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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2015 by Aristotle University Of Thessaloniki
Sponsor:
Information provided by (Responsible Party):
Vasilios Kotsis, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01001962
First received: October 26, 2009
Last updated: April 6, 2015
Last verified: April 2015
  Purpose

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

Condition Intervention Phase
Hypertension
Type II Diabetes
Drug: empagliflozin
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Double Blind Comparison Study of JARDIANCE® (Empagliflozin) in Prehypertensives Type II Diabetics With Metformin

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • New onset of hypertension [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 24h blood pressure levels [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Total cardiovascular risk [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Morbidity cardiovascular [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Arterial stiffness [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Central aortic blood pressure [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Mortality cardiovascular [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1054
Study Start Date: January 2016
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin
527 Patients treated with Metformin 850x2mg titrated to 1000x2mg Daily oral
Drug: Metformin
ACTIVE TREATMENT FOR DIABETES
Other Name: GLUCOPHAGE
Active Comparator: Empagliflozin
527 Patients treated with empagliflozin 10mg titrated to 25 mg Daily oral
Drug: empagliflozin
ACTIVE TREATMENT FOR DIABETES
Other Name: JARDIANCE

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001962

Contacts
Contact: VASILEIOS KOTSIS, PROF +306974748860 vkotsis@auth.gr

Locations
Greece
Hypertension 24h ABPM center Papageorgiou Hospital Not yet recruiting
Thessaloniki, Greece
Contact: VASILEIOS KOTSIS, PROF         
Principal Investigator: VASILEIOS KOTSIS, PROF         
Sponsors and Collaborators
Aristotle University Of Thessaloniki
  More Information

No publications provided

Responsible Party: Vasilios Kotsis, Prof. Med, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT01001962     History of Changes
Other Study ID Numbers: PREHYPERTENSION
Study First Received: October 26, 2009
Last Updated: April 6, 2015
Health Authority: Greece: Ethics Committee

Keywords provided by Aristotle University Of Thessaloniki:
Hypertension in type II diabetes
Cardiovascular morbidity and mortality

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 29, 2015