Diabetes Mellitus Clinical Trial
— AcADEMEOfficial title:
One-center, Observational, Non-interventional, Prospective Study of the Efficacy of Azilsartan Medoxomil in Patients With Arterial Hypertension Associated With Stable Ischemic Heart Disease and Type 2 Diabetes Mellitus.
One-center, observational, non-interventional, prospective study of the efficacy of azilsartan medoxomil in patients with arterial hypertension associated with stable ischemic heart disease and type 2 diabetes mellitus.
Status | Completed |
Enrollment | 184 |
Est. completion date | April 29, 2022 |
Est. primary completion date | April 29, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Informed consent signed by the patient. 2. Men and women aged 18 years and older with a previously diagnosed hypertension and type 2 diabetes mellitus and stable ischemic heart disease. 3. Stable therapy of hypertension, T2DM and ischemic heart disease for at least 12 weeks before screening. 4. Not achievement of target values * of blood pressure against the background of previously prescribed and steadily accepted antihypertensive therapy. * not reaching the target figures of arterial pressure means mean systolic blood pressure more than 130 mm Hg and / or an average diastolic blood pressure more than 90 mmHg. 5. Investigator's decision on the advisability of correction of previously prescribed therapy with the replacement of ACE inhibitors or other ARBs with azilsartan medoxomil. Exclusion Criteria: 1. Contraindications to the azilsartan medoxomil in accordance with instruction for use, including information on the individual intolerance of the drug. 2. Any circumstances in the opinion of the investigator that interfere with the participation of the patient in the study. 3. The patient included in the study is an employee of the center or a relative of the investigator. 4. Participation in other clinical trials. Participation in register studies is allowed. 5. Any disease or condition that leads to a decrease in the patient's life expectancy. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Anastasia Kochergina | Kemerovo |
Lead Sponsor | Collaborator |
---|---|
Research Institute for Complex Problems of Cardiovascular Diseases, Russia |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | |
Secondary | Dynamics of renal function (filtration) | Dynamics of eGFR | interval: up to 24 weeks | |
Secondary | 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 | |
Secondary | Dynamics of renal function (evidence of kidney injury) | N-GAL-dynamics | interval: up to 24 weeks | |
Secondary | Dynamics of renal function (proteinuria detecton) | UACR dynamics | interval: up to 24 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03743779 -
Mastering Diabetes Pilot Study
|
||
Completed |
NCT03786978 -
Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus
|
N/A | |
Completed |
NCT01804803 -
DIgital Assisted MONitoring for DiabeteS - I
|
N/A | |
Completed |
NCT05039970 -
A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT04068272 -
Safety of Bosentan in Type II Diabetic Patients
|
Phase 1 | |
Completed |
NCT03243383 -
Readmission Prevention Pilot Trial in Diabetes Patients
|
N/A | |
Completed |
NCT03730480 -
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
|
N/A | |
Recruiting |
NCT02690467 -
Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
|
N/A | |
Completed |
NCT02229383 -
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
|
Phase 3 | |
Completed |
NCT06181721 -
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
|
N/A | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Recruiting |
NCT04489043 -
Exercise, Prediabetes and Diabetes After Renal Transplantation.
|
N/A | |
Withdrawn |
NCT03319784 -
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
|
Phase 4 | |
Completed |
NCT03542084 -
Endocrinology Auto-Triggered e-Consults
|
N/A | |
Completed |
NCT02229396 -
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
|
Phase 3 | |
Recruiting |
NCT05544266 -
Rare and Atypical Diabetes Network
|
||
Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
Completed |
NCT05031000 -
Blood Glucose Monitoring Systems: Discounter Versus Brand
|
N/A | |
Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A |