2025-521188-11-00招募中3 期
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
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.365 个研究点 分布在 5 个国家目标入组 4,386 人开始时间: 2025年9月24日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 4,386
- 试验地点
- 365
- 主要终点
- Time to first event of CV death or HFE (defined as HHF or urgent HF visit)
研究概览
简要总结
The primary objective is to demonstrate the superiority of the combination of vicadrostat and empagliflozin compared with vicadrostat-placebo and empagliflozin for the time to first CV death, HHF, or urgent HF visit in participants with T2DM, HTN and established CVD.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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
- •Male or female participants. WOCBP (see Section 4.2.2.3) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
- •Participants with medical history of hypertension and on active pharmacological treatment according to best possible SOC in accordance with applicable local/international guidelines (according to the judgment of the investigator)
- •Participants with medical history of T2DM and on active pharmacological treatment according to best possible SOC in accordance with applicable local/international guidelines (according to the judgment of the investigator)
- •Established CV disease and on active pharmacological treatment according to best possible SOC in accordance with applicable local/international guidelines (according to the judgment of the investigator).
- •At least one additional risk factor for developing 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 bpm documented by ECG at Visit 1 (screening)
- •Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)
- •Treatment with an 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: o A direct renin inhibitor (e.g. aliskiren) o More than one ACEi and/or ARB (including ARNi) used simultaneously o Other aldosterone synthase inhibitors (e.g. baxdrostat) o Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone)
- •Further exclusion criteria apply.
结局指标
主要结局
Time to first event of CV death or HFE (defined as HHF or urgent HF visit)
Time to first event of CV death or HFE (defined as HHF or urgent HF visit)
次要结局
- Time to first event of CV death or HHF
- Absolute change from baseline in mean SBP [mmHg] at Week 24
- Relative change from baseline in UACR [mg/g] at Week 24
- Time to first occurrence of the composite outcome of kidney disease progression, HHF, CV death
- Time to first event of CV death, HFE, non-fatal MI or non-fatal stroke (4-point MACE)
- Occurrences of all-cause hospitalisations (first and recurrent)
- 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
- Time to all-cause death
- Time to CV death
- Time to first HHF
- Time to first event of new-onset HF or CV death
- Occurrences of HHF (first and recurrent)
- Absolute change from baseline in mean DBP [mmHg] at Week 24
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (365)
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