BAY1237592
DrugOral inhalation with dry powder inhaler, single dose.
NCT Number: NCT03754660
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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Notify Me18 year–80 year
All sexes
Interventional
Phase 1
Medizinische Universität Graz, Graz, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Main Inclusion Criteria:
Part A:
Part B:
-- Group 1 (total will be summed up with corresponding dosage group from Part A)
Main Exclusion Criteria:
Oral inhalation with dry powder inhaler, single dose.
Time frame: Up to 5 hours post inhalation of BAY1237592 compared to "baseline 2"
PVR = 80* (PAP - PCWP) / CO (dyn·sec·cm-5)
Time frame: Up to 5 hours post inhalation of BAY1237592 compared to "baseline"
PVR = 80* (PAP - PCWP) / CO (dyn·sec·cm-5)
Time frame: Up to 7 days after treatment
Bayer
Industry
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
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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