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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

NCT ID: NCT07064473
Registry status: Recruiting
Study type: Not specified in the registry data
Phase: Phase 3
Sponsor: Boehringer Ingelheim

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 11800 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages: Not specified in the registry data
Sex: Not specified in the registry data
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility 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 locations

1,138 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States, Vietnam

Australian Capital Territory, Australia: 1
New South Wales, Australia: 7
Queensland, Australia: 6
South Australia, Australia: 3
Tasmania, Australia: 1
Victoria, Australia: 6
Western Australia, Australia: 3
Alberta, Canada: 2
British Columbia, Canada: 5
New Brunswick, Canada: 1
Nova Scotia, Canada: 1
Ontario, Canada: 15
Quebec, Canada: 9
Canterbury, New Zealand: 1
Wellington Region, New Zealand: 1
Alabama, United States: 3
Arizona, United States: 6
California, United States: 14
Colorado, United States: 2
Connecticut, United States: 3
Florida, United States: 36
Georgia, United States: 7
Hawaii, United States: 1
Idaho, United States: 1
Illinois, United States: 4
Indiana, United States: 6
Kansas, United States: 3
Kentucky, United States: 3
Louisiana, United States: 7
Maryland, United States: 4

Sample of listed locations

CEC- Centro de Especialidades Cardiovasculares — Bahía Blanca, Argentina — Site recruitment status not specified in the registry data
Buenos Aires Macula S.A. — Buenos Aires, C1061AAE, Argentina — Site recruitment status not specified in the registry data
IDIM - Instituto de Diagnostico e Investigaciones Metabolicas — Buenos Aires, 1012, Argentina — Site recruitment status not specified in the registry data
CEDIC - Centro de Investigacion Clinica — CABA, C1060ABN, Argentina — Site recruitment status not specified in the registry data
Centro Medico Fleischer — CABA, 1414, Argentina — Site recruitment status not specified in the registry data
CPSIC SRL - Cardiologia Palermo — CABA, 1425, Argentina — Site recruitment status not specified in the registry data
Equipo Ciencia — CABA, C1428BNF, Argentina — Site recruitment status not specified in the registry data
Mautalen- Salud e Investigacion — CABA, C1128AAF, Argentina — Site recruitment status not specified in the registry data
Sanatorio Anchorena — CABA, 1425, Argentina — Site recruitment status not specified in the registry data
STAT Research — CABA, C1023AAB, Argentina — Site recruitment status not specified in the registry data
Instituto Cardiovascular de Buenos Aires — Ciudad Autonoma Buenos Aires, C1428ART, Argentina — Site recruitment status not specified in the registry data
Centro Medico Viamonte — Ciudad Autonoma de Bs As, A1120AAC, Argentina — Site recruitment status not specified in the registry data
Consultorio de Investigacion Clinica EMO SRL — Ciudad Autonoma de Buenos Aire, 1405, Argentina — Site recruitment status not specified in the registry data
Cemaic (Centro de Especialidades Medicas Ambulatorias E Investigacion Clinica) — Córdoba, 5008, Argentina — Site recruitment status not specified in the registry data
Centro Diabetologico Dr Waitman — Córdoba, 5000, Argentina — Site recruitment status not specified in the registry data
Clinica Universitaria Reina Fabiola - Universidad Catolica de Cordoba — Córdoba, 5004, Argentina — Site recruitment status not specified in the registry data
Instituto Privado de Investigaciones Clinica Cordoba S.A. — Córdoba, X5000AAW, Argentina — Site recruitment status not specified in the registry data
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes — Godoy Cruz, 5501, Argentina — Site recruitment status not specified in the registry data
Centro de Investigaciones Clinicas Baigorria — Granadero Baigorria, 2152, Argentina — Site recruitment status not specified in the registry data
Instituto de Investigaciones Clinicas Mar del Plata — Mar del Plata, B7600FZN, Argentina — Site recruitment status not specified in the registry data
Hospital Privado - Centro Medico de Cordoba S.A. — Parque Velez Sarsfield, X5016KEH, Argentina — Site recruitment status not specified in the registry data
Instituto Medico Rio Cuarto — Río Cuarto, 5800, Argentina — Site recruitment status not specified in the registry data
Instituto Medico Catamarca - IMEC — Rosario, S2000AJU, Argentina — Site recruitment status not specified in the registry data
CEDIR Santa Fe — Santa Fe, S3000GBL, Argentina — Site recruitment status not specified in the registry data
Centro de Investigaciones Clinicas del Litoral — Santa Fe, S3000FWO, Argentina — Site recruitment status not specified in the registry data

Study details

Start date: July 22, 2025
Primary completion date: December 14, 2029
First posted: July 14, 2025

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07064473
Registry last updated: September 16, 2026
QualifiedStudies registry data refreshed: September 21, 2026

View NCT07064473 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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