| Trial ID: | L0513 |
| Source ID: | NCT05491642
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| Associated Drug: |
Bay3283142
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| Title: |
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
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| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
NO
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| Results: |
|
| Conditions: |
Chronic Kidney Disease|Hypertension
|
| Interventions: |
DRUG: BAY3283142|DRUG: Placebo to BAY3283142
|
| Outcome Measures: |
Primary: Number of participants with treatment-emergent adverse events per treatment arm, Up to 7 days after end of treatment with study intervention | Secondary: Area under the concentration versus time curve in a dosing interval (AUCτ) after single dose of BAY3283142 on Day 1, Up to 24 hours post-dose|AUCτ after single dose of BAY3283142 on Day 1 divided by dose (AUCτ/D), Up to 24 hours post-dose|Maximum observed drug concentration in measured matrix (Cmax) after single dose of BAY3283142 on Day 1, Up to 24 hours post-dose|Cmax after single dose of BAY3283142 on Day 1 divided by dose (Cmax/D), Up to 24 hours post-dose|AUC in a dosing interval after multiple doses of BAY3283142 on Day 12 (AUCτ,md), Up to 24 hours post-dose|AUCτ,md after multiple doses of BAY3283142 on Day 12 divided by dose (AUCτ,md/D), Up to 24 hours post-dose|Maximum observed drug concentration in measured matrix after multiple doses of BAY3283142 on Day 12 (Cmax,md), Up to 24 hours post-dose|Cmax,md after multiple doses of BAY3283142 on Day 12 divided by dose (Cmax,md/D), Up to 24 hours post-dose
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| Sponsor/Collaborators: |
Sponsor: Bayer
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE1
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| Enrollment: |
56
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
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| Start Date: |
2022-09-08
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| Completion Date: |
2023-04-28
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| Results First Posted: |
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| Last Update Posted: |
2023-05-17
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| Locations: |
Medical Center Comac Medical EOOD, Sofia, 1612, Bulgaria|CRS Clinical-Research-Services Mannheim GmbH, Mannheim, Baden-Württemberg, 68167, Germany|Charité Research Organisation GmbH, Berlin, 10117, Germany|CTC North GmbH & Co. KG, Hamburg, 20251, Germany
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| URL: |
https://clinicaltrials.gov/show/NCT05491642
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