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

An observational study of Hypertension, run by Takeda at 66 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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.. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: Azilsartan Medoxomil
Type of treatment: Pill or oral medicine
How many people: 1,945 participants
Where: 66 sitesin 2 countries
Study dates: 18 Jul 2016to 8 May 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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®

Show all 10Show fewer

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.

Who cannot join

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.

Trial locations and contacts

66 sites in 2 countries.

Country

City, postcode or hospital

66 sites in 2 countries

Russia59 sites

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

Other trials in Russia

Kazakhstan7 sites

JSC Central Clinical hospital
Almaty, 050000
Research Institute of Cardiology and Internal Diseases
Almaty, 050000
Kazakh Medical University of Continuing Education
Almaty, 050070
Central Clinical Hospital
Almaty
National Scientific center of oncology and transpontology
Astana, 10000
Karaganda State Medical Academy
Karaganda, 100012
Semipalatinsk State Medical Academy
Semey, 71400

Other trials in Kazakhstan

About this study

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

Read the 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.

Conditions: Hypertension
Being tested: Azilsartan Medoxomil
Keywords: Drug Therapy
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Azilsartan MedoxomilDrug
Also called Edarbi®
Azilsartan medoxomil tablets

Study groups in NCT02756819
Study group	Role	What they receive
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. Receives: Drug: Azilsartan Medoxomil

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Month 6

Secondary outcomes (6)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jul 20168 May 2018

First posted29 Apr 2016 (estimated)
Study start18 Jul 2016
Primary completion8 May 2018
Study completion8 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,945 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02756819
Sponsor's protocol ID: Azilsmedox-5008
Other IDs: MACS-2014-100663
Status last verified: Oct 2019
First submitted: 27 Apr 2016
Last updated: 20 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02756819
Acronym / sponsor ID: Azilsmedox-5008
Conditions: Hypertension
Keywords: Drug Therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 1,945 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 18 Jul 2016 (actual)
Primary completion: 8 May 2018 (actual)
Study completion: 8 May 2018 (actual)
First posted: 29 Apr 2016 (estimated)
Results: Posted 20 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study enrolled 1945 patients. All participants were asked to take azilsartan medoxomil as prescribed by their physician according to local SmPC.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Azilsartan Medoxomil	–	Drug: Azilsartan MedoxomilOverweight 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Overweight or obese participants with Hypertension (HTN) grade 1-2 were observed.

Key inclusion criteria (10 listed)

Male and female participants ≥ 18 years of age with hypertension 1-2 grade.
Participants with:
The physician decides to prescribe Edarbi®
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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Azilsartan MedoxomilAlso: Edarbi®Azilsartan medoxomil tablets	Drug	Azilsartan Medoxomil

Primary outcome

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.

6 secondary outcomes

Change From Baseline in Clinic Diastolic Blood Pressure (DBP) at Month 6
Time frame: Baseline and Month 6
Percentage of Participants With Response at Month 6
Time frame: Month 6
Percentage of Participants Who Achieved Target Blood Pressure (BP) SBP<140 mm Hg and DBP<90 mm Hg
Time frame: Month 6
Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6
Time frame: 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
Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6
Time frame: Month 6

Results and safety

Results posted to the registry on 20 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Azilsartan Medoxomil	1,945	1,893

Primary outcome: Change From Baseline in Clinic Systolic Blood Pressure (SBP) at Month 6

Time frame: Baseline and Month 6. Mean (Standard Deviation). Unit: mmHg

Measure	Azilsartan Medoxomil n = 1945
Baseline	156.8 (11.8)
Change from baseline at Month 6	-30.5 (13.4)

Azilsartan Medoxomil: p <0.001, Wilcoxon test

Population analysed: Full analysis set (FAS) included all participants who were enrolled and received azilsartan medoxomil (Edarbi®) therapy. Number analyzed is the number of participants with data available for analysis at the given timepoint.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Month 6. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Azilsartan Medoxomil	6 of 1,934 (0.3%)	39 of 1,934 (2%)	0 of 1,934

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director Clinical Science study director

Takeda

66 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by Takeda at 66 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in Russia, Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Clinic Systolic Blood Pressure (SBP) at Month 6 (time frame: Baseline and Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02756819.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.