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)

Hypertension, Pulmonary Clinical Trial

— ATMOS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03754660
• Other study ID #: 17293
• Secondary ID: 2018-001791-37
• Status: Completed
• Phase: Phase 1
• Start date: January 21, 2019
• Est. completion date: November 3, 2022

Study information

• Verified date: September 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 3, 2022
• Est. primary completion date: April 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension

Intervention

Drug:
• BAY1237592
Oral inhalation with dry powder inhaler, single dose.

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz	Graz
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Czechia	Institut Klinicke a Experimentalni Mediciny	Praha 4
Germany	Universitätsklinikum Carl Gustav Carus Dresden	Dresden	Sachsen
Germany	Universitätsklinikum Giessen und Marburg	Gießen	Hessen
Germany	Krankenhaus Neuwittelsbach	München	Bayern
Germany	Universitätsklinikum Regensburg	Regensburg	Bayern
Poland	Szpital Specjalistyczny im. Jana Pawla II	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Czechia,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 5 hours post inhalation of BAY1237592 compared to "baseline 2"
Primary	Peak percent reduction in PVR from "baseline" for pre-treated patients	PVR = 80* (PAP - PCWP) / CO (dyn·sec·cm-5)	Up to 5 hours post inhalation of BAY1237592 compared to "baseline"
Secondary	Incidence of treatment-emergent adverse events (TEAEs)		Up to 7 days after treatment

External Links

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