Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female subjects aged 18 to 75 years
Symptomatic Pulmonary Artery Hypertension (PAH) classified (Dana Point Classification 1)
New York Heart Association (NYHA)/World Health Organization (WHO) functional class III or IV
PAPmean at rest \> 25 mm Hg, Pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure \</= 15 mm Hg and Pulmonary Vascular resistance (PVR) \>/= 240 dyn.sec.cm-5 (\>/= 400 dyn.sec.cm-5 for patients treated with both endothelin receptor antagonist (ERA) and phosphodiesterase-5 inhibitor (PDE5i) ) as measured by Right Heart Catheter test
Women of childbearing potential and men must agree to use adequate contraception when sexually active
You may not be if
Baseline 6-minute walk distance of less than 100 meters or more than 500 meters
Subjects with critical severe PAH
Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio \< 60% and/or Total Lung Capacity (TLC) \< 70% predicted (especially at interstitial lung disease, TLC \< 60% predicted)
More than mild patchy interstitial lung disease on High Resolution Computerized Tomography (HRCT)
History of left-sided heart disease
Uncontrolled systemic hypertension as evidenced by systolic blood pressure \>/= 160 mm Hg or diastolic blood pressure \>/= 100 mm Hg on repeated measurement
Systemic hypotension with systolic blood pressure \< 85 mm Hg
Clareo Health | Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study
