Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension
Completed
Gilead Sciences
Phase 3
2006-08-01
The primary objective of this study was to evaluate the safety and efficacy of ambrisentan in
a broad population of participants with pulmonary hypertension (PH). Secondary objectives of
this study were to evaluate the effects of ambrisentan on other clinical measures of
pulmonary arterial hypertension (PAH), long-term treatment success, and survival.
Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1)
Completed
Gilead Sciences
Phase 4
2008-04-01
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.
A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma).
Completed
Stanford University
N/A
2008-06-01
This is a research study of an investigational drug called ambrisentan (Letairis) in the
treatment and prevention of digital ulcers in patients with systemic sclerosis.
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