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Clinical Trials List

Protocol Number1378-0041
NCT Number(ClinicalTrials.gov Identfier)NCT07064473
Active

2025-10-01 - 2030-06-30

Recruiting13

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

  • Trial Applicant

    Boehringer Ingelheim

  • Sponsor

    Boehringer Ingelheim Taiwan Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/10/19

Investigators and Locations

Principal Investigator JUN-SING WANG Division of Endocrinology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yen-Wen Wu Division of Cardiovascular Diseases
Far Eastern Memorial Hospital

Co-Principal Investigator

  • 林恆旭 Division of Cardiovascular Diseases
  • 張藝耀 Division of Cardiovascular Diseases
  • 許榮城 Division of Cardiovascular Diseases
  • 曾炳憲 Division of Cardiovascular Diseases
  • 黃繼正 Division of Cardiovascular Diseases
  • 蔡浩元 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Yao Huang Division of Cardiovascular Diseases
Taipei Medical University Hospital

Co-Principal Investigator

  • 洪元 Division of Cardiovascular Diseases
  • Chien-Yi Hsu Division of Cardiovascular Diseases
  • Yung-Ta Kao Division of Cardiovascular Diseases
  • 陳志維 Division of Cardiovascular Diseases
  • 陳彥舟 Division of Cardiovascular Diseases
  • 鄭宇倫 Division of Cardiovascular Diseases
  • 蕭卜源 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ting-Hsing Chao Division of Cardiovascular Diseases
Chung Shan Medical University Hospital

Co-Principal Investigator

  • 翁國昌 Division of Cardiovascular Diseases
  • 莊曜聰 Division of Cardiovascular Diseases
  • 楊宗元 Division of Cardiovascular Diseases
  • 詹貴川 Division of General Internal Medicine
  • 蔡青峰 Division of Cardiovascular Diseases
  • 蕭文智 Division of Cardiovascular Diseases
  • 蘇峻弘 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHO-KAI WU Division of Cardiovascular Diseases
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 洪崇烈 Division of Cardiovascular Diseases
MacKay Memorial Hospital

Co-Principal Investigator

  • 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
  • 簡世杰 Division of General Internal Medicine
  • 簡楨彥 Division of Cardiovascular Surgery
  • 藍偉仁 Division of Cardiovascular Diseases
  • 顏志軒 Division of General Internal Medicine
  • 陳冠廷 Division of Cardiovascular Diseases
  • 蔡憲岳 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 方志元 Division of Cardiovascular Diseases
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shih-Hsien Sung Division of Cardiovascular Diseases
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shih-Sheng Chang Division of General Internal Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsung-Hsien Lin Division of Cardiovascular Diseases
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
Chia-Yi Christian Hosptal

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator I-Chang Hsieh
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

  • 何明昀 Division of Cardiovascular Diseases
  • 陳東藝 Division of Cardiovascular Diseases
  • 葉日凱 Division of Cardiovascular Diseases
  • 謝明哲 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Diabetes Mellitus, Type 2 Hypertension Cardiovascular Diseases

Objectives

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.

Test Drug

BI 690517 (Vicadrostat) or matching placebo
Empagliflozin

Active Ingredient

BI 690517 (Vicadrostat) or matching placebo
6820401000

Dosage Form

film-coated tablet
film-coated tablet

Dosage

10 MG
10 mg

Endpoints

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

Inclution 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.

The Estimated Number of Participants

  • Taiwan

    95 participants

  • Global

    11800 participants

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