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
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
2 other identifiers
observational
1,945
2 countries
66
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..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2016
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2016
CompletedFirst Posted
Study publicly available on registry
April 29, 2016
CompletedStudy Start
First participant enrolled
July 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2018
CompletedResults Posted
Study results publicly available
November 20, 2019
CompletedNovember 20, 2019
October 1, 2019
1.8 years
April 27, 2016
May 7, 2019
October 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Clinic Systolic Blood Pressure (SBP) at Month 6
The change in clinic sitting SBP measured at Month 6 relative to baseline.
Baseline and Month 6
Secondary Outcomes (6)
Change From Baseline in Clinic Diastolic Blood Pressure (DBP) at Month 6
Baseline and Month 6
Percentage of Participants With Response at Month 6
Month 6
Percentage of Participants Who Achieved Target Blood Pressure (BP) SBP<140 mm Hg and DBP<90 mm Hg
Month 6
Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants 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
- +1 more secondary outcomes
Study Arms (1)
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.
Interventions
Eligibility Criteria
Overweight or obese participants with Hypertension (HTN) grade 1-2 were observed.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (66)
JSC Central Clinical hospital
Almaty, 050000, Kazakhstan
Research Institute of Cardiology and Internal Diseases
Almaty, 050000, Kazakhstan
Kazakh Medical University of Continuing Education
Almaty, 050070, Kazakhstan
Central Clinical Hospital
Almaty, Kazakhstan
National Scientific center of oncology and transpontology
Astana, 10000, Kazakhstan
Karaganda State Medical Academy
Karaganda, 100012, Kazakhstan
Semipalatinsk State Medical Academy
Semey, 71400, Kazakhstan
Altay regional cardiological center
Barnaul, 656055, Russia
Belgorod Regional Clinical Hospital of St. Joasaph
Belgorod, 308007, Russia
Bryansk Regional Cardiological center
Bryansk, 241050, Russia
Medical center Lotos
Chelyabinsk, 454004, Russia
Regional clinical Hospital #3
Chelyabinsk, 454021, Russia
Istochnik Clinic
Chelyabinsk, 454100, Russia
Medical Center Academy of Health
Chita, 672038, Russia
Chita State Medical Academy
Chita, 672090, Russia
Regional Clinical Consultative Diagnostic center
Irkutsk, 664047, Russia
Cardiological center
Ivanovo, 153012, Russia
Consultative Diagnostic Center Ministry of Health of Udmurt Republic
Izhevsk, 426008, Russia
City clinical hospital #2 sosnovaya roscha
Kaluga, 248010, Russia
Kemerovo Regional Clinical Cardiological center named after Barabash L.S.
Kemerovo, 650002, Russia
Kemerovo Regional Clinical hospital named after Belyaev S.V.
Kemerovo, 650066, Russia
Regional Clinical Hospital #1 named after S.I.Sergeev
Khabarovsk, 680009, Russia
Road clinical hospital at the station Khabarovsk JSC "Russian Railways"
Khabarovsk, 680022, Russia
Northern Clinical Emergency Hospital
Kirov, 610011, Russia
Kirov Clinical hospital named after Yurlova V.I.
Kirov, 610014, Russia
Kostroma Regional Clinical Hospital named after Korolev E.I.
Kostroma, 156013, Russia
Lipetsk City policlinic #7
Lipetsk, 398036, Russia
LLC Medical center Semeynyiy doctor
Magnitogorsk, 455034, Russia
City policlinic #166, branch 1
Moscow, 115304, Russia
City policlinic #166, branch 2
Moscow, 115516, Russia
City clinical hospital #1 named after N.I. Pirogova
Moscow, 117049, Russia
City polyclinic #22
Moscow, 117335, Russia
City polyclinic #11,branch #1
Moscow, 117393, Russia
City polyclinic #11
Moscow, 119331, Russia
City polyclinic #11, branch #3
Moscow, Russia
Volga District Medical Centre (VDMC) under Federal Medical and Biological Agency (FMBA)
Nizhny Novgorod, 603001, Russia
Volga District Medical Centre (VDMC) under Federal Medical and Biological Agency (FMBA)
Nizhny Novgorod, 603137, Russia
Omsk state medical university
Omsk, 644099, Russia
Medical Center "Novaya medicina"
Orekhovo-Zuyevo, 142600, Russia
Penza Regional Clinical hospital named after N.N. Burdenko
Penza, 440026, Russia
Regional clinical hospital named after N.N. Burdenko
Penza, 440026, Russia
Clinical Cardiological Center
Perm, 614002, Russia
Road Clinical Hospital at the Rostov-Ch. JSC Russian Railways
Rostov-on-Don, 344011, Russia
Rostov State Medical University
Rostov-on-Don, 344022, Russia
City Consultative Diagnostic Center #1
Saint Petersburg, 194354, Russia
City polyclinic #117
Saint Petersburg, 195299, Russia
CJSC Cardioclinic
Saint Petersburg, 196105, Russia
City Consultative Diagnostic Clinic#1 Primorsky District, Diabetological center #5
Saint Petersburg, 197183, Russia
City polyclinic #14
Samara, 443011, Russia
Samara Regional Clinical Cardiological center
Samara, 443070, Russia
Saratov city polyclinic #2
Saratov, 410005, Russia
LLC Multiprofile medical clinic Sova
Saratov, 410056, Russia
City polyclinic #3
Tomsk, 634009, Russia
Scientific Research Institute of Cardiology
Tomsk, 634034, Russia
Tomsk Clinical hospital
Tomsk, 634063, Russia
Regional Clinical Cardiological center
Tver', 170041, Russia
Tyumen Cardiological center
Tyumen, 625000, Russia
Regional Cardiological center
Ulyanovsk, 432012, Russia
City hospital #4
Vladimir, 600020, Russia
Volgograd Regional Clinical hospital #1
Volgograd, 400000, Russia
Volgograd Regional Clinical Cardiological center #1
Volgograd, 400008, Russia
Voronezh Regional Clinical Diagnostic center
Voronezh, 394018, Russia
Voronezh City Clinical polyclinic #4
Voronezh, 394077, Russia
National Medical Center
Yakutsk, 677010, Russia
Yaroslavl Regional Clinical Hospital of War Veterans
Yaroslavl, 150047, Russia
Medical AssociationNew Hospital
Yekaterinburg, 620109, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2016
First Posted
April 29, 2016
Study Start
July 18, 2016
Primary Completion
May 8, 2018
Study Completion
May 8, 2018
Last Updated
November 20, 2019
Results First Posted
November 20, 2019
Record last verified: 2019-10