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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Systolic blood pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed by the patient.
- •Men and women aged 18 years and older with a previously diagnosed hypertension and type 2 diabetes mellitus and stable ischemic heart disease.
- •Stable therapy of hypertension, T2DM and ischemic heart disease for at least 12 weeks before screening.
- •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.
- •Investigator's decision on the advisability of correction of previously prescribed therapy with the replacement of ACE inhibitors or other ARBs with azilsartan medoxomil.
排除标准
- •Contraindications to the azilsartan medoxomil in accordance with instruction for use, including information on the individual intolerance of the drug.
- •Any circumstances in the opinion of the investigator that interfere with the participation of the patient in the study.
- •The patient included in the study is an employee of the center or a relative of the investigator.
- •Participation in other clinical trials. Participation in register studies is allowed.
- •Any disease or condition that leads to a decrease in the patient's life expectancy.
研究组 & 干预措施
patients with hypertension, CAD and diabetes
Patients with hypertension associated with stable CAD and diabetes on azilsartan medoxomil (Edarbi) therapy
干预措施: Azilsartan Medoxomil 40 MG Oral Tablet [Edarbi] (Drug)
结局指标
主要结局
Systolic blood pressure
时间窗: interval: up to 24 weeks
Dynamics of clinical SBP from the baseline against the background of therapy with Edarbi®
次要结局
- Diastolic blood pressure(interval: up to 24 weeks)
- Dynamics of renal function (proteinuria detecton)(interval: up to 24 weeks)
- Dynamics of renal function (evidence of kidney injury)(interval: up to 24 weeks)
- Dynamics of renal function (filtration)(interval: up to 24 weeks)
- Edarbi® efficacy(interval: up to 24 weeks)
研究者
Olga Barbarash
Professor
Research Institute for Complex Problems of Cardiovascular Diseases, Russia