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A Study to Learn About the Safety of BAY3283142 in People With Mild to Moderate High Blood Pressure

NCT06428825 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-12-08

No results posted yet for this study

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). CKD is a condition in which the kidneys' ability to work gradually decrease over time. 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 and 7 days respectively. 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. 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.

Conditions

Interventions

DRUG

BAY3283142

oral administration

DRUG

Placebo to BAY3283142

oral administration

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-07
Primary Completion
2025-11-21
Completion
2025-11-21

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06428825 on ClinicalTrials.gov