Overview

Double Blind Placebo Study of JARDIANCE® (Empagliflozin) in Prehypertensives Type II Diabetics

Status:
Unknown status

Trial end date:
2020-01-01

Target enrollment:
0

Participant gender:
All

Summary

Objectives: Primary 1. Primary prevention of new onset of hypertension Secondary 1. Reduction of 24h BP in type II diabetics with prehypertension 2. Reduction of non dipping status, day and nighttime BP, morning BP surge in subjects receiving EMPAGLIFLOZIN 3. Reduction in the total cardiovascular risk 4. 3 years morbidity and mortality rates 5. Arterial de-stiffening, reduction in central aortic blood pressure in subjects receiving EMPAGLIFLOZIN

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Aristotle University Of Thessaloniki

Treatments:

Empagliflozin
Metformin

Criteria

Inclusion criteria

1. Age between 45 and 65 years.

2. All patients are going to give their informed consent to participate in the study.

3. Patients who are not receiving antihypertensive or diabetes treatment (newly diagnosed
diabetics)

4. BP between 130 to 140 mmHg for systolic BP (prehypertensives)

5. Type II diabetes (HbA1c 7.0-8.0)

Exclusion criteria

1. Known oversensitiveness

2. chronic renal disease (GFR<60 ml/min) or ESRD

3. heart or respiratory failure, recent MI, shock

4. pregnancy or lactation.