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

Launched by BAYER · May 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called BAY3283142 to see how safe it is for people with mild to moderate high blood pressure. BAY3283142 is designed to help relax blood vessels, which could be beneficial for conditions like chronic kidney disease (CKD) and non-proliferative diabetic retinopathy (NPDR). The trial will involve participants taking either the study drug or a placebo (a pill that looks like the medication but has no active ingredients) over a period of 10 weeks. Researchers will closely monitor the participants' health, including taking blood and urine samples, to assess how well the medication works and if there are any side effects.

To be eligible for this study, participants must be between 30 and 72 years old and have been diagnosed with mild to moderate high blood pressure that has been stable for at least eight weeks. They should not be taking more than two blood pressure medications and should not have any planned changes to their treatment during the study. Additionally, the trial is open to men and postmenopausal women. Participants should be prepared for some discomfort when providing blood samples, but the research team will be there to help manage any medical concerns that arise during the study. This research aims to gather important information that could help in developing BAY3283142 for treating more serious health conditions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participant must be 30 to 72 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
• • No planned changes to antihypertensive treatment during active treatment phase of the study.
• • Estimated glomerular filtration rate ≥45 mL/min/1.73 m2 (CKD-Epi formula) at screening and Study Day -2.
• • Men and confirmed postmenopausal women (documented by medical report verification and defined as exhibiting spontaneous amenorrhea for at least 12 months before screening or as exhibiting spontaneous amenorrhea for at least 6 months before screening with documented serum follicle-stimulating hormone levels \>40 miU/mL) or women with iatrogenic menopause due to bilateral oophorectomy
• Exclusion Criteria:
• • 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)
• • Any surgical or medical condition which significantly alters the absorption, distribution, metabolism or excretion of study drugs, including, but not limited to: history of major gastrointestinal tract surgery, cholecystectomy, inflammatory bowel disease, chronic diarrhea, currently active gastritis, and pancreatitis
• • Long-acting or short-acting nitrates or NO donors for any route including isosorbide dinitrate, isosorbide-5-mononitrate, pentaerythritol tetranitrate, nicorandil, nitrotriglyceride, molsidomin starting 7 days (or at least 5 half-lives of the active substance whichever is longer) before first study intervention until Follow-up.
• • PDE inhibitors starting 7 days (or at least 5 half-lives of the active substance whichever is longer) before first study intervention until Follow-up.
• • sGC stimulators or activators starting 7 days (or at least 5 half-lives of the active substance whichever is longer) before first study intervention until Follow-up.