| Trial ID: | L6342 |
| Source ID: | NCT03089333
|
| Associated Drug: |
Dapagliflozin 10mg
|
| Title: |
Effects of SGLT2 Inhibitor on Hemodynamic Parameters in Resistant Hypertensive Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hypertension|Diabetes Mellitus, Type 2|Blood Pressure|Obesity|Cardiac Hypertrophy|Microalbuminuria|Vascular Stiffness
|
| Interventions: |
DRUG: Dapagliflozin 10mg|DRUG: Glibenclamide 5Mg Tablet
|
| Outcome Measures: |
Primary: Change in Systolic Blood Pressure, Change in Office Systolic Blood Pressure after 12 weeks of treatment, Baseline and 12 weeks | Secondary: Change in Ambulatory Systolic Blood Pressure, Change in Ambulatory Systolic Blood Pressure after 12 weeks of treatment, Baseline and 12 weeks|Change in weight, Change in body weight, Baseline and 12 weeks|Change in arterial stiffness, Change in arterial stiffness measured by Sphygmocor device, Baseline and 12 weeks|Change in left ventricular hypertrophy, Change in left ventricular hypertrophy measured by Echocardiogram, Baseline and 12 weeks|Change in microalbuminuria, Change in microalbuminuria measured by Urine Albumin/Creatinine Ratio, Baseline and 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: University of Campinas, Brazil | Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
16
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-07
|
| Completion Date: |
2017-12
|
| Results First Posted: |
|
| Last Update Posted: |
2018-05-08
|
| Locations: |
University of Campinas (UNICAMP), Campinas, São Paulo, 13083970, Brazil
|
| URL: |
https://clinicaltrials.gov/show/NCT03089333
|