Study to Asses the Effect of Dapagliflozin on Central Blood Pressure Reduction.

Sponsor
IInstituto Gallego de Medicina Vascular
Study ID
NCT02919059
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 mg — DRUG
    Dagliflozin will be administred once daily before the first meal of the day for the duration of the study or until early discontinuation. Subjects will take the first dose of study drug at the study centre on Day 1. On the day of study visits when fasting blood samples are collected, subjects will be instructed to refrain from taking the study drug before the clinic visit. The subject will be instructed to take the dose of study drug before the subject´s next meal. The study drug must be swallowed whole with liquid and not chewed, divided, dissolved or crushed. If the subject doesn´t take the study drug within 12 hours after the first meal of the day, the dose of the study drug should be skipped for that day and keep on taking the study drug on the following day before the first meal.
  • Glimepiride 4 mg — DRUG
    Glimepiride will be administred once daily before the first meal of the day for the duration of the study or until early discontinuation. Subjects will take the first dose of study drug at the study centre on Day 1. On the day of study visits when fasting blood samples are collected, subjects will be instructed to refrain from taking the study drug before the clinic visit. The subject will be instructed to take the dose of study drug before the subject´s next meal. The study drug must be swallowed whole with liquid and not chewed, divided, dissolved or crushed. If the subject doesn´t take the study drug within 12 hours after the first meal of the day, the dose of the study drug should be skipped for that day and keep on taking the study drug on the following day before the first meal.

Study Details

This superiority of central pressure versus peripheral measures to predict cardiovascular events has also been reported in general population or in elder people

Key Dates

Start date
Dec 13, 2016
Status verified
Mar 2017
Primary completion
Dec 31, 2018
Completion
Aug 31, 2019

Study Design

Enrollment
159 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin 10 mg
    Dapagliflozin 10 mg once daily during 24 weeks
  • Active Comparator: Glimepiride 4 mg
    Glimepiride 4 mg once daily during 24 weeks

Primary Outcome Measure

Effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period regarding central systolic blood pressure [ Time Frame: 24 weeks ]

Central Contacts

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