Clareo Health | EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease
EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease
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)
You may not be if
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)
