Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
30–78
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participant must be 30 to 78 years of age inclusive, at the time of signing the informed consent.
Participants with diagnosis of mild to moderate systemic arterial hypertension receiving stable treatment for ≥8 weeks before the screening visit with not more than 2 antihypertensive drugs (note: 2 antihypertensive drugs combined within one pill count as 2 antihypertensive drugs).
Mean systolic blood pressure (SBP) 120 - 160 mm Hg and mean diastolic blood pressure (DBP) 70-95 mm Hg at screening (mean out of triplicate measurements after supine rest for 15 min at screening).
Estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73 m\^2 (Chronic Kidney Disease Epidemiology Collaboration \[CKD-Epi\] formula) at screening and Study Day -2.
Thrombo-embolic events, e.g. stroke, TIA, deep vein thrombosis, pulmonary embolism.
Systemic diseases: cancer (with the exception of appropriately treated basal cell carcinomas of the skin or uterine carcinoma in situ), autoimmune diseases (including also topically treated autoimmune diseases such as atopic dermatitis).
Latent bleeding risk (diabetic retinopathy, history of gastrointestinal bleeding due to e.g. ulcers), inherited or acquired coagulopathies.
Orthostatic intolerance in the modified standing blood pressure procedure at screening.
Long-acting or short-acting nitrates or NO donors for any route including isosorbide dinitrate, isosorbide-5-mononitrate, pentaerythritol tetranitrate, nicorandil, nitrotriglyceride, molsidomin.
Phosphodiesterase-5 (PDE-5) inhibitors or other soluble guanylate cyclase (sGC) stimulators or activators.
Inhibitors of Uridine-5'-diphospho glucuronosyltransferase (UGT) 1A1, 1A3, 1A8 (e.g., probenecid) from 7 days before first study intervention until follow-up.
Signs of hepatic dysfunction at the screening visit or at randomization as indicated by at least one of the following:
