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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
11,800
Pinnacle Research Group, LLC
Anniston, Alabama, United States
RECRUITINGEastern Shore Research Group
Fairhope, Alabama, United States
RECRUITINGLakeview Clinical Research
Guntersville, Alabama, United States
NOT_YET_RECRUITINGArizona Clinical Trials - Chandler
Chandler, Arizona, United States
Time to first event of cardiovascular (CV) death or heart failure event (HFE)
Time frame: Up to 51 months
Time to first event of cardiovascular (CV) death or hospitalisation for heart failure (HHF)
Time frame: Up to 51 months
Absolute change from baseline in mean systolic blood pressure (SBP) [mmHg] at Week 24
Time frame: At baseline and week 24
Relative change from baseline in Urine Albumin Creatinine Ratio (UACR) [mg/g] at Week 24
Time frame: At baseline and week 24
Time to first occurrence of the composite outcome of kidney disease progression, HHF, CV death
Time frame: 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))
Time frame: Up to 51 months
Occurrences of all-cause hospitalisations (first and recurrent)
Time frame: 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
Time frame: Up to 51 months
Time to all-cause death
Time frame: Up to 51 months
Time to CV death
Time frame: Up to 51 months
Time to first HHF
Time frame: Up to 51 months
Time to first event of new-onset HF or CV death
Time frame: Up to 51 months
Occurrences of HHF (first and recurrent)
Time frame: Up to 51 months
Absolute change from baseline in mean diastolic blood pressure (DBP) [mmHg] at Week 24
Time frame: At baseline and week 24
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Elite Clinical Studies
Phoenix, Arizona, United States
RECRUITINGClinical Research Institute of Arizona, LLC
Sun City West, Arizona, United States
RECRUITINGFiel Family & Sports Medicine
Tempe, Arizona, United States
NOT_YET_RECRUITINGArizona Clinical Trials
Tucson, Arizona, United States
NOT_YET_RECRUITINGYuma Clinical Trials
Yuma, Arizona, United States
RECRUITINGNational Heart Institute - Beverly Hills
Beverly Hills, California, United States
RECRUITING...and 1144 more locations