Trial Condition(s):

Hypertension, Pulmonary

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) (ATMOS)

Bayer Identifier:

17293

ClinicalTrials.gov Identifier:

NCT03754660

EudraCT Number:

2018-001791-37

Study Completed

Trial Purpose

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 Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Pulmonary hypertension is characterized by the elevation of pressure in the pulmonary arteries (PAP) and of the pulmonary vascular resistance (PVR) leading to increased workload of the right chamber of the heart to eject blood against this elevated resistance. The goal of this study is to measure the safety and tolerability of the drug as well as the reduction of the PVR at different doses

In Part A patients without specific treatment for PH (untreated patients) will be tested. In Part B also patients stably pre-treated with specific PH drugs will be studied in combination with the new inhaled drug

Inclusion Criteria
- 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 Criteria
- 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

Trial Summary

Enrollment Goal
38
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
BAY1237592
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitätsklinikum Giessen und Marburg

Gießen, Germany, 35392

Status
Completed
 
Locations

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany, 01307

Status
Completed
 
Locations

Krankenhaus Neuwittelsbach

München, Germany, 80639

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

Institut Klinicke a Experimentalni Mediciny

Praha 4, Czech Republic, 140 21

Status
Completed
 
Locations

Vseobecna fakultni nemocnice v Praze

Praha 2, Czech Republic, 128 08

Status
Completed
 
Locations

Universitätsklinikum Regensburg

Regensburg, Germany, 93053

Status
Completed
 
Locations

Szpital Specjalistyczny im. Jana Pawla II

Krakow, Poland, 31-202

Status
Completed
 

Trial Design