This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
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
Patients with PAH or CTEPH undergoing medically indicated routine invasive diagnostics
Men and women aged 18 to 80 years
Part A:
\- Untreated patients: Therapy-naïve patients (defined as off treatment with PDE-5 inhibitors, endothelin receptor antagonists, prostanoids, or other sGC stimulators/activators) with PAH or CTEPH or patients pre-treated with these medications who have to undergo a drug specific wash-out period at the discretion of the investigator for least 24 h prior to Day -1 if medically safe
Part B:
Untreated patients with PAH or CTEPH:
\-- Group 1 (total will be summed up with corresponding dosage group from Part A)
Pre-treated patients with PAH or CTEPH:
* Group 2: Pre-treated patients with any kind of monotherapy\* for PAH/CTEPH
* Group 3: Pre-treated patients with any kind of double combination therapy\* for PAH/CTEPH \* patients receiving inhaled Iloprost, and patients who are known responders to iNO are excluded
You may not be if
\- Medical history indicating a different cause for PH than PAH or CTEPH according to the guidelines of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), such as significant left heart disease, valvular disease, or structural heart defects, as assessed by the investigator, significant pulmonary disease or clinical suspicion of pulmonary venoocclusive disease
Clareo Health | This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
