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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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

المرحلة 3مطلوب 11,800 مشارك1,143 موقعاً51 دولة

الفئات

القلب والأوعية الدموية83%الغدد الصمّاء والأيض17%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

ملخص

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.

الحالات

  • Diabetes Mellitus, Type 2
  • Hypertension
  • Cardiovascular Diseases

الأهلية

الجنسالجميع
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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.

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةQUADRUPLE (4)
التجنيدمطلوب 11,800 مشارك

الجهة الراعية والمتعاونون

  • Boehringer Ingelheim الجهة الراعية

الأذرع والتدخلات

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

التدخلات

  • دواء Empagliflozin

    Empagliflozin

  • دواء Placebo matching Vicadrostat

    Placebo matching Vicadrostat

  • دواء Vicadrostat

    Vicadrostat

مقاييس النتائج

  1. مقياس النتيجة الأولي

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

    الإطار الزمني Up to 51 months

  2. مقياس النتيجة الثانوي

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

    الإطار الزمني Up to 51 months

  3. مقياس النتيجة الثانوي

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

    الإطار الزمني At baseline and week 24

  4. مقياس النتيجة الثانوي

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

    الإطار الزمني At baseline and week 24

  5. مقياس النتيجة الثانوي

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

    الإطار الزمني Up to 51 months

  6. مقياس النتيجة الثانوي

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

    الإطار الزمني Up to 51 months

  7. مقياس النتيجة الثانوي

    Occurrences of all-cause hospitalisations (first and recurrent)

    الإطار الزمني Up to 51 months

  8. مقياس النتيجة الثانوي

    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

    الإطار الزمني Up to 51 months

  9. مقياس النتيجة الثانوي

    Time to all-cause death

    الإطار الزمني Up to 51 months

  10. مقياس النتيجة الثانوي

    Time to CV death

    الإطار الزمني Up to 51 months

  11. مقياس النتيجة الثانوي

    Time to first HHF

    الإطار الزمني Up to 51 months

  12. مقياس النتيجة الثانوي

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

    الإطار الزمني Up to 51 months

  13. مقياس النتيجة الثانوي

    Occurrences of HHF (first and recurrent)

    الإطار الزمني Up to 51 months

  14. مقياس النتيجة الثانوي

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

    الإطار الزمني At baseline and week 24

التواريخ

تاريخ البدء22 يوليو 2025 (فعلي)
الإتمام الأولي14 ديسمبر 2029 (تقديري)
الإتمام21 ديسمبر 2029 (تقديري)
أول نشر14 يوليو 2025 (فعلي)
آخر تحديث16 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةسبتمبر 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

1,094 موقعاً قيد التجنيد

Argentina

المنشأةالمدينةالولاية أو المنطقةالحالة
CEC- Centro de Especialidades CardiovascularesBahía Blancaقيد التجنيد
Buenos Aires Macula S.A.Buenos Airesقيد التجنيد
IDIM - Instituto de Diagnostico e Investigaciones MetabolicasBuenos Airesقيد التجنيد
Centro Medico FleischerCABAقيد التجنيد
CEDIC - Centro de Investigacion ClinicaCABAقيد التجنيد
Mautalen- Salud e InvestigacionCABAقيد التجنيد
Equipo CienciaCABAقيد التجنيد
STAT ResearchCABAقيد التجنيد
Sanatorio AnchorenaCABAقيد التجنيد
CPSIC SRL - Cardiologia PalermoCABAقيد التجنيد
Instituto Cardiovascular de Buenos AiresCiudad Autonoma Buenos Airesقيد التجنيد
Centro Medico ViamonteCiudad Autonoma de Bs Asقيد التجنيد
Consultorio de Investigacion Clinica EMO SRLCiudad Autonoma de Buenos Aireقيد التجنيد
Centro Diabetologico Dr WaitmanCórdobaقيد التجنيد
Clinica Universitaria Reina Fabiola - Universidad Catolica de CordobaCórdobaقيد التجنيد
Cemaic (Centro de Especialidades Medicas Ambulatorias E Investigacion Clinica)Córdobaقيد التجنيد
Instituto Privado de Investigaciones Clinica Cordoba S.A.Córdobaقيد التجنيد
CIPADI - Centro Integral de Prevencion y Atencion en DiabetesGodoy Cruzقيد التجنيد
Centro de Investigaciones Clinicas BaigorriaGranadero Baigorriaقيد التجنيد
Instituto de Investigaciones Clinicas Mar del PlataMar del Plataقيد التجنيد
Hospital Privado - Centro Medico de Cordoba S.A.Parque Velez Sarsfieldقيد التجنيد
Instituto Medico Catamarca - IMECRosarioقيد التجنيد
Instituto Medico Rio CuartoRío Cuartoقيد التجنيد
Centro de Investigaciones Clinicas del LitoralSanta Feقيد التجنيد
CEDIR Santa FeSanta Feقيد التجنيد
CEMEDIC - Centro de Especialidades MedicasVilla Luroقيد التجنيد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Nightingale Research Pty LtdAdelaideSouth Australiaقيد التجنيد
Flinders Medical CentreBedford ParkSouth Australiaقيد التجنيد
Blacktown HospitalBlactownNew South Walesقيد التجنيد
Advara Heartcare Research BurwoodBurwoodNew South Walesقيد التجنيد
Royal Prince Alfred HospitalCamperdownNew South Walesقيد التجنيد
Heart of AustraliaChelmerQueenslandقيد التجنيد
Prince Charles HospitalChermsideQueenslandقيد التجنيد
Monash HealthClaytonVictoriaقيد التجنيد
Concord Repatriation General HospitalConcordNew South Walesقيد التجنيد
The Northern HospitalEppingVictoriaقيد التجنيد
Nightingale Research VictoriaFrankstonVictoriaقيد التجنيد
Canberra HospitalGarranAustralian Capital Territoryقيد التجنيد
Royal Brisbane and Women's HospitalHerstonQueenslandمكتمل
Royal Hobart HospitalHobartTasmaniaقيد التجنيد
HeartwestHoppers CrossingVictoriaقيد التجنيد
Life Clinical ResearchIpswichQueenslandقيد التجنيد
Advara Heartcare Research WAJoondalupWestern Australiaقيد التجنيد
Advara Heart Care-Leabrook-69072LeabrookSouth Australiaقيد التجنيد
Sydney Cardiometabolic CentreLiverpoolNew South Walesقيد التجنيد
Cabrini HealthMalvernVictoriaقيد التجنيد
Advara HeartCare - MulgraveMulgraveVictoriaقيد التجنيد
Fiona Stanley HospitalMurdochWestern Australiaقيد التجنيد
John Hunter HospitalNew Lambton HeightsNew South Walesقيد التجنيد
Gold Coast University HospitalSouthportQueenslandقيد التجنيد

يُدرَج 1,093 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 16 سبتمبر 2026

    أُزيل موقع

    4 sites removed (1143 total)

    11471143

  2. 20 أغسطس 2026

    أُزيل موقع

    2 sites removed (1147 total)

    11491147

  3. 27 يوليو 2026

    أُزيل موقع

    5 sites removed (1149 total)

    11541149

السجل: ClinicalTrials.gov · NCT########

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