Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
With
Gilead Sciences
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects must have a diagnosis of Pulmonary Arterial Hypertension (PAH) due to the following:
You may not be if
Subject must have a current diagnosis of being in World Health Organisation (WHO) Functional Class II or III.
Subject must meet all of the following haemodynamic criteria by means of a right heart catheterization prior to screening:
i. mPAP of ≥25 mmHg ii. PVR ≥ 300 dynes/sec/cm5 iii. PCWP or LVEDP of ≤12 mmHg if PVR ≥300 to \<500 dyne/sec/cm5 , or PCWP/LVEDP ≤ 15 mmHg if PVR ≥500 dynes/sec/cm5
Subject must walk a distance of ≥125m and ≤500m at the screening visit
Subject received previous PAH therapy (phosphodiesterase type 5 inhibitor (PDE5i), endothelin receptor antagonist (ERA), chronic prostanoid\*) within 4 weeks prior to the screening visit (\*Chronic prostanoid use is considered \>7 days of treatment)
Subject received ERA treatment (e.g., bosentan or sitaxentan) or PDE5i treatment (e.g. Sildenafil) at any time AND discontinued due to tolerance issues other than those associated with liver function abnormalities
Subjects who have previously discontinued ambrisentan or tadalafil in either another clinical study or commercial product (Volibris/Letairis or Adcirca) for safety or tolerability reasons.
