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NCT Number: NCT02756819

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

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..

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Central Clinical Hospital, Almaty, Kazakhstan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Azilsartan medoxomil

Drug

Azilsartan medoxomil tablets

Other names: Edarbi®

Primary outcomes

  1. Change From Baseline in Clinic Systolic Blood Pressure (SBP) at Month 6

    Time frame: Baseline and Month 6

    The change in clinic sitting SBP measured at Month 6 relative to baseline.

Secondary outcomes

  1. Change From Baseline in Clinic Diastolic Blood Pressure (DBP) at Month 6

    Time frame: Baseline and Month 6

    The change in clinic sitting DBP measured at Month 6 relative to baseline.

  2. Percentage of Participants With Response at Month 6

    Time frame: Month 6

    Response was defined as a decrease of SBP ≥20 mm Hg or a decrease of DBP ≥10 mm Hg.

  3. Percentage of Participants Who Achieved Target Blood Pressure (BP) SBP<140 mm Hg and DBP<90 mm Hg

    Time frame: Month 6

  4. Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6

    Time frame: 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.

  5. Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at Month 6

    Time frame: 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.

  6. Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 29, 2016
Registry last updated
Nov 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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