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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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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…

שלב 3דרושים 11,800 משתתפים1,143 אתרים51 מדינות

קטגוריות

לב וכלי דם83%אנדוקריני ומטבולי17%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

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.

מצבים רפואיים

  • Diabetes Mellitus, Type 2
  • Hypertension
  • Cardiovascular Diseases

זכאות

מיןהכול
גילאים18 Years – ללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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.

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהQUADRUPLE (4)
גיוסדרושים 11,800 משתתפים

נותן חסות ושותפים

  • Boehringer Ingelheim נותן חסות

זרועות והתערבויות

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

התערבויות

  • תרופה Empagliflozin

    Empagliflozin

  • תרופה Placebo matching Vicadrostat

    Placebo matching Vicadrostat

  • תרופה Vicadrostat

    Vicadrostat

מדדי תוצאה

  1. מדד תוצאה ראשוני

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

    מסגרת זמן Up to 51 months

  2. מדד תוצאה משני

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

    מסגרת זמן Up to 51 months

  3. מדד תוצאה משני

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

    מסגרת זמן At baseline and week 24

  4. מדד תוצאה משני

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

    מסגרת זמן At baseline and week 24

  5. מדד תוצאה משני

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

    מסגרת זמן Up to 51 months

  6. מדד תוצאה משני

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

    מסגרת זמן Up to 51 months

  7. מדד תוצאה משני

    Occurrences of all-cause hospitalisations (first and recurrent)

    מסגרת זמן Up to 51 months

  8. מדד תוצאה משני

    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

    מסגרת זמן Up to 51 months

  9. מדד תוצאה משני

    Time to all-cause death

    מסגרת זמן Up to 51 months

  10. מדד תוצאה משני

    Time to CV death

    מסגרת זמן Up to 51 months

  11. מדד תוצאה משני

    Time to first HHF

    מסגרת זמן Up to 51 months

  12. מדד תוצאה משני

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

    מסגרת זמן Up to 51 months

  13. מדד תוצאה משני

    Occurrences of HHF (first and recurrent)

    מסגרת זמן Up to 51 months

  14. מדד תוצאה משני

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

    מסגרת זמן At baseline and week 24

תאריכים

תאריך התחלה22 ביולי 2025 (בפועל)
סיום ראשוני14 בדצמבר 2029 (משוער)
סיום21 בדצמבר 2029 (משוער)
פורסם לראשונה14 ביולי 2025 (בפועל)
עודכן לאחרונה16 בספטמבר 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהספטמבר 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

1,094 אתרים מגייסים

Argentina

מתקןעירמדינה או אזורמצב
CEC- Centro de Especialidades CardiovascularesBahía Blancaמגייס
Buenos Aires Macula S.A.Buenos Airesמגייס
IDIM - Instituto de Diagnostico e Investigaciones MetabolicasBuenos Airesמגייס
Centro Medico FleischerCABAמגייס
CEDIC - Centro de Investigacion ClinicaCABAמגייס
Mautalen- Salud e InvestigacionCABAמגייס
Equipo CienciaCABAמגייס
STAT ResearchCABAמגייס
Sanatorio AnchorenaCABAמגייס
CPSIC SRL - Cardiologia PalermoCABAמגייס
Instituto Cardiovascular de Buenos AiresCiudad Autonoma Buenos Airesמגייס
Centro Medico ViamonteCiudad Autonoma de Bs Asמגייס
Consultorio de Investigacion Clinica EMO SRLCiudad Autonoma de Buenos Aireמגייס
Centro Diabetologico Dr WaitmanCórdobaמגייס
Clinica Universitaria Reina Fabiola - Universidad Catolica de CordobaCórdobaמגייס
Cemaic (Centro de Especialidades Medicas Ambulatorias E Investigacion Clinica)Córdobaמגייס
Instituto Privado de Investigaciones Clinica Cordoba S.A.Córdobaמגייס
CIPADI - Centro Integral de Prevencion y Atencion en DiabetesGodoy Cruzמגייס
Centro de Investigaciones Clinicas BaigorriaGranadero Baigorriaמגייס
Instituto de Investigaciones Clinicas Mar del PlataMar del Plataמגייס
Hospital Privado - Centro Medico de Cordoba S.A.Parque Velez Sarsfieldמגייס
Instituto Medico Catamarca - IMECRosarioמגייס
Instituto Medico Rio CuartoRío Cuartoמגייס
Centro de Investigaciones Clinicas del LitoralSanta Feמגייס
CEDIR Santa FeSanta Feמגייס
CEMEDIC - Centro de Especialidades MedicasVilla Luroמגייס

Australia

מתקןעירמדינה או אזורמצב
Nightingale Research Pty LtdAdelaideSouth Australiaמגייס
Flinders Medical CentreBedford ParkSouth Australiaמגייס
Blacktown HospitalBlactownNew South Walesמגייס
Advara Heartcare Research BurwoodBurwoodNew South Walesמגייס
Royal Prince Alfred HospitalCamperdownNew South Walesמגייס
Heart of AustraliaChelmerQueenslandמגייס
Prince Charles HospitalChermsideQueenslandמגייס
Monash HealthClaytonVictoriaמגייס
Concord Repatriation General HospitalConcordNew South Walesמגייס
The Northern HospitalEppingVictoriaמגייס
Nightingale Research VictoriaFrankstonVictoriaמגייס
Canberra HospitalGarranAustralian Capital Territoryמגייס
Royal Brisbane and Women's HospitalHerstonQueenslandהושלם
Royal Hobart HospitalHobartTasmaniaמגייס
HeartwestHoppers CrossingVictoriaמגייס
Life Clinical ResearchIpswichQueenslandמגייס
Advara Heartcare Research WAJoondalupWestern Australiaמגייס
Advara Heart Care-Leabrook-69072LeabrookSouth Australiaמגייס
Sydney Cardiometabolic CentreLiverpoolNew South Walesמגייס
Cabrini HealthMalvernVictoriaמגייס
Advara HeartCare - MulgraveMulgraveVictoriaמגייס
Fiona Stanley HospitalMurdochWestern Australiaמגייס
John Hunter HospitalNew Lambton HeightsNew South Walesמגייס
Gold Coast University HospitalSouthportQueenslandמגייס

1,093 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

  1. 16 בספטמבר 2026

    אתר הוסר

    4 sites removed (1143 total)

    11471143

  2. 20 באוגוסט 2026

    אתר הוסר

    2 sites removed (1147 total)

    11491147

  3. 27 ביולי 2026

    אתר הוסר

    5 sites removed (1149 total)

    11541149

מרשם: ClinicalTrials.gov · NCT########

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