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| ID | Type | Description | Link |
|---|---|---|---|
| MACS-2014-100663 | Other Identifier | Takeda |
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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..
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azilsartan Medoxomil | Drug | Azilsartan medoxomil tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Percentage of Participants With Response at Month 6 |
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Inclusion Criteria:
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.
Exclusion Criteria:
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Overweight or obese participants with Hypertension (HTN) grade 1-2 were observed.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JSC Central Clinical hospital | Almaty | 050000 | Kazakhstan | |||
| Research Institute of Cardiology and Internal Diseases |
Participants with a diagnosis of hypertension and who were obese, prescribed azilsartan medoxomil in accordance with local summary of product characteristics (SmPC) were enrolled in this observational study.
Participants took part at 65 sites in the study in Russian Federation and the Republic of Kazakhstan from 18-Jul-2016 to 08-May-2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Azilsartan Medoxomil | Overweight or obese participants with hypertension who received azilsartan medoxomil tablets, orally, as prescribed by physician according to local SmPC were observed for approximately 6 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 20, 2019 | May 7, 2019 |
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Response was defined as a decrease of SBP ≥20 mm Hg or a decrease of DBP ≥10 mm Hg.
| 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 | 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 |
| 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 |
| 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 |
| 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 |
| Per-protocol Set (PPS) |
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| Safety Analysis Set (SAS) |
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| COMPLETED |
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| NOT COMPLETED |
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All enrolled participants who received azilsartan medoxomil.
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| ID | Title | Description |
|---|---|---|
| BG000 | Azilsartan Medoxomil | Overweight or obese participants with hypertension who received azilsartan medoxomil tablets, orally, as prescribed by physician according to local SmPC were observed for approximately 6 months. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Number analyzed is the number of participants with data available for analysis at the given timepoint. | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline and Month 6 |
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| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline and Month 6 |
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| 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. | Participants from FAS, all participants who were enrolled and received azilsartan medoxomil (Edarbi®) therapy with data available for analysis at the given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 6 |
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| Secondary | Percentage of Participants Who Achieved Target Blood Pressure (BP) SBP<140 mm Hg and DBP<90 mm Hg | Participants from FAS, all participants who were enrolled and received azilsartan medoxomil (Edarbi®) therapy with data available for analysis at the given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 6 |
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| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline and Month 6 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percentage of participants | Baseline and Month 6 |
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| 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 6 |
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Baseline up to Month 6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population included all participants who received at least one dose of study treatment and had any follow-up data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azilsartan Medoxomil | Overweight or obese participants with hypertension who received azilsartan medoxomil tablets, orally, as prescribed by physician according to local SmPC were observed for approximately 6 months. | 0 | 1,934 | 6 | 1,934 | 39 | 1,934 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Angioedema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Deafness neurosensory | Ear and labyrinth disorders | Systematic Assessment |
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| Skull fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Dyslipidaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Left ventricular hypertrophy | Cardiac disorders | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Blood cholesterol increased | Investigations | Systematic Assessment |
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| Blood pressure decreased | Investigations | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
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| Tracheitis | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Asthenia | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Drug effect increased | General disorders | Systematic Assessment |
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| Drug ineffective | General disorders | Systematic Assessment |
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The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 9, 2019 | May 7, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C557413 | azilsartan medoxomil |
| C521273 | azilsartan |
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