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/amlodipine combination tablets Low Dose (LD) & High Dose (HD) (Zacras Combination Tablets LD & HD) in hypertensive patients in daily medical practice.
Detailed description
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.
Interventions
DRUGAzilsartan/Amlodipine
Azilsartan/Amlodipine combination tablets LD & HD
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
-Hypertensive patients
Exclusion criteria
-Hypertensive patients who meet any of the following conditions, \[1\] to \[3\], are excluded from the survey: 1. Patients with a history of hypersensitivity to any of the ingredients of azilsartan/amlodipine combination tablets or other dihydropyridine drugs 2. Patients who are pregnant or having possibilities of being pregnant 3. Diabetic patients taking aliskiren fumarate (excluding those with markedly poor blood pressure control even after other antihypertensive treatment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Had One or More Adverse Events | Up to Month 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Office Blood Pressure | Baseline, Month 1, and final assessment point (up to Month 12) | Systolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported. |
| Diastolic Office Blood Pressure | Baseline, Month 1, and final assessment point (up to Month 12) | Diastolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 271 investigative sites in Japan, from 26 June 2014 to 31 January 2017.
Pre-assignment details
Participants with a historical diagnosis of hypertension were enrolled. Participants received interventions as part of routine medical care.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,031 |
| Total | 1,031 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case Report Forms Uncollected | 38 |
| Overall Study | Protocol Deviation | 21 |
Baseline characteristics
| Characteristic | Azilsartan/Amlodipine | — |
|---|---|---|
| Age, Continuous | 68.5 Years STANDARD_DEVIATION 12.92 | — |
| BMI | 24.92 kg/meter (m)^2 STANDARD_DEVIATION 4.652 | — |
| Breast-Feeding Not Nursing | 479 Participants | — |
| Breast-Feeding Unknown | 3 Participants | — |
| Drinking Habit No | 556 Participants | — |
| Drinking Habit Unknown | 203 Participants | — |
| Drinking Habit Yes | 272 Participants | — |
| Duration of Diagnosis of Hypertension < 1 Year | 167 Participants | — |
| Duration of Diagnosis of Hypertension >= 1 Year and < 3 Years | 126 Participants | — |
| Duration of Diagnosis of Hypertension >= 3 Years and < 5 Years | 63 Participants | — |
| Duration of Diagnosis of Hypertension >= 5 Years | 312 Participants | — |
| Duration of Diagnosis of Hypertension Unknown | 363 Participants | — |
| Estimate Glomerular Filtration Rate (eGFR) | 69.0 milliliter (mL)/Minute (min)/1.73m^2 STANDARD_DEVIATION 19.64 | — |
| Healthcare Category Inpatient | 4 Participants | — |
| Healthcare Category Outpatient | 1027 Participants | — |
| Medical Complications Had Medical Complications | 786 Participants | — |
| Medical Complications Had No Medical Complications | 245 Participants | — |
| Medical History Had Medical History | 164 Participants | — |
| Medical History Had No Medical History | 790 Participants | — |
| Medical History Unknown | 77 Participants | — |
| Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity | 909 Participants | — |
| Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity | 58 Participants | — |
| Predisposition to Hypersensitivity Unknown | 64 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 1031 Participants | — |
| Sex: Female, Male Female | 482 Participants | — |
| Sex: Female, Male Male | 549 Participants | — |
| Smoking Classification Current Smoker | 132 Participants | — |
| Smoking Classification Ex-Smoker | 195 Participants | — |
| Smoking Classification Never Smoked | 489 Participants | — |
| Smoking Classification Unknown | 215 Participants | — |
| Weight | 63.10 Kilograms (kg) STANDARD_DEVIATION 14.601 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 1,031 |
| other Total, other adverse events | 15 / 1,031 |
| serious Total, serious adverse events | 16 / 1,031 |
Outcome results
Primary
Percentage of Participants Who Had One or More Adverse Events
Time frame: Up to Month 12
Population: Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azilsartan/Amlodipine | Percentage of Participants Who Had One or More Adverse Events | 8.34 Percentage of Participants |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azilsartan/Amlodipine | Diastolic Office Blood Pressure | Baseline | 83.3 mmHg | Standard Deviation 13.64 |
| Azilsartan/Amlodipine | Diastolic Office Blood Pressure | Month 1 | 77.4 mmHg | Standard Deviation 11.35 |
| Azilsartan/Amlodipine | Diastolic Office Blood Pressure | Final Assessment Point | 75.0 mmHg | Standard Deviation 10.88 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azilsartan/Amlodipine | Systolic Office Blood Pressure | Baseline | 149.5 Millimeter of Mercury (mmHg) | Standard Deviation 19.13 |
| Azilsartan/Amlodipine | Systolic Office Blood Pressure | Month 1 | 137.2 Millimeter of Mercury (mmHg) | Standard Deviation 14.69 |
| Azilsartan/Amlodipine | Systolic Office Blood Pressure | Final Assessment Point | 133.0 Millimeter of Mercury (mmHg) | Standard Deviation 14.14 |