brief Title:
Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor PDE5i Therapy in Pulmonary Arterial Hypertension ATHENA-1
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATHENA-1
Brief 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
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
Detailed Description:
The primary objective of this study is 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 secondary objectives of this study are to evaluate the change from baseline in other clinical measures of PAH 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
The safety and tolerability of ambrisentanPDE-5i combination therapy will be evaluated throughout the study In addition long-term efficacy will be examined
The secondary objectives of this study are to evaluate the change from baseline in other clinical measures of PAH 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
The safety and tolerability of ambrisentanPDE-5i combination therapy will be evaluated throughout the study In addition long-term efficacy will be examined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None