International Multicenter, Observational, Non-Interventional Prospective Study of Azilsartan Medoxomil in Participants With Arterial Hypertension Who Are Overweight or Obese in the Russian Federation and The Republic of Kazakhstan

Completed

Conditions: Hypertension

Interventions: Drug: Azilsartan Medoxomil

Registration Number: NCT02756819

Lead Sponsor: Takeda

Brief Summary: 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..

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1945

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Azilsartan Medoxomil	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Clinic Systolic Blood Pressure (SBP) at Month 6	Baseline and Month 6	The change in clinic sitting SBP measured at Month 6 relative to baseline.

Secondary Outcome Measures

Name	Time	Method
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	Response was defined as a decrease of SBP ≥20 mm Hg or a decrease of DBP ≥10 mm Hg.
Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6	Month 6	Target BP was SBP\<140 mm Hg and DBP\<90 mm Hg. Subgroups included BMI, overweight, Obesity I (BMI 30-34.9), class II (BMI 35-39.9) and class III (BMI ≥ 40), impaired glucose tolerance (Yes/No), metabolic syndrome (Yes/No) and diabetes mellitus (Yes/No).
Change From Baseline in Clinic Diastolic Blood Pressure (DBP) at Month 6	Baseline and Month 6	The change in clinic sitting DBP measured at Month 6 relative to baseline.
Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at Month 6	Baseline and Month 6	The change in clinic sitting DBP measured at Month 6 relative to baseline. Subgroups included overweight, obesity I (basic metabolic rate \[BMI\] 30-34.9), class II (BMI 35-39.9) and class III (BMI ≥ 40), impaired glucose tolerance, normal glucose metabolism, diabetes mellitus (Yes/No), metabolic syndrome, neither diabetes mellitus nor metabolic syndrome.
Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6	Baseline and Month 6	The change in clinic sitting SBP measured at Month 6 relative to baseline. Subgroups included overweight, obesity I (basic metabolic rate \[BMI\] 30-34.9), class II (BMI 35-39.9) and class III (BMI ≥ 40), impaired glucose tolerance, normal glucose metabolism, diabetes mellitus (Yes/No), metabolic syndrome, neither diabetes mellitus (DM) nor metabolic syndrome.

Trial Locations

Locations (65): JSC Central Clinical hospital
🇰🇿
Almaty, Kazakhstan
Research Institute of Cardiology and Internal Diseases
🇰🇿
Almaty, Kazakhstan
Kazakh Medical University of Continuing Education
🇰🇿
Almaty, Kazakhstan
Central Clinical Hospital
🇰🇿
Almaty, Kazakhstan
National Scientific center of oncology and transpontology
🇰🇿
Astana, Kazakhstan
Karaganda State Medical Academy
🇰🇿
Karaganda, Kazakhstan
Semipalatinsk State Medical Academy
🇰🇿
Semey, Kazakhstan
Altay regional cardiological center
🇷🇺
Barnaul, Russian Federation
Belgorod Regional Clinical Hospital of St. Joasaph
🇷🇺
Belgorod, Russian Federation
Bryansk Regional Cardiological center
🇷🇺
Bryansk, Russian Federation
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JSC Central Clinical hospital
🇰🇿Almaty, Kazakhstan