drugset / Trial / NCT01001962

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

NCT01001962

Phase 4 Unknown 1054 enrolled Aristotle University Of Thessaloniki
RandomizedParallel-groupTriple-blindPrevention

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

Timeline

Start
2016-01
Primary completion
2019-01
Completion
2020-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Empagliflozin Small molecule 25 mg Oral
Comparator Metformin Small molecule 1000 mg Oral