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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 11,800
- 试验地点
- 2,262
- 主要终点
- Time to first event of cardiovascular (CV) death or heart failure event (HFE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Vicadrostat-placebo + empagliflozin treatment arm
干预措施: Placebo matching Vicadrostat (Drug)
Vicadrostat + empagliflozin treatment arm
干预措施: Empagliflozin (Drug)
Vicadrostat-placebo + empagliflozin treatment arm
干预措施: Empagliflozin (Drug)
Vicadrostat + empagliflozin treatment arm
干预措施: Vicadrostat (Drug)
结局指标
主要结局
Time to first event of cardiovascular (CV) death or heart failure event (HFE)
时间窗: Up to 51 months
Time to first event of cardiovascular (CV) death or heart failure event (HFE)
时间窗: Up to 51 months
次要结局
- Time to first event of cardiovascular (CV) death or hospitalisation for heart failure (HHF)(Up to 51 months)
- Absolute change from baseline in mean systolic blood pressure (SBP) [mmHg] at Week 24(At baseline and week 24)
- Relative change from baseline in Urine Albumin Creatinine Ratio (UACR) [mg/g] at Week 24(At baseline and week 24)
- Time to first occurrence of the composite outcome of kidney disease progression, HHF, CV death(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))(Up to 51 months)
- Occurrences of all-cause hospitalisations (first and recurrent)(Up to 51 months)
- Time to first event of new-onset HF or CV death(Up to 51 months)
- Occurrences of HHF (first and recurrent)(Up to 51 months)
- Absolute change from baseline in mean diastolic blood pressure (DBP) [mmHg] at Week 24(At baseline and week 24)
- Time to first event of cardiovascular (CV) death or hospitalisation for heart failure (HHF)(Up to 51 months)
- Absolute change from baseline in mean systolic blood pressure (SBP) [mmHg] at Week 24(At baseline and week 24)
- Relative change from baseline in Urine Albumin Creatinine Ratio (UACR) [mg/g] at Week 24(At baseline and week 24)
- Time to first occurrence of the composite outcome of kidney disease progression, HHF, CV death(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))(Up to 51 months)
- Occurrences of all-cause hospitalisations (first and recurrent)(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(Up to 51 months)
- Time to all-cause death(Up to 51 months)
- Time to CV death(Up to 51 months)
- Time to first HHF(Up to 51 months)
- Time to first event of new-onset HF or CV death(Up to 51 months)
- Occurrences of HHF (first and recurrent)(Up to 51 months)
- Absolute change from baseline in mean diastolic blood pressure (DBP) [mmHg] at Week 24(At baseline and week 24)