Clinical trial 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
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-04-29
Enrollment: 1945
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overweight or obese participants with Hypertension (HTN) grade 1-2 were observed.

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..

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Clinic Systolic Blood Pressure (SBP) at Month 6
timeFrame: Baseline and Month 6
Secondary outcomes:
measure: Change From Baseline in Clinic Diastolic Blood Pressure (DBP) at Month 6
timeFrame: Baseline and Month 6
measure: Percentage of Participants With Response at Month 6
timeFrame: Month 6
measure: Percentage of Participants Who Achieved Target Blood Pressure (BP) SBP<140 mm Hg and DBP<90 mm Hg
timeFrame: Month 6
measure: Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at Month 6
timeFrame: Baseline and Month 6
measure: Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6
timeFrame: Month 6
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: JSC Central Clinical hospital
city: Almaty
country: Kazakhstan
facility: Research Institute of Cardiology and Internal Diseases
city: Almaty
country: Kazakhstan
facility: Kazakh Medical University of Continuing Education
city: Almaty
country: Kazakhstan
facility: Central Clinical Hospital
city: Astana
country: Kazakhstan
facility: National Scientific center of oncology and transpontology
city: Karaganda
country: Kazakhstan
facility: Karaganda State Medical Academy
city: Semey
country: Kazakhstan
facility: Semipalatinsk State Medical Academy
city: Barnaul
country: Russian Federation
facility: Altay regional cardiological center
city: Belgorod
country: Russian Federation
facility: Belgorod Regional Clinical Hospital of St. Joasaph
city: Bryansk
country: Russian Federation
facility: Bryansk Regional Cardiological center
city: Chelyabinsk
country: Russian Federation
facility: Medical center Lotos
city: Chelyabinsk
country: Russian Federation
facility: Regional clinical Hospital #3
city: Chelyabinsk
country: Russian Federation
facility: Istochnik Clinic
city: Chita
country: Russian Federation
facility: Medical Center Academy of Health
city: Chita
country: Russian Federation
facility: Chita State Medical Academy
city: Ekaterinburg
country: Russian Federation
facility: Medical AssociationNew Hospital
city: Irkutsk
country: Russian Federation
facility: Regional Clinical Consultative Diagnostic center
city: Ivanovo
country: Russian Federation
facility: Cardiological center
city: Izhevsk
country: Russian Federation
facility: Consultative Diagnostic Center Ministry of Health of Udmurt Republic
city: Kaluga
country: Russian Federation
facility: City clinical hospital #2 sosnovaya roscha
city: Kemerovo
country: Russian Federation
facility: Kemerovo Regional Clinical Cardiological center named after Barabash L.S.
city: Kemerovo
country: Russian Federation
facility: Kemerovo Regional Clinical hospital named after Belyaev S.V.
city: Khabarovsk
country: Russian Federation
facility: Regional Clinical Hospital #1 named after S.I.Sergeev
city: Khabarovsk
country: Russian Federation
facility: Road clinical hospital at the station Khabarovsk JSC "Russian Railways"
city: Kirov
country: Russian Federation
facility: Northern Clinical Emergency Hospital
city: Kirov
country: Russian Federation
facility: Kirov Clinical hospital named after Yurlova V.I.
city: Kostroma
country: Russian Federation
facility: Kostroma Regional Clinical Hospital named after Korolev E.I.
city: Lipetsk
country: Russian Federation
facility: Lipetsk City policlinic #7
city: Magnitogorsk
country: Russian Federation
facility: LLC Medical center Semeynyiy doctor
city: Moscow
country: Russian Federation
facility: City policlinic #166, branch 1
city: Moscow
country: Russian Federation
facility: City policlinic #166, branch 2
city: Moscow
country: Russian Federation
facility: City clinical hospital #1 named after N.I. Pirogova
city: Moscow
country: Russian Federation
facility: City polyclinic #22
city: Moscow
country: Russian Federation
facility: City polyclinic #11,branch #1
city: Moscow
country: Russian Federation
facility: City polyclinic #11
city: Moscow
country: Russian Federation
facility: City polyclinic #11, branch #3
city: Nizhny Novgorod
country: Russian Federation
facility: Volga District Medical Centre (VDMC) under Federal Medical and Biological Agency (FMBA)
city: Nizhny Novgorod
country: Russian Federation
facility: Volga District Medical Centre (VDMC) under Federal Medical and Biological Agency (FMBA)
city: Omsk
country: Russian Federation
facility: Omsk state medical university
city: Orekhovo-Zuyevo
country: Russian Federation
facility: Medical Center "Novaya medicina"
city: Penza
country: Russian Federation
facility: Penza Regional Clinical hospital named after N.N. Burdenko
city: Penza
country: Russian Federation
facility: Regional clinical hospital named after N.N. Burdenko
city: Perm
country: Russian Federation
facility: Clinical Cardiological Center
city: Rostov-on-Don
country: Russian Federation
facility: Road Clinical Hospital at the Rostov-Ch. JSC Russian Railways
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
city: Saint-Petersburg
country: Russian Federation
facility: City Consultative Diagnostic Center #1
city: Saint-Petersburg
country: Russian Federation
facility: City polyclinic #117
city: Saint-Petersburg
country: Russian Federation
facility: CJSC Cardioclinic
city: Saint-Petersburg
country: Russian Federation
facility: City Consultative Diagnostic Clinic#1 Primorsky District, Diabetological center #5
city: Samara
country: Russian Federation
facility: City polyclinic #14
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Cardiological center
city: Saratov
country: Russian Federation
facility: Saratov city polyclinic #2
city: Saratov
country: Russian Federation
facility: LLC Multiprofile medical clinic Sova
city: Tomsk
country: Russian Federation
facility: City polyclinic #3
city: Tomsk
country: Russian Federation
facility: Scientific Research Institute of Cardiology
city: Tomsk
country: Russian Federation
facility: Tomsk Clinical hospital
city: Tver
country: Russian Federation
facility: Regional Clinical Cardiological center
city: Tyumen
country: Russian Federation
facility: Tyumen Cardiological center
city: Ulyanovsk
country: Russian Federation
facility: Regional Cardiological center
city: Vladimir
country: Russian Federation
facility: City hospital #4
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Clinical hospital #1
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Clinical Cardiological center #1
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Diagnostic center
city: Voronezh
country: Russian Federation
facility: Voronezh City Clinical polyclinic #4
city: Yakutsk
country: Russian Federation
facility: National Medical Center
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Clinical Hospital of War Veterans
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References: