Last updated 12 days ago

A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease

11800 patients around the world

Available in Puerto Rico, Colombia, Chile, Brazil, Argentina, United States, Mexico

Boehringer Ingelheim

65Research sites

11800Patients around the world

This study is for people with

Diabetes

Diabetes mellitus type 2

Arterial hypertension

Cardiovascular disease

Established cardiovascular disease

From 18 Years

All Gender

: 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).

: 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 ecocardiogram (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.