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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142592 | 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/amlodipine combination tablets Low Dose (LD) & High Dose (HD) (Zacras Combination Tablets LD & HD) in hypertensive patients in daily medical practice.
This survey was designed to evaluate the safety and efficacy of long-term use of azilsartan/amlodipine combination tablets LD & HD (Zacras Combination Tablets LD & HD) in hypertensive patients in daily medical practice.
For adults, one azilsartan/amlodipine combination tablet (20 mg/2.5 mg [for LD tablets] or 20 mg/5 mg [for HD tablets] of azilsartan/amlodipine) is administered orally once daily. Azilsartan/amlodipine combination tablets should not be used as the first-line drug for the treatment of hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azilsartan/Amlodipine | Azilsartan/Amlodipine combination tablets (20 mg/2.5 mg or 20 mg/5 mg), orally, once daily for up to 12 months. Participants will receive interventions as part of routine medical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azilsartan/Amlodipine | Drug | Azilsartan/Amlodipine combination tablets LD & HD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Had One or More Adverse Events | Up to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Office Blood Pressure | Systolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported. | Baseline, Month 1, and final assessment point (up to Month 12) |
| Diastolic Office Blood Pressure |
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Inclusion Criteria:
-Hypertensive patients
Exclusion Criteria:
-Hypertensive patients who meet any of the following conditions, [1] to [3], are excluded from the survey:
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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. Participants received interventions as part of routine medical care.
Participants took part in the study at 271 investigative sites in Japan, from 26 June 2014 to 31 January 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Azilsartan/Amlodipine | Azilsartan/Amlodipine combination tablets (20 mg/2.5 mg or 20 mg/5 mg), orally, once daily for up to 12 months. Participants received interventions as part of routine medical care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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/Amlodipine | Azilsartan/Amlodipine combination tablets (20 mg/2.5 mg or 20 mg/5 mg), orally, once daily for up to 12 months. 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 | 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 Month 12 |
|
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Up to Month 12
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/Amlodipine | Azilsartan/Amlodipine combination tablets (20 mg/2.5 mg or 20 mg/5 mg), orally, once daily for up to 12 months. Participants received interventions as part of routine medical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peritonitis | Infections and infestations | MedDRA Ver.20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA Ver.20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 2, 2017 | Feb 26, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 29, 2017 | Feb 26, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C521273 | azilsartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Diastolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.
| Baseline, Month 1, and final assessment point (up to Month 12) |
| 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 |
|
| Duration of Diagnosis of Hypertension | Mean duration between start of study and first time of diagnosis of hypertension was reported. | Count of Participants | Participants |
|
| Healthcare Category | Participants were categorized as outpatient and inpatient. | Count of Participants | Participants |
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| Predisposition to Hypersensitivity | The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity. | Count of Participants | Participants |
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| 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 |
|
| Medical History | Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above. | Count of Participants | Participants |
|
| Weight | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kilograms (kg) |
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| 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/meter (m)^2 |
|
| Estimate Glomerular Filtration Rate (eGFR) | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | milliliter (mL)/Minute (min)/1.73m^2 |
|
| Smoking Classification | Count of Participants | Participants |
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| Drinking Habit | Participants who answered Yes or No for a question "Drink Alcohol Almost Every Day?" were reported. | Count of Participants | Participants |
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| Breast-Feeding | This baseline characteristic was analyzed only in female participants. | Count of Participants | Participants |
|
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| Secondary | Systolic Office Blood Pressure | Systolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported. | The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. The number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Mean | Standard Deviation | Millimeter of Mercury (mmHg) | Baseline, Month 1, and final assessment point (up to Month 12) |
|
|
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| Secondary | Diastolic Office Blood Pressure | Diastolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported. | The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. The number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 1, and final assessment point (up to Month 12) |
|
|
|
| 6 |
| 1,031 |
| 16 |
| 1,031 |
| 15 |
| 1,031 |
| Pneumonia | Infections and infestations | MedDRA Ver.20.0 | Systematic Assessment |
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| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver.20.0 | Systematic Assessment |
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| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver.20.0 | Systematic Assessment |
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| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver.20.0 | Systematic Assessment |
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| Brain stem haemorrhage | Nervous system disorders | MedDRA Ver.20.0 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA Ver.20.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA Ver.20.0 | Systematic Assessment |
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| Prinzmetal angina | Cardiac disorders | MedDRA Ver.20.0 | Systematic Assessment |
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| Sinus node dysfunction | Cardiac disorders | MedDRA Ver.20.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA Ver.20.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA Ver.20.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA Ver.20.0 | Systematic Assessment |
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| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA Ver.20.0 | Systematic Assessment |
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| Renal disorder | Renal and urinary disorders | MedDRA Ver.20.0 | Systematic Assessment |
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| Death | General disorders | MedDRA Ver.20.0 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
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| Sudden death | General disorders | MedDRA Ver.20.0 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
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| Fall | Injury, poisoning and procedural complications | MedDRA Ver.20.0 | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA Ver.20.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA Ver.20.0 | 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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| Final Assessment Point |
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| Final Assessment Point |
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