| Trial ID: | L4149 |
| Source ID: | NCT03887416
|
| Associated Drug: |
Dapagliflozin 10 Mg Oral Tablet [Farxiga]
|
| Title: |
Effect of Dapagliflozin on Nighttime Blood Pressure in Type 2 Diabetes
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type2 Diabetes
|
| Interventions: |
DRUG: Dapagliflozin 10 MG Oral Tablet [Farxiga]|DRUG: Placebo Oral Tablet
|
| Outcome Measures: |
Primary: Changes in nighttime blood pressure, Changes in mean nighttime blood pressure (systolic and diastolic) between baseline and last visit (units: mmHg), 12 weeks | Secondary: Changes in office blood pressure. Both systolic and diastolic blood pressure will be assessed, Changes in office blood pressure. Both systolic and diastolic blood pressure will be assessed (units: mmHg), 12 weeks|Changes in albuminuria, Changes in albuminuria (units:mg/g creatinine), 12 weeks|Changes in HBA1C, Changes in HBA1C (units: %), 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: LM Diagnósticos S.L. | Collaborators: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
225
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-04-12
|
| Completion Date: |
2020-02
|
| Results First Posted: |
|
| Last Update Posted: |
2019-09-03
|
| Locations: |
Hospital Clínico San Carlos, Madrid, 28040, Spain|Hospital Universitario 12 de Octubre, Madrid, 28041, Spain|Hospital Universitario La Paz, Madrid, 28046, Spain
|
| URL: |
https://clinicaltrials.gov/show/NCT03887416
|
