A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis
Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
Summary
This will be a 36-week, single group, open label study assessing the effects of Tadalafil
plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension
associated with the scleroderma spectrum of disease (PAH-SSD). Standard outcome measures such
as six-minute walk distance (6MWD), New York heart Association (NYHA) classification, and
hemodynamic measurements will be assessed, as well as novel functional measures of RV-PV
function including the transthoracic echocardiogram parameter tricuspid annular plane
systolic ejection (TAPSE), contrast-enhanced cardiac MRI and heart rate variability assessed
by Holter monitoring. This design (excluding a placebo arm) was selected for ethical concerns
and to provide optimal efficiency and active therapy to all study subjects. It also allows
for comparisons between the two monotherapies and with combination therapy.
Phase:
Phase 4
Details
Lead Sponsor:
Johns Hopkins University United Therapeutics
Collaborators:
Eli Lilly and Company Johns Hopkins University National Heart, Lung, and Blood Institute (NHLBI) National Institutes of Health (NIH) Stanford University The Cleveland Clinic United Therapeutics University of Texas