Purpose

This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin. Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo. Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

: - At least 18 years old at time of consent - Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial - Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2). - Participants with medical history of hypertension and on active pharmacological treatment - Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment - Established cardiovascular (CV) disease and on active pharmacological treatment - At least one additional risk factor for developing heart failure (HF)

Exclusion Criteria

  • History of HF or hospitalization for HF or treatment of HF - Atrial fibrillation or Atrial flutter with a resting heart rate >110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening) - Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening) - Treatment with an Mineralocorticoid receptor antagonist (MRA) - Treatment with amiloride or other potassium-sparing diuretic - Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial: - A direct renin inhibitor (e.g. aliskiren) - More than one Angiotensin-converting enzyme inhibitor (ACEi) and/or Angiotensin receptor blocker (ARB) (including Angiotensin receptor-neprilysin inhibitor (ARNi)) used simultaneously - Other aldosterone synthase inhibitors (e.g. baxdrostat) - Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Vicadrostat + empagliflozin treatment arm
  • Drug: Vicadrostat
    Vicadrostat
    Other names:
    • BI 690517
  • Drug: Empagliflozin
    Empagliflozin
Active Comparator
Vicadrostat-placebo + empagliflozin treatment arm
  • Drug: Empagliflozin
    Empagliflozin
  • Drug: Placebo matching Vicadrostat
    Placebo matching Vicadrostat

Recruiting Locations

Medstar Montgomery Medical Center
Olney, Maryland 20832
Contact:
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

More Details

Status
Recruiting
Sponsor
Boehringer Ingelheim

Study Contact

Boehringer Ingelheim
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.