Pulmonary Arterial Hypertension Clinical Trial
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
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 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 ambrisentan/PDE-5i combination therapy will be evaluated
throughout the study. In addition, long-term efficacy will be examined.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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