Azilsartan Medoxomil in Hypertensive pAtients With Stable Ischemic Heart Disease and DiabEtes MEllitus. (AcADEME)
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|ClinicalTrials.gov Identifier: NCT03539627|
Recruitment Status : Not yet recruiting
First Posted : May 28, 2018
Last Update Posted : May 28, 2018
|Condition or disease||Intervention/treatment|
|Arterial Hypertension Diabetes Mellitus Stable Chronic Angina||Drug: Azilsartan Medoxomil 40 MG Oral Tablet [Edarbi]|
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.
During the study 5 visits to the research center are planned. At each visit, a physical examination, sampling of bio-samples for evaluation in the local laboratory, and collection of information on adverse events will be performed. 24-hours monitoring of blood pressure will be performed at screening, after 1 months of therapy and at the final visit (6 months of therapy).
Data will be collected during 5 consecutive visits to the research center. The observation period will be about 6 months, the active treatment period will be at least 6 months (24 weeks). Patients included in the study will be observed in an outpatient clinic according to the local practice of the research center.
It is planned that potentially eligible patients will be invited to the screening visit. Based on the results of daily monitoring of blood pressure, a final decision will be made about the suitability of the patient to participate in the study. Patients who have not reached the target values of blood pressure will start taking the study drug (Edarbi). By not achieving the target values of blood pressure, the mean daily systolic blood pressure is more than 130 mm Hg and the diastolic blood pressure is more than 90 mm Hg. The length of time between Visit 1 and Visit 2 is suspected to be no longer than 2 weeks.
All examinations (examination and evaluation of vital functions, laboratory tests, instrumental examinations) will be performed in accordance with the general standards of medical practice and in accordance with the routine practice of the institution.
Based on the number of patients hospitalized in the Research Institute For Complex Issues Of Cardiovascular Diseases (1500 patients), as well as the data on the prevalence of type 2 diabetes in this group (23.5%, 353 patients), the required sample size will be 184 patients (Confidence interval ± 5 %, the confidence probability is 95%).
SS = Z2 * (p) * (1-p) C2 where: Z = Z factor (1,96 for 95% confidence interval) p = percentage of respondents required, in decimal form (0,5 by default) c = confidence interval, in decimal form (for example, 0,04 = ±4%).
|Study Type :||Observational|
|Estimated Enrollment :||184 participants|
|Official 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.|
|Estimated Study Start Date :||July 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
patients with hypertension, CAD and diabetes
Patients with hypertension associated with stable CAD and diabetes on azilsartan medoxomil (Edarbi) therapy
Drug: Azilsartan Medoxomil 40 MG Oral Tablet [Edarbi]
patients are to receive azilsartan medoxomil
- Systolic blood pressure [ Time Frame: interval: up to 24 weeks ]Dynamics of clinical SBP from the baseline against the background of therapy with Edarbi®
- Diastolic blood pressure [ Time Frame: interval: up to 24 weeks ]Dynamics of clinical DBP from the baseline against the background of therapy with Edarbi® (interval: Visit of inclusion - Visit 5);
- Dynamics of renal function (filtration) [ Time Frame: interval: up to 24 weeks ]Dynamics of eGFR
- Edarbi® efficacy [ Time Frame: interval: up to 24 weeks ]proportion of patients who respond to Edarbi® therapy (defined as decrease of SBP≥ 20 mm Hg or decrease of DBP≥10 mm Hg)
- Dynamics of renal function (evidence of kidney injury) [ Time Frame: interval: up to 24 weeks ]N-GAL-dynamics
- Dynamics of renal function (proteinuria detecton) [ Time Frame: interval: up to 24 weeks ]UACR dynamics
Biospecimen Retention: Samples Without DNA