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OpenTrials
Completed

NCT Number: NCT03754660

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)

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medizinische Universität Graz, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY1237592

Drug

Oral inhalation with dry powder inhaler, single dose.

Primary outcomes

  1. 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
  2. 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)

Secondary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Up to 7 days after treatment

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Acronym: ATMOS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 27, 2018
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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