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

NCT01001962 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1054

Last updated 2015-04-07

No results posted yet for this study

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

Conditions

Interventions

DRUG

empagliflozin

ACTIVE TREATMENT FOR DIABETES

DRUG

Metformin

ACTIVE TREATMENT FOR DIABETES

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2019-01-31
Completion
2020-01-31

Countries

  • Greece

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01001962 on ClinicalTrials.gov