- Overview:
- This global study evaluates the effectiveness of combining an investigational medicine with empagliflozin in reducing serious heart health events.
- Staus:
- Enrolling
- Clinical Description:
- This study is a global clinical study called EASi-PROTKT™ that aims to find out whether combining an investigational medicine with an approved medicine called empagliflozin could help people reduce their risk of developing serious heart health events, including heart failure, in the future. If you’re eligible and choose to join, you’ll be randomly assigned to one of two groups. GROUP 1: You’ll be given the investigational medicine and empagliflozin daily. GROUP 2: You’ll be given a placebo (a tablet that looks like the investigational medicine but contains no active medicine) and empagliflozin daily. You’ll be asked to take your assigned study medicines as two oral tablets daily.
- Target Age/Sex:
- Male & Female: Individuals who have been diagnosed with high blood pressure, type 2 diabetes, and cardiovascular disease (and are taking medicine for all three conditions).
- Benefits:
- Your health and well-being will be closely monitored throughout the study with scheduled clinic visits and telephone calls. Health assessments will include: physical examinations, electrocardiograms (ECGs), and blood and urine samples. This health monitoring, along with the study medicines, will be provided at no cost to you, regardless of your insurance status. You may receive reimbursement for accommodation and travel costs, in line with local regulations.
- Study Length:
- 2.5 – 4.25 years
