Clinical Trials List
Protocol Number1378-0041
Active
2025-10-01 - 2030-06-30
Recruiting13
EASi-PROTKT™ is a phase III, double-blind, randomized, parallel-group superiority trial evaluating the efficacy and safety of oral vicadrostat (BI 690517) combined with empagliflozin compared to placebo combined with empagliflozin in participants with type 2 diabetes, hypertension, and a history of cardiovascular disease.
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Trial Applicant
Boehringer Ingelheim
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Sponsor
Boegringer Ingelheim Taiwan Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/15
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yung-Ta Kao Division of Cardiovascular Diseases
- Chien-Yi Hsu Division of Cardiovascular Diseases
- 洪元 Division of Cardiovascular Diseases
- 陳志維 Division of Cardiovascular Diseases
- 蕭卜源 Division of Cardiovascular Diseases
- 鄭宇倫 Division of Cardiovascular Diseases
- 陳彥舟 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- LIAN-YU LIN Division of General Internal Medicine
- MAO-HSIN LIN Division of General Internal Medicine
- YEN-HUNG LIN Division of General Internal Medicine
- Tzung-Dau Wang Division of General Internal Medicine
- Hsien Li Kao Division of General Internal Medicine
- HUNG-JU LIN Division of General Internal Medicine
- JEN-KUANG LEE Division of General Internal Medicine
- 陳盈憲 Division of General Internal Medicine
- 洪啟盛 Division of General Internal Medicine
- Chih-Fan Yeh Division of General Internal Medicine
- 林柏志 Division of General Internal Medicine
- 黃慶昌 Division of General Internal Medicine
- 賀立婷 Division of General Internal Medicine
- 林廷澤 Division of General Internal Medicine
- 孟士瑋 Division of General Internal Medicine
- 鄭人方 Division of General Internal Medicine
- 柯宗佑 Division of General Internal Medicine
- 陳俊凱 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 藍偉仁 Division of Cardiovascular Diseases
- 顏志軒 Division of General Internal Medicine
- 簡世杰 Division of General Internal Medicine
- 吳書豪 Division of Cardiovascular Diseases
- 宋國慈 Division of Cardiovascular Diseases
- 黃文弘 Division of Cardiovascular Diseases
- 蔡佳伶 Division of Cardiovascular Diseases
- 簡楨彥 Division of Cardiovascular Surgery
- 陳冠廷 Division of Cardiovascular Diseases
- 蔡憲岳 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 劉文浩 Division of Cardiovascular Diseases
- 柴漢東 Division of Cardiovascular Diseases
- Huang-Chung Chen Division of Cardiovascular Diseases
- 方燕楠 Division of Cardiovascular Diseases
- 鍾文榮 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chern-En Chiang Division of Cardiovascular Diseases
- Wen-Chung Yu Division of Cardiovascular Diseases
- Tse-Min Lu Division of Cardiovascular Diseases
- 吳承學 Division of Cardiovascular Diseases
- 李慶威 Division of Cardiovascular Diseases
- 張俊欽 Division of Cardiovascular Diseases
- 蔡依霖 Division of Cardiovascular Diseases
- 蔡泉財 Division of Cardiovascular Diseases
- 張皓智 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ping-Han Lo Division of General Internal Medicine
- 謝禮全 Division of General Internal Medicine
- 吳宏彬 無
- 林晏年 無
- 呂尚謁 Division of General Internal Medicine
- 陳科維 Division of General Internal Medicine
- Wei-Chung Wang Division of Neurology
- 張靜芬 無
- 鄭英男 Division of General Internal Medicine
- 魏榮廷 Division of General Internal Medicine
- 陳琦棟 Division of General Internal Medicine
- 黃志勤 Division of General Internal Medicine
- 羅翊賓 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Mei Yueh Lee 無
- 朱志生 Division of Cardiovascular Diseases
- Chun-Yuan Chu Division of Cardiovascular Diseases
- 吳韋璁 Division of Cardiovascular Diseases
- 黃天祈 Division of Cardiovascular Diseases
- 林子傑 Division of Cardiovascular Diseases
- 張建偉 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
I-Chang Hsieh
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
• The time elapsed before the first occurrence of a CV death or HFE (defined as HHF or emergency HF visit). CV deaths include deaths of unknown cause.
Objectives
The aim of this trial is to provide substantial evidence that, in addition to standard of care (SOC), vicadrostat 10 mg combined with empagliflozin 10 mg is effective and safe compared to vicadrostat placebo combined with empagliflozin 10 mg in reducing CV risk and preventing heart failure (HF) in participants with type 2 diabetes mellitus (T2DM), hypertensive renal disease (HTN), and confirmed CVD.
The primary objective is to demonstrate that vicadrostat 10 mg combined with empagliflozin 10 mg is superior to vicadrostat placebo combined with empagliflozin 10 mg in terms of time to first CV death, hospitalization for heart failure (HHF), or presentation of acute heart failure (HF) in T2DM participants with comorbid HTN and confirmed CVD.
The key secondary objective was to demonstrate that vicadrostat 10 mg plus empagliflozin 10 mg was superior to vicadrostat placebo plus empagliflozin 10 mg in the following aspects: time elapsed before the first CV death or HHF event; absolute change in mean systolic blood pressure at week 24 compared to baseline; relative change in UACR at week 24 compared to baseline; time elapsed before the first composite outcome of renal disease exacerbation or HHF or CV death; time elapsed before the first 4P-MACE event; incidence of all-cause hospitalization (first and relapse); time elapsed before the first new-onset atrial fibrillation or atrial flutter (applicable to participants without a history of atrial fibrillation and atrial flutter) or CV death event; and time elapsed before all-cause death.
Other secondary objectives include evaluating vicadrostat 10 mg plus empagliflozin 10 mg compared to vicadrostat placebo plus empagliflozin 10 mg in the following aspects: time to CV death, time to first HHF, HHF incidence (first and recurrence), and time to first new HF or CV death event. Additionally, the absolute change in mean diastolic blood pressure (DBP) at week 24 compared to baseline will be assessed.
Test Drug
BI 690517 (Vicadrostat) or matching placebo
Empagliflozin
Empagliflozin
Active Ingredient
BI 690517 (Vicadrostat) or matching placebo
6820401000
6820401000
Dosage Form
Film-coated tablets
Film-coated tablets
Film-coated tablets
Dosage
10毫克
10毫克
10毫克
Endpoints
• The time elapsed before the first occurrence of a CV death or HFE (defined as HHF or emergency HF visit). CV deaths include deaths of unknown cause.
Inclution Criteria
1. The patient was 18 years of age or older at the time of consent.
2. Prior to admission to this trial, the patient signed and dated a written consent form in accordance with the International Council for Concordance on Good Clinical Practice (ICH-GCP) and local laws.
3. Male or female participants. Women of childbearing age (WOCBP) must be willing and able to use highly effective contraceptive methods according to ICH M3 (R2), i.e., a low failure rate of less than 1% per year when used consistently and correctly. A list of contraceptive methods meeting these criteria and instructions on the duration of use are provided in the participant information.
4. Participants with a history of hypertension (HTN) and actively receiving pharmacological treatment according to the best feasible standard of care (SOC) (as determined by the trial administrator) in accordance with applicable local and international guidelines.
5. Participants with a history of type 2 diabetes mellitus (T2DM) and actively receiving pharmacological treatment according to the best feasible standard of care (as determined by the trial administrator) in accordance with applicable local/international guidelines.
6. Participants diagnosed with cardiovascular (CV) disease and actively receiving pharmacological treatment according to the best feasible standard of care (as determined by the trial administrator) in accordance with applicable local/international guidelines. Diagnosed cardiovascular disease includes at least one of the following: coronary artery disease, peripheral artery disease, or cerebrovascular disease.
* Coronary artery disease is defined as:
▪ A history of myocardial infarction (MI) or coronary revascularization (e.g., coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI])
Or
▪ Coronary angiography or other coronary angiography (e.g., coronary computed tomography [CT] angiography) showing ≥50% stenosis, or the presence of a bypass vessel.
* Peripheral artery disease (whether symptomatic or not) is defined as:
▪ A history of limb angioplasty, stenting, or bypass surgery
Or
▪ A history of limb or foot amputation due to circulatory failure
Or
▪ Evidence primarily from angiography or non-invasive methods showing significant (≥50%) peripheral artery stenosis in at least one limb or a vascular distribution area
Or
▪ An ankle-brachial index <0.9 in at least one limb. 0.9, and currently has symptoms of intermittent claudication.
o Cerebrovascular disease is defined as:
o History of ischemic stroke (known transient ischemic attack, hemorrhagic stroke, primary intracerebral hemorrhage, or subarachnoid hemorrhage are ineligible)
or
o Previous cerebrovascular reconstruction surgery (e.g., carotid endarterectomy and/or stent placement)
7. At the first follow-up visit (screening), at least one of the following other risk factors for heart failure (HF) is present:
o Type 2 diabetes requiring insulin therapy
or
o Elevated natriuretic peptides, defined as N-terminal proBNP >125 pg/ml or B-type natriuretic peptide (BNP) >35 pg/ml (within the past 6 months or at the first follow-up visit at screening [documented]**)
or
o Evidence of left ventricular hypertrophy
▪ Previous echocardiography or magnetic resonance imaging (MRI) History of diagnosis of left ventricular hypertrophy
Or
▪ Evidence of left ventricular hypertrophy on a 12-lead electrocardiogram (ECG) according to the Sokolow Lyon index: RV5 + SV1 >3.5 mV
Or
o History of atrial fibrillation or atrial flutter
or
Multivascular disease, defined as peripheral artery disease with at least one of the following: coronary artery disease or cerebrovascular disease
or
o At least 30 days of cyclic diuretic prescriptions within the most recent 3 months prior to screening (first follow-up visit)
or
o At screening (first follow-up visit), mean systolic blood pressure ≥140 mmHg despite taking at least 2 antihypertensive medications
or
o Urine albumin to creatinine ratio (UACR) ≥200 mg/g (documented within the past 6 months or at screening [first follow-up visit]*)
* BNP/NT-proBNP testing by a local laboratory within the most recent 6 months prior to screening is permitted. Alternatively, UACR assessment. NT-proBNP and UACR will be analyzed by the central laboratory during screening (first follow-up visit).
2. Prior to admission to this trial, the patient signed and dated a written consent form in accordance with the International Council for Concordance on Good Clinical Practice (ICH-GCP) and local laws.
3. Male or female participants. Women of childbearing age (WOCBP) must be willing and able to use highly effective contraceptive methods according to ICH M3 (R2), i.e., a low failure rate of less than 1% per year when used consistently and correctly. A list of contraceptive methods meeting these criteria and instructions on the duration of use are provided in the participant information.
4. Participants with a history of hypertension (HTN) and actively receiving pharmacological treatment according to the best feasible standard of care (SOC) (as determined by the trial administrator) in accordance with applicable local and international guidelines.
5. Participants with a history of type 2 diabetes mellitus (T2DM) and actively receiving pharmacological treatment according to the best feasible standard of care (as determined by the trial administrator) in accordance with applicable local/international guidelines.
6. Participants diagnosed with cardiovascular (CV) disease and actively receiving pharmacological treatment according to the best feasible standard of care (as determined by the trial administrator) in accordance with applicable local/international guidelines. Diagnosed cardiovascular disease includes at least one of the following: coronary artery disease, peripheral artery disease, or cerebrovascular disease.
* Coronary artery disease is defined as:
▪ A history of myocardial infarction (MI) or coronary revascularization (e.g., coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI])
Or
▪ Coronary angiography or other coronary angiography (e.g., coronary computed tomography [CT] angiography) showing ≥50% stenosis, or the presence of a bypass vessel.
* Peripheral artery disease (whether symptomatic or not) is defined as:
▪ A history of limb angioplasty, stenting, or bypass surgery
Or
▪ A history of limb or foot amputation due to circulatory failure
Or
▪ Evidence primarily from angiography or non-invasive methods showing significant (≥50%) peripheral artery stenosis in at least one limb or a vascular distribution area
Or
▪ An ankle-brachial index <0.9 in at least one limb. 0.9, and currently has symptoms of intermittent claudication.
o Cerebrovascular disease is defined as:
o History of ischemic stroke (known transient ischemic attack, hemorrhagic stroke, primary intracerebral hemorrhage, or subarachnoid hemorrhage are ineligible)
or
o Previous cerebrovascular reconstruction surgery (e.g., carotid endarterectomy and/or stent placement)
7. At the first follow-up visit (screening), at least one of the following other risk factors for heart failure (HF) is present:
o Type 2 diabetes requiring insulin therapy
or
o Elevated natriuretic peptides, defined as N-terminal proBNP >125 pg/ml or B-type natriuretic peptide (BNP) >35 pg/ml (within the past 6 months or at the first follow-up visit at screening [documented]**)
or
o Evidence of left ventricular hypertrophy
▪ Previous echocardiography or magnetic resonance imaging (MRI) History of diagnosis of left ventricular hypertrophy
Or
▪ Evidence of left ventricular hypertrophy on a 12-lead electrocardiogram (ECG) according to the Sokolow Lyon index: RV5 + SV1 >3.5 mV
Or
o History of atrial fibrillation or atrial flutter
or
Multivascular disease, defined as peripheral artery disease with at least one of the following: coronary artery disease or cerebrovascular disease
or
o At least 30 days of cyclic diuretic prescriptions within the most recent 3 months prior to screening (first follow-up visit)
or
o At screening (first follow-up visit), mean systolic blood pressure ≥140 mmHg despite taking at least 2 antihypertensive medications
or
o Urine albumin to creatinine ratio (UACR) ≥200 mg/g (documented within the past 6 months or at screening [first follow-up visit]*)
* BNP/NT-proBNP testing by a local laboratory within the most recent 6 months prior to screening is permitted. Alternatively, UACR assessment. NT-proBNP and UACR will be analyzed by the central laboratory during screening (first follow-up visit).
Exclusion Criteria
1. A history of heart failure or hospitalization for heart failure, or treatment for heart failure at the first follow-up visit (screening) and the second follow-up visit (randomization).
2. At the first follow-up visit, participants with sinus rhythm had NT-proBNP >600 pg/ml; or participants with atrial fibrillation or atrial flutter had NT-proBNP >1200 pg/ml (analysis performed at the central laboratory at screening).
3. At the first follow-up visit (screening), the electrocardiogram shows atrial fibrillation or atrial flutter with a resting heart rate >110 bpm.
4. At the first follow-up visit (screening), the patient has untreated late conduction disorder (e.g., symptomatic bradycardia, sick sinus syndrome, Moses type II second-degree atrioventricular block, third-degree heart block) or untreated clinically significant ventricular arrhythmia.
5. The patient has received mineral corticosteroid receptor antagonist (MRA) therapy (e.g., spironolactone, eplerenone, finerenone) within 2 weeks prior to the first follow-up visit (screening), or is required to receive such therapy before the second follow-up visit (randomization) or is scheduled to receive such therapy during the trial, as determined by the trial administrator. MRA therapy should not be discontinued to qualify for this trial.
6. Received amiloride or other potassium-sparing diuretics within 2 weeks prior to the first follow-up visit (screening), or, at the discretion of the trial administrator, requires such treatment before the second follow-up visit (randomization) or is scheduled to receive such treatment during the trial.
7. Received any of the following treatments at the first follow-up visit (screening), or requires such treatment before the second follow-up visit (randomization) or is scheduled to receive such treatment during the trial:
o Use of a direct renin inhibitor (e.g., aliskiren)
o Concomitant use of more than one angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB) (including angiotensin receptor-neprilysin inhibitors [ARNi])
o Use of other aldosterone synthase inhibitors (e.g., baxdrostat)
o Use of systemic mineral corticosteroid replacement therapy (e.g., fludrocortisone)
8. Use of a potassium-binding agent (e.g., sodium zirconium) within 4 weeks prior to the first follow-up visit (screening). 9. Having hyperkalemia requiring hospitalization within 12 weeks prior to the first follow-up visit (screening).
10. Serum potassium >5.2 mmol/L as measured by the central laboratory at the first follow-up visit (screening) (Note: Serum potassium may be reassessed once during screening).
11. Impaired renal function, defined as eGFR <20 mL/min/1.73 m2 as measured by the central laboratory at the first follow-up visit (screening) (using the Chronic Kidney Disease Epidemiology [CKD-EPI] formula), or currently receiving renal replacement therapy. (Note: One reassessment of eGFR is permitted during screening.)
12. Known adrenal insufficiency (e.g., Addison's disease) or Cushing's syndrome.
13. Symptomatic hypotension and/or mean systolic blood pressure (SBP) <100 mmHg at the first follow-up visit (screening) or up to the second follow-up visit (including the second follow-up visit, i.e., randomization).
14. Mean systolic blood pressure ≥180 mmHg or mean diastolic blood pressure (DBP) ≥120 mmHg at the first follow-up visit (screening) or the second follow-up visit (randomization).
15. Experiencing myocardial infarction, stroke, transient ischemic attack, or acute inflammatory heart disease (e.g., acute myocarditis) within 12 weeks prior to the first follow-up visit (screening) and up to the second follow-up visit (randomization), or undergoing major surgery (as assessed as major by the trial administrator); or scheduled for major non-urgent surgery (e.g., hip replacement, coronary artery bypass grafting [CABG]).
16. Undergoing percutaneous vascular intervention or any angiography using iodine-containing contrast agents within 1 week prior to the second follow-up visit (randomization).
17. Known for severe valvular heart disease (obstructive or regurgitant) in the trial administrator's judgment; excluding mitral regurgitation secondary to left ventricular dilatation, or having valvular heart disease scheduled for surgery or invasive procedures at the first follow-up visit (screening), or anticipated to undergo invasive treatment during the trial.
18. Alanine transaminase (ALT) measured at the central laboratory at the first follow-up visit (screening). Or aspartate transaminase (AST) >3 times the upper limit of normal (ULN)
19. Known severe liver dysfunction (i.e., Child-Pugh stage C cirrhosis)
20. Underwent gastrointestinal surgery or has gastrointestinal disease that, according to the trial administrator, may interfere with the absorption of the investigational drug, such as: bowel resection, inflammatory bowel disease, current active gastritis, pancreatitis
21. At the first follow-up visit (screening), had type 1 diabetes, a history of diabetes due to other autoimmune causes (e.g., latent autoimmune diabetes in adults [LADA]), or uncontrolled type 2 diabetes (HbA1c >10% as measured by the central laboratory)
22. History of ketoacidosis within 5 years prior to the first follow-up visit (screening) or up to the second follow-up visit (randomization)
23. Within 5 years prior to the first follow-up visit (screening) 23. Any documented active or suspected malignant tumor or history of malignant tumor within the year, excluding appropriately treated basal cell carcinoma of the skin, cervical carcinoma in situ, or low-risk prostate cancer (patients with pre-treatment prostate-specific antigen [PSA] <10 ng/mL and a slice Gleason score ≤6 and clinical stage T1c or T2a).
24. Any other medical condition for which the trial administrator determines the life expectancy is <1 year.
25. Participants who must or wish to continue using restricted medications or any medications deemed likely to interfere with the safe execution of the trial.
26. Participants who are not expected to comply with the trial protocol or are not expected to complete the trial on schedule (e.g., long-term alcohol or drug abuse, or any other condition deemed by the trial administrator to render the participant an unreliable participant).
27. Participants who have previously been randomized in this trial.
28. Participants currently enrolled in another investigational device or drug trial, or who have ended participation in another investigational device or drug trial or other investigational treatment within 30 days of their first follow-up visit (screening). Patients participating in purely observational trials will not be excluded.
29. Women who are pregnant, breastfeeding, or planning to conceive during the trial.
30. Any condition not included in any other exclusion criteria, but which the trial administrator believes may jeopardize the safety of participants or the adherence to the trial protocol.
31. Any vulnerable person under local regulations (defined as: a pregnant or breastfeeding woman; a person deprived of their liberty; a minor; someone who may lack sufficient power, intelligence, education, resources, physical strength, or other capacity to protect their own interests; or someone unable to expressly consent).
32. Those who are intolerant to or have a known allergy or anaphylactic reaction to vicadrostat or empagliflozin or other sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors and/or any excipients (including lactose).
2. At the first follow-up visit, participants with sinus rhythm had NT-proBNP >600 pg/ml; or participants with atrial fibrillation or atrial flutter had NT-proBNP >1200 pg/ml (analysis performed at the central laboratory at screening).
3. At the first follow-up visit (screening), the electrocardiogram shows atrial fibrillation or atrial flutter with a resting heart rate >110 bpm.
4. At the first follow-up visit (screening), the patient has untreated late conduction disorder (e.g., symptomatic bradycardia, sick sinus syndrome, Moses type II second-degree atrioventricular block, third-degree heart block) or untreated clinically significant ventricular arrhythmia.
5. The patient has received mineral corticosteroid receptor antagonist (MRA) therapy (e.g., spironolactone, eplerenone, finerenone) within 2 weeks prior to the first follow-up visit (screening), or is required to receive such therapy before the second follow-up visit (randomization) or is scheduled to receive such therapy during the trial, as determined by the trial administrator. MRA therapy should not be discontinued to qualify for this trial.
6. Received amiloride or other potassium-sparing diuretics within 2 weeks prior to the first follow-up visit (screening), or, at the discretion of the trial administrator, requires such treatment before the second follow-up visit (randomization) or is scheduled to receive such treatment during the trial.
7. Received any of the following treatments at the first follow-up visit (screening), or requires such treatment before the second follow-up visit (randomization) or is scheduled to receive such treatment during the trial:
o Use of a direct renin inhibitor (e.g., aliskiren)
o Concomitant use of more than one angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB) (including angiotensin receptor-neprilysin inhibitors [ARNi])
o Use of other aldosterone synthase inhibitors (e.g., baxdrostat)
o Use of systemic mineral corticosteroid replacement therapy (e.g., fludrocortisone)
8. Use of a potassium-binding agent (e.g., sodium zirconium) within 4 weeks prior to the first follow-up visit (screening). 9. Having hyperkalemia requiring hospitalization within 12 weeks prior to the first follow-up visit (screening).
10. Serum potassium >5.2 mmol/L as measured by the central laboratory at the first follow-up visit (screening) (Note: Serum potassium may be reassessed once during screening).
11. Impaired renal function, defined as eGFR <20 mL/min/1.73 m2 as measured by the central laboratory at the first follow-up visit (screening) (using the Chronic Kidney Disease Epidemiology [CKD-EPI] formula), or currently receiving renal replacement therapy. (Note: One reassessment of eGFR is permitted during screening.)
12. Known adrenal insufficiency (e.g., Addison's disease) or Cushing's syndrome.
13. Symptomatic hypotension and/or mean systolic blood pressure (SBP) <100 mmHg at the first follow-up visit (screening) or up to the second follow-up visit (including the second follow-up visit, i.e., randomization).
14. Mean systolic blood pressure ≥180 mmHg or mean diastolic blood pressure (DBP) ≥120 mmHg at the first follow-up visit (screening) or the second follow-up visit (randomization).
15. Experiencing myocardial infarction, stroke, transient ischemic attack, or acute inflammatory heart disease (e.g., acute myocarditis) within 12 weeks prior to the first follow-up visit (screening) and up to the second follow-up visit (randomization), or undergoing major surgery (as assessed as major by the trial administrator); or scheduled for major non-urgent surgery (e.g., hip replacement, coronary artery bypass grafting [CABG]).
16. Undergoing percutaneous vascular intervention or any angiography using iodine-containing contrast agents within 1 week prior to the second follow-up visit (randomization).
17. Known for severe valvular heart disease (obstructive or regurgitant) in the trial administrator's judgment; excluding mitral regurgitation secondary to left ventricular dilatation, or having valvular heart disease scheduled for surgery or invasive procedures at the first follow-up visit (screening), or anticipated to undergo invasive treatment during the trial.
18. Alanine transaminase (ALT) measured at the central laboratory at the first follow-up visit (screening). Or aspartate transaminase (AST) >3 times the upper limit of normal (ULN)
19. Known severe liver dysfunction (i.e., Child-Pugh stage C cirrhosis)
20. Underwent gastrointestinal surgery or has gastrointestinal disease that, according to the trial administrator, may interfere with the absorption of the investigational drug, such as: bowel resection, inflammatory bowel disease, current active gastritis, pancreatitis
21. At the first follow-up visit (screening), had type 1 diabetes, a history of diabetes due to other autoimmune causes (e.g., latent autoimmune diabetes in adults [LADA]), or uncontrolled type 2 diabetes (HbA1c >10% as measured by the central laboratory)
22. History of ketoacidosis within 5 years prior to the first follow-up visit (screening) or up to the second follow-up visit (randomization)
23. Within 5 years prior to the first follow-up visit (screening) 23. Any documented active or suspected malignant tumor or history of malignant tumor within the year, excluding appropriately treated basal cell carcinoma of the skin, cervical carcinoma in situ, or low-risk prostate cancer (patients with pre-treatment prostate-specific antigen [PSA] <10 ng/mL and a slice Gleason score ≤6 and clinical stage T1c or T2a).
24. Any other medical condition for which the trial administrator determines the life expectancy is <1 year.
25. Participants who must or wish to continue using restricted medications or any medications deemed likely to interfere with the safe execution of the trial.
26. Participants who are not expected to comply with the trial protocol or are not expected to complete the trial on schedule (e.g., long-term alcohol or drug abuse, or any other condition deemed by the trial administrator to render the participant an unreliable participant).
27. Participants who have previously been randomized in this trial.
28. Participants currently enrolled in another investigational device or drug trial, or who have ended participation in another investigational device or drug trial or other investigational treatment within 30 days of their first follow-up visit (screening). Patients participating in purely observational trials will not be excluded.
29. Women who are pregnant, breastfeeding, or planning to conceive during the trial.
30. Any condition not included in any other exclusion criteria, but which the trial administrator believes may jeopardize the safety of participants or the adherence to the trial protocol.
31. Any vulnerable person under local regulations (defined as: a pregnant or breastfeeding woman; a person deprived of their liberty; a minor; someone who may lack sufficient power, intelligence, education, resources, physical strength, or other capacity to protect their own interests; or someone unable to expressly consent).
32. Those who are intolerant to or have a known allergy or anaphylactic reaction to vicadrostat or empagliflozin or other sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors and/or any excipients (including lactose).
The Estimated Number of Participants
-
Taiwan
95 participants
-
Global
11800 participants
