Trial Outcomes & Findings for Azilsartan/Amlodipine Combination Tablets LD & HD Specified Drug-use Survey "Long-term Use Survey" (NCT NCT02181816)
NCT ID: NCT02181816
Last Updated: 2019-06-03
Results Overview
Recruitment status
COMPLETED
Target enrollment
1090 participants
Primary outcome timeframe
Up to Month 12
Results posted on
2019-06-03
Participant Flow
Participants took part in the study at 271 investigative sites in Japan, from 26 June 2014 to 31 January 2017.
Participants with a historical diagnosis of hypertension were enrolled. Participants received interventions as part of routine medical care.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
1090
|
|
Overall Study
COMPLETED
|
1031
|
|
Overall Study
NOT COMPLETED
|
59
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Case Report Forms Uncollected
|
38
|
|
Overall Study
Protocol Deviation
|
21
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Azilsartan/Amlodipine
n=1031 Participants
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.
|
|---|---|
|
Age, Continuous
|
68.5 Years
STANDARD_DEVIATION 12.92 • n=1031 Participants
|
|
Sex: Female, Male
Female
|
482 Participants
n=1031 Participants
|
|
Sex: Female, Male
Male
|
549 Participants
n=1031 Participants
|
|
Region of Enrollment
Japan
|
1031 Participants
n=1031 Participants
|
|
Duration of Diagnosis of Hypertension
< 1 Year
|
167 Participants
n=1031 Participants
|
|
Duration of Diagnosis of Hypertension
>= 1 Year and < 3 Years
|
126 Participants
n=1031 Participants
|
|
Duration of Diagnosis of Hypertension
>= 3 Years and < 5 Years
|
63 Participants
n=1031 Participants
|
|
Duration of Diagnosis of Hypertension
>= 5 Years
|
312 Participants
n=1031 Participants
|
|
Duration of Diagnosis of Hypertension
Unknown
|
363 Participants
n=1031 Participants
|
|
Healthcare Category
Outpatient
|
1027 Participants
n=1031 Participants
|
|
Healthcare Category
Inpatient
|
4 Participants
n=1031 Participants
|
|
Predisposition to Hypersensitivity
Had No Predisposition to Hypersensitivity
|
909 Participants
n=1031 Participants
|
|
Predisposition to Hypersensitivity
Had Predisposition to Hypersensitivity
|
58 Participants
n=1031 Participants
|
|
Predisposition to Hypersensitivity
Unknown
|
64 Participants
n=1031 Participants
|
|
Medical Complications
Had No Medical Complications
|
245 Participants
n=1031 Participants
|
|
Medical Complications
Had Medical Complications
|
786 Participants
n=1031 Participants
|
|
Medical History
Had No Medical History
|
790 Participants
n=1031 Participants
|
|
Medical History
Had Medical History
|
164 Participants
n=1031 Participants
|
|
Medical History
Unknown
|
77 Participants
n=1031 Participants
|
|
Weight
|
63.10 Kilograms (kg)
STANDARD_DEVIATION 14.601 • n=759 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
BMI
|
24.92 kg/meter (m)^2
STANDARD_DEVIATION 4.652 • n=709 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Estimate Glomerular Filtration Rate (eGFR)
|
69.0 milliliter (mL)/Minute (min)/1.73m^2
STANDARD_DEVIATION 19.64 • n=647 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Smoking Classification
Never Smoked
|
489 Participants
n=1031 Participants
|
|
Smoking Classification
Current Smoker
|
132 Participants
n=1031 Participants
|
|
Smoking Classification
Ex-Smoker
|
195 Participants
n=1031 Participants
|
|
Smoking Classification
Unknown
|
215 Participants
n=1031 Participants
|
|
Drinking Habit
Yes
|
272 Participants
n=1031 Participants
|
|
Drinking Habit
No
|
556 Participants
n=1031 Participants
|
|
Drinking Habit
Unknown
|
203 Participants
n=1031 Participants
|
|
Breast-Feeding
Not Nursing
|
479 Participants
n=482 Participants • This baseline characteristic was analyzed only in female participants.
|
|
Breast-Feeding
Unknown
|
3 Participants
n=482 Participants • This baseline characteristic was analyzed only in female participants.
|
PRIMARY outcome
Timeframe: Up to Month 12Population: Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
Outcome measures
| Measure |
Azilsartan/Amlodipine
n=1031 Participants
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.
|
|---|---|
|
Percentage of Participants Who Had One or More Adverse Events
|
8.34 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 1, and final assessment point (up to Month 12)Population: 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.
Systolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.
Outcome measures
| Measure |
Azilsartan/Amlodipine
n=1031 Participants
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.
|
|---|---|
|
Systolic Office Blood Pressure
Baseline
|
149.5 Millimeter of Mercury (mmHg)
Standard Deviation 19.13
|
|
Systolic Office Blood Pressure
Month 1
|
137.2 Millimeter of Mercury (mmHg)
Standard Deviation 14.69
|
|
Systolic Office Blood Pressure
Final Assessment Point
|
133.0 Millimeter of Mercury (mmHg)
Standard Deviation 14.14
|
SECONDARY outcome
Timeframe: Baseline, Month 1, and final assessment point (up to Month 12)Population: 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.
Diastolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.
Outcome measures
| Measure |
Azilsartan/Amlodipine
n=1031 Participants
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.
|
|---|---|
|
Diastolic Office Blood Pressure
Baseline
|
83.3 mmHg
Standard Deviation 13.64
|
|
Diastolic Office Blood Pressure
Month 1
|
77.4 mmHg
Standard Deviation 11.35
|
|
Diastolic Office Blood Pressure
Final Assessment Point
|
75.0 mmHg
Standard Deviation 10.88
|
Adverse Events
Azilsartan/Amlodipine
Serious events: 16 serious events
Other events: 15 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Azilsartan/Amlodipine
n=1031 participants at risk
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.
|
|---|---|
|
Infections and infestations
Peritonitis
|
0.10%
1/1031 • 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.
|
|
Infections and infestations
Pneumonia
|
0.10%
1/1031 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.19%
2/1031 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.10%
1/1031 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.10%
1/1031 • 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.
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.10%
1/1031 • 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.
|
|
Nervous system disorders
Cerebral infarction
|
0.10%
1/1031 • 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.
|
|
Cardiac disorders
Cardiac failure
|
0.10%
1/1031 • 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.
|
|
Cardiac disorders
Prinzmetal angina
|
0.10%
1/1031 • 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.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.10%
1/1031 • 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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.10%
1/1031 • 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.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.19%
2/1031 • 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.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.10%
1/1031 • 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.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.10%
1/1031 • 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.
|
|
Renal and urinary disorders
Renal disorder
|
0.10%
1/1031 • 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.
|
|
General disorders
Death
|
0.10%
1/1031 • 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.
|
|
General disorders
Sudden death
|
0.10%
1/1031 • 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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.10%
1/1031 • 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.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.10%
1/1031 • 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.
|
Other adverse events
| Measure |
Azilsartan/Amlodipine
n=1031 participants at risk
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.
|
|---|---|
|
Nervous system disorders
Dizziness
|
0.87%
9/1031 • 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.
|
|
Investigations
Blood creatinine increased
|
0.58%
6/1031 • 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.
|
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