Hypertension, PulmonaryPhase 1ATMOSNCT03754660
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)
A Phase 1 study testing BAY1237592 in people with Hypertension, Pulmonary, run by Bayer at 8 sites in 4 countries.
Trial 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 Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- BAY1237592
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 21 Jan 2019to 3 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main 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 locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Germany4 sites
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, 01307
Universitätsklinikum Giessen und Marburg
Giessen, Hesse, 35392
Krankenhaus Neuwittelsbach
München, Bavaria, 80639
Universitätsklinikum Regensburg
Regensburg, Bavaria, 93042
Czechia2 sites
Vseobecna fakultni nemocnice v Praze
Prague, 12808
Institut Klinicke a Experimentalni Mediciny
Prague, 140 21
About this study
Official title: A Non-randomized Two Part Multi-center, Open-label, Single Dose Trial With an Escalation Part in Untreated Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Patients (Part A), Followed by a Parallel-group Part in Untreated and Pre-treated Patients With PAH and CTEPH (Part B) to Investigate the Safety, Tolerability and Pharmacodynamics of Inhaled BAY1237592
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
- Conditions
- Hypertension, Pulmonary
- Being tested
- BAY1237592
- Keywords
- PAH, CTEPH, pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1237592Drug
Oral inhalation with dry powder inhaler, single dose.
| Study group | Role | What they receive |
|---|---|---|
| Untreated patients (Part A and Part B) | Experimental | Part A: Untreated PAH and CTEPH patients will be enrolled to test 5 ascending doses of BAY1237592 with 4 patients per dose group up to a maximum dose of 4000 µg.
Part B: The highest safe, well tolerated and effective dose of Part A will be tested in further untreated patients. Receives: Drug: BAY1237592 |
| Monotherapy (Part B) | Experimental | The highest safe, well tolerated and effective dose chosen from Part A will be tested in pre-treated patients with any kind of monotherapy for PAH/CTEPH. Receives: Drug: BAY1237592 |
| Combined therapy (Part B) | Experimental | The highest safe, well tolerated and effective dose from Part A will be tested in pre-treated patients with any kind of double combination treatment for PAH/CTEPH. Receives: Drug: BAY1237592 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak percent reduction in PVR (Pulmonary vascular resistance) from "baseline 2" for untreated patients
PVR = 80* (PAP - PCWP) / CO (dyn·sec·cm-5)
- PAP = pulmonary arterial pressure
- PCWP = pulmonary capillary wedge pressure
- CO = cardiac output
Measured: Up to 5 hours post inhalation of BAY1237592 compared to "baseline 2"
Peak percent reduction in PVR from "baseline" for pre-treated patients
PVR = 80* (PAP - PCWP) / CO (dyn·sec·cm-5)
Measured: Up to 5 hours post inhalation of BAY1237592 compared to "baseline"
Secondary outcomes (1)
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Up to 7 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start21 Jan 2019
- Primary completion24 Apr 2022
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754660
- Sponsor's protocol ID
- 17293
- Other IDs
- 2018-001791-37, 2018
- Acronym
- ATMOS
- Status last verified
- May 2025
- First submitted
- 23 Nov 2018
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Publications
Ghofrani HA, Leuchte HH, Al-Hiti H, Halank M, Jansa P, Lange T, Olschewski H, Tello K, Becker-Pelster E, Ligges S, Nagelschmitz J, Nikkho S, Penugonda S, Saleh S, Vesterinen P, Woischnik M, Jung D, Kopec G. Phase 1b ATMOS trial of the inhaled sGC activator mosliciguat in patients with PAH/CTEPH. Thorax. 2026 Sep 11:thorax-2025-224583. doi: 10.1136/thorax-2025-224583. Online ahead of print.
PubMed 42728065
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized Two Part Multi-center, Open-label, Single Dose Trial With an Escalation Part in Untreated Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Patients (Part A), Followed by a Parallel-group Part in Untreated and Pre-treated Patients With PAH and CTEPH (Part B) to Investigate the Safety, Tolerability and Pharmacodynamics of Inhaled BAY1237592
- ClinicalTrials.gov ID
- NCT03754660
- Acronym / sponsor ID
- ATMOS / 17293
- Conditions
- Hypertension, Pulmonary
- Keywords
- PAH, CTEPH, pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 24 Apr 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Untreated patients (Part A and Part B) | Experimental | Drug: BAY1237592Part A: Untreated PAH and CTEPH patients will be enrolled to test 5 ascending doses of BAY1237592 with 4 patients per dose group up to a maximum dose of 4000 µg. Part B: The highest safe, well tolerated and effective dose of Part A will be tested in further untreated patients. |
| Monotherapy (Part B) | Experimental | Drug: BAY1237592The highest safe, well tolerated and effective dose chosen from Part A will be tested in pre-treated patients with any kind of monotherapy for PAH/CTEPH. |
| Combined therapy (Part B) | Experimental | Drug: BAY1237592The highest safe, well tolerated and effective dose from Part A will be tested in pre-treated patients with any kind of double combination treatment for PAH/CTEPH. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY1237592Oral inhalation with dry powder inhaler, single dose. | Drug | Combined therapy (Part B), Monotherapy (Part B), Untreated patients (Part A and Part B) |
Primary outcome
Peak percent reduction in PVR (Pulmonary vascular resistance) from "baseline 2" for untreated patients
Time frame: Up to 5 hours post inhalation of BAY1237592 compared to "baseline 2"
PVR = 80* (PAP - PCWP) / CO (dyn·sec·cm-5) * PAP = pulmonary arterial pressure * PCWP = pulmonary capillary wedge pressure * CO = cardiac output
Peak percent reduction in PVR from "baseline" for pre-treated patients
Time frame: Up to 5 hours post inhalation of BAY1237592 compared to "baseline"
PVR = 80* (PAP - PCWP) / CO (dyn·sec·cm-5)
1 secondary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 7 days after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Derived from this study: PubMed 42728065Ghofrani HA, Leuchte HH, Al-Hiti H, Halank M, Jansa P, Lange T, Olschewski H, Tello K, Becker-Pelster E, Ligges S, Nagelschmitz J, Nikkho S, Penugonda S, Saleh S, Vesterinen P, Woischnik M, Jung D, Kopec G. Phase 1b ATMOS trial of the inhaled sGC activator mosliciguat in patients with PAH/CTEPH. Thorax. 2026 Sep 11:thorax-2025-224583. doi: 10.1136/thorax-2025-224583. Online ahead of print.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY1237592 in people with Hypertension, Pulmonary, run by Bayer at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Czechia, Austria, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak percent reduction in PVR (Pulmonary vascular resistance) from "baseline 2" for untreated patients (time frame: Up to 5 hours post inhalation of BAY1237592 compared to "baseline 2"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03754660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.