Hypertension
Conditions
Keywords
Pharmacological therapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGAzilsartan
Azilsartan tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Hypertensive patients
Exclusion criteria
1. Patients with a history of hypersensitivity to any of the ingredients of Azilsartan 2. Patients who are pregnant or having possibilities of being pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | Up to 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Baseline, Month 1 and final assessment (up to 12 Months) | Reported data are changes in SBP from baseline at Month 1 and final assessment (up to 12 months). |
| Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point | Baseline, Month 1 and Final assessment (up to 12 Months) | Reported data are changes in DBP from baseline at Month 1 and final assessment (up to 12 months). |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 738 investigative sites in Japan, from 20 June 2012 to 15 January 2016.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 3,369 |
| Total | 3,369 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case Report Forms Uncollected | 44 |
| Overall Study | Protocol Deviation | 24 |
Baseline characteristics
| Characteristic | Azilsartan |
|---|---|
| Age, Continuous | 68.3 Years STANDARD_DEVIATION 13.48 |
| BMI | 24.27 kg/m^2 STANDARD_DEVIATION 4.096 |
| Clinical Diastolic Blood Pressure (DBP) | 86.7 Participants STANDARD_DEVIATION 14.25 |
| Clinical Systolic Blood Pressure (SBP) | 155.1 mmHg STANDARD_DEVIATION 20.43 |
| Drinking Habits Current Drinker | 828 Participants 20.43 |
| Drinking Habits Not Current Drinker | 1823 Participants |
| Drinking Habits Unknown | 718 Participants |
| Estimated Glomerular Filtration Rate (eGFR) < 15 mL/min/1.73 m^2 | 61 Participants |
| Estimated Glomerular Filtration Rate (eGFR) ≥ 15 mL/min/1.73 m^2 and < 30 mL/min/1.73 m^2 | 45 Participants |
| Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min/1.73 m^2 and < 45 mL/min/1.73 m^2 | 184 Participants |
| Estimated Glomerular Filtration Rate (eGFR) ≥ 45 mL/min/1.73 m^2 and < 60 mL/min/1.73 m^2 | 390 Participants |
| Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73 m^2 and < 90 mL/min/1.73 m^2 | 1198 Participants |
| Estimated Glomerular Filtration Rate (eGFR) ≥ 90 mL/min/1.73 m^2 | 288 Participants |
| Estimated Glomerular Filtration Rate (eGFR) Unknown | 1203 Participants |
| Healthcare Category Inpatient | 78 Participants |
| Healthcare Category Outpatient | 3291 Participants |
| Medical Complications Had no Presence of Medical Complications | 956 Participants |
| Medical Complications Had Presence of Medical Complications | 2413 Participants |
| Pulse Rate | 74.1 bpm STANDARD_DEVIATION 10.99 |
| Region of Enrollment Japan | 3369 Participants |
| SBP/DBP Classification Not Measured | 10 Participants |
| SBP/DBP Classification SBP < 140 mmHg and DBP < 90 mmHg | 552 Participants |
| SBP/DBP Classification SBP ≥ 140 mmHg and DBP ≥ 90 mmHg | 2807 Participants |
| Sex: Female, Male Female | 1690 Participants |
| Sex: Female, Male Male | 1679 Participants |
| Smoking Classification Current Smoker | 396 Participants |
| Smoking Classification Ex-Smoker | 539 Participants |
| Smoking Classification Never Smoked | 1572 Participants 14.25 |
| Smoking Classification Unknown | 862 Participants |
| Taking Hypertension Drug in 2 Months Before Baseline Had Not Taken | 1080 Participants |
| Taking Hypertension Drug in 2 Months Before Baseline Had Taken | 2289 Participants |
| Weight | 60.81 kg STANDARD_DEVIATION 13.716 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 3,369 |
| serious Total, serious adverse events | 10 / 3,369 |
Outcome results
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.
Time frame: Up to 12 Months
Population: Safety Analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Azilsartan | Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | 94 Participants |
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).
Time frame: Baseline, Month 1 and Final assessment (up to 12 Months)
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. Here 'n' is number of participants analyzed at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azilsartan | Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point | Change in DBP at Month 1 | -7.7 mmHg | Standard Deviation 12.55 |
| Azilsartan | Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point | Change in DBP at Final Assessment | -10.3 mmHg | Standard Deviation 13.91 |
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).
Time frame: Baseline, Month 1 and final assessment (up to 12 Months)
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. Here 'n' is number of participants analyzed at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azilsartan | Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Change in SBP at Month 1 | -15.4 mmHg | Standard Deviation 19.99 |
| Azilsartan | Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Change in SBP at Final Assessment | -19.8 mmHg | Standard Deviation 22.8 |