Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428825
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-21
Brief Title:
A Study to Learn About the Safety of BAY3283142 in People With Mild to Moderate High Blood Pressure
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Study in Participants With Mild to Moderate Arterial Hypertension to Investigate Safety and Tolerability of BAY3283142 in a Randomized Single-blind Placebo-controlled Multi-center Group Comparison Design
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
In this study researchers want to learn about the safety of BAY3283142 after a single dose and multiple doses in participants with mild to moderate high blood pressure The study treatment called BAY3283142 helps to relax blood vessels It is currently under development for the treatment of chronic kidney disease CKD and nonproliferative diabetic retinopathy NPDR CKD is a condition in which the kidneys ability to work gradually decrease over time NPDR is a condition in which high blood glucose levels cause damage to the blood vessels of the retina which is a tissue at the back of the eyes During this study participants will take either different doses of the study drug BAY3283142 as tablets by mouth or a placebo A placebo looks like the study drug but does not have any medicine in it At the start of this study the study doctor will check the medical history and current medications of the participants They will also perform a complete health check on all the participants Researchers will collect blood and urine samples from the participants at different time points to assess the safety and effects of BAY3283142 Each treatment scheme will consist of three doses that are given in a consecutive manner For the first 7 days participants will receive a lower dose of BAY3283142 in each treatment scheme The middle and the higher dose of each treatment scheme will be given for 14 days each Participants will not know which treatment placebo or BAY3283142 they will be given but the study doctor will know which group received which treatment A participant can be in the study for 10 weeks This study will be conducted on men or postmenopausal women participants with mild to moderate high blood pressure who may not directly benefit from treatment with BAY3283142 However information collected in this study will serve as a basis for the development of BAY3283142 for the treatment of people with CKD or NPDR Participants may experience pain and discomfort when blood samples are taken
The researchers will closely monitor and manage any medical problems that the participants may have during the study
The researchers will closely monitor and manage any medical problems that the participants may have during the study
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 |
|---|---|---|---|
| 2024-512060-58-00 | OTHER | CTIS EU | None |