Идёт набор NCT07064473

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

Фаза III С лечением Diabetes Mellitus, Type 2 Hypertension Cardiovascular Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Vicadrostat, Empagliflozin, Placebo matching Vicadrostat.
Кому может быть актуально: Состояния в реестре: Diabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Аргентина, Австралия, Австрия, Бельгия +46
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Препарат Vicadrostat
Vicadrostat
Препарат Empagliflozin
Empagliflozin
Препарат Placebo matching Vicadrostat
Placebo matching Vicadrostat

Первичные конечные точки

Time to first event of cardiovascular (CV) death or heart failure event (HFE) [Срок оценки: Up to 51 months]

Вторичные конечные точки (12)

Time to first event of cardiovascular (CV) death or hospitalisation for heart failure (HHF) [Срок оценки: Up to 51 months]
Absolute change from baseline in mean systolic blood pressure (SBP) [mmHg] at Week 24 [Срок оценки: At baseline and week 24]
Relative change from baseline in Urine Albumin Creatinine Ratio (UACR) [mg/g] at Week 24 [Срок оценки: At baseline and week 24]
Time to first occurrence of the composite outcome of kidney disease progression, HHF, CV death [Срок оценки: Up to 51 months]
Time to first event of CV death, HFE, non-fatal myocardial infarction (MI) or non-fatal stroke (4-point Major adverse cardiovascular events (MACE)) [Срок оценки: Up to 51 months]
Occurrences of all-cause hospitalisations (first and recurrent) [Срок оценки: Up to 51 months]
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 [Срок оценки: Up to 51 months]
Time to all-cause death [Срок оценки: Up to 51 months]
Time to CV death [Срок оценки: Up to 51 months]
Time to first HHF [Срок оценки: Up to 51 months]
Time to first event of new-onset HF or CV death [Срок оценки: Up to 51 months]
Occurrences of HHF (first and recurrent) [Срок оценки: Up to 51 months]

Критерии участия

Критерии включения

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)

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Четверное слепое
Основная цель: Лечение