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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142441 | Registry Identifier | JapicCTI |
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The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in patients with hypertension in a routine clinical setting.
This surveillance was designed to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in hypertensive patients in daily medical practice.
The usual dosage for adult is 20 mg of azilsartan administered orally once daily. The dose can be adjusted according to the patient's age and condition. The maximum daily dose is 40 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azilsartan | Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants will receive interventions as part of routine medical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azilsartan | Drug | Azilsartan tablets |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. | Up to 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Reported data are changes in SBP from baseline at Month 1 and final assessment (up to 12 months). | Baseline, Month 1 and final assessment (up to 12 Months) |
| Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point |
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Inclusion Criteria:
Exclusion Criteria:
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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 hypertension were enrolled to receive Azilsartan 20 milligram (mg) - 40 mg tablet, orally, once daily for up to 12 months.
Participants took part in the study at 738 investigative sites in Japan, from 20 June 2012 to 15 January 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Azilsartan | Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants will receive interventions as part of routine medical care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety Analysis set included all participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Azilsartan | Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants will receive 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 | Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. | Safety Analysis set included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 12 Months |
|
Up to 12 Month
Investigator had to document any occurrence of AEs 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. Only non-serious ADRs were collected in this study. Participants may be represented in more than 1 category.
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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 | Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants will receive interventions as part of routine medical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 18.1 | 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 are changes in DBP from baseline at Month 1 and final assessment (up to 12 months). |
| Baseline, Month 1 and Final assessment (up to 12 Months) |
| Tokyo |
| Japan |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Weight | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | kg |
|
| 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 |
|
| Healthcare Category | Participants were categorized as outpatient and inpatient. | Count of Participants | Participants |
|
| Medical Complications | Complications defined as a disease or a health condition for each participant at the start of study. 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) | Count of Participants | Participants |
|
| Drinking Habits | Count of Participants | Participants |
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| Smoking Classification | Count of Participants | Participants |
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| Clinical Systolic Blood Pressure (SBP) | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | mmHg |
|
| Clinical Diastolic Blood Pressure (DBP) | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Participants |
|
| SBP/DBP Classification | Count of Participants | Participants |
|
| Pulse Rate | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | bpm |
|
| Taking Hypertension Drug in 2 Months Before Baseline | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Reported data are changes in SBP from baseline at Month 1 and final assessment (up to 12 months). | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given time point. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 1 and final assessment (up to 12 Months) |
|
|
|
| Secondary | Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point | Reported data are changes in DBP from baseline at Month 1 and final assessment (up to 12 months). | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given time point. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 1 and Final assessment (up to 12 Months) |
|
|
|
| 10 |
| 3,369 |
| 15 |
| 3,369 |
| Cerebral infarction | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Prinzmetal angina | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Sinus arrest | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Drowning | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | 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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