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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142466 | Registry Identifier | JapicCTI |
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The purpose of this study is to evaluate the efficacy of azilsartan tablets (Azilva Tablets) in patients with hypertension complicated by diabetes mellitus whose blood pressure cannot be sufficiently reduced by monotherapy with angiotensin II receptor blockers (ARBs) other than azilsartan, in routine clinical practice
This study was designed to evaluate the efficacy of azilsartan tablets (Azilva Tablets) in patients with hypertension complicated by diabetes mellitus whose blood pressure cannot be sufficiently reduced by monotherapy with ARBs, other than azilsartan, in daily medical practice.
Patient enrollment will be started on April 1, 2014. The usual dosage for adults is 20 mg of azilsartan administered orally once daily. The dose can be adjusted according to the participant's age and condition. The maximum daily dose is 40 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azilsartan at a dose of 20 to 40 mg, orally, once daily | Azilsartan tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azilsartan | Drug | Azilsartan tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in Blood Pressure on Final Assessment Point (up to Week 24) Measured at the Medical Institution | Reported data were changes from baseline in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) measured at the medical institution. | From baseline up to final assessment point (up to Week 24) |
| Changes From Baseline in Home Blood Pressure on Final Assessment Point (up to Week 24) | Reported data were changes from baseline in blood pressure (SBP and DBP) measured at home right after waking up and at bedtime. | From baseline up to final assessment point (up to Week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in Pulse Rate on Final Assessment Point (up to Week 24) at the Medical Institution | Reported data were changes from baseline in pulse rate measured at the medical institution. | From baseline up to final assessment point (up to Week 24) |
| Changes From Baseline in Hemoglobin A1c (HbA1c) on Final Assessment Point (up to Week 24) at the Medical Institution |
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Inclusion Criteria:
Patients with hypertension who meet all the following criteria will be enrolled:
Patients who has complications of diabetes mellitus
Patients who is on monotherapy with ARBs (other than azilsartan) as antihypertensive treatment (Patients who have continued monotherapy with the same ARB product for at least 8 weeks at the time of Step-1* of participant enrollment and will continue such treatment until the first administration of Azilsartan Tablets)
Patients who has a systolic blood pressure of ≥ 130 millimeter of mercury (mmHg) and/or diastolic blood pressure of 80 ≥ mmHg at the examination performed at the medical institution
Patients who is an outpatient
Patient who keeps a regular lifestyle and whose usual waking time is between 4 a.m. and 9:30 a.m.
*For this surveillance, participant enrollment will be performed in two divided steps: Step-1 (at hospital visit before prescription of Azilsartan Tablets) and Step-2 (at the time of prescription of Azilsartan Tablets).
Exclusion Criteria:
Patients with contraindications to azilsartan
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Hypertension
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka | Japan | |||||
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Participants with a historical diagnosis of both hypertension and type 2 diabetes mellitus were enrolled. Participants received interventions as part of routine medical care.
Participants took part in the study at 146 investigative sites in Japan, from 03 March 2014 to 29 February 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Azilsartan 20 to 40 mg | Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 24 weeks in participants based upon the disease severity. Participants received interventions as part of routine medical care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set: The safety analysis set was defined as all participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Azilsartan 20 to 40 mg | Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 24 weeks in participants based upon the disease severity. Participants received interventions as part of routine medical care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Changes From Baseline in Blood Pressure on Final Assessment Point (up to Week 24) Measured at the Medical Institution | Reported data were changes from baseline in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) measured at the medical institution. | Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Millimeter of Mercury (mmHg) | From baseline up to final assessment point (up to Week 24) |
|
Up to Week 24
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.
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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 20 to 40 mg | Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 24 weeks in participants based upon the disease severity. Participants received interventions as part of routine medical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C521273 | azilsartan |
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Reported data were changes from baseline in HbA1c (National glycohemoglobin standardization program [NGSP] value) measured at the Medical Institution. |
| From baseline up to final assessment point (up to Week 24) |
| Changes From Baseline in Creatinine-adjusted Urinary Albumin Level on Final Assessment Point (up to Week 24) at the Medical Institution | Reported data were changes from baseline in creatinine-adjusted urinary albumin level (that is calculated from urinary albumin level divided by creatinine level) measured at the medical institution. Here "mg/gCr" is Milligrams per Gram of Creatinine. | From baseline up to final assessment point (up to Week 24) |
| Percentage of Participants Who Had One or More Adverse Events | Up to Week 24 |
| Tokyo |
| Japan |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Type of Diabetes Mellitus | Count of Participants | Participants |
|
| Predisposition to Hypersensitivity | The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity. | Count of Participants | Participants |
|
| Medical Complications | Complications defined as a disease or a health condition for each participant at the start of study excluding type 2 diabetes mellitus. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above. | Count of Participants | Participants |
|
| Estimated Glomerular Filtration Rate (eGFR) | Here "mL" is milliliter, "min" is minute, and "m" is meter. | The number analyzed is the number of participants with data available for analysis. | Count of Participants | Participants |
|
| BMI | Body Mass Index = weight (kg)/[height (m)^2] | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | kg/m^2 |
|
| Smoking Classification | Count of Participants | Participants |
|
| Drinking Habits | Participants who answered Yes or No for a question "Drink Alcohol Almost Every Day?" were reported | Count of Participants | Participants |
|
| Pre-treatment ARB before Study Start | ARB = Angiotensin II Receptor Blocker. Reported data was treatment drug of ARB before observational duration. | Count of Participants | Participants |
|
|
|
| Primary | Changes From Baseline in Home Blood Pressure on Final Assessment Point (up to Week 24) | Reported data were changes from baseline in blood pressure (SBP and DBP) measured at home right after waking up and at bedtime. | Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmHg | From baseline up to final assessment point (up to Week 24) |
|
|
|
| Secondary | Changes From Baseline in Pulse Rate on Final Assessment Point (up to Week 24) at the Medical Institution | Reported data were changes from baseline in pulse rate measured at the medical institution. | Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Beat per Minutes (bpm) | From baseline up to final assessment point (up to Week 24) |
|
|
|
| Secondary | Changes From Baseline in Hemoglobin A1c (HbA1c) on Final Assessment Point (up to Week 24) at the Medical Institution | Reported data were changes from baseline in HbA1c (National glycohemoglobin standardization program [NGSP] value) measured at the Medical Institution. | Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent | From baseline up to final assessment point (up to Week 24) |
|
|
|
| Secondary | Changes From Baseline in Creatinine-adjusted Urinary Albumin Level on Final Assessment Point (up to Week 24) at the Medical Institution | Reported data were changes from baseline in creatinine-adjusted urinary albumin level (that is calculated from urinary albumin level divided by creatinine level) measured at the medical institution. Here "mg/gCr" is Milligrams per Gram of Creatinine. | Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mg/gCr | From baseline up to final assessment point (up to Week 24) |
|
|
|
| Secondary | Percentage of Participants Who Had One or More Adverse Events | Safety Analysis Set; The safety analysis set was defined as all participants who completed the study. | Posted | Number | Percentage of Participants | Up to Week 24 |
|
|
|
| 2 |
| 371 |
| 5 |
| 371 |
| 20 |
| 371 |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Sudden death | General disorders | MedDRA 19.1 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
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| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Large intestine polyp | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Vaginal discharge | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Glycosylated haemoglobin increased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 19.1 | 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.
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| SBP at Bedtime |
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| DBP at Bedtime |
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