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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

StatusRecruiting
PhasePhase 3
Started2025-07-22
View on ClinicalTrials.gov ↗

Amendment history

2026-09-17
minor
Trial sites reduced: 1147 → 1143 locations
2026-09-02
minor
Study Status, Contacts/Locations v32
Study sites1147 entries, revised
ClinicalJohnson ResearchCounty Consultants,ClinTrials Asociacion LLC IPS médicosmedicos internistas de Caldas S.A.S. Hospital Pablo TobónTobon Uribe Terveystalo RuoholahtiKamppi HôpitalHopital Louis Pradel Sahlgrenska Universitetssjukhuset, ÖstraOstra
2026-08-19
minor
Study Status, Contacts/Locations v31
Study sites1149→1147
2026-08-06
minor
Study Status, Contacts/Locations v30
Study sites1149 entries, revised
Vector Clinical Trials - Las Vegas Lausmed Kft. Region Outpatient Unit of Internal Medicine Länssjukhuset Sundsvall HärnösandVaesternorrland
2026-07-24
minor
Study Status, Contacts/Locations v29
Trial sites reduced: 1154 → 1149 locations
Show 2 earlier versions
2026-07-08
minor
Study Status, Contacts/Locations v28
Study sites1155→1154
2026-06-23
minor
Study Status, Contacts/Locations v27
Study sites1155 entries, revised
Headlands Research - Brownsville HôpitalHopital Pasteur
2026-06-09
minor
Study Status, Contacts/Locations v26
Trial sites expanded: 1152 → 1155 locations
2026-05-28
minor
Study Status, Contacts/Locations v25
Start date2025-07-09→2025-07-22
Study sites1153→1152
2026-05-12
minor
Study Status, Contacts/Locations v24
Start date2025-05-09→2025-07-09
Study sites1152→1153
2026-04-28
minor
Study Status, Contacts/Locations v23
Study sites1150→1152
2026-04-20
minor
Study Status, Contacts/Locations v22
Study sites1151→1150
2026-04-01
minor
Study Status, Contacts/Locations v21
Study sites1153→1151
2026-03-17
minor
Study Status, Contacts/Locations v20
Study sites1154→1153
2026-03-03
minor
Study Status, Contacts/Locations v19
Study sites1154 entries, revised
HOPHôpital Jean Minjoz HOPHôpital Louis Pradel HOPHôpital Pasteur HOPHôpital Lade la Pitié Salpêtrière Velocity Clinical Research Germany GmbH, Hamburg UniversitätsklinikumFutureMeds Ulm- Newcastle
2026-02-17
minor
Study Status, Contacts/Locations v18
Study sites1154 entries, revised
CESMACStudienzentrum Bocholderstrasse Hausarztzentrum Butendorf Medic-Center Nürnberg Kardiologie Isar-Loisachtal AMEOS Klinikum Warendorf Joseph Zumloh ASST degli Spedali Civili di Brescia Azienda Socio Sanitaria Territoriale Di Monza Manila Doctors Hospital do Coração de Alagoas Forth Clinical Hospital of Harbin Medical University Gemeinschaftspraxis Kardiologie Köln Kardiologische Gemeinschaftspraxis Dres. med. Martin Fleckenstein/Nicola Eberl/Tilmann Pohl/Moritz Rumpf Josephs-Hospital Warendorf Prince of Wales Hospital-Hong Kong-20715 Spitalul Judet [...]
2026-02-03
minor
Study Identification, Study Status, Contacts/Locations, IPDSharing, References v17
Start date2025-07-22→2025-05-09
Study sites1154 entries, revised
Covenant Metabolic SpecialistSpecialists, LLC - Brandon IowaCEC- Diabetes and Endocrinology Research Center Centro de EnfermedadesEspecialidades Cardiovasculares (CEC) West China Hospital of, Sichuan University HOPHôpital Rangueil - CHU de Toulouse UniversitätsklinikumAzienda KölnOspedaliera (AöR) AOUniversitaria CittàCitta dellaDella Salute E Della Scienza Di Torino Kyoto University Hospital CHUC - Centro Hospitalar e Scienza Centro Hospitais da UniversidadeUniversitário de Coimbra, EPE ULSCentro Hospitalar Vila Nova de Gaia/Espinho, EPEE.P.E Wythenshawe Hospital
Study title+15 characters
EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With [...]
2026-01-20
minor
Study Status, Contacts/Locations v16
Study sites1153→1154
2026-01-07
minor
Study Status, Contacts/Locations v15
Study sites1151→1153
2025-12-22
minor
Study Status, Contacts/Locations v14
Study sites1157→1151
2025-12-11
minor
Study Status, Contacts/Locations v13
Study sitescontacts updated at 79 of 1157 sites
2025-12-10
minor
Study Status, Contacts/Locations v12
Study sites1156→1157
2025-11-25
minor
Study Status, Contacts/Locations v11
Study sites1153→1156
2025-11-11
minor
Study Status, Contacts/Locations v10
Study sites1150→1153
2025-10-29
minor
Study Status, Contacts/Locations v9
Study sites1151→1150
2025-10-15
minor
Study Status, Contacts/Locations v8
Study sites1144→1151
2025-10-01
minor
Study Status, Contacts/Locations v7
Study sites1113→1144
2025-09-15
minor
Study Status, Contacts/Locations v6
Study sites1100→1113
2025-09-02
minor
Study Status, Contacts/Locations v5
Study sites1057→1100
2025-08-19
minor
Study Status, Contacts/Locations v4
Study sites996→1057
2025-08-05
minor
Study Status, Contacts/Locations v3
Study sites970→996
2025-07-25
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-07-28→confirmed 2025-07-22
Study sites865→970
2025-07-14
minor
Study Status, Eligibility, IPDSharing v1
Eligibility criteria+1 characters
[...] esting heart rate >110 beats per minute (bpm) documented by ecocardiogramechocardiogram (ECG) at Visit 1 (screening) Advanced untreated conduction [...]
2025-07-11
minor
Original filing
4,247 trials monitored
See 176 trials at risk
2,117 trials monitored
See 101 trials at risk
2,082 trials monitored
See 101 trials at risk
and 1 more disease
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.
Trial Details
NCT Number NCT07064473
Lead Sponsor Boehringer Ingelheim
Conditions Diabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases
Enrollment 11,800 participants
Start Date 2025-07-22
Primary Completion 2029-12-14 (estimated)
Study Completion 2029-12-21 (estimated)
Updated on ClinicalTrials.gov 2026-09-30