Safety assessment of BAY3283142 for high blood pressure
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
This study tests if a new drug called BAY3283142 is safe for people with mild to moderate high blood pressure, especially those with chronic kidney disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 30 Years to 72 Years |
| Sex | All |
| Sponsor | Bayer Industry-sponsored |
| Locations | 2 sites (Mannheim, Baden-Württemberg and 1 other locations) |
| Trial ID | NCT06428825 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety of BAY3283142, a drug designed to relax blood vessels, in individuals with mild to moderate high blood pressure. Participants will receive either the study drug in varying doses or a placebo, with their health monitored through medical history checks and blood and urine sample collections. The study will focus on understanding the effects of the drug after both single and multiple doses. It targets patients with chronic kidney disease, as the drug is under development for this condition.
Who should consider this trial
Good fit: Ideal candidates are men and postmenopausal women aged 30 to 72 with mild to moderate systemic arterial hypertension and stable antihypertensive treatment.
Not a fit: Patients with systemic diseases such as cancer or those not meeting the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with high blood pressure and chronic kidney disease.
How similar studies have performed: Other studies have shown promise in similar approaches, but the specific drug BAY3283142 is still under investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Mannheim, Baden-Württemberg and 1 other locations
- Clinical Research Services | Clinical Research Services Mannheim - Phase one unit — Mannheim, Baden-Württemberg, Germany (Recruiting)
- CRS Clinical Research Services Berlin GmbH — Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.