Status:
UNKNOWN
Double Blind Placebo Study of JARDIANCE® (Empagliflozin) in Prehypertensives Type II Diabetics
Lead Sponsor:
Aristotle University Of Thessaloniki
Conditions:
Hypertension
Type II Diabetes
Eligibility:
All Genders
45-65 years
Phase:
PHASE4
Brief 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 night...
Detailed Description
Study rationale: The majority of patients with diabetes are having higher blood pressure than optimal. More than 30% of patients with type II diabetes are prehypertensives with systolic blood pressure...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Age between 45 and 65 years.
- All patients are going to give their informed consent to participate in the study.
- Patients who are not receiving antihypertensive or diabetes treatment (newly diagnosed diabetics)
- BP between 130 to 140 mmHg for systolic BP (prehypertensives)
- Type II diabetes (HbA1c 7.0-8.0)
- Exclusion criteria
- Known oversensitiveness
- chronic renal disease (GFR\<60 ml/min) or ESRD
- heart or respiratory failure, recent MI, shock
- pregnancy or lactation.
Exclusion
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2020
Estimated Enrollment :
1054 Patients enrolled
Trial Details
Trial ID
NCT01001962
Start Date
January 1 2016
End Date
January 1 2020
Last Update
April 7 2015
Active Locations (1)
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1
Hypertension 24h ABPM center Papageorgiou Hospital
Thessaloniki, Greece