| Trial ID: | L2055 |
| Source ID: | NCT03539627
|
| Associated Drug: |
Azilsartan Medoxomil 40 Mg Oral Tablet [Edarbi]
|
| Title: |
Azilsartan Medoxomil in Hypertensive pAtients With Stable Ischemic Heart Disease and DiabEtes MEllitus.
|
| Acronym: |
AcADEME
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Arterial Hypertension|Diabetes Mellitus|Stable Chronic Angina
|
| Interventions: |
DRUG: Azilsartan Medoxomil 40 MG Oral Tablet [Edarbi]
|
| Outcome Measures: |
Primary: Systolic blood pressure, Dynamics of clinical SBP from the baseline against the background of therapy with Edarbi®, interval: up to 24 weeks | Secondary: Diastolic blood pressure, Dynamics of clinical DBP from the baseline against the background of therapy with Edarbi® (interval: Visit of inclusion - Visit 5);, interval: up to 24 weeks|Dynamics of renal function (filtration), Dynamics of eGFR, interval: up to 24 weeks|Edarbi® efficacy, proportion of patients who respond to Edarbi® therapy (defined as decrease of SBP≥ 20 mm Hg or decrease of DBP≥10 mm Hg), interval: up to 24 weeks|Dynamics of renal function (evidence of kidney injury), N-GAL-dynamics, interval: up to 24 weeks|Dynamics of renal function (proteinuria detecton), UACR dynamics, interval: up to 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
184
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2018-11-07
|
| Completion Date: |
2022-04-29
|
| Results First Posted: |
|
| Last Update Posted: |
2022-10-26
|
| Locations: |
Anastasia Kochergina, Kemerovo, 650002, Russian Federation
|
| URL: |
https://clinicaltrials.gov/show/NCT03539627
|
