Ignite Creation Date:
2024-05-06 @ 12:25 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03754660
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2018-11-23
Brief Title:
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
Sponsor:
Bayer
Organization:
Bayer
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATMOS
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-001791-37 | EUDRACT_NUMBER | None | None |