Trial Condition(s):
Hypertension, Pulmonary
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)
Bayer Identifier:
17293
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Universitätsklinikum Giessen und Marburg Gießen, Germany, 35392 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsklinikum Carl Gustav Carus Dresden Dresden, Germany, 01307 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Krankenhaus Neuwittelsbach München, Germany, 80639 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Institut Klinicke a Experimentalni Mediciny Praha 4, Czech Republic, 140 21 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Vseobecna fakultni nemocnice v Praze Praha 2, Czech Republic, 128 08 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsklinikum Regensburg Regensburg, Germany, 93053 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Szpital Specjalistyczny im. Jana Pawla II Krakow, Poland, 31-202 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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
Primary Outcome
- Peak percent reduction in PVR (Pulmonary vascular resistance) from "baseline 2" for untreated patientsPVR = 80* (PAP - PCWP) / CO (dyn·sec·cm-5) - PAP = pulmonary arterial pressure - PCWP = pulmonary capillary wedge pressure - CO = cardiac outputTimeframe: Up to 5 hours post inhalation of BAY1237592 compared to "baseline 2"
- Peak percent reduction in PVR from "baseline" for pre-treated patientsPVR = 80* (PAP - PCWP) / CO (dyn·sec·cm-5)Timeframe: Up to 5 hours post inhalation of BAY1237592 compared to "baseline"
Secondary Outcome
- Incidence of treatment-emergent adverse events (TEAEs)Timeframe: Up to 7 days after treatment
Additional Information
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