Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of idiopathic pulmonary arterial hypertension (IPAH), heritable pulmonary arterial hypertension (HPAH), drug- and toxin-induced PAH, or PAH associated with connective tissue disease, human immunodeficiency virus (HIV) infection, or congenital heart defects (repaired greater than 1 year prior to Screening)
Meet all of the following hemodynamic criteria by means of a screening right heart catheterization (RHC) completed prior to randomization:
* Mean pulmonary artery pressure (mPAP) of greater than or equal to (≥) 25 millimeters of mercury (mm Hg)
* Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) of less than or equal to (≤) 12 mm Hg if PVR ≥ 400 and less than (\<) 500 dynes\*sec/cm\^5, or PCWP/LVEDP ≤ 15 mm Hg if PVR ≥ 500 dynes•sec/cm\^5
Be able to walk a distance of at least 100 meters
Have World Health Organization (WHO) Functional Class II or III symptoms
Meet the following criteria determined by pulmonary function tests completed no more than 24 weeks prior to screening, performed with or without bronchodilation:
* Forced expiratory volume in one second (FEV1) ≥ 55 percent (%) of predicted normal
* FEV1: forced vital capacity (FVC) ratio ≥ 0.60
Receiving treatment with one or more drugs approved for PAH for ≥ 12 consecutive weeks and at stable dose for ≥ 8 consecutive weeks
You may not be if
Diagnosis of PAH associated with significant venous or capillary involvement (PCWP greater than \[\>\] 15 mm Hg), pulmonary capillary hemangiomatosis, portal hypertension, or unrepaired congenital heart defects
Pulmonary hypertension (PH) belonging to groups 2 to 5 of the 2013 NICE classification
Left ventricular ejection fraction (LVEF) ≤ 40% or clinically significant ischemic, valvular or constrictive heart disease
Uncontrolled hypertension (≥ 180/110 mm Hg) at Screening
End stage renal disease (receiving peritoneal dialysis, hemodialysis, or status after renal transplantation)
Severe liver disease (Child-Pugh Class C, with or without cirrhosis)
Individuals may be rescreened one additional time with prior notification to and approval by the sponsor.
