A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease
Hypertension | Cardiovascular Diseases | Diabetes Mellitus, Type 2This 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.
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
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 Location
CaRe Clinic (Calgary)
CaRe Clinic (Calgary)Calgary, Alberta
Canada
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Medical Arts Research (North Vancouver)
Medical Arts Research (North Vancouver)North Vancouver, British Columbia
Canada
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QEII Health Sciences Centre
QEII Health Sciences CentreHalifax, Nova Scotia
Canada
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KMH Cardiology Centres (Mississauga)
KMH Cardiology Centres (Mississauga)Mississauga, Ontario
Canada
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Kawartha Cardiology Clinical Trials
Kawartha Cardiology Clinical TrialsPeterborough, Ontario
Canada
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Stouffville Medical Centre
Stouffville Medical CentreStouffville, Ontario
Canada
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Ecogene-21
Ecogene-21Chicoutimi, Quebec
Canada
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Montreal Heart Institute
Montreal Heart InstituteMontreal, Quebec
Canada
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Centre de Medecine Metabolique de Lanaudiere
Centre de Medecine Metabolique de LanaudiereTerrebonne, Quebec
Canada
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Medical Arts Research (Kelowna)
Medical Arts Research (Kelowna)Kelowna, British Columbia
Canada
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SMH Cardiology Clinical Trials Inc.
SMH Cardiology Clinical Trials Inc.Surrey, British Columbia
Canada
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Medical Trust Clinics
Medical Trust ClinicsCourtice, Ontario
Canada
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James Cha, MD
James Cha, MDOshawa, Ontario
Canada
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Heart Health Institute (Scarborough)
Heart Health Institute (Scarborough)Scarborough Village, Ontario
Canada
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Women's College Hospital
Women's College HospitalToronto, Ontario
Canada
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Diex Recherche (Joliette)
Diex Recherche (Joliette)Joliette, Quebec
Canada
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Endocrinologie Oasis Inc
Endocrinologie Oasis IncMontreal, Quebec
Canada
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Fraser Clinical Trials
Fraser Clinical TrialsNew Westminster, British Columbia
Canada
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GA Research Associates Ltd.
GA Research Associates Ltd.Moncton, New Brunswick
Canada
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Centre for Studies in Family Medicine, Western University (LHRI)
Centre for Studies in Family Medicine, Western University (LHRI)London, Ontario
Canada
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University of Ottawa Heart Institute
University of Ottawa Heart InstituteOttawa, Ontario
Canada
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KMH Cardiology Centers (Hamilton)
KMH Cardiology Centers (Hamilton)Stoney Creek, Ontario
Canada
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Diabetes Heart Research Centre
Diabetes Heart Research CentreToronto, Ontario
Canada
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THEO Medical - Concorde (Laval)
THEO Medical - Concorde (Laval)Laval, Quebec
Canada
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Diex Recherche (Sherbrooke)
Diex Recherche (Sherbrooke)Sherbrooke, Quebec
Canada
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CARe Clinic (Red Deer)
CARe Clinic (Red Deer)Red Deer, Alberta
Canada
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Medical Arts Research (Penticton)
Medical Arts Research (Penticton)Penticton, British Columbia
Canada
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Saul Vizel Medicine Professional Corporation
Saul Vizel Medicine Professional CorporationCambridge, Ontario
Canada
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PACE (Partners in Advanced Cardiac Evaluation)
PACE (Partners in Advanced Cardiac Evaluation)Newmarket, Ontario
Canada
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CardioQuest Research Centre
CardioQuest Research CentreSarnia, Ontario
Canada
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St. Michael's Hospital
St. Michael's HospitalToronto, Ontario
Canada
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ViaCar Recherches Cliniques Inc. (Greenfield Park)
ViaCar Recherches Cliniques Inc. (Greenfield Park)Greenfield Park, Quebec
Canada
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McGill University Health Centre (MUHC)
McGill University Health Centre (MUHC)Montreal, Quebec
Canada
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Diex Recherche (Trois-Rivieres)
Diex Recherche (Trois-Rivieres)Trois-Rivières, Quebec
Canada
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- Study Sponsored By
- Boehringer Ingelheim
- Participants Required
- More Information
- Study ID:
NCT07064473