| Trial ID: | L7371 |
| Source ID: | NCT04602754
|
| Associated Drug: |
Berlim 25/20 Association
|
| Title: |
Efficacy and Safety of Berlim 25/20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Dyslipidemia Associated With Type II Diabetes Mellitus
|
| Interventions: |
DRUG: BERLIM 25/20 ASSOCIATION|OTHER: EMPAGLIFLOZIN PLACEBO|OTHER: ROSUVASTATIN CALCIUM PLACEBO|DRUG: EMPAGLIFLOZIN|DRUG: ROSUVASTATIN CALCIUM|OTHER: BERLIM 25/20 ASSOCIATION PLACEBO
|
| Outcome Measures: |
Primary: Reduction of glycated hemoglobin levels measured between the first visit and the last visit., 120 days|Percentual reduction of LDL-c levels measured between the first visit and the last visit., 120 days | Secondary: Incidence and severity of adverse events recorded during the study., 150 days
|
| Sponsor/Collaborators: |
Sponsor: EMS
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
228
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-12-01
|
| Completion Date: |
2025-08
|
| Results First Posted: |
|
| Last Update Posted: |
2024-02-16
|
| Locations: |
Allergisa, Campinas, São Paulo, Brazil
|
| URL: |
https://clinicaltrials.gov/show/NCT04602754
|
