International Multicentre, Observational, Non-Interventional Prospective Study of Azilsartan Medoxomil in Patients With Arterial Hypertension Who Are Overweight or Obese in the Russian Federation and The Republic of Kazakhstan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,945
- 试验地点
- 65
- 主要终点
- Change From Baseline in Clinic Systolic Blood Pressure (SBP) at Month 6
研究概览
简要总结
The purpose of this study is to estimate antihypertensive effect of azilsartan medoxomil (Edarbi®) therapy on blood pressure in participants with overweight or obesity in routine clinical practice of hypertension (HTN) treatment in the Russian Federation and in the Republic of Kazakhstan..
详细描述
The drug being tested in this study is called azilsartan medoxomil (Edarbi®). Azilsartan medoxomil is being tested to treat people who have hypertension. This study looks at the clinic systolic and diastolic blood pressure (SBP, DBP) in obese participants who were prescribed azilsartan medoxomil by physicians.
The study enrolled 1945 patients. All participants were asked to take azilsartan medoxomil as prescribed by their physician according to local SmPC.
This multi-center trial was conducted in the Russian Federation and the Republic of Kazakhstan. The overall duration of study for observation was approximately 6 months. Participants made multiple visits to the clinics as assigned by each physician according to their routine practice, in every 3 months.
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
- •Male and female participants ≥ 18 years of age with hypertension 1-2 grade.
- •Participants with:
- •newly diagnosed arterial HTN or
- •inadequately controlled previously prescribed monotherapy with Renin-Angiotensin-Aldosterone System (RAAS) blocker or
- •inadequately controlled previously prescribed combination therapy with RAAS blocker + diuretic or RAAS blocker + calcium antagonist.
- •The physician decides to prescribe Edarbi®
- •as monotherapy or
- •as a part of combination therapy including diuretics or calcium antagonists;
- •Overweight or obesity of any degree (body mass index> 25 kg/m^2);
- •Is capable of understanding the written informed consent, provides signed and written informed consent, and agrees to comply with protocol requirements. In case the participant is blind or unable to read, informed consent will also be witnessed.
排除标准
- •Confirmed secondary HTN;
- •Contraindications for Edarbi® of respective approved local summary of product characteristics (SmPC) of Edarbi®;
- •Any reasons of medical and non-medical character, which in the opinion of the physician can prevent participant participation in the study.
- •Is an employee or family member of the investigator or study site personnel.
- •Is currently participating in a clinical trial. Participation in non-interventional registries is permitted.
研究组 & 干预措施
Azilsartan Medoxomil
Overweight or obese participants with hypertension who received azilsartan medoxomil tablets, orally, as prescribed by physician according to local summary of product characteristics (SmPC) were observed for approximately 6 months.
干预措施: Azilsartan Medoxomil (Drug)
结局指标
主要结局
Change From Baseline in Clinic Systolic Blood Pressure (SBP) at Month 6
时间窗: Baseline and Month 6
The change in clinic sitting SBP measured at Month 6 relative to baseline.
次要结局
- Percentage of Participants Who Achieved Target Blood Pressure (BP) SBP<140 mm Hg and DBP<90 mm Hg(Month 6)
- Percentage of Participants With Response at Month 6(Month 6)
- Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6(Month 6)
- Change From Baseline in Clinic Diastolic Blood Pressure (DBP) at Month 6(Baseline and Month 6)
- Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at Month 6(Baseline and Month 6)
- Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6(Baseline and Month 6)