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
NCT ID: NCT02756819
Last Updated: 2019-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
1945 participants
OBSERVATIONAL
2016-07-18
2018-05-08
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Azilsartan Medoxomil
Azilsartan medoxomil tablets
Interventions
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Azilsartan Medoxomil
Azilsartan medoxomil tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
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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, , Russia
Belgorod Regional Clinical Hospital of St. Joasaph
Belgorod, , Russia
Bryansk Regional Cardiological center
Bryansk, , Russia
Medical center Lotos
Chelyabinsk, , Russia
Regional clinical Hospital #3
Chelyabinsk, , Russia
Istochnik Clinic
Chelyabinsk, , Russia
Medical Center Academy of Health
Chita, , Russia
Chita State Medical Academy
Chita, , Russia
Regional Clinical Consultative Diagnostic center
Irkutsk, , Russia
Cardiological center
Ivanovo, , Russia
Consultative Diagnostic Center Ministry of Health of Udmurt Republic
Izhevsk, , Russia
City clinical hospital #2 sosnovaya roscha
Kaluga, , Russia
Kemerovo Regional Clinical Cardiological center named after Barabash L.S.
Kemerovo, , Russia
Kemerovo Regional Clinical hospital named after Belyaev S.V.
Kemerovo, , Russia
Regional Clinical Hospital #1 named after S.I.Sergeev
Khabarovsk, , Russia
Road clinical hospital at the station Khabarovsk JSC "Russian Railways"
Khabarovsk, , Russia
Northern Clinical Emergency Hospital
Kirov, , Russia
Kirov Clinical hospital named after Yurlova V.I.
Kirov, , Russia
Kostroma Regional Clinical Hospital named after Korolev E.I.
Kostroma, , Russia
Lipetsk City policlinic #7
Lipetsk, , Russia
LLC Medical center Semeynyiy doctor
Magnitogorsk, , Russia
City policlinic #166, branch 1
Moscow, , Russia
City policlinic #166, branch 2
Moscow, , Russia
City clinical hospital #1 named after N.I. Pirogova
Moscow, , Russia
City polyclinic #22
Moscow, , Russia
City polyclinic #11,branch #1
Moscow, , Russia
City polyclinic #11
Moscow, , Russia
City polyclinic #11, branch #3
Moscow, , Russia
Volga District Medical Centre (VDMC) under Federal Medical and Biological Agency (FMBA)
Nizhny Novgorod, , Russia
Volga District Medical Centre (VDMC) under Federal Medical and Biological Agency (FMBA)
Nizhny Novgorod, , Russia
Omsk state medical university
Omsk, , Russia
Medical Center "Novaya medicina"
Orekhovo-Zuyevo, , Russia
Penza Regional Clinical hospital named after N.N. Burdenko
Penza, , Russia
Regional clinical hospital named after N.N. Burdenko
Penza, , Russia
Clinical Cardiological Center
Perm, , Russia
Road Clinical Hospital at the Rostov-Ch. JSC Russian Railways
Rostov-on-Don, , Russia
Rostov State Medical University
Rostov-on-Don, , Russia
City Consultative Diagnostic Center #1
Saint Petersburg, , Russia
City polyclinic #117
Saint Petersburg, , Russia
CJSC Cardioclinic
Saint Petersburg, , Russia
City Consultative Diagnostic Clinic#1 Primorsky District, Diabetological center #5
Saint Petersburg, , Russia
City polyclinic #14
Samara, , Russia
Samara Regional Clinical Cardiological center
Samara, , Russia
Saratov city polyclinic #2
Saratov, , Russia
LLC Multiprofile medical clinic Sova
Saratov, , Russia
City polyclinic #3
Tomsk, , Russia
Scientific Research Institute of Cardiology
Tomsk, , Russia
Tomsk Clinical hospital
Tomsk, , Russia
Regional Clinical Cardiological center
Tver', , Russia
Tyumen Cardiological center
Tyumen, , Russia
Regional Cardiological center
Ulyanovsk, , Russia
City hospital #4
Vladimir, , Russia
Volgograd Regional Clinical hospital #1
Volgograd, , Russia
Volgograd Regional Clinical Cardiological center #1
Volgograd, , Russia
Voronezh Regional Clinical Diagnostic center
Voronezh, , Russia
Voronezh City Clinical polyclinic #4
Voronezh, , Russia
National Medical Center
Yakutsk, , Russia
Yaroslavl Regional Clinical Hospital of War Veterans
Yaroslavl, , Russia
Medical AssociationNew Hospital
Yekaterinburg, , Russia
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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MACS-2014-100663
Identifier Type: OTHER
Identifier Source: secondary_id
Azilsmedox-5008
Identifier Type: -
Identifier Source: org_study_id
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