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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)

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ClinicalTrials.gov Identifier: NCT03754660
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

In this trial the effects of the inhaled drug BAY1237592 will be studied in patients with high blood pressure affecting the blood vessels in the lungs 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 patients stably pretreated with specific PH drugs will be studied in combination with the new inhaled drug


Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Drug: BAY1237592 Drug: PH-monotherapy Drug: PH-combination therapy Procedure: NO gas Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : December 22, 2020
Estimated Study Completion Date : February 8, 2021


Arm Intervention/treatment
Experimental: Untreated patients (Part A)
Untreated PAH and CTEPH patients will be enrolled to test 3 ascending doses of BAY1237592 with 4 patients per dose group up to a maximum dose of 1000 µg.
Drug: BAY1237592
Oral inhalation with dry powder inhaler, single dose.

Procedure: NO gas
Inhaled NO (nitric oxide) given for vasoreagibility testing as part of the standard right heart catheterization diagnostic procedure.

Experimental: Untreated patients (Part B)
The highest safe, well tolerated and effective dose of Part A will be chosen for Part B.
Drug: BAY1237592
Oral inhalation with dry powder inhaler, single dose.

Procedure: NO gas
Inhaled NO (nitric oxide) given for vasoreagibility testing as part of the standard right heart catheterization diagnostic procedure.

Experimental: Monotherapy (Part B)
The highest safe, well tolerated and effective dose chosen from Part A will be tested in patients pretreated with PH specific monotherapy.
Drug: BAY1237592
Oral inhalation with dry powder inhaler, single dose.

Drug: PH-monotherapy
Any kind of monotherapy for PAH/CTEPH with the exception of inhaled Iloprost. Known vasoresponders are excluded.

Experimental: Combined therapy (Part B)
The highest safe, well tolerated and effective dose from Part A will be tested in patients dually pretreated with PH specific therapy.
Drug: BAY1237592
Oral inhalation with dry powder inhaler, single dose.

Drug: PH-combination therapy
Any kind of double or triple combination treatment for PAH/CTEPH with the exception of inhaled Iloprost. Known vasoresponders are excluded.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 30 days after treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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-naive patients (defined as off treatment with PDE-5 inhibitors, endothelin receptor antagonists, prostanoids, or other sGC stimulators/activators with PAH or CTEPH or patients pretreated with approved or specific medication for PH like endothelin antagonists, prostanoids, phosphodiesterase type 5 inhibitor (PDE5 I) or soluble guanylate cyclase (sGC) stimulators who have to undergo a drug specific wash-out period at the discretion of the investigator for least 24 hours 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 double5 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754660


Contacts
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Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com

Locations
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Germany
Krankenhaus Neuwittelsbach Not yet recruiting
München, Bayern, Germany, 80639
Universitätsklinikum Giessen und Marburg Recruiting
Gießen, Hessen, Germany, 35392
Klinikum der Ernst-Moritz-Arndt-Universität Not yet recruiting
Greifswald, Mecklenburg-Vorpommern, Germany, 17475
Medizinische Hochschule Hannover (MHH) Not yet recruiting
Hannover, Niedersachsen, Germany, 30625
Universitätsklinikum Köln Not yet recruiting
Köln, Nordrhein-Westfalen, Germany, 50924
Universitätsklinikum des Saarlandes Not yet recruiting
Homburg, Saarland, Germany, 66421
Universitätsklinikum Carl Gustav Carus Dresden Recruiting
Dresden, Sachsen, Germany, 01307
Universitätsklinikum Leipzig AöR Not yet recruiting
Leipzig, Sachsen, Germany, 04103
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03754660    
Other Study ID Numbers: 17293
2018-001791-37 ( EudraCT Number )
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Availability of this study's data will 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
PAH
CTEPH
pulmonary arterial hypertension
chronic thromboembolic pulmonary hypertension
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases