check_circleStudy Completed

Hypertension, Pulmonary

Bayer Identifier:

17293

ClinicalTrials.gov Identifier:

NCT03754660

EudraCT Number:

2018-001791-37

EU CT Number:

Not Available
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)

Trial purpose

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

Key Participants Requirements

Sex

All

Age

18 - 80 Years
  • Main :
    - 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
  • - 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 summary

Enrollment Goal
38
Trial Dates
January 2019 - November 2022
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY1237592
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Universitätsklinikum Giessen und MarburgGießen, 35392, Germany
Withdrawn
Medizinische Hochschule Hannover (MHH)Hannover, 30625, Germany
Withdrawn
Universitätsklinikum KölnKöln, 50924, Germany
Completed
Universitätsklinikum Carl Gustav Carus DresdenDresden, 01307, Germany
Completed
Krankenhaus NeuwittelsbachMünchen, 80639, Germany
Withdrawn
Universitätsklinikum des SaarlandesHomburg, 66421, Germany
Withdrawn
Universitätsklinikum Leipzig AöRLeipzig, 04103, Germany
Withdrawn
Universitätsklinikum GreifswaldGreifswald, 17475, Germany
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
Institut Klinicke a Experimentalni MedicinyPraha 4, 140 21, Czechia
Withdrawn
Fakultni Nemocnice OlomoucOlomouc, 77900, Czechia
Completed
Vseobecna fakultni nemocnice v PrazePraha 2, 12808, Czechia
Completed
Universitätsklinikum RegensburgRegensburg, 93053, Germany
Withdrawn
DRK-Kliniken WestendBerlin, 14450, Germany
Withdrawn
Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)Bad Oeynhausen, 32545, Germany
Completed
Szpital Specjalistyczny im. Jana Pawla IIKrakow, 31-202, Poland
Withdrawn
Gornoslaskie CM im. Prof. Leszka Gieca SUM w KatowicachKatowice, 40-635, Poland

Primary Outcome

  • 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
    date_rangeTime Frame:
    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)
    date_rangeTime Frame:
    Up to 5 hours post inhalation of BAY1237592 compared to "baseline"

Secondary Outcome

  • Incidence of treatment-emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Up to 7 days after treatment

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Non-randomized
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
3

Additional Information

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