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NCT02756819 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02756819
Other study ID # Azilsmedox-5008
Secondary ID MACS-2014-100663
Status Completed
Phase
First received
Last updated
Start date July 18, 2016
Est. completion date May 8, 2018

Study information
Verified date October 2019
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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..

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.

Recruitment information / eligibility
Status Completed
Enrollment 1945
Est. completion date May 8, 2018
Est. primary completion date May 8, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Azilsartan Medoxomil
Azilsartan medoxomil tablets

Locations
Country Name City State
Kazakhstan Central Clinical Hospital Almaty
Kazakhstan JSC Central Clinical hospital Almaty
Kazakhstan Kazakh Medical University of Continuing Education Almaty
Kazakhstan Research Institute of Cardiology and Internal Diseases Almaty
Kazakhstan National Scientific center of oncology and transpontology Astana
Kazakhstan Karaganda State Medical Academy Karaganda
Kazakhstan Semipalatinsk State Medical Academy Semey
Russian Federation Altay regional cardiological center Barnaul
Russian Federation Belgorod Regional Clinical Hospital of St. Joasaph Belgorod
Russian Federation Bryansk Regional Cardiological center Bryansk
Russian Federation Istochnik Clinic Chelyabinsk
Russian Federation Medical center Lotos Chelyabinsk
Russian Federation Regional clinical Hospital #3 Chelyabinsk
Russian Federation Chita State Medical Academy Chita
Russian Federation Medical Center Academy of Health Chita
Russian Federation Medical AssociationNew Hospital Ekaterinburg
Russian Federation Regional Clinical Consultative Diagnostic center Irkutsk
Russian Federation Cardiological center Ivanovo
Russian Federation Consultative Diagnostic Center Ministry of Health of Udmurt Republic Izhevsk
Russian Federation City clinical hospital #2 sosnovaya roscha Kaluga
Russian Federation Kemerovo Regional Clinical Cardiological center named after Barabash L.S. Kemerovo
Russian Federation Kemerovo Regional Clinical hospital named after Belyaev S.V. Kemerovo
Russian Federation Regional Clinical Hospital #1 named after S.I.Sergeev Khabarovsk
Russian Federation Road clinical hospital at the station Khabarovsk JSC "Russian Railways" Khabarovsk
Russian Federation Kirov Clinical hospital named after Yurlova V.I. Kirov
Russian Federation Northern Clinical Emergency Hospital Kirov
Russian Federation Kostroma Regional Clinical Hospital named after Korolev E.I. Kostroma
Russian Federation Lipetsk City policlinic #7 Lipetsk
Russian Federation LLC Medical center Semeynyiy doctor Magnitogorsk
Russian Federation City clinical hospital #1 named after N.I. Pirogova Moscow
Russian Federation City policlinic #166, branch 1 Moscow
Russian Federation City policlinic #166, branch 2 Moscow
Russian Federation City polyclinic #11 Moscow
Russian Federation City polyclinic #11, branch #3 Moscow
Russian Federation City polyclinic #11,branch #1 Moscow
Russian Federation City polyclinic #22 Moscow
Russian Federation Volga District Medical Centre (VDMC) under Federal Medical and Biological Agency (FMBA) Nizhny Novgorod
Russian Federation Volga District Medical Centre (VDMC) under Federal Medical and Biological Agency (FMBA) Nizhny Novgorod
Russian Federation Omsk state medical university Omsk
Russian Federation Medical Center "Novaya medicina" Orekhovo-Zuyevo
Russian Federation Penza Regional Clinical hospital named after N.N. Burdenko Penza
Russian Federation Regional clinical hospital named after N.N. Burdenko Penza
Russian Federation Clinical Cardiological Center Perm
Russian Federation Road Clinical Hospital at the Rostov-Ch. JSC Russian Railways Rostov-on-Don
Russian Federation Rostov State Medical University Rostov-on-Don
Russian Federation City Consultative Diagnostic Center #1 Saint-Petersburg
Russian Federation City Consultative Diagnostic Clinic#1 Primorsky District, Diabetological center #5 Saint-Petersburg
Russian Federation City polyclinic #117 Saint-Petersburg
Russian Federation CJSC Cardioclinic Saint-Petersburg
Russian Federation City polyclinic #14 Samara
Russian Federation Samara Regional Clinical Cardiological center Samara
Russian Federation LLC Multiprofile medical clinic Sova Saratov
Russian Federation Saratov city polyclinic #2 Saratov
Russian Federation City polyclinic #3 Tomsk
Russian Federation Scientific Research Institute of Cardiology Tomsk
Russian Federation Tomsk Clinical hospital Tomsk
Russian Federation Regional Clinical Cardiological center Tver
Russian Federation Tyumen Cardiological center Tyumen
Russian Federation Regional Cardiological center Ulyanovsk
Russian Federation City hospital #4 Vladimir
Russian Federation Volgograd Regional Clinical Cardiological center #1 Volgograd
Russian Federation Volgograd Regional Clinical hospital #1 Volgograd
Russian Federation Voronezh City Clinical polyclinic #4 Voronezh
Russian Federation Voronezh Regional Clinical Diagnostic center Voronezh
Russian Federation National Medical Center Yakutsk
Russian Federation Yaroslavl Regional Clinical Hospital of War Veterans Yaroslavl

Sponsors (1)
Lead Sponsor Collaborator
Takeda

Countries where clinical trial is conducted

Kazakhstan,  Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Change From Baseline in Clinic Diastolic Blood Pressure (DBP) at Month 6 The change in clinic sitting DBP measured at Month 6 relative to baseline. Baseline and Month 6
Secondary Percentage of Participants With Response at Month 6 Response was defined as a decrease of SBP =20 mm Hg or a decrease of DBP =10 mm Hg. Month 6
Secondary Percentage of Participants Who Achieved Target Blood Pressure (BP) SBP<140 mm Hg and DBP<90 mm Hg Month 6
Secondary Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at 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
Secondary Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at 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
Secondary Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at 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
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