Skip Ribbon Commands
Skip to main content
 


AMBITION Study


Trial Focus

Trial Focus

Lungs & Respiratory

Objective

        
This is a phase III/IV, double-blinded study to compare two treatment strategies; first line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with PAH.  This will be assessed to the first clinical failure event.

IRB Protocol #

10-0828

Trial Status

Accepting Participants

Contact

Pulmonary Hypertension Center at 720-848-6518

Eligibility and Other Participant Information


Main Inclusion Criteria:
1) Age 18-75
2) WHO Group 1.1, 1.2, 1.3.1, 1.3.4, 1.3.5, (Idiopathic PAH, Heritable/Familial PAH, Drug- and toxin-induced PAH, PAH associated with collagen vascular disease, HIV infection) 1.3.2 repaired >1 year (PAH associated with congenital systemic-to-pulmonary shunts)
3) Functional class II or III
4) mPAP >/= 25mm Hg, PVR >/= 240 dynes, PCWP or LVEDP </= 15mm Hg
5) TLC >/= 60%, FEV1 >/= 55%
Main Exclusion Criteria:
1) Treatment with a PAH therapy within four weeks of screening (ERA, PDE5, prostanoid)
2) Subjects who previously discontinued an ERA or PDE5 treatment for safety or tolerability reasons