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

Takeda

Status: Completed

Conditions: Hypertension

Treatments: Drug: Azilsartan Medoxomil

Study type: Observational

Funder types: Industry

Identifiers

NCT02756819

Azilsmedox-5008

MACS-2014-100663 (Other Identifier)

Details and patient eligibility

About

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..

Full 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.

Enrollment: 1,945 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female participants ≥ 18 years of age with hypertension 1-2 grade.

2. 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.

3. The physician decides to prescribe Edarbi®

   • as monotherapy or
   • as a part of combination therapy including diuretics or calcium antagonists;

4. Overweight or obesity of any degree (body mass index> 25 kg/m^2);

5. 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

1. Confirmed secondary HTN;
2. Contraindications for Edarbi® of respective approved local summary of product characteristics (SmPC) of Edarbi®;
3. Any reasons of medical and non-medical character, which in the opinion of the physician can prevent participant participation in the study.
4. Is an employee or family member of the investigator or study site personnel.
5. Is currently participating in a clinical trial. Participation in non-interventional registries is permitted.

Trial design

1,945 participants in 1 patient group

Azilsartan Medoxomil

Description:

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.

Treatment:

Drug: Azilsartan Medoxomil