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

October 30, 2019 updated by: Takeda

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

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..

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1945

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Almaty, Kazakhstan, 050000
        • JSC Central Clinical hospital
      • Almaty, Kazakhstan, 050000
        • Research Institute of Cardiology and Internal Diseases
      • Almaty, Kazakhstan, 050070
        • Kazakh Medical University of Continuing Education
      • Almaty, Kazakhstan
        • Central Clinical Hospital
      • Astana, Kazakhstan, 10000
        • National Scientific center of oncology and transpontology
      • Karaganda, Kazakhstan, 100012
        • Karaganda State Medical Academy
      • Semey, Kazakhstan, 71400
        • Semipalatinsk State Medical Academy
  • Russian Federation
      • Barnaul, Russian Federation, 656055
        • Altay regional cardiological center
      • Belgorod, Russian Federation, 308007
        • Belgorod Regional Clinical Hospital of St. Joasaph
      • Bryansk, Russian Federation, 241050
        • Bryansk Regional Cardiological center
      • Chelyabinsk, Russian Federation, 454004
        • Medical center Lotos
      • Chelyabinsk, Russian Federation, 454021
        • Regional Clinical Hospital #3
      • Chelyabinsk, Russian Federation, 454100
        • Istochnik clinic
      • Chita, Russian Federation, 672090
        • Chita State Medical Academy
      • Chita, Russian Federation, 672038
        • Medical Center Academy of Health
      • Ekaterinburg, Russian Federation, 620109
        • Medical AssociationNew Hospital
      • Irkutsk, Russian Federation, 664047
        • Regional Clinical Consultative Diagnostic center
      • Ivanovo, Russian Federation, 153012
        • Cardiological center
      • Izhevsk, Russian Federation, 426008
        • Consultative Diagnostic Center Ministry of Health of Udmurt Republic
      • Kaluga, Russian Federation, 248010
        • City clinical hospital #2 sosnovaya roscha
      • Kemerovo, Russian Federation, 650002
        • Kemerovo Regional Clinical Cardiological center named after Barabash L.S.
      • Kemerovo, Russian Federation, 650066
        • Kemerovo Regional Clinical hospital named after Belyaev S.V.
      • Khabarovsk, Russian Federation, 680009
        • Regional Clinical Hospital #1 named after S.I.Sergeev
      • Khabarovsk, Russian Federation, 680022
        • Road clinical hospital at the station Khabarovsk JSC "Russian Railways"
      • Kirov, Russian Federation, 610011
        • Northern Clinical Emergency Hospital
      • Kirov, Russian Federation, 610014
        • Kirov Clinical hospital named after Yurlova V.I.
      • Kostroma, Russian Federation, 156013
        • Kostroma Regional Clinical Hospital named after Korolev E.I.
      • Lipetsk, Russian Federation, 398036
        • Lipetsk City policlinic #7
      • Magnitogorsk, Russian Federation, 455034
        • LLC Medical center Semeynyiy doctor
      • Moscow, Russian Federation, 115304
        • City policlinic #166, branch 1
      • Moscow, Russian Federation, 115516
        • City policlinic #166, branch 2
      • Moscow, Russian Federation, 117049
        • City clinical hospital #1 named after N.I. Pirogova
      • Moscow, Russian Federation, 117335
        • City polyclinic #22
      • Moscow, Russian Federation, 117393
        • City polyclinic #11,branch #1
      • Moscow, Russian Federation, 119331
        • City polyclinic #11
      • Moscow, Russian Federation
        • City polyclinic #11, branch #3
      • Nizhny Novgorod, Russian Federation, 603001
        • Volga District Medical Centre (VDMC) under Federal Medical and Biological Agency (FMBA)
      • Nizhny Novgorod, Russian Federation, 603137
        • Volga District Medical Centre (VDMC) under Federal Medical and Biological Agency (FMBA)
      • Omsk, Russian Federation, 644099
        • Omsk state medical university
      • Orekhovo-Zuyevo, Russian Federation, 142600
        • Medical Center "Novaya medicina"
      • Penza, Russian Federation, 440026
        • Penza Regional Clinical Hospital named after N.N. Burdenko
      • Penza, Russian Federation, 440026
        • Regional clinical hospital named after N.N. Burdenko
      • Perm, Russian Federation, 614002
        • Clinical Cardiological Center
      • Rostov-on-Don, Russian Federation, 344022
        • Rostov State Medical University
      • Rostov-on-Don, Russian Federation, 344011
        • Road Clinical Hospital at the Rostov-Ch. JSC Russian Railways
      • Saint-Petersburg, Russian Federation, 194354
        • City Consultative Diagnostic Center #1
      • Saint-Petersburg, Russian Federation, 195299
        • City polyclinic #117
      • Saint-Petersburg, Russian Federation, 196105
        • CJSC Cardioclinic
      • Saint-Petersburg, Russian Federation, 197183
        • City Consultative Diagnostic Clinic#1 Primorsky District, Diabetological center #5
      • Samara, Russian Federation, 443011
        • City polyclinic #14
      • Samara, Russian Federation, 443070
        • Samara Regional Clinical Cardiological center
      • Saratov, Russian Federation, 410005
        • Saratov city polyclinic #2
      • Saratov, Russian Federation, 410056
        • LLC Multiprofile medical clinic Sova
      • Tomsk, Russian Federation, 634009
        • City polyclinic #3
      • Tomsk, Russian Federation, 634034
        • Scientific Research Institute of Cardiology
      • Tomsk, Russian Federation, 634063
        • Tomsk Clinical hospital
      • Tver, Russian Federation, 170041
        • Regional Clinical Cardiological center
      • Tyumen, Russian Federation, 625000
        • Tyumen Cardiological center
      • Ulyanovsk, Russian Federation, 432012
        • Regional Cardiological center
      • Vladimir, Russian Federation, 600020
        • City Hospital #4
      • Volgograd, Russian Federation, 400000
        • Volgograd Regional Clinical hospital #1
      • Volgograd, Russian Federation, 400008
        • Volgograd Regional Clinical Cardiological center #1
      • Voronezh, Russian Federation, 394018
        • Voronezh Regional Clinical Diagnostic center
      • Voronezh, Russian Federation, 394077
        • Voronezh City Clinical polyclinic #4
      • Yakutsk, Russian Federation, 677010
        • National Medical Center
      • Yaroslavl, Russian Federation, 150047
        • Yaroslavl Regional Clinical Hospital of War Veterans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Overweight or obese participants with Hypertension (HTN) grade 1-2 were observed.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Azilsartan Medoxomil
Azilsartan medoxomil tablets
Other Names:
  • Edarbi®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Month 6
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.
Month 6
Percentage of Participants Who Achieved Target Blood Pressure (BP) SBP<140 mm Hg and DBP<90 mm Hg
Time Frame: Month 6
Month 6
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.
Baseline and Month 6
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.
Baseline and Month 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).
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2016

Primary Completion (Actual)

May 8, 2018

Study Completion (Actual)

May 8, 2018

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

April 27, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Actual)

November 20, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Azilsmedox-5008
  • MACS-2014-100663 (Other Identifier: Takeda)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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