Status:
COMPLETED
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)
Lead Sponsor:
Bayer
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
In this trial the effects of the inhaled drug BAY1237592 will be studied in patients with high blood pressure in the pulmonary blood vessels due to Pulmonary Arterial Hypertension (PAH) and due to Chr...
Eligibility Criteria
Inclusion
- Main
- 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
- Main
Exclusion
- \- 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
Key Trial Info
Start Date :
January 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2022
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03754660
Start Date
January 21 2019
End Date
November 3 2022
Last Update
May 7 2025
Active Locations (8)
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1
Medizinische Universität Graz
Graz, Austria, 8036
2
Vseobecna fakultni nemocnice v Praze
Prague, Czechia, 12808
3
Institut Klinicke a Experimentalni Mediciny
Prague, Czechia, 140 21
4
Krankenhaus Neuwittelsbach
München, Bavaria, Germany, 80639