Trial Outcomes & Findings for Azilsartan Tablets Special Drug Use Surveillance: Long-term Use (NCT NCT02092025)
NCT ID: NCT02092025
Last Updated: 2019-01-15
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
3437 participants
Primary outcome timeframe
Up to 12 Months
Results posted on
2019-01-15
Participant Flow
Participants took part in the study at 738 investigative sites in Japan, from 20 June 2012 to 15 January 2016.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
3437
|
|
Overall Study
COMPLETED
|
3369
|
|
Overall Study
NOT COMPLETED
|
68
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Case Report Forms Uncollected
|
44
|
|
Overall Study
Protocol Deviation
|
24
|
Baseline Characteristics
The number analyzed is the number of participants with data available for analysis.
Baseline characteristics by cohort
| Measure |
Azilsartan
n=3369 Participants
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.
|
|---|---|
|
Age, Continuous
|
68.3 Years
STANDARD_DEVIATION 13.48 • n=3369 Participants
|
|
Sex: Female, Male
Female
|
1690 Participants
n=3369 Participants
|
|
Sex: Female, Male
Male
|
1679 Participants
n=3369 Participants
|
|
Region of Enrollment
Japan
|
3369 Participants
n=3369 Participants
|
|
Weight
|
60.81 kg
STANDARD_DEVIATION 13.716 • n=2396 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
BMI
|
24.27 kg/m^2
STANDARD_DEVIATION 4.096 • n=2261 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Healthcare Category
Outpatient
|
3291 Participants
n=3369 Participants
|
|
Healthcare Category
Inpatient
|
78 Participants
n=3369 Participants
|
|
Medical Complications
Had no Presence of Medical Complications
|
956 Participants
n=3369 Participants
|
|
Medical Complications
Had Presence of Medical Complications
|
2413 Participants
n=3369 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR)
< 15 mL/min/1.73 m^2
|
61 Participants
n=3369 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR)
≥ 15 mL/min/1.73 m^2 and < 30 mL/min/1.73 m^2
|
45 Participants
n=3369 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR)
≥ 30 mL/min/1.73 m^2 and < 45 mL/min/1.73 m^2
|
184 Participants
n=3369 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR)
≥ 45 mL/min/1.73 m^2 and < 60 mL/min/1.73 m^2
|
390 Participants
n=3369 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR)
≥ 60 mL/min/1.73 m^2 and < 90 mL/min/1.73 m^2
|
1198 Participants
n=3369 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR)
≥ 90 mL/min/1.73 m^2
|
288 Participants
n=3369 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR)
Unknown
|
1203 Participants
n=3369 Participants
|
|
Drinking Habits
Current Drinker
|
828 Participants
20.43 • n=3369 Participants
|
|
Drinking Habits
Not Current Drinker
|
1823 Participants
n=3369 Participants
|
|
Drinking Habits
Unknown
|
718 Participants
n=3369 Participants
|
|
Smoking Classification
Never Smoked
|
1572 Participants
14.25 • n=3369 Participants
|
|
Smoking Classification
Current Smoker
|
396 Participants
n=3369 Participants
|
|
Smoking Classification
Ex-Smoker
|
539 Participants
n=3369 Participants
|
|
Smoking Classification
Unknown
|
862 Participants
n=3369 Participants
|
|
Clinical Systolic Blood Pressure (SBP)
|
155.1 mmHg
STANDARD_DEVIATION 20.43 • n=3359 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Clinical Diastolic Blood Pressure (DBP)
|
86.7 Participants
STANDARD_DEVIATION 14.25 • n=3359 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
SBP/DBP Classification
SBP < 140 mmHg and DBP < 90 mmHg
|
552 Participants
n=3369 Participants
|
|
SBP/DBP Classification
SBP ≥ 140 mmHg and DBP ≥ 90 mmHg
|
2807 Participants
n=3369 Participants
|
|
SBP/DBP Classification
Not Measured
|
10 Participants
n=3369 Participants
|
|
Pulse Rate
|
74.1 bpm
STANDARD_DEVIATION 10.99 • n=2983 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Taking Hypertension Drug in 2 Months Before Baseline
Had Not Taken
|
1080 Participants
n=3369 Participants
|
|
Taking Hypertension Drug in 2 Months Before Baseline
Had Taken
|
2289 Participants
n=3369 Participants
|
PRIMARY outcome
Timeframe: Up to 12 MonthsPopulation: Safety Analysis set included all participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Azilsartan
n=3369 Participants
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.
|
|---|---|
|
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
|
94 Participants
|
SECONDARY outcome
Timeframe: 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.
Reported data are changes in SBP from baseline at Month 1 and final assessment (up to 12 months).
Outcome measures
| Measure |
Azilsartan
n=3359 Participants
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.
|
|---|---|
|
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
|
|
Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point
Change in SBP at Final Assessment
|
-19.8 mmHg
Standard Deviation 22.80
|
SECONDARY outcome
Timeframe: 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.
Reported data are changes in DBP from baseline at Month 1 and final assessment (up to 12 months).
Outcome measures
| Measure |
Azilsartan
n=3359 Participants
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.
|
|---|---|
|
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
|
|
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
|
Adverse Events
Azilsartan
Serious events: 10 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azilsartan
n=3369 participants at risk
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.
|
|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.03%
1/3369 • 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.
|
|
Nervous system disorders
Cerebral infarction
|
0.03%
1/3369 • 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.
|
|
Nervous system disorders
Loss of consciousness
|
0.03%
1/3369 • 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.
|
|
Cardiac disorders
Prinzmetal angina
|
0.03%
1/3369 • 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.
|
|
Cardiac disorders
Sinus arrest
|
0.03%
1/3369 • 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.
|
|
Cardiac disorders
Bradycardia
|
0.03%
1/3369 • 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.
|
|
Cardiac disorders
Cardiac failure
|
0.03%
1/3369 • 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.
|
|
Gastrointestinal disorders
Ileus
|
0.03%
1/3369 • 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.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.03%
1/3369 • 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.
|
|
Renal and urinary disorders
Renal impairment
|
0.03%
1/3369 • 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.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.03%
1/3369 • 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.
|
|
General disorders
Asthenia
|
0.03%
1/3369 • 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.
|
|
General disorders
Drowning
|
0.03%
1/3369 • 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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.03%
1/3369 • 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.
|
Other adverse events
| Measure |
Azilsartan
n=3369 participants at risk
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.
|
|---|---|
|
Nervous system disorders
Dizziness
|
0.45%
15/3369 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER