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)

NCT03754660 | Completed Phase 1

• 2 other identifiers: 172932018-001791-37
• Study Type: interventional
• Target: 38
• Locations: 4 countries
• Sites: 8

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 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

Keywords

PAH; CTEPH; pulmonary arterial hypertension; chronic thromboembolic pulmonary hypertension

Outcome Measures

Primary Outcomes (2)

• 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"

• 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 Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs)

  Up to 7 days after treatment

Study Arms (3)

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.

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.

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.

Drug: BAY1237592

Interventions

BAY1237592 DRUG

Oral inhalation with dry powder inhaler, single dose.

Combined therapy (Part B); Monotherapy (Part B); Untreated patients (Part A and Part B)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (8)

Medizinische Universität Graz

Graz, 8036, Austria

Location

Vseobecna fakultni nemocnice v Praze

Prague, 12808, Czechia

Location

Institut Klinicke a Experimentalni Mediciny

Prague, 140 21, Czechia

Location

Krankenhaus Neuwittelsbach

München, Bavaria, 80639, Germany

Location

Universitätsklinikum Regensburg

Regensburg, Bavaria, 93042, Germany

Location

Universitätsklinikum Giessen und Marburg

Giessen, Hesse, 35392, Germany

Location

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Saxony, 01307, Germany

Location

Szpital Specjalistyczny im. Jana Pawla II

Krakow, 31-202, Poland

Location

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe
• Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: November 27, 2018
• Study Start: January 21, 2019
• Primary Completion: April 24, 2022
• Study Completion: November 3, 2022
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); AU (1); DE (4); CZ (2)