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NCT07064473ClinicalTrials.gov

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 Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Type 2 Diabetes, Hypertension and Established Cardiovascular Disease

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En resumen

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…

Fase 311.800 participantes buscados1143 centros51 países

Categorías

Cardiovascular83%Endocrino y metabólico17%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2025-07-14; recorded start 2025-07-22
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 1218 other studies in this databaseCounted from the lead sponsor named in the record (Boehringer Ingelheim)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 3 conditions.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding20/20

    Quadruple-blind

  • Control arm15/15

    Active-comparator control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type10/10

    Mortality / MACE endpoint (hard clinical outcome)

  • Multi-centre8/8

    Multi-centre: 1154 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEGA

A very large study, international in scope: 11,800 participants (target), run at 1,143 sites, across 51 countries.

How this score is built
  • Enrolment38/40

    11,800 participants (target)

  • Site count25/25

    1,154 sites

  • Country count15/15

    51 countries

  • Planned duration9/10

    Planned over about 54 months

  • Sponsor scale10/10

    Boehringer Ingelheim has led 1,211 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

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.

Afecciones

  • Diabetes Mellitus, Type 2
  • Hypertension
  • Cardiovascular Diseases

Elegibilidad

SexoTodos
Edades18 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

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.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoQUADRUPLE (4)
Inscripción11.800 participantes buscados

Patrocinador y colaboradores

  • Boehringer Ingelheim Patrocinador

Grupos e intervenciones

  • Vicadrostat + empagliflozin treatment armEXPERIMENTAL
  • Vicadrostat-placebo + empagliflozin treatment armACTIVE_COMPARATOR

Intervenciones

  • Fármaco Empagliflozin

    Empagliflozin

  • Fármaco Placebo matching Vicadrostat

    Placebo matching Vicadrostat

  • Fármaco Vicadrostat

    Vicadrostat

Variables de resultado

  1. Variable de resultado principal

    Time to first event of cardiovascular (CV) death or heart failure event (HFE)

    Plazo Up to 51 months

  2. Variable de resultado secundaria

    Time to first event of cardiovascular (CV) death or hospitalisation for heart failure (HHF)

    Plazo Up to 51 months

  3. Variable de resultado secundaria

    Absolute change from baseline in mean systolic blood pressure (SBP) [mmHg] at Week 24

    Plazo At baseline and week 24

  4. Variable de resultado secundaria

    Relative change from baseline in Urine Albumin Creatinine Ratio (UACR) [mg/g] at Week 24

    Plazo At baseline and week 24

  5. Variable de resultado secundaria

    Time to first occurrence of the composite outcome of kidney disease progression, HHF, CV death

    Plazo Up to 51 months

  6. Variable de resultado secundaria

    Time to first event of CV death, HFE, non-fatal myocardial infarction (MI) or non-fatal stroke (4-point Major adverse cardiovascular events (MACE))

    Plazo Up to 51 months

  7. Variable de resultado secundaria

    Occurrences of all-cause hospitalisations (first and recurrent)

    Plazo Up to 51 months

  8. Variable de resultado secundaria

    Time to first event of new-onset atrial fibrillation or atrial flutter (in participants without history of atrial fibrillation and atrial flutter) or CV death

    Plazo Up to 51 months

  9. Variable de resultado secundaria

    Time to all-cause death

    Plazo Up to 51 months

  10. Variable de resultado secundaria

    Time to CV death

    Plazo Up to 51 months

  11. Variable de resultado secundaria

    Time to first HHF

    Plazo Up to 51 months

  12. Variable de resultado secundaria

    Time to first event of new-onset HF or CV death

    Plazo Up to 51 months

  13. Variable de resultado secundaria

    Occurrences of HHF (first and recurrent)

    Plazo Up to 51 months

  14. Variable de resultado secundaria

    Absolute change from baseline in mean diastolic blood pressure (DBP) [mmHg] at Week 24

    Plazo At baseline and week 24

Fechas

Fecha de inicio22 de julio de 2025 (real)
Finalización principal14 de diciembre de 2029 (estimada)
Finalización21 de diciembre de 2029 (estimada)
Primera publicación14 de julio de 2025 (real)
Última actualización16 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezseptiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

1094 centros están en reclutamiento

Argentina

CentroCiudadEstado o regiónEstado
CEC- Centro de Especialidades CardiovascularesBahía BlancaEn reclutamiento
Buenos Aires Macula S.A.Buenos AiresEn reclutamiento
IDIM - Instituto de Diagnostico e Investigaciones MetabolicasBuenos AiresEn reclutamiento
Centro Medico FleischerCABAEn reclutamiento
CEDIC - Centro de Investigacion ClinicaCABAEn reclutamiento
Mautalen- Salud e InvestigacionCABAEn reclutamiento
Equipo CienciaCABAEn reclutamiento
STAT ResearchCABAEn reclutamiento
Sanatorio AnchorenaCABAEn reclutamiento
CPSIC SRL - Cardiologia PalermoCABAEn reclutamiento
Instituto Cardiovascular de Buenos AiresCiudad Autonoma Buenos AiresEn reclutamiento
Centro Medico ViamonteCiudad Autonoma de Bs AsEn reclutamiento
Consultorio de Investigacion Clinica EMO SRLCiudad Autonoma de Buenos AireEn reclutamiento
Centro Diabetologico Dr WaitmanCórdobaEn reclutamiento
Clinica Universitaria Reina Fabiola - Universidad Catolica de CordobaCórdobaEn reclutamiento
Cemaic (Centro de Especialidades Medicas Ambulatorias E Investigacion Clinica)CórdobaEn reclutamiento
Instituto Privado de Investigaciones Clinica Cordoba S.A.CórdobaEn reclutamiento
CIPADI - Centro Integral de Prevencion y Atencion en DiabetesGodoy CruzEn reclutamiento
Centro de Investigaciones Clinicas BaigorriaGranadero BaigorriaEn reclutamiento
Instituto de Investigaciones Clinicas Mar del PlataMar del PlataEn reclutamiento
Hospital Privado - Centro Medico de Cordoba S.A.Parque Velez SarsfieldEn reclutamiento
Instituto Medico Catamarca - IMECRosarioEn reclutamiento
Instituto Medico Rio CuartoRío CuartoEn reclutamiento
Centro de Investigaciones Clinicas del LitoralSanta FeEn reclutamiento
CEDIR Santa FeSanta FeEn reclutamiento
CEMEDIC - Centro de Especialidades MedicasVilla LuroEn reclutamiento

Australia

CentroCiudadEstado o regiónEstado
Nightingale Research Pty LtdAdelaideSouth AustraliaEn reclutamiento
Flinders Medical CentreBedford ParkSouth AustraliaEn reclutamiento
Blacktown HospitalBlactownNew South WalesEn reclutamiento
Advara Heartcare Research BurwoodBurwoodNew South WalesEn reclutamiento
Royal Prince Alfred HospitalCamperdownNew South WalesEn reclutamiento
Heart of AustraliaChelmerQueenslandEn reclutamiento
Prince Charles HospitalChermsideQueenslandEn reclutamiento
Monash HealthClaytonVictoriaEn reclutamiento
Concord Repatriation General HospitalConcordNew South WalesEn reclutamiento
The Northern HospitalEppingVictoriaEn reclutamiento
Nightingale Research VictoriaFrankstonVictoriaEn reclutamiento
Canberra HospitalGarranAustralian Capital TerritoryEn reclutamiento
Royal Brisbane and Women's HospitalHerstonQueenslandCompletado
Royal Hobart HospitalHobartTasmaniaEn reclutamiento
HeartwestHoppers CrossingVictoriaEn reclutamiento
Life Clinical ResearchIpswichQueenslandEn reclutamiento
Advara Heartcare Research WAJoondalupWestern AustraliaEn reclutamiento
Advara Heart Care-Leabrook-69072LeabrookSouth AustraliaEn reclutamiento
Sydney Cardiometabolic CentreLiverpoolNew South WalesEn reclutamiento
Cabrini HealthMalvernVictoriaEn reclutamiento
Advara HeartCare - MulgraveMulgraveVictoriaEn reclutamiento
Fiona Stanley HospitalMurdochWestern AustraliaEn reclutamiento
John Hunter HospitalNew Lambton HeightsNew South WalesEn reclutamiento
Gold Coast University HospitalSouthportQueenslandEn reclutamiento

En el registro figuran 1093 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 16 de septiembre de 2026

    Centro eliminado

    4 sites removed (1143 total)

    11471143

  2. 20 de agosto de 2026

    Centro eliminado

    2 sites removed (1147 total)

    11491147

  3. 27 de julio de 2026

    Centro eliminado

    5 sites removed (1149 total)

    11541149

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07064473