An observational study in Arterial Hypertension, Diabetes Mellitus and Stable Chronic Angina, sponsored by Research Institute for Complex Problems of Cardiovascular Diseases, Russia. Completed at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-26.
Sponsored by Research Institute for Complex Problems of Cardiovascular Diseases, Russia · Observational
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.
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%).
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 184 is below the median of 210 across 1,359 observational studies indexed under Hypertension.
Browse Hypertension studies →Research Institute for Complex Problems of Cardiovascular Diseases, Russia is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with arterial hypertension associated with stable ischemic heart disease and type 2 diabetes mellitus
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.
Exclusion Criteria:
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
Dynamics of clinical SBP from the baseline against the background of therapy with Edarbi®
Time frame: interval: up to 24 weeks
Diastolic blood pressure
Dynamics of clinical DBP from the baseline against the background of therapy with Edarbi® (interval: Visit of inclusion - Visit 5);
Time frame: interval: up to 24 weeks
Dynamics of renal function (filtration)
Dynamics of eGFR
Time frame: 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)
Time frame: interval: up to 24 weeks
Dynamics of renal function (evidence of kidney injury)
N-GAL-dynamics
Time frame: interval: up to 24 weeks
Dynamics of renal function (proteinuria detecton)
UACR dynamics
Time frame: interval: up to 24 weeks
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Research Institute for Complex Problems of Cardiovascular Diseases, Russia