Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female patients, 18 to 80 years of age at Visit 0
Women of childbearing potential must have a negative pre-treatment pregnancy test, negative monthly pregnancy test, and must use reliable methods of contraception according to the Risk Evaluation Mitigation Strategies (REMS) guidance
Symptomatic pulmonary arterial hypertension, World Health Organization Group 1 with a pulmonary vascular resistance (PVR) \>300 dyn\*sec\*cm-5, mean pulmonary artery pressure (PAP mean) ≥25 mmHg, and pulmonary capillary wedge pressure (PCWP) ≤15 mmHg as assessed by right heart catheterization within 6 months prior to Screening (Visit 0)
PAH of the following types:
Idiopathic (IPAH) Familial (FPAH)
Associated with PAH (APAH) due to:
Connective tissue disease Congenital heart disease, but only if patient underwent surgical repair more than one year before enrollment Anorexigen or amphetamine use Portal hypertension with liver cirrhosis
Not treated with PAH-specific pulmonary medications within 14 days of Screening (Visit 0)
6MWD between 150 meters and 450 meters
You may not be if
Patients who are pregnant
Patients currently on nitrate and/or nitric oxide (NO) donor therapy; patients currently taking phosphodiesterase 5 (PDE5) inhibitors (such as sildenafil, tadalafil, vardenafil) and non-specific PDE inhibitors (theophylline, dipyridamole)
Non-WHO group 1 Pulmonary Hypertension
Severe restrictive lung disease
History of uncontrolled high blood pressure or hypotension
A medical disorder, condition, or history that in the opinion of the Investigator would impair their ability to participate or complete this study
Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization
