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Clinical Trial Details

Trial ID: L2842
Source ID: NCT03592667
Associated Drug: Dapagliflozin
Title: Dapagliflozin on Blood Pressure Variability and Ambulatory Arterial Stiffness Index in Hypertension
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Hypertension
Interventions: DRUG: Dapagliflozin|DRUG: Placebo - Cap
Outcome Measures: Primary: Indices of blood pressure: 24 h, daytime and night-time SD and CV, 24 h weighted SD, day-to-nigth BP changes and ARV, Blood pressure variability will be evaluated with ambulatory blood pressure monitoring, Baseline to Week 12|Ambulatory arterial stiffness index, Arterial stiffness will be evaluated with ambulatory blood pressure monitoring, Baseline to Week 12 | Secondary: Pulse Pressure of 24 h, Will be evaluated with ambulatory blood pressure monitoring, systolic BP minus diastolic BP., Baseline to Week 12|Mean arterial pressure of 24 h, daytime and nigth-time, Will be evaluated with ambulatory blood pressure monitoring, systolic BP minus diastolic BP/3, plus diastolic BP., Baseline to Week 12|Heart rate of 24 h, daytime and nigth-time, Will be evaluated with ambulatory blood pressure monitoring., Baseline to Week 12|Hypertensive load daytime and nigth-time, Will be evaluated with ambulatory blood pressure monitoring., Baseline to Week 12|White coat hypertension, will be evaluated with ambulatory blood pressure monitoring, Baseline to Week 12|Fasting glucose levels, The fasting glucose levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12., Baseline to Week 12|Total cholesterol, Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12, Baseline to Week 12|Triglycerides levels, Triglycerides levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12, Baseline to Week 12|High density lipoprotein (c-HDL) levels, c-HDL levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12, Baseline to Week 12|Creatinine levels, Creatinine levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques, Baseline to Week 12|Uric acid levels, Uric acid levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques, Baseline to Week 12|Body Weight, The body weight will be measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the body weight at week 12, Baseline, week 4, week 8 and week 12|Body Mass Index, Body Mas Index will be calculated at baseline, week 4, week 8 and week 12 with the Quetelet index formula and the entered values reflect the body mass index at week 12, Baseline, week 4, week 8 and week 12|Waist circumference, Waist circumference will be evaluated with the method proposed by ISAK., Baseline, week 4, week 8 and week 12|Glomerular filtration rate, Glomerular filtration rate will be calculated at baseline and week 12 with the Cockcroft-Gault formula and the entered values reflect the Glomerular filtration rate at week 12, Baseline to Week 12
Sponsor/Collaborators: Sponsor: University of Guadalajara
Gender: ALL
Age: ADULT
Phases: PHASE4
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2019-02-14
Completion Date: 2021-07
Results First Posted:
Last Update Posted: 2020-12-28
Locations: Instituto de TerapeĂștica Experimental y ClĂ­nica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara, Guadalajara, Jalisco, 44340, Mexico
URL: https://clinicaltrials.gov/show/NCT03592667